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The Conformity Assessment Toolbox

Contents

i) About ISO

ii) About UNIDO

iii) Preface

iv) Disclaimer

v) Acknowledgements

vi) Introduction

vii) Acronyms and abbreviations

Chapter 1 Basic concepts of conformity assessment

Chapter 2 Conformity assessment techniques

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Chapter 3 Conformity assessment schemes and systems

Chapter 4 Conformity assessment bodies

Chapter 5 What UNIDO can contribute to setting up a quality infrastructure

Chapter 6 Case studies

Appendix 1 ISO/CASCO sets conformity assessment standards

Appendix 2 The role of international and regional accreditation body forums

Appendix 3 Conformity assessment and the WTO Agreement on Technical Barriers to Trade

The Conformity Assessment Toolbox

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ISO (International Organization for Standardization) is a global net- work that identifies which interna- tional standards are required by busi- ness, government and society, develops them in partnership with the sectors that will put them to use, adopts them by transparent procedures based on national, multi-stakeholder input, and delivers them to be implemented worldwide.

ISO standards distil an internation- al consensus from the broadest possi- ble base of stakeholder groups. Expert input comes from those closest to the needs for the standards and also to the results of implementing them. In this way, although voluntary, ISO stan- dards are widely respected and accept- ed by public and private sectors inter- nationally.

ISO – a non-governmental organization – is a federation of national standards bodies, from all regions of the world, one per country, including developed and de- veloping countries as well as countries with economies in transition. Each ISO member is the principal standards or- ganization in its country. The members propose the new standards, participate in their development and provide support in collaboration with ISO Central Secre- tariat for the 3 000 technical groups that actually develop the standards.

Within ISO, the conformity assess- ment policy development committee ISO/CASCO has a dual function. It is responsible for developing and making recommendations on conformity as- sessment policy to the ISO/CASCO membership and for developing confor- mity assessment standards and guides.

i) About ISO

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The United Nations Industrial De- velopment Organization (UNIDO) helps developing countries and coun- tries with economies in transition to develop competitive and environmen- tally sustainable industry to accelerate economic growth, reduce poverty and achieve the Millennium Development Goals. In pursuit of these objectives, UNIDO draws on global resources and ex- pertise, and combines operational technical cooperation services with an- alytical, normative and convening ac- tivities, both globally and locally.

UNIDO holds a special place in the United Nations system as the only organization promoting the creation of wealth and tackling poverty through manufacturing. The Organization focuses on three inter-related thematic priorities : poverty reduction through productive activities, trade capacity- building, and energy and environment

UNIDO has 173 Member States and is headquartered in Vienna, Austria, but operates worldwide. Established in 1966, it became a spe- cialized agency of the United Nations in 1985.

ii) About UNIDO

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Businessmen, consumers and public of- ficials have certain expectations about the quality, safety, reliability, interop- erability, efficiency, effectiveness and environmental sustainability of prod- ucts and services. Conformity assess- ment provides the means for testing the compliance of such products and services with these expectations, in ac- cordance with relevant standards, regu- lations and other specifications. It helps to ensure that products and servic- es deliver on their promises. In other words, conformity assessment builds trust.

By obviating the need for buyers to verify directly whether the products they acquire meet the required spec- ifications, conformity assessment fa- cilitates trade at both national and in- ternational levels. It allows buyers to make their decisions on the basis of test reports and certificates issued by specialized laboratories and certifi- cation bodies thereby creating confi- dence of customers that their expecta- tions will be met.

However, non-acceptance of test re- ports and certificates of conformi- ty continues to be an obstacle to in- ternational trade. This often requires exporters to submit to costly multi-

ple testing and/or certification of their products. The World Trade Organiza- tion has sought to overcome this prob- lem through its Agreements on Tech- nical Barriers to Trade and on the Application of Sanitary and Phytosan- itary Measures, which are intended to ensure that technical regulations and standards, and the procedures for as- sessing conformity with them, do not obstruct international trade.

Successive reviews of the Agreement on Technical Barriers to Trade have noted the usefulness of the conformi- ty assessment standards and guides de- veloped by ISO and the International Electrotechnical Commission (IEC) in harmonizing conformity assessment practices and as benchmarks for the technical competence of assessment bodies. The use of these standards and guides therefore helps to overcome trade barriers. ISO also promotes the international harmonization of con- formity assessment activities and the worldwide acceptance of the results of these assessments. UNIDO, mean- while, has acquired more than 40 years of experience in supporting the estab- lishment and upgrading of standards and conformity assessment structures worldwide.

iii) Preface

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Building trust – The Conformity As- sessment Toolbox is a comprehensive, user-friendly handbook covering all as- pects of conformity assessment and its role in international trade, and will be useful for business managers, regula- tors and consumer representatives. It is the latest in a series of joint publica- tions issued by ISO and UNIDO, and is the result of the long-standing and fruitful partnership between the two organizations to strengthen the stan- dardization and quality infrastructures of developing countries and coun- tries with economies in transition. Al- though aimed specifically at this group of countries, these publications are also intended to serve as handy refer- ence tools for all who are involved or interested in conformity assessment and trade.

Rob Steele ISO Secretary-General

Dr. Kandeh K. Yumkella UNIDO Director-General

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ISO and UNIDO gratefully acknowl- edge the dedicated work of Anthony Russell, Martin Kellermann and Ian Cleare, edited and coordinated by Beer Budoo (ISO), Sean Mac Curtain (ISO), Nicolas Fleury (ISO), Martin Chesire (ISO), Lalith Goonatilake (UNIDO), Gerardo Patacconi (UNIDO), Ouseph Padickakudi (UNIDO) and Bernar- do Calzadilla Sarmiento (UNIDO, Geneva).

We also acknowledge the contribu- tion made by Oswald Chinyamakobvu of the Southern African Development Community (SADC) and Vyjayanthi F. Lopez of the Caribbean Community (CARICOM) regional organization for Standards and Quality (CROSQ).

We acknowledge, too, the contribution made by Malachy Scullion, UNIDO consultant editor.

iv) Disclaimer

v) Acknowledgements

This document has been produced without formal United Nations editing. The designations employed and the presentation of the material in this document do not imply the expression of any opinion whatsoever on the part of the Secretariat of the United Nations Industrial Development Organization (UNIDO) concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries, or its economic system or degree of development. Designations such as “developed”, “industrialized” and “developing” are intended for statistical convenience and do not necessarily express a judgment about the stage reached by a particular country or area in the development process. Mention of firm names or commercial products does not constitute an endorsement by UNIDO.

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vi) Introduction

The role of conformity assessment in the quality infrastructure and its importance to trade capacity building and economic development

Figure 1 – The role of the quality infrastructure

THE QUALITY INFRASTRUCTURE

Metrology Conformity assessment

Standardization

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Conformity assessment is fundamental for all economies

The UNIDO-ISO publication Fast for- ward introduced the concept of the quality infrastructure as a key facilita- tor of trade capacity building and eco- nomic development. The three main components of the quality infrastruc- ture (see Figure 1) are metrology, stan- dardization and conformity assess- ment. The benefits of standardization in improving economic efficiency and providing access to world markets cannot be achieved without the ability to make reliable measurements and to be able to demonstrate that items con- form to the requirements specified in the standards.

As part of their quality infrastructure, all economies need access to credible conformity assessment services. These are needed for a variety of purposes, including : �� Demonstration that products, pro-

cesses, services, commodities and personnel meet required specifica- tions. These may include require- ments specified under regulations (domestic or foreign), purchasers’ specifications, trade agreements etc. �� Establishing and monitoring appro-

priate requirements for protection of health, safety and the environ- ment

�� Underpinning public infrastruc- ture services in construction, energy, water and gas supplies, defence, transportation and communication systems �� Protection of consumers through

control of unfair trading practices �� Demonstrating the credibility of

forensic and justice systems �� Ensuring the compatibility and

interoperability of components in products and systems �� Assisting the quarantining of harm-

ful commodities, products, pests and diseases from entry into in an economy �� Improving international trading

opportunities by reducing technical barriers to trade and demonstrat- ing compliance with specifications of international standards, technical regulations and commercial specifi- cations.

Most societies recognise the domes- tic benefits of their quality infrastruc- ture and many have established the appropriate national bodies and inter- national relationships to support their system. However, national systems that are not harmonised regionally or inter- nationally have the potential to intro- duce new technical barriers to trade. Both developed and developing coun- tries are increasingly being expected to demonstrate not only for their own citizens, but also to the wider world,

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that the products and services they produce are reliable, safe and environ- mentally responsible. To achieve this aim, each economy requires an effec- tive domestic technical capability (or access to foreign expertise) to under- pin the conformity assessment services in their country.

This publication is intended to help those in developing countries, whether they have governmental, business or consumer interests, to understand con- formity assessment and to create an effective infrastructure within their economy. It provides information to help them in setting up and running the conformity assessment arrangements which are appropriate for their needs.

Chapter 1 gives an overview of the rationale for and the benefits of con- formity assessment. In Chapter 2, the techniques which can be used for assessing conformity are described, while Chapter 3 looks at the way in which conformity assessment schemes can be designed and operated.

Chapter 4 examines the requirements for conformity assessment bodies while Chapter 5 provides information about how UNIDO can help with set- ting up and operating a conformity assessment infrastructure as part of a quality infrastructure. It highlights rel- evant and current practices and the roles of key organizations which affect the contribution of conformity assess- ment to economic development and to international consistency of confor- mity assessment activities. Chapter 6 provides some case studies to illus- trate how the principles outlined in this document can be applied.

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A2LA American Association for Laboratory Accreditation APEC Asia Pacific Economic Cooperation APLAC Asia-Pacific Laboratory Accreditation Cooperation APLMF Asia Pacific Legal Metrology Forum APMP Asia Pacific Metrology Programme BIPM International Bureau of Weights and Measures BRC British Retail Consortium BSTI Bangladesh Standards and Testing Institute CASCO ISO Committee on conformity assessment CD Committee Draft CEN European Committee for Standardization CENELEC European Committee for Electrotechnical Standards CEOC International Confederation of Inspection and Certification Organizations CIPM International Committee for Weights and Measures CMC Calibration and measurement capability COFRAC French National Accreditation Committee COPOLCO ISO Committee on consumer policy CPC Chairman’s policy and coordination group (of CASCO) CRM Certified reference material DEVCO ISO Committee on developing country matters DIS Draft International Standard EA European cooperation for Accreditation EE MRA Electrical and Electronic Equipment Mutual Recognition Agreement (of APEC) ETRACE Egyptian Traceability Centre for Agro-Industrial Exports FDIS Final Draft International Standard GATT General Agreement on Tariffs and Trade HACCP Hazard Analysis Critical Control Point IAAC Inter-American Accreditation Cooperation IAF International Accreditation Forum IEC International Electrotechnical Commission IFAN International Federation of Standards Users IFIA International Federation of Inspection Agencies IIOC Independent International Organization for Certification Limited ILAC International Laboratory Accreditation Co-operation IPC International Personnel Certification Association IQNET The International Certification Network ISO International Organization for Standardization ISONET ISO/IEC Information Centre ITC International Trade Centre ITU International Telecommunication Union ITU-T ITU’s Telecommunication Standardization Sector

vii) Acronyms and abbreviations

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UILI International Union of Independent Laboratories JAS-ANZ Joint Accreditation System of Australia and New Zealand JCCC Joint Committee for Closer Cooperation (of ILAC and IAF) JCDCMAS Joint Committee for Coordination of Technical Assistance to Developing Countries

in Metrology, Accreditation and Standardization JDSC Joint Development Support Committee (IAF and ILAC) JIG Joint Inspection Group (of IAF and ILAC) KMG Knowledge Management Group (of CASCO) MAA Mutual Acceptance Arrangement (of OIML) MLA Multilateral Recognition Arrangement MOU Memorandum of Understanding MRA Mutual Recognition Arrangement NATA National Association of Testing Authorities, Australia NBSM Nepal Bureau of Standards and Metrology NMI National Measurement Institute OIML International Organization for Legal Metrology PAC Pacific Accreditation Cooperation PASC Pacific Area Standards Congress PT Proficiency Testing REMCO ISO Committee on Reference Materials RM Reference material SADCA Southern African Development Community Accreditation SADCAS Southern African Development Community Accreditation Service SANAS South African National Accreditation System SOAC West African Accreditation System SPS Sanitary and Phytosanitary Measures STAMEQ Directorate for Standards, Metrology and Quality (Viet Nam) STAR Strategic Alliance and Regulatory Group (of CASCO) SQAM Standards, Quality, Accreditation and Metrology SWEDAC The Swedish Board for Accreditation and Conformity Assessment TA Technical Assistance TBT Technical Barriers to Trade TIG Technical Interface Group (of CASCO) UEMOA West African Economic and Monetary Union UNIDO United Nations Industrial Development Organization VMI Vietnam Metrology Institute WAITRO World Association of Industrial and Technological Research Organizations WELMEC European cooperation in legal metrology WTO World Trade Organization

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Why conformity assessment?

Everyone has an interest in finding out whether something (or somebody, orga- nization or system) meets their expecta- tions. Does the product do what I expect? Is that person competent to carry out the work I want them to do? Will the shop provide the right item at the right price when I need it? Is my product safe?

Products and services are like prom- ises. Business customers, consumers, users and public officials have expec- tations about products and services relating to features like quality, ecology, safety, economy, reliability, compatibili- ty, interoperability, efficiency and effec- tiveness. The process for demonstrating that these features meet the require- ments of standards, regulations and other specifications is called conformity assessment. In brief, conformity assess- ment helps to ensure that products and services deliver on their promises.

Consumers benefit from conform- ity assessment because it provides them with a basis for selecting prod- ucts or services. They may have more confidence in products or services that are supported by a formal supplier’s

declaration, or bearing a mark or certifi- cate of conformity, that attest to quality, safety or other desirable characteristics.

Manufacturers and service providers need to make sure that their products and services meet their declared specifications and deliver on customer expectations. Assessing their products and services in accordance with ISO and IEC International Standards helps them to meet the current state of the art and to avoid the costs of product failures in the market.

When public health, safety or the en- vironment may be at stake, conformi- ty assessment is often made obligato- ry by government regulations. Without appropriate assessment and approval, goods may be barred from sale, or sup- pliers disqualified from bidding for government procurement contracts. ISO/IEC International Standards and Guides also provide requirements and guidance for good practice and recog- nition of such assessments.

Regulators too benefit from conformi- ty assessment that gives them a means to enforce national health, safety and environmental legislation and achieve public policy goals.

Chapter 1 – Basic concepts of conformity assessment

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Harmonizing conformity assessment procedures around the world also has far-reaching benefits for internation- al trade in general. One of the main hurdles to cross-border trade that exporters face is costly multiple test- ing and/or certification of products. Non-transparent or discriminatory conformity assessment procedures can become effective protectionist tools, or “technical barriers to trade”.

The World Trade Organization Agree- ment on Technical Barriers to Trade (WTO/TBT Agreement) was estab- lished to ensure that technical regula- tions and standards, and the procedures for assessing conformity with them, do not create unnecessary obstacles to international trade. Successive reviews of the TBT Agreement have noted the usefulness of ISO/IEC conformity assessment standards and guides in har- monizing conformity assessment prac- tice and as benchmarks for the techni- cal competence of assessment bodies so that credibility and confidence in their results can be obtained. ISO/IEC’s con- formity assessment work therefore helps to overcome trade barriers.

All countries are dependent on conformity assessment, but many de- veloping countries face particular challenges in establishing and main- taining viable conformity assessment resources. This situation is made even

more challenging in an era of global- ization, where international “best prac- tice” is becoming increasingly expect- ed by all parties involved in trade and commerce. This not only includes those directly involved in trade, but others in- fluencing the trading environment, such as regulators and government author- ities, who are seeking to protect their citizens from dangerous or inferior products and other negative influenc- es such as environmental degradation.

Conformity assessment has been a part of the fabric of most societies since an- cient times as a tool to provide reassur- ance to users of products, services, and commodities that some action has been taken to affirm their quantities, quali- ties, characteristics, performance or other expectations. Conformity assess- ment, therefore, needs to be viewed in a much wider perspective than as a facilitator of trade. It is a “whole of society” activity and, in most econo- mies, its domestic applications may far outweigh its roles in supporting trade.

While “best practice” in conformi- ty assessment may be desirable, it is also important that it is used practical- ly and cost-effectively. This is particu- larly significant for developing coun- tries, which need to make judgments on the best solutions for their conformity assessment needs to satisfy both their domestic and international client groups.

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Definition of conformity assessment

Having introduced the concept of con- formity assessment, it is time to look at the subject from the point of view of the international standardization orga- nizations, ISO and IEC. Through these organizations, practitioners and users of conformity assessment from around the world have pooled their knowledge and experience to produce a series of standards and guides setting out cur- rent best practice. These standards and guides are produced through the ISO Committee on conformity assessment, ISO/CASCO, and form what is known as the “CASCO toolbox”. See Appen- dix 1 for more information. The rele- vant standards and guides are referred to throughout this publication.

ISO/IEC 17000 defines conformi- ty assessment as : demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled. A few points to note : �� In line with the terminology of ISO

9000, a service is regarded as a par- ticular form of product �� The methods for demonstrating

conformity include testing, inspec- tion, suppliers’ declarations of con- formity and certification �� Specified requirements include

those contained in suppliers’ or purchasers’ specifications, national,

regional or international standards or governmental regulations �� Accreditation of conformity assess-

ment bodies is included within the definition of conformity assessment �� The term object of conformity

assessment, or sometimes just object, is used in the standard to refer to “product, process, system, person or body”.

Conformity assessment is often charac- terized as part of a quality infrastruc- ture. This publication highlights the significance of conformity assessment within a national or regional quality infrastructure and the interactions be- tween the various elements of such an infrastructure.

In addition to testing, inspection and certification, there are other activities which may fall under the umbrella of conformity assessment and there has been considerable international debate on whether activities such as accredita- tion, production of reference materials and conduct of proficiency testing are conformity assessment activities.

Even within the realm of testing, there has been varying opinion on whether some forms of diagnostic testing, such as pathology services, fit the formal definition of conformity assessment. In practical terms, however, all of these various activities are part of the every

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day world of conformity assessment and are important elements in broader national or regional quality infrastruc- tures.

In the case of accreditation (discussed later in more detail) the relevant ISO definitions on the topic recognize that accreditation bodies carry out conformi- ty assessment of conformity assessment bodies but are not themselves regarded as conformity assessment bodies.

The definition of conformity assessment and explanatory text in ISO/IEC 17000 provide sufficient flexibility to use the concept in a practical manner to ensure the principles can be used effectively. To illustrate this flexibility, the Introduction of ISO/IEC 17000 notes that “...confor- mity assessment interacts with other fields such as management systems, me- trology, standardization, and statistics. This International Standard does not define the boundaries of conformity as- sessment. These remain elastic.”

Some key components in the definition also have related activities, and subsets. For example, “certification” includes management systems, product and personnel certification. The concept of “testing” includes the related activities of calibration and measurement. The roles of different types of conformity assessment bodies are discussed later in Chapter 4.

Conformity assessment in the quality infrastructure

As noted in the Introduction, there are three main components of the quali- ty infrastructure (see Figure 1 – page 6), metrology, standards and conformi- ty assessment. Infrastructure systems vary from country to country, but there is broad agreement that the elements making up any comprehensive system (see Figure 2) are : �� Capabilities to develop written stan-

dards �� Access to physical, chemical, and

more recently, biological standards of measurement �� Provision of a legal metrology ser-

vice �� Availability of inspection, testing and

calibration services at a level of so- phistication commensurate with the industrial, trading and societal needs and aspirations of each country �� Availability of assistance for suppliers

of goods and services to enable them to specify the requirements which need to be met and to adopt the poli- cies and practices necessary to ensure that the requirements are met �� Availability of third-party confor-

mity assessment services such as product certification to meet the needs of regulatory bodies, both do- mestically and abroad, and those of suppliers and customers who require some independent confirmation of

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the conformity of goods and services �� Mechanisms to ensure that all service

providers are competent. Accredita- tion is often used for this purpose.

The national system for the develop- ment of technical regulations should

have an input to the quality infrastruc- ture so as to ensure that the regulators’ needs are met and that the regulations use the infrastructure to best effect.

Normally, there are also organiza- tions dedicated to the development

Figure 2 – Example of a conformity assessment model

SUPPLIER

CONFORMITY ASSESSMENT

Prove technical requirements are met Testing and calibration

Inspection Certification

CUSTOMER

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of people and organizations on issues related to quality improvement and de- velopment of quality and management systems auditing.

Conformity assessment and standards

It is critical that a national infrastruc- ture has the ability to engage in the preparation, publication and distribu- tion of documentary standards, wheth- er at the national, regional or interna- tional level. In the context of conformity assessment there are two major aspects of standardization that need to be ap- preciated.

The first aspect is the availability of national, regional and international standards that can be used by suppli- ers, purchasers, conformity assessment bodies and regulators for setting the requirements for an object and assess- ing its conformity with them. ISO/IEC 17007 gives an overview of the essen- tial features of a standard to be used for conformity assessment : �� The standard must be so written that

it can be applied by any of the fol- lowing : − a manufacturer or supplier (first

party) − a user or purchaser (second party) − an independent body (third party).

Conformity with the standard must not be dependent on a particular

form of assessment such as certifica- tion or accreditation �� The scope of the standard should be

clearly stated in terms both of the type of objects to which it relates and to the characteristics of those objects which it specifies. For exam- ple, a standard could relate to plastic pipes for water supply, but be limit- ed to their suitability for use with potable water. Other characteristics such as dimensions and mechani- cal strength might be specified in a different standard or be left to the manufacturer to specify �� Standards should always be writ-

ten in such a way that they facilitate and do not retard the development of technology. Usually, this is accom- plished by specifying performance requirements rather than product design requirements �� The requirements should be clearly

specified, together with the required limiting values and tolerances, and the test methods to verify the speci- fied characteristics �� The requirements should be free

from subjective elements ; the use of such phrases as “sufficiently strong to” or “of adequate strength” should be avoided �� Test methods should be clearly

identified and be consistent with the purpose of the standard. They should be objective, concise and accurate, and produce unambigu-

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ous, repeatable and reproducible results, so that results of tests made under defined conditions are com- parable. It is recommended that the description of test methods incorpo- rate a statement as to their accura- cy, reproducibility and repeatability �� To the extent practicable and con-

sistent with their objective, the tests should provide results within a rea- sonable period of time and at a reasonable cost �� Non-destructive test methods

should be chosen, whenever they can replace, within the same level of confidence, destructive test methods �� When choosing test methods, account

should be taken of standards for gen- eral test methods and of related tests for similar characteristics in other standards. As regards the description of test methods, it is recommended that reference be made to other rele- vant standards, rather than quote the test methods in full in each standard �� Where test equipment is only avail-

able from one source, or is not com- mercially available and has to be individually manufactured, the stan- dard should include such specifica- tions for the equipment as to ensure that comparable testing can be con- ducted by all involved parties.

While these features apply more to tangible products than other objects of conformity assessment, the principles

can be applied to standards for ser- vices, processes, systems, persons and bodies. The objective is to avoid the problems which can arise from differ- ing interpretations of the standard and the different expectations which the various parties may have.

Although standards can be prepared by many organizations, including com- panies and regulators, it is normally the role of national standards bodies to develop consensus standards. As such, they take into account the balanced views of all stakeholders af- fected by such standards. National standards bodies also provide the link- ages and conduits for national inputs into the development of internation- al standards. Many such standards are used by regulators as discussed later in this chapter.

The roles of national standards bodies in developing countries are described in detail in the ISO/UNIDO hand- book Fast forward – National Standards Bodies in Developing Countries.

The ISO policy committee dedicated to developing country matters, ISO/ DEVCO, has also produced a number of information documents and hand- books designed to assist developing countries in development and admin- istration of their national standards bodies and related functions.

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The second aspect of particular rele- vance to conformity assessment bodies is the availability of standards which set out requirements for best prac- tice of conformity assessment and the bodies which carry it out. These stan- dards are intended to ensure that there are consistent and internationally har- monized practices amongst conformity assessment bodies and the bodies with which they work (such as accreditation bodies). The responsibility for prepa- ration and maintenance of these con- formity assessment standards lies with ISO/CASCO (see Appendix 1).

It is essential that conformity assess- ment activities are as consistent as pos- sible internationally as they play such a significant role in the trading of goods and services. It is also of benefit to do- mestic consumers of products and ser- vices if conformity assessment is con- ducted consistently within economies. This is why standardization of confor- mity assessment practices is so critical.

It is also essential to note that stan- dards not only play a key role in trade and commerce, but they also cover many aspects of people’s daily lives including social issues such as public health, worker safety, and environmen- tal and consumer protection. Again, conformity assessment is comprehen- sively involved in verifying that the regulations affecting these aspects of

our lives are being adhered to, and, if not, it should be a catalyst for action by the relevant authorities.

Conformity assessment and metrology

The third major component in a qual- ity infrastructure is the availability of a national measurement system that can ensure that measurements are made with appropriate accuracy and reliabil- ity and can be related to other mea- surements made domestically or inter- nationally. This is essential to ensure compatibility in trade and commerce.

Measurement also underpins testing (and often inspection) as many items of equipment require calibration by competent specialist laboratories to ensure that such tests are traceable to international standards of measure- ment.

Manufacturing also requires consis- tent and reliable measurements for interoperability of components, as do measurements associated with traded commodities.

When products are certified (as dis- cussed in Chapter 4), such certification is usually based on testing for confor- mity. Here again there is a fundamental reliance on capable measurement for certification itself to be reliable.

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This fact demonstrates the great degree of interdependence between various types of conformity assess- ment and between the other segments of quality infrastructures.

The international framework for pro- viding compatibility of measure- ments is coordinated at the national level by national measurement insti- tutes (NMIs). It is their responsibility to provide the measurement capabili- ties needed within their economies (to the extent possible) and to maintain their own measurement capabilities at levels which provide comparabili- ty with institutes in other economies. However, in many economies (in both developed and developing countries), access to appropriate high level mea- surements for some quantities needs to be through NMIs in other economies.

International coordination of measure- ment science and capabilities is provid- ed through the International Bureau of Weights and Measures (BIPM). The ac- tivities of BIPM and its member NMIs have a number of key interactions with conformity assessment bodies and standards. These include : �� BIPM’s member NMIs make avail-

able appropriate ranges of measure- ment standards with uncertainties commensurate with the technical needs of their countries’ laborato- ries, industry users and other clients

of their calibration services (includ- ing foreign users) �� They maintain traceability of na-

tional measurement standards to international standards and the SI units through a credible and trans- parent process of international in- tercomparisons. (Traceability to international measurement stan- dards is a fundamental requirement of a number of ISO/CASCO and other ISO standards, such as ISO/ IEC 17025, ISO/IEC 17020 and ISO 9001) �� They implement the CIPM Mutual

Recognition Arrangement between NMIs. This MRA uses ISO/IEC 17025 as a fundamental criterion for NMIs participating in the MRA and accreditation of NMIs is one of the pathways to its membership. (The other mechanism for membership is based on a peer review by experts from other NMIs). Participating NMIs include bodies from devel- oped and developing countries �� BIPM maintains a publicly avail-

able database of the calibration and measurement capabilities (CMCs) of each of the NMIs in the CIPM MRA. This information is based on key intercomparisons regularly con- ducted between the NMIs �� BIPM members provide techni-

cal expertise for use in accredita- tion assessments and often provide reference values and measurement

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artefacts for measurement and cali- bration proficiency tests.

Information on the roles and activities of BIPM is available at www.bipm.org.

Information from the key compar- isons data base is accessed through www.kcdb.bipm.org.

BIPM is also actively involved in the development of a number of relevant conformity assessment standards as an A-Liaison member of ISO/CASCO.

Legal metrology A national standards and conformity in- frastructure should include a body or bodies responsible for legal metrology. This branch of measurement science deals with metrology in the domestic market and is sometimes referred to as trade measurement. It includes the ap- proval of measurement devices used in daily commerce to ensure fair trading practices. Examples include scales and other weighing devices, volume mea- sures, gas and electricity meters etc. It also embraces the regulation of package sizing for retail items.

It does, however, have a wider appli- cation beyond trade measurement in many economies, dealing with other forms of measurement which may have a legal or regulatory basis, such as ve- hicle speed measurement and breath analysis for alcohol content.

The international forum for legal me- trology is the International Organi- zation for Legal Metrology (OIML). It and its member bodies also have a number of conformity assessment roles and interactions. These include : �� OIML members undertake pat-

tern approval of measuring devic- es used in legal metrology applica- tions. Essentially these national type approvals are a device-specific form of product certification. This pro- cess requires testing against specif- ic OIML specifications (often with some national variations) �� OIML has also developed its own

mutual recognition arrangement to reduce the need for multiple testing and certification of measuring devices. This arrangement is called the OIML Mutual Acceptance Arrangement (MAA) and is intended to facilitate acceptance of OIML Certificates of Conformity across national borders �� The OIML MAA uses ISO/IEC 17025

compliance as part of the acceptance requirements for signatory bodies and also uses either accreditation or peer evaluation as the processes for deter- mining acceptance into the MAA.

Information on OIML is available on its website at www.oiml.org.

The Website also provides details of OIML’s Permanent Working Group on Developing Countries.

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Conformity assessment and regulations

Technical regulations are a feature in most economies and most have some direct or indirect interaction with both standards and conformity assessment. While most technical regulations are country-specific, there are some regula- tions which are multi-national in nature. European Directives, for example, often contain technical regulations which are applicable in all the member states of the European Union.

Often technical regulations include com- pliance with a national or an internation- al standard, technical specification or code of practice, but may contain additional re- quirements set by the regulator (such as product labeling specifications). Some technical regulations also may only speci- fy parts of standards, such as those aspects affecting safety and might not cover prod- uct performance or quality aspects.

Most regulatory arrangements have some common features such as : �� A nominated organization responsi-

ble for the implementation and ad- ministration of compulsory specifi- cations – the regulator �� Conformity assessment requirements

– how compliance with requirements will be assessed. (Sometimes alterna- tive conformity assessment arrange- ments might be allowed.)

�� The essential technical require- ments that must be satisfied – often through specification of a specif- ic standard or the equivalent stan- dards that can demonstrate com- pliance with essential requirements (deemed to satisfy provisions, often in technical guidance supplements to technical regulations) �� Post-market surveillance arrange-

ments, (where applicable) – these might require repeated conformi- ty assessments or different forms of conformity assessment to those needed for initial approval �� Sanctions to be applied when failures

to conform are identified – addition- al conformity assessment may be re- quired as a result of such failures �� Labeling and marking requirements

– such markings may be different to the marks of conformity issued by the conformity assessment bodies.

Clearly, conformity assessment is a fun- damental activity in administration of many technical regulations. However, the possibility for economies to intro- duce unnecessary regulations or tech- nical requirements which are sub- stantially different to those in other economies can lead to technical bar- riers to trade. Such barriers become even more complicated when there is no basis in an importing economy to accept conformity assessment results from foreign bodies

22

The ISO/IEC brochure Using and ref- erencing ISO and IEC standards for technical regulations (ISBN 978-92-67- 10454-6) provides practical advice for regulators on how to use Internation- al Standards to achieve their objectives.

Ideally, regulators will use uniform or standard technical requirements in their regulations and will be able to access the results of conformity as- sessments conducted by competent bodies in other economies. This task is made easier if conformity assessment bodies operate under internationally agreed standards, and additional confi- dence is also achieved if the conformity assessment bodies are independently

assessed for their competence through a process of accreditation.

These mechanisms to reduce technical barriers to trade are highlighted in the WTO Agreement on Technical Barriers to Trade (see Appendix 3). If regulators in different economies make amendments to core technical standards, then testing, inspection and certification bodies, acting on behalf of exporters to those markets, need to be aware of all the variations and their significance when undertaking their conformity assessment tasks.

Such add-on variations by regulators (see Figure 3) may add considerable extra costs to exporters and import-

Figure 3 – The challenge of multiple specifications

Regulator 3

Regulator 2Regulator 1

Regulator 4

Regulator 5

International Method (eg ISO XYZ)

23

ers and place additional responsibili- ty on conformity assessment bodies to be aware of each of the variations on a core standard needed to satisfy multi- ple markets.

Conformity assessment and economic development

While much attention in econom- ic development is paid to interna- tional trade, there are many aspects of the national economy which bene- fit from a systematic approach to the development of a national or regional quality infrastructure which includes conformity assessment. The quality in- frastructure can help to promote inter- national best practice in all the fields where it is applied and can improve the economics of agriculture, manufacture, distribution and commerce. It can also provide a sound basis for social devel- opment, education, health and legal justice systems.

It is as important to apply the principles of conformity assessment to imported goods and services as it is to their export. Having confidence that the items meet the specification in terms of quality and quantity, indeed that the specification is sufficiently clear in the first place so that there are no misunderstandings and sur- prises later on, will avoid waste of time and money as well as disappointment among those affected.

It is helpful to specify that imported goods and services must comply with clearly stated requirements such as those given in ISO or IEC standards. It is also important to state the means by which suppliers will be required to demonstrate conformity with the specified requirements. Will a suppli- er’s declaration of conformity suffice, or will it be necessary for a third party attestation such as a certificate of con- formity or an inspection certificate to be provided?

In the case of voluntary transactions, the parties concerned in the transac- tion are free to decide for themselves on the conformity assessment pro- cedures. If the purchaser is willing to accept the supplier’s assurances of con- formity (supplier’s declaration of con- formity), then there is no need to in- volve a third party.

In large transactions, where risks of making a mistake are higher, third party conformity assessment providers may be called in to provide unbiased and factual assurances to both par- ties, thereby facilitating the exchange of goods and services. In many devel- oping countries, however, the use of third party conformity assessment pro- viders has become a necessity in prac- tice, owing often to an absence of strict product liability legislation.

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Where technical regulations govern the transaction, the decision as to the means of conformity assessment may be taken out of the hands of the two main parties to the transaction, and proof of conformity, in a prescribed format, might be required. This raises the question of how the competence and independence of the third party conformity assessment providers can be demonstrated, and introduces the subject of accreditation.

ISO/IEC 17000 defines accreditation as the “third-party attestation related to a conformity assessment body con- veying formal demonstration of its competence to carry out specific con- formity assessment tasks”. Accredita-

tion can relate to competence in the performance of tests and calibrations in laboratories, or to the competence of certification and inspection bodies.

Accreditation bodies need themselves to show that they are independent and unbiased, and for this reason are often established as national or regional en- tities that in practice need to demon- strate the existence of mutual rec- ognition arrangements by means of membership of relevant international bodies that engage in peer reviews of each other.

In the accreditation sphere, two key in- ternational groups are the International Laboratory Accreditation Cooperation

25

(ILAC) and the International Accred- itation Forum (IAF) both having the aim of facilitating international trade through enhanced confidence.

Developing countries often do not have the resources or the expertise to establish national accreditation bodies, and frequently are operating at a low economic level that makes it unprofit- able for third party conformity assess- ment providers to operate exclusively in their territory.

One of the major decisions for a devel- oping country therefore involves the way in which its conformity assessment and accreditation requirements are to

be carried out. Use of a combination of national and foreign conformity assess- ment providers, backed up by region- al accreditation structures, may be an answer, although specific solutions to specific countries’ needs will always re- quire to be tailored to suit the circum- stances.

For more details on IAF and ILAC see Appendix 2.

The “CASCO toolbox” (see Appen- dix 1) can be used to provide the basis of a quality infrastructure that is effec- tive, tailored to the specific needs of the country concerned, and is compli- ant with the requirements of the WTO.

26

Conformity assessment and international trade

For developing countries, particularly, there needs to be some prioritization of competing needs for scarce resourc- es and judgment on whether the estab- lishment and maintenance of particu- lar conformity assessment activities (or their supporting infrastructure bodies) are justified.

Conformity assessment needs of developing countries

As with all economies, developing countries have needs for testing, mea- surement, inspection and certifica- tion. To satisfy some markets, they may also need access to accreditation ser- vices for their conformity assessment bodies.

Testing laboratories will also often need complementary services such as : �� Access to specialist calibration ser-

vices (able to demonstrate traceabil- ity to international measurement standards) to support their own test- ing and measurement �� Access to reference materials

(RMs) and certified reference ma- terials (CRMs) �� Access to proficiency testing services �� Access to equipment repair and

maintenance expertise

�� Access to research and development expertise to meet new demands for testing �� Training of technical, management

and support staff.

Similarly, inspection and certification bodies may have needs for the support- ing activities of : �� Specialist laboratories to provide

inputs to their own inspection or certification activities �� Specialist auditors, or other key per-

sonnel �� Training of staff.

Additionally, if there is an agreed need for a locally available accreditation body (or bodies), that body will also need access to a number of supporting resources. These resources may include (depending on the type of accredita- tion required) : �� Access to experts to act as technical,

product-specific, management-spe- cific or other specialist assessors �� Access to a national metrology in-

frastructure �� Access to membership of multilater-

al MRAs at either the regional or in- ternational level.

Within a developing country there may also be needs for information servic- es, including access to details of foreign standards, technical and other regula- tions, and associated translation services.

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Resolving the needs of developing countries for conformity assessment

Chapter 5 lists some of the activi- ties that UNIDO itself undertakes to assist the development of conformi- ty assessment and supporting infra- structure bodies, such as metrology centres and accreditation bodies. Ad- and accreditation bodies. Ad- ditionally, UNIDO and other interna- tional bodies such as ISO, IAF, ILAC, BIPM, and OIML, and their associated regional bodies, have implemented a number of training and awareness-cre- ation projects on topics of relevance to conformity assessment and its support.

Other aid agencies have also been active at both a single-country and a regional level to assist development and training in these areas. No doubt these activities will continue as specif- ic needs are identified. The identifica- tion and prioritization of such needs will always need to be a matter of judg- ment by the governments and industry bodies in individual countries, in coop- eration with the appropriate sources of development assistance.

Some of the approaches used (or pro- posed) to satisfy developing country needs for conformity assessment access and development have included : �� Attachment training abroad of per-

sonnel at well-established conformity

assessment and supporting bodies, such as accreditation bodies �� Twinning of new or proposed bodies

with an established conformity as- sessment or supporting body (often also abroad) �� Development of a regional solution

to a conformity assessment or relat- ed service need. An emerging ex- ample of that approach (to pooling scarce resources between countries) has been the recent establishment of the Southern African Development Community Accreditation Service (SADCAS), which will provide ac- creditation services to many econo- mies within the region �� Selected contracting of foreign as-

sessors to complement the available pool of technical experts within the country �� Facilitating access to regional or other

proficiency testing programmes �� Facilitating membership of region-

al and international bodies (some of these bodies have reduced fees for developing country members) �� Facilitating access to measurement

traceability through services of foreign metrology institutes (including insti- tutes in other developing countries) �� Full project development of a new

conformity assessment or related service capability �� Facilitating access to repair and

maintenance expertise for equip- ment ; and, where justifiable

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�� Facilitating use of established foreign conformity assessment and accreditation bodies.

This latter activity (direct use of for- eign conformity assessment and relat- ed services) is also a matter requiring judgement and sensitivity. On the one hand, it may be more cost effective in the short term to use-well established foreign bodies, rather than create a similar capability in the developing country.

On the other hand, the activity of for- eign bodies in a developing country may inhibit the use of newly devel- oped local bodies and the transfer of knowledge domestically. UNIDO has a process for effective implementa- tion of a quality infrastructure which can be helped by “cross-frontier poli- cies” adopted by both IAF and ILAC which require their accreditation body members to have appropriate policies to cover their foreign accreditation ac- tivities.

The World Trade Organization Agree- ment on Technical Barriers to Trade (WTO/TBT) underscores the signif- icance of conformity assessment in global trade and its potential to act as a barrier to trade. Non-acceptance of foreign standards and conformity assessment results has long been rec- ognized as a significant non-tariff trade

barrier. As such, all members of the World Trade Organization are required to adhere to the WTO Agreement on Technical Barriers to Trade.

The Agreement acknowledges the significant contributions that inter- national standards and conformi- ty assessment can make in improving efficiency of production and facilitat- ing international trade and encourages the development of international sys- tems. However, its prime purpose is to ensure that technical regulations, stan- dards and the systems used to demon- strate conformity with technical reg- ulations and standards do not create unnecessary obstacles to trade. For more information on WTO/TBT see Appendix 3.

Having established that conformity assessment has much to offer in facil- itating economic development, in the next chapter the various techniques which are available to those involved in implementing a national or region- al quality infrastructure are examined.

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Introduction to conformity assessment techniques

In this chapter, we will look more close- ly at the techniques which can be used in conformity assessment and draw at- tention to the relevant tools in the CASCO toolbox mentioned in Chap- ter 1. One characteristic of conformity assessment is that it can take on differ- ent forms, using different techniques ac- cording to the purposes for which it is being used. The information provided in this document sets out the main tech- niques in current use but should not be considered to be exhaustive.

In the conformity assessment field as in any other, the competence of the people managing and carrying out the conformity assessment activities is of paramount importance. Whether the work is being carried out by the sup- plier of the products, the purchaser or an independent body, there must be a clear understanding of the knowl- edge, skills and experience necessary for those performing the conformi- ty assessment tasks. Every organiza- tion, whatever its role, should operate a competence management system in which the required competences are laid down and the means of demon-

strating that individuals meet the re- quirements are specified.

Too often “conformity assessment” is taken to mean certification and noth- ing else. In fact, as discussed in Chap- ter 1, conformity assessment can be undertaken by many people, includ- ing the supplier of a product or service, its purchaser and other parties which might have an interest such as insur- ance companies and regulatory au- thorities. It is convenient when talking about conformity assessment to refer to the parties as follows : �� First party (1st party) – the person

or organization that provides the object which is being assessed �� Second party (2nd party) – a person

or organization that has a user inter- est in the object �� Third party (3rd party) – a person

or body that is independent of the person or organization that provides the object, and of user interests in the object.

In general, the conformity assessment techniques described in this chapter can be carried out by a 1st, 2nd or 3rd party. The decision as to which party should carry them out is addressed in Chapter 3.

Chapter 2 – Conformity assessment techniques

30

ISO/IEC 17000 sets out the “functional approach” to conformity assessment. The functional approach involves the basic process :

Selection – Determination – Review & Attestation, plus Surveillance when required.

Each stage involves certain activities which are described below, the output from one stage being the input to the next. Figure 4 shows an outline of the functional approach.

The activities carried out in each stage can include :

Selection

�� Specification of the standard(s) or other document(s) to which confor- mity is to be assessed �� Selection of the examples of the

object which is to be assessed �� Specification of statistical sampling

techniques if applicable.

Figure 4 – Functional approach to conformity assessment

Surveillance needed?

Yes

No

Need to demonstrate fulfilment of specified requirements

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Determination

�� Testing to determine specified char- acteristics of the object of assess- ment �� Inspection of physical features of

the object of the assessment �� Auditing of systems and records re-

lating to the object of assessment �� Evaluation of qualities of the object

of assessment �� Examination of specifications and

drawings for the object of assess- ment.

Review & attestation

�� Reviewing the evidence collected from the determination stage as to the conformity of the object with the specified requirements �� Referring back to the determination

stage to resolve nonconformities �� Drawing up and issuing a statement

of conformity �� Placing a mark of conformity on

conforming products.

Surveillance

�� Carrying out determination activi- ties at the point of production or in the supply chain to the marketplace �� Carrying out determination activi-

ties in the marketplace �� Carrying out determination activi-

ties at the place of use

�� Reviewing the outcome from the determination activities �� Referring back to the determination

stage to resolve nonconformities �� Drawing up and issuing confirma-

tion of continued conformity �� Initiating remedial and preventive

action in the case of nonconformities.

In the following sections, we look at these techniques in greater detail.

Selection

Selection involves planning and prep- aration activities in order to collect or produce all the information and input needed for the subsequent determina- tion function. Selection activities vary widely in number and complexity. In some instances, very little selection ac- tivity may be needed.

Some consideration may need to be given to selection of the object of con- formity assessment. Frequently, the object may be : a large number of iden- tical items ; ongoing production ; a con- tinuous process or a system, or involve numerous locations.

In such cases, consideration may need to be given to sampling or selection of specimens to be used for determination activities. For example, the sampling plan for river water related to a demon- stration that pollution requirements are

32

fulfilled would be an example of a size- able and significant sampling activity.

However, occasionally the object may be the whole population, for instance when a single, individual product is the object of conformity assessment. Even in such cases, sampling may be neces- sary to select a part of the entire object that is representative of the whole (e.g. selection of critical parts of a bridge for a determination of material fatigue).

It may also be necessary to consider the specified requirements. In many cases, a standard or other pre-exist- ing set of requirements exists. Howev- er, care should be taken when applying the pre-existing requirements to the specific object of conformity assess- ment. For example, caution might be needed when applying a standard writ- ten for metal pipes to plastic pipes. In some cases, only a very general set of requirements may exist which must be expanded for assessment to be mean- ingful or acceptable to the users.

For example, a government regula- tor may require that products pose no unacceptable safety risks (the gener- al requirement) and expect a certifica- tion body to establish specific require- ments for individual certified products or types of products. Alternatively, gen- eral management system requirements may need to be more focused when the

management system addresses fulfil-fulfil- ment of specific service requirements.

Selection may also include choice of the most appropriate procedures (for exam- ple, testing methods or inspection meth- ods) to be used for determination ac- tivities. It is not uncommon that new or modified methods need to be developed to conduct determination activities. It may be necessary to select the proper lo- cations and the proper conditions, or the individuals to perform the procedure.

Finally, additional information may be needed in order to perform deter- mination activities properly so that the demonstration that specified re- quirements are fulfilled will be effec- tive. For example, the scope of testing to be covered by laboratory accredita- tion must be identified before appro- priate determination activities can be performed. Alternatively, a description of a service may be needed before per- forming appropriate determination ac- tivities.

In addition, a determination activity may be a review of information alone, and that information must be identified and collected. For example, a copy of a product’s instructions for use or warn- ing markings may be needed.

In Figure 4 (see page 30), all the infor- mation, samples (if sampling is used),

33

decisions and other output from the se- lection function is represented as “in- formation on selected items”.

Determination

Determination activities are under- taken to develop complete information regarding fulfi lment of the specifi ed re-fulfilment of the specifi ed re- of the specified re- quirements by the object of conformity assessment or its sample. Some types of determination activities are described below.

The terms testing, inspection, audit and peer assessment, which are defined as types of determination activities only, may be used with “system” or “scheme” to describe conformity assessment sys- tems or schemes that include the type of determination activity indicated. Thus, a “peer assessment system” is a conformi- ty assessment system that includes peer assessment as the determination activity.

Various determination activities have no specific name or designation. An example is the examination or anal- ysis of a design, or other descriptive information, in relation to specified requirements. Individual sub-fields of conformity assessment (e.g. testing, cer- tification, accreditation) may have terms defined for determination activities that are unique to that sub-field. There is no generic term used or in practice to rep- resent all determination activities.

Care should be taken to understand clearly the determination activities characterized as testing or inspection.

In Figure 4, all the output from the de- termination function is represented as “information on fulfilment of specified requirements”. The output is a combi- nation of all the information created through determination activity, as well as all the input to the determination function. The output is usually struc- tured to facilitate review and attesta- tion activities.

Testing

As noted earlier, there is a degree of overlap between testing, calibration and metrology. For the purposes of confor- mity assessment – demonstration that an object conforms to specified require- ments – calibration and other aspects of metrology would fall outside this defi- nition. However the confidence in the measurements made during testing (and inspection) depends on the nation- al measurement system and the trace- ability to international measurement standards through calibration.

Conformity assessment related to testing and calibration

Testing, measurement and calibration affect almost all facets of daily life.

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They affect trade and commerce, man- ufacturing, professional services, public health and safety, construction, envi- ronmental monitoring, transport, ag- riculture, quarantine, forensic scienc- es, meteorology, telecommunications, mining, forestry, and defence, to name just a few sectors. Of these, testing con- ducted in human medicine is perhaps the most comprehensive undertaken on a daily basis around the world.

Testing is the most common conformi- ty assessment technique that is used. It is therefore of interest to examine its defi- nition, as it relates to conformity assess- ment. ISO/IEC 17000 defines testing as :

“determination of one or more charac-

teristics of an object of conformity as-

sessment, according to a procedure”.

Where a procedure is defined as a speci- fied way to carry out an activity or a pro- cess. A note to the definition of testing states that testing typically applies to ma- terials, products or processes. In the case of testing used for conformity assess- ment, the characteristics will be includ- ed in the “specified requirements” which form the focus of the assessment.

It is noteworthy that calibration, while an essential input to testing, is not con- sidered to be a conformity assessment technique. It comes within the field of metrology which is outside the scope of this publication. However, it is worth

considering the definition of calibra- tion in the International Vocabulary of Metrology – basic and general concepts and associated terms (VIM) :

“Operation that, under specified condi-

tions, in a first step, establishes a rela-

tion between the quantity values with

measurement uncertainties provided

by measurement standards and cor-

responding indications with associat-

ed measurement uncertainties and, in

a second step uses this information to

establish a relation for obtaining a mea-

surement result from an indication.”

Noting that here the “standards” re- ferred to are measurement standards traceable to the SI units of measure- ment, e.g. mass and length, not doc- uments which specify requirements. Calibration is covered in the scopes of both ISO/IEC 17025 (for testing and calibration laboratory competence) and ISO/IEC 17011 (for accreditation body requirements).

ISO/IEC 17025 specifies the require- ments for testing and calibration labora- tories and is discussed in detail in Chap- ter 4. Included in its requirements are all of the elements essential to the conduct of testing for conformity assessment : �� Competent people �� Validated methods which are re-

peatable and reproducible �� Properly maintained and calibrated

equipment

35

�� Measurements which are traceable to the SI standard units of measurement �� Sampling and handling of test items �� Reporting of the testing results.

For the most reliable test results, the test methods should be specified in the stan- dard or other document to which con- formity is being assessed. Where a test is used for a number of different purposes it could be specified in a separate standard such as ISO 3452-2, Non-destructive test- ing – Penetrant testing – Part 2 : Testing of penetrant materials, or ISO 13982-2, Pro- tective clothing for use against solid partic- ulates – Part 2 : Test method of determina- tion of inward leakage of aerosols of fine particles into suits, which can then be re- ferred to in standards specifying require- ments for particular objects.

In other cases the test method could be defined in the requirements standard itself as in ISO 15012-2, Health and safety in welding and allied processes – Requirements, for testing and marking of equipment for air filtration – Part 2 : Determination of the minimum air volume flow rate of captor hoods and nozzles, or ISO 11199-2, Walking aids manipulated by both arms requirements and test methods – Part 2 : Rollators.

In some cases, the requirements standard might simply give a value for a particular characteristic such as mass without specifying the method by which the

characteristic is to be determined. In such cases, the testing laboratory would need to decide on the method to be used, fol- lowing good laboratory practice. Where a number of testing laboratories are in- volved in conformity assessment work for the same set of requirements, it could be necessary for them to work together to agree a test method so that reliable and comparable results can be obtained.

Inspection

Inspection is a form of conformity as- sessment which has a long history. Some inspection activities are closely aligned with testing activities ; others may be closely associated with certification ac- tivities (and particularly product cer- tification) ; while other inspection is a stand-alone activity without any rela- tion to testing or certification. The ISO/ IEC 17000 definition for inspection is :

“Examination of a product design,

product (3.3)*, process or installation

and determination of its conformity

with specific requirements or, on the

basis of professional judgment, with

general requirements.

Note : inspection of a process may in-

clude inspection of persons, facilities,

technology and methodology.”

* ISO/IEC 17000 : 2004 Clause 3.3 quotes the ISO 9000 :2005 Clause 3.4.2 definition of prod- uct as “the result of a process” which includes services, software, hardware and processed materials.

36

The requirements for inspection bodies are specified in ISO/IEC 17020 and are discussed in more detail in Chapter 4. Looking here at inspection as a confor- mity assessment technique it can include : �� Visual examination of physical items �� Measurement or testing of physical

items �� Examination of specification docu-

ments such as design drawings �� Comparison of the findings with the

requirements of specification doc- uments or with generally accepted good practice in the field �� Drawing up a report on the results

of the inspection.

One of the key phrases in the definition of inspection is “on the basis of profes- sional judgement…”. This underlines the fact that the competence of inspec- tion bodies is highly dependent on the knowledge, experience and interpre- tive skills of the inspection bodies’ per- sonnel. For some types of inspections there may be specified requirements for the qualifications and experience of the inspectors involved. In some cases certification of such personnel may be a requirement. This is common, for ex- ample, in some types of safety-related inspection activities.

Inspection also covers a very broad spectrum of sectors and characteristics being inspected. It may, for example, cover cargo-superintending of com-

modities and products, for determina- tion of quantity, quality, safety, fitness for use, and compliance of plants, instal- lations, operating systems, and design suitability. Inspection might also, for ex- ample, embrace the rating systems used to classify accommodation, airline ser- vices, tourism services, etc.

As has already been pointed out, conformity assessment is an elastic concept in that particular types of ac- tivities might be called testing in some fields, inspection in others and certifica- tion in yet further fields. This fact high- lights the need to concentrate on de- ciding what is needed for a particular situation and specifying it accordingly.

For example, is the inspection required in its own right, such as that relating to regulatory inspection of pressure vessels, or is it one of the inputs to a certification process? Chapter 3 looks at the design of conformity assessment systems and schemes, where such mat- ters have to be considered.

Auditing

ISO 19011 provides guidance on audit- ing. The ISO 9000 and ISO 14000 series of International Standards emphasize the importance of audits as a manage- ment tool for monitoring and verify- ing the effective implementation of an organization’s quality and/or environ-

37

mental policy. Audits are also an essen- tial part of conformity assessment ac- tivities such as external certification/ registration and of supply chain evalu- ation and surveillance.

An audit is defined in ISO 19011 as a systematic, independent and document- ed process for obtaining audit evidence and evaluating it objectively to deter- mine the extent to which the audit cri- teria are fulfilled.

Audit criteria are contained in a set of policies, procedures or requirements which have been established by the or- ganization being audited as meeting their needs, including the implementation of such management system standards as ISO 9001. The audit criteria are used as a reference against which conformity is determined and may include applicable policies, procedures, standards, laws and regulations, management system require- ments, contractual requirements or indus- try/business sector codes of conduct.

Audit evidence comprises records, state- ments of fact or other information rele- vant to the audit criteria and which are verifiable. Audit evidence may be quali- tative or quantitative.

Internal audits, sometimes called first- party audits, are conducted by, or on behalf of, the organization itself for management review and other internal

purposes, and may form the basis for an organization’s self-declaration of confor- mity. In many cases, particularly in smaller organizations, independence can be dem- onstrated by the freedom from responsi- bility for the activity being audited.

External audits include those generally termed second- and third-party audits. Second-party audits are conducted by parties having an interest in the orga- nization, such as customers, or by other persons on their behalf. Third-party audits are conducted by external, inde- pendent auditing organizations, such as those providing registration or cer- tification of conformity to the require- ments of ISO 9001 or ISO 14001.

When a quality management system and an environmental management system are audited together, this is termed a combined audit. When two or more auditing organizations coop- erate to audit a single organization this is termed a joint audit.

A typical audit process should consist of the following : �� Identification of sources of informa-

tion �� Collecting the information by ap-

propriate sampling and verifying �� Establishing audit evidence from

the information �� Evaluating the information and evi-

dence against audit criteria

38

�� Identifying audit findings �� Reviewing the audit findings and

evidence �� Audit conclusion.

Methods for collecting audit evidence include interviews, observation of ac- tivities and review of documents

Evaluation

Evaluation is the term used in ISO/ IEC Guide 65 and ISO/IEC 17024 to cover the range of activities concerned with gathering evidence of conformi- ty. These activities can include testing, inspection and auditing but can also

include other activities such as study- ing design drawings and specifications to ascertain that the features required to meet the specified requirements are adequately defined.

For some products, for example where the internal parts are protected by a cast resin, it would not be possible to verify from a finished product that components of the correct rating had been incorporated. Having a definitive set of drawings of a product helps in the control of changes which may need to be made after conformity assess- ment has been completed.

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Examination

Examination is one of the terms used almost interchangeably to cover a number of determination activities, but it is used in a more specific way when referring to methods for measuring the competence of a person. In this con- text, as explained in ISO/IEC 17024, an examination may be carried out in written, oral or practical form.

Examinations need to be planned and structured in a manner which ensures that all specified requirements are ob- jectively and systematically verified, with sufficient documented evidence produced to confirm the competence of the candidate.

Peer assessment (peer evaluation)

Peer assessment, also known as peer evaluation, is a process used to ascertain the conformity of a person or organiza- tion with a set of requirements for mem- bership of a group which the person or body wishes to join. The assessment is carried out by members of the group, in other words the peers of the applicant.

For the conformity assessment field, the process is specified in ISO/IEC 17040 and is used by groups of bodies which wish to be able to accept each others’ conformity assessment results.

Peer assessment is used for example by certification bodies in the IEC con- formity assessment systems and by accreditation bodies in ILAC and IAF. Peer assessment requires the following elements : �� Competent assessors, drawn from

members of the group �� Clearly specified membership crite-

ria decided by the group �� A methodical assessment of the can-

didate organization’s conformity with the criteria �� A report of the findings with suffi-

cient information for the group to decide on the candidate organiza- tion’s suitability for membership.

The group will decide upon whether there is a need for periodic auditing and re-assessment of the members of the group. If so, the relevant parts of the process will be undertaken.

The members of peer assessment agreement groups are generally all expert in the particular technical areas covered by the agreement and so pro- vide a high level of technical compe- tence for the peer assessment. On the other hand, the bodies could be in com- petition with each other and might not be totally impartial. The peer assess- ment scheme needs to be well-managed in order to maintain its effectiveness in inspiring confidence in the work of its members.

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One aspect of peer assessment in a multilateral arrangement is to ensure that the assessment teams are drawn from across the membership and do not involve assessors from two differ- ent members assessing each others’ organizations.

Accreditation

Accreditation is a conformity assessment technique specifically related to the as- sessment of the conformity of confor- mity assessment bodies by a third party body, generally known as an accredita- tion body. The requirements for accred- itation bodies are specified in ISO/IEC 17011 and are discussed in Chapter 4. Accreditation generally involves the use of auditing techniques by assessment teams including experts in the organiza- tional aspects such as management sys- tems and also in the technical activities of the body. For example, for a testing laboratory the team would include one or more experts in the types of measure- ment and testing being carried out.

Report

At the completion of every determina- tion activity it is necessary to produce the evidence of conformity which has been gathered. The evidence is usually contained in a report, sometimes referred to as a technical file, which includes :

�� A definitive identification of the item which has been assessed �� A statement of the requirements to

which conformity has been assessed �� Details of the determination ac-

tivities which have been carried out, such that it would be possible to repeat the activities in the same manner if it was necessary to verify the evidence �� Details of the resources used, in-

cluding people, measuring instru- ments and other evaluation tools, to provide traceability of the results �� The results of the activities in suf-

ficient detail for a person not in- volved in the activities to verify con- formity (or nonconformity) with the specified requirements.

The report is passed to the person or body responsible for review and attes- tation and should be made available to the person or organization for which the work has been done.

Review & attestation

In the functional approach, review and attestation are presented as a com- bined activity. It is possible, though, for different people to carry out each of them. What is important is that neither activity should be carried out by a person who has been involved in the determination activities. Of course, where the risks of nonconformity

41

are low, this safeguard might not be necessary, but the principle of having the results reviewed by someone else does provide an enhanced level of con- fidence in the statement of conformi- ty. As the risks of nonconformity rise, so the degree of independence of the reviewer(s) should increase.

For lower levels of risk, another person in the same department could be used. For medium risks, the review could be done by a person from an- other department in the organization while, for higher risks, the work should be undertaken by an independent or- ganization.

It is important that, whether the con- formity assessment is being carried out as a 1st, 2nd or 3rd party process, the person(s) conducting the review have the competence to understand the in- formation presented to them and to analyze it for demonstrating conformi- ty with the specified requirements.

The reviewer must have the necessary competence relating to the specified requirements, the object being assessed and the determination activities that have been used. For example, knowl- edge of the test methods would enable the reviewer to identify anomalous results and refer the report back to the person(s) who carried out the test for it to be repeated.

In some 3rd party attestation schemes the body may only carry out the review and attestation, with the selection and determination having already been carried out either by another 3rd party or by the supplier of the object. It is particularly important in such cases for the reviewing and attesting body to have arrangements to keep the compe- tence of its reviewers up to date with the current state of the art.

The conclusion of the review stage is a recommendation for a statement of conformity to be issued. The recom- mendation should make reference to the report and to any other findings from the review which substantiates the conformity of the object with the specified requirements.

Resolution of nonconformities

One possible outcome from the review is a finding that the object does not conform to the specified requirements in one or more respects. Alternatively it could be the case that the evidence of conformity is incomplete and one or more of the specified requirements has been overlooked. In either case the report should be returned to the person responsible for the determina- tion activities for remedial action to be taken.

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In the case that the object is found not to conform, the person or organization responsible for the object, e.g. the de- velopment engineer or, for a 2nd or 3rd party situation, the supplier, should be informed and invited to make the changes necessary to achieve confor- mity. It is important that the reviewer does not suggest possible solutions so as not to lose their objectivity when the object is returned for a further review. Discussion of the assessment results is permissible so that the person or orga- nization responsible can understand the cause of the nonconformity.

The relevant determination activities will need to be repeated and a further

report will be presented for review. By agreement with the reviewer, the report need only deal with the changes which have been made.

Statement of conformity

The conclusion of the conformity assess- ment process is the issuing of a statement of conformity which can take a number of forms as described below. Whichever form it takes, the statement should pro- vide unequivocal identification of the object and of the specified requirements with which it has been found to con- form. The statement may be on paper or in some other retrievable means such as photographic or digital media.

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Declaration of conformity

A statement of conformity issued by a 1st party, e.g. the supplier of a prod- uct, or a 2nd party, e.g. the purchaser, is known as a declaration of conformity. This practice has been adopted to dif- ferentiate these statements from those issued by a 3rd party body, which are known as “certificates”.

ISO/IEC 17050 provides information on the content of a supplier’s declara- tion of conformity. A declaration by a 2nd party could take a similar form.

Certificate of conformity

A statement of conformity issued by a 3rd party is often referred to as a cer- tificate of conformity. However the term used and the specific content can vary according to the object being as- sessed and the nature of the speci- fied requirements. The related ISO/ CASCO standards referred to in Ap- pendix 1 provide information on the nature and content of the conformity statements.

Mark of conformity

It is common for products to bear marks of conformity, whether these are the supplier’s own trade mark, a certi- fication mark controlled by a certifi- cation body or a conformity mark re-

quired by legislation, such as the EU’s CE marking. Advice on marks of con- formity is contained in ISO/IEC 17030 and ISO Guide 27. Marks must be dis- tinctive and their ownership and con- ditions of use should be clearly stated. In particular the use of a mark should not be misleading to purchasers and users of the products. For example, a supplier which has a certified manage- ment system conforming to ISO 9001 must not place the certification body’s mark on its products, since that would imply that the body had certified the products.

Frequently, the use of a mark of con- formity is controlled through a licence issued by the owner of the mark or by an organization operating on behalf of the owner such as a certification body. The licence spells out the conditions under which the licensee can use the mark such as the restriction to use it only on products which the supplier has verified as conforming to the certi- fied product type.

Policing of the use of marks of con- formity is vital for the interests of the owner and licensing body, since prod- ucts bearing their mark are often pro- duced under a system in which only occasional samples of product are ver- ified by the licensing body. See Chap- ter 3 for more information on different conformity assessment systems.

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Surveillance

Conformity assessment can end when attestation is performed, but where there is a need to provide continuing assurance of conformity, surveillance can be used. Surveillance is defined as a systematic iteration of conformity as- sessment activities as a basis for main- taining the validity of the statement of conformity.

The needs of users drive such activi- ties. For example, an object of confor- mity assessment may change over time, which could affect its continuing fulfi l-fulfil- ment of specified requirements. Or, users may demand ongoing demon- stration that specified requirements are fulfilled ; for example, when a product is produced continuously.

The activities undertaken in surveil- lance are planned in order to satisfy the need to maintain the validity of an existing statement resulting from attes- tation. A complete repeat of the initial assessment is usually not necessary in every iteration of surveillance to sat- isfy this need. Thus, the activities in each function in Figure 4 (see page 30) during surveillance may be reduced, or different from, the activities undertak- en in the initial assessment.

Selection activities take place in both the initial assessment and in surveil-

lance. However, entirely different choices might be made in surveillance. For example, a test for a product may have been selected in the initial assess- ment. In surveillance, an inspection might be selected to determine that a sample of the product is the same as the sample originally tested. In fact, the choices in selection may change from time to time, based on informa- tion from previous iterations of surveil- lance and other inputs. Ongoing risk analysis or consideration of market feedback regarding actual fulfilment of specified requirements may be part of selection activities in surveillance.

Choices about the specified require- ments can be different as well. For example, only a subset of the specified requirements might be selected in any given iteration of surveillance. Or, sim- ilarly, only a portion of the object of conformity assessment may be select- ed for determination activities in sur- veillance ; for example, only a portion of an accredited certification body may be audited during surveillance.

As noted above, the different choices in selection can lead to different de- termination activities for surveillance purposes. However, in both initial as- sessment and surveillance, the output from selection defines the determina- tion activities and how they will be car- ried out.

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The review and attestation function is also used in both initial assessment and surveillance. In surveillance, a review of all the inputs and outputs in Figure 4 leads to a decision whether the state- ment resulting from attestation con- tinues to be valid. In many cases, no special action is taken if the statement continues to be valid. In other cases, for example, if the scope of attestation has been extended, a new statement of conformity might be issued.

If the decision is that the statement of conformity is no longer valid, appropriate activities are necessary to advise users ; for example, that the scope of attesta- tion has been reduced or that the state- ment has been suspended or withdrawn.

Market surveillance

Market surveillance is a particular form of post attestation activity. It could be conducted by the supplier in the form of customer surveys or periodic inspection of installed products, perhaps as part of a servicing contract. Market surveillance is also carried out in some certification schemes, where samples of certified products are taken from the market- place and subjected to inspection or testing to determine whether they con- form to the specified requirements.

In many countries, the regulatory au- thorities have a responsibility for pro-

tecting consumers and enforcing the health and safety regulations by carry- ing out market surveillance. This kind of work can be carried out on a rou- tine basis but the economic constraints usually lead to a targeted surveillance, either concentrating on the highest areas of risk or responding to reports of nonconforming products. A report on the ISO/CASCO workshop on market surveillance is available from http ://iso.org/cascoworkshop2008

Whether the market surveillance is carried out by the supplier, a certifica- tion body or the regulatory authorities, it needs to be done in a systematic way with comprehensive and accessible records. There should also be a system- atic follow up so that any adverse ef- fects can be corrected, if possible, and can be prevented from happening in the future. Measures can include reme- dial action and product recall.

In today’s global economy, it is advan- tageous for regulatory authorities in different countries to share market sur- veillance information, so that lessons learned from an incident in one coun- try can be used in others to prevent de- fective items from reaching the market or to take them out of use before they cause damage.

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Who carries out conformity assessment?

The question of who should carry out the conformity assessment is a crucial one when it comes to putting theory into practice. One of the basic principles of conformity assessment is that the or- ganization which owns the object of as- sessment or places it on the market has the primary responsibility for its con- formity with the stated requirements. In this chapter we discuss the role of other parties and how the arrangements for particular situations can be decided. Reference to relevant tools from the CASCO toolbox is included.

To illustrate the principle of primary responsibility, the supplier of a product will have a contractual and a legal duty to the user that the product will per- form its declared function and that it will not endanger the health or safety of the user. Even if the supplier obtains a certificate from an independent body stating that the product conforms to the relevant specification, if anything goes wrong, the supplier remains re- sponsible.

Although the independent body might incur some degree of liability,

particularly if it had been negligent in performing the conformity assessment, that would not absolve the suppli- er from the primary responsibility. Of course, misuse by the end user, particu- larly a failure to carry out proper main- tenance, could absolve the supplier from liability for subsequent damage and its consequences.

1st, 2nd and 3rd parties – roles and responsibilities

In order to identify the parties which might be involved in conformity as- sessment it is useful to refer to first, second and third parties as referred to in Chapter 2.

In the case of commercial transactions such as the supply of a product or ser- vice, the supplier is the first party, the purchaser is the second party and any other organization which has no com- mercial interest in the transaction is a third party. Looking at the roles and responsibilities of the different parties, using the example of a product : �� The first party provides the product

and is responsible for its conformi- ty with the specified requirements. These requirements could be the first party’s own specification, a

Chapter 3 – Conformity assessment schemes and systems

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specification provided by the pur- chaser or legal requirements relat- ing to the product or any combi- nation of the three. In any of these cases reference could be made to one or more national, regional or in- ternational standards �� The second party specifies its

requirements and is responsible for assuring itself that the product con- forms to them �� A third party could be requested

by the first or second party to assess conformity of the product with the specified requirements and would be responsible for providing a state- ment of conformity (or nonconfor- mity).

Definition of schemes and systems

Before looking in detail at the activi- ties of the different parties it is useful to introduce the idea of conformi- ty assessment schemes and systems. While each conformity assessment situation could be treated different- ly, there are many advantages to a sys- tematic approach. The basic building block is a scheme which relates to a particular group of objects having suf- ficiently similar characteristics that the same set of rules and procedures can be carried out under the same manage- ment for assessing conformity with the same set of specified requirements.

A conformity assessment system uses a common set of rules, procedures and management for several conformi- ty assessment schemes. The rules and procedures may need to be detailed in different ways for different schemes, but there are advantages in terms of efficiency and consistency to working within a common framework.

Scheme owner

Each conformity assessment scheme will have an owner. A number of dif- ferent arrangements could apply and some examples are : a. A manufacturing organization

could set up a conformity assess- ment scheme for its products, including testing, inspection and auditing, leading to the issuing of declarations of conformity.

b. A scheme could be developed by a certification body for sole use of its clients, in which case the certi- fication body takes on full respon- sibility for the design, application, management and maintenance of the scheme. The body would be the scheme owner.

c. An organization such as a regula- tory body or a trade association might develop a scheme and invite one or more certification bodies to operate it. In that case, the organi- zation would be the scheme owner and would take responsibility for

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the operation of the scheme, prob- ably through a contract or other formal agreement with the certifi- cation bodies.

d. A group of certification bodies, perhaps in different countries, might together set up a certifica- tion scheme. In that case, it would be necessary for the bodies, as joint owners of the scheme, to create a management structure so that the scheme could be operated effec- tively by all participating bodies.

If it was found necessary to operate several schemes which used the same rules, procedures and management, the scheme owner could set up a product certification system under which the different schemes could operate with- out the need for replicating the man- agement structure for each scheme. In that case, the scheme owner would become the system owner and be re- sponsible for the management of the system and the schemes operating within it.

Scheme design based on risk

A key decision when setting up a scheme is who should be involved in carrying out the conformity assess- ment. The decision should be based on an assessment of the risks which could arise from nonconformity, looked at

from the point of view of both the like- lihood and the consequences of the product, service, etc. failing to conform to the specified requirements.

Sometimes the consequences could be of a commercial nature such as loss of market reputation and sales volume if a series of product failures occurred or interruptions to production if a suppli- er delivered faulty goods. In other situ- ations it could be hazards to the health and safety of people which could be of concern.

Conformity assessment costs money and takes time. The amount of money and time to spend on it needs to be bal- anced against the risks of nonconfor- mity. While conformity assessment car- ried out in-house by the supplier could be limited to inspection, the inspector has to be paid and there can be delays to production or dispatch while the in- spection is carried out.

As the nature of the product becomes more complex and the risks of noncon- formity become higher, conformity as- sessment activities will become more extensive, possibly involving expen- sive test equipment and extended test- ing programmes. Sometimes it can be more cost effective to contract out the conformity assessment work to a third party, but this is more of a commercial decision by the supplier.

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Where the risks of nonnconformity are high, it is usual to require an indepen- dent body to carry out some defined conformity assessment activities and at least to review the evidence of con- formity and issue an attestation doc- ument such as a certificate. The body will charge for its services and will need to take time to complete its work. The scheme owner will need to spec- ify whether the work is to be carried out by one particular body or by any body which meets the scheme’s re- quirements.

Costs associated with conformity assessment

When deciding on the appropriate conformity assessment arrangements for a particular situation, it helps to be aware of the nature and extent of the costs of alternative approaches. As stated above, there are costs entailed in carrying out self assessment but as soon as another party becomes in- volved it is necessary to take account of what additional costs might be in- curred and by whom. If the purchas- er of a product decides to carry out their own assessment, they will gener- ally have to bear the costs of employ- ing their own inspectors.

If an independent body is contracted to carry out conformity assessment, the body will need to recover its costs

from whoever it is working for. In the case of product certification, it is usu- ally the supplier who will engage and pay the certification body. The body’s costs will not only relate to the asses- sors involved in the assessment work, but also all of the expenditure incurred in running its business, a proportion of which will be charged to each certifica- tion customer.

Thus the decision to establish a certi- fication scheme can add to the costs incurred in the supply of the certified products. Similarly, a decision to re- quire certification bodies to be accred- ited will add a further layer of costs as the expenditure incurred in operating the accreditation body has also to be recovered.

In addition to the direct costs of con- formity assessment, there are other factors which have financial implica- tions particularly for suppliers of certi- fied products. The involvement of a 3rd party can lead to delays in producing and delivering products if there is a sig- nificant time lag between the applica- tion for certification and the receipt of the certificate of conformity.

With the ever-accelerating pace of product and market development, such delays can lead to lost opportunities to sell products and can even have an adverse effect on the reputation of the

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supplier. The financial consequences can be serious and measures need to be adopted to minimize them, such as fully understanding the specified requirements and maintaining good communications with the certification body from the outset.

One important aspect to consider when designing a conformity assess- ment scheme is whether to allow or encourage competition between con- formity assessment bodies. The main benefits of competition are to provide choice for the suppliers and to prevent a single body from abusing a monopo- ly position. At the same time, compet- ing bodies might be tempted to cut cor- ners in an effort to meet the needs of customers and care needs to be taken to prevent the standard of assessment from falling. Accreditation or peer as- sessment can help to counteract the ad- verse effects of competition.

In summary, the benefits of indepen- dent conformity assessment in terms of market acceptance and the avoid- ance of the consequences of product failures can far outweigh the direct and indirect costs of the conformity assess- ment arrangements, but such an out- come should be the result of a careful analysis of the risks, rather than being a matter of simply following the current fashion.

Voluntary and regulatory schemes

Conformity assessment schemes can be set up for commercial purposes such as to improve market perception for a group of suppliers, to share assessment facilities by a group of purchasers or to respond to market needs by a third party assessment organization. In each of these cases there is no legal require- ment for suppliers or purchasers to use the scheme, although there can be strong market and peer pressure to do so.

At the same time, regulatory authori- ties can find it useful to introduce spe- cific conformity assessment arrange- ments in order to provide assurance that legal requirements are being met. The authorities will consider the dan- gers to workers, consumers, the envi- ronment and the economy posed by deficient goods, services or processes. The measures which they adopt will need to be proportional to the risks involved, with statutory inspection or certification schemes being introduced where the risks are highest.

Setting the “ specified requirements ” – standardization

When it comes to specifying the require- ments to which conformity is to be as- sessed, there are many benefits in using

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international standards such as those published by ISO and IEC. To begin with, the standards represent the cur- rent, collective wisdom of those involved in the particular technical areas where the standards are being applied ; so users of these standards can apply well tried and tested solutions. In addition, prod- ucts, services and other objects of assess- ment will gain acceptability on world markets more readily if they conform to these standards. The UNIDO-ISO pub- lication Fast forward provides informa- tion and advice on standardization

Supplier’s declaration of conformity

Regardless of whether any other par- ties are involved in the conformity as- sessment, there will always be some form of declaration of conformity by the supplier of the product or service. The declaration might take the form of an advertisement or leaflet describing the features of a product or could be incorporated in a formal document set- ting out the identification of the sup- plier and the product, the specification of the standards or other documents to which conformity is being declared, perhaps the particular regulations with which the item complies and the signa- ture of a responsible person.

Even the placing of the supplier’s name, trade mark or logo on or in con-

junction with the product implies that it conforms to the supplier’s specifica- tion. ISO/IEC 17050 provides guidance on the content of a supplier’s declara- tion of conformity.

Independent and expert conformity assessment

Where the risks of nonconformity have been judged to be sufficiently high, an independent body could be involved in the conformity assessment. Wheth- er the scheme owner is a group of first parties, one or more second parties, a third party or a regulatory authority, the decision to provide for or require third party conformity assessment needs to be accompanied by a care- ful selection of the criteria which will be used to judge the suitability of third party conformity assessment bodies. It is recommended that the CASCO tool- box (Appendix 1) is used for this pur- pose, as discussed in Chapter 4.

Sector schemes

Most conformity assessment schemes will be developed by and used in a par- ticular sector of industry or commerce. Even management system schemes which monitor the application of ge- neric system standards such as ISO 9001 and ISO 14001 require the bodies and the auditors to have knowledge and experience relevant to each sector.

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There is some discussion over what constitutes a sector. There are the broad sectors covering : �� Primary activities such as farming

and mining �� Secondary activities such as manu-

facturing �� Tertiary activities including distribu-

tion and retailing and the provision of services.

Each of these sectors can be subdivid- ed into further sectors according to the nature of the activities. Within manu- facturing, for example, there could be metal goods, cars and trucks, electrical products, processed food, chemicals, pharmaceuticals, and so on.

What matters for a sector definition for conformity assessment purposes is that the characteristics of the objects being assessed and their means of produc- tion and delivery are sufficiently sim- ilar that a single scheme can work ef- fectively. Where, for example, diverse areas of competence, differing test- ing equipment and varying assessment methods are required then it could be advantageous to set up a scheme for each sector.

From the point of view of the eco- nomics of conformity assessment, one of the dangers with setting up narrow schemes for small sectors is that the practices could diverge from sector to

sector, making it hard to operate to a single set of policies and procedures under the same management. There can also be pressure to develop diverg- ing general requirements for the con- formity assessment activities, making it more difficult to maintain international equivalence and recognition.

Product certification systems

ISO/IEC Guide 67 describes seven major types of product certification systems, while noting that the elements in those systems can be combined in other ways to create additional sys- tems. The features of the seven systems described in Guide 67, with the terms updated to those used in the functional approach, are as follows :

System 1a (based on testing)

�� Product samples requested by the certification body �� Determination of the relevant prod-

uct characteristics by testing (ISO/ IEC 17025) or assessment �� Review of the test or assessment

report �� Attestation of conformity.

In this system, the samples taken may not be representative of, or be statistical- ly significant for, the entire population of products as, for example, in a system where the initial products are tested

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and subsequent conformity of produc- tion items is assessed and attested by the manufacturer with no 3rd party involve- ment. Such systems are sometimes re- ferred to as “type approval” systems.

Manufacturers need to be careful not to refer to production items as “certified” as only the initial sample was tested by the certification body. Such statements as “produced to a design certified by xxx” might be acceptable but purchas- ers and end users need to be aware of the limitations of the statement.

System 1b (based on testing all products)

�� Samples requested by the certifica- tion body �� Determination of the relevant prod-

uct characteristics by testing (ISO/ IEC 17025) or assessment �� Review of the test or assessment

report �� Attestation of conformity �� Issue of a licence to use certificates

or marks on the products.

In this system, the entire population is available to the certification body, which will decide whether and to what extent statistical sampling is appropriate. The attestation of conformity will relate to the whole population and a certificate of conformity for each product could be provided by the certification body. Where the system includes the use of a mark of conformity, the certification

body will licence the manufacturer to apply the mark to all of the products covered by the attestation.

System 2 (based on testing plus market surveillance)

�� Samples requested by the certifica- tion body �� Determination of the relevant prod-

uct characteristics by testing (ISO/ IEC 17025) or assessment �� Initial auditing of the production

process or quality system �� Review of the test or assessment

reports �� Attestation of conformity �� Issue of a licence to use certificates

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or marks on the products �� Surveillance by certification body

taking samples from the market and testing or inspection to confirm on- going conformity.

While this system may identify the impact of the distribution chain on conformity, the resources it requires can be extensive. Also, when significant nonconformities are found, effective preventative mea- sures may be limited since the product has already been distributed to the market.

System 3 (based on testing and factory surveillance)

�� Samples requested by the certifica- tion body �� Determination of the relevant prod-

uct characteristics by testing (ISO/ IEC 17025) or assessment �� Initial auditing of the production

process or quality system �� Review of the test or assessment re-

ports �� Attestation of conformity �� Issue of a licence to use certificates

or marks on the products �� Surveillance by testing or inspection

of samples from the factory and au- diting of the production process.

This system includes testing and fac- tory surveillance. Factory surveillance is conducted and samples of the prod- uct from the point of production are assessed for ongoing conformity. This

system does not provide any indication of the impact the distribution chan- nel plays on conformity. When serious nonconformities are found, the oppor- tunity may exist to resolve them before widespread market distribution de- pending on the frequency of surveil- lance. For example, if surveillance is carried out every six months and non- conforming product is found, the entire production since the previous surveil- lance could be suspect.

System 4 (based on testing plus surveil- lance from factory or open market, or both)

�� Samples requested by the certifica- tion body �� Determination of the relevant prod-

uct characteristics by testing (ISO/ IEC 17025) or assessment �� Initial auditing of the production

process or quality system �� Review of the test or assessment

reports �� Attestation of conformity �� Issue of a licence to use certificates

or marks on the products �� Surveillance by testing or inspec-

tion of samples from the factory and auditing of the production process �� Surveillance by testing or inspection

of samples from the market.

This system can both indicate the impact of the distribution channel on conformity and provide a pre-market

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mechanism to identify and resolve seri- ous non conformities. Significant dupli- cation of effort may take place for those products whose conformity is not affect- ed during the distribution process.

System 5 (based on testing, quality system assessment and surveillance, plus ongoing surveillance of product from production, market or both)

�� Samples requested by the certifica- tion body �� Determination of the relevant prod-

uct characteristics by testing (ISO/ IEC 17025) or assessment �� Initial auditing of the production

process or quality system �� Review of the test or assessment

reports �� Attestation of conformity �� Issue of a licence to use certificates

or marks on the products �� Surveillance of production process

or quality system or both �� Surveillance by testing or inspec-

tion of samples from factory, open market or both.

This system includes both testing and the assessment of that part of the quality system which relates to the conformity of the products with the specified require- ments. Surveillance of the quality system is conducted and samples of the product may be taken from either the market or the point of production, or both, and are assessed for ongoing conformity.

The extent to which the three elements of ongoing surveillance – quality system, factory samples and open market sam- ples – are conducted may be adjusted for a given situation. As a result, this system provides significant flexibility for ongoing surveillance.

System 6 (covering certification of pro- cesses and services)

�� Determination of characteristics of processes or services by assessment �� Initial auditing of the quality system �� Review of assessment results �� Attestation of conformity �� Issue of a licence to use certificates

or marks in relation to the process or service �� Surveillance by audits of the quali-

ty system �� Surveillance by assessments of the

processes or services.

This system uses techniques adapted to the characteristics of the service or process under assessment.

Flexibility of conformity assessment

The systems described above repre- sent some of the more common ap- proaches to conformity assessment but other combinations of techniques can be used according to the nature and purpose of the system. The descrip- tions illustrate the flexibility which is

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available to designers and owners of conformity assessment systems. The systems need to be fit for purpose so that the costs involved in their opera- tion and maintenance are consistent with the benefits being obtained and the risks being managed.

International conformity assessment systems

The International Electrotechnical Commission (IEC) operates three con- formity assessment systems under the control of its Conformity Assessment Board (CAB) : �� IECEE for electrical and electronic

products for industrial and domes- tic use. The IECEE system includes two schemes − The CB Scheme, through which

test reports prepared by ap- proved testing laboratories and endorsed by national certification bodies using a CB test certificate can be accepted by other national certification bodies in issuing their own national (or regional) certification

− The CB-FCS Scheme which in- cludes assessment and periodic surveillance of the manufacture of the products as well as the type testing as in the CB Scheme.

�� IECQ for electronic components. There are three schemes :

− The Process Approvals Scheme which provides independent verification that electronic com- ponents and related materials and processes, including those below the user’s level of specification in the supply chain, are compliant to appropriate standards, specifica- tions or other documents

− Hazardous Substances Process Management (HSPM) Scheme using a quality management stan- dard that companies can use to ensure their processes and con- trols adhere to local regulations about hazardous substances, such as lead, mercury and cadmium, in electronic components

− Electronic Component Manage- ment Plan (ECMP) Scheme for avionic components, providing accredited third party assessment of electronic component manage- ment plans, prepared to comply with IEC TS 62239.

�� IECEx relating to safety in explo- sive atmospheres and comprising four schemes : − The Certified Equipment Scheme

for products used in explosion hazard areas, “Ex products”

− The Certified Service Facilities Scheme for the repair of Ex prod- ucts

− The Conformity Mark Licensing System to be used in conjunc-

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tion with the certified equipment scheme

− The Certified Persons Scheme providing evidence of the com- petence of people for a range of specified duties relating to explo- sive atmospheres.

The European Union’s Global Approach to conformity assessment

The Global Approach to conformi- ty assessment is part of a package of legislation designed to remove techni- cal trade barriers within the Europe- an Union (EU) and the wider Europe- an Economic Area (EEA) by aligning the legislation of the member states in areas of particular sensitivity such as safety.

Originally introduced in 1993, it was amended in 2008 through a new leg- islative framework including Deci- sion No. 768/2008/EC 9 July 2008 on a common framework for the marketing of products, and repealing Council De- cision 93/465/EEC. The decision was published in the Official Journal of the EU No. L/ 218 dated 2008-08-13.

The Global Approach specifies a series of conformity assessment modules to be used by legislators when drafting legislation to align the laws of member states, usually on matters relating to

safety, where differing laws have imped- ed trade between member states. For each piece of legislation, usually in the form of an EU Directive, the modules will be chosen in relation to the risks arising from nonconformity with the re- quirements specified in the directive.

For low risks, a supplier’s declaration of conformity will suffice while for the highest risks third party assessment of products and quality management sys- tems will be specified. Various com- binations of modules can be included so as to give suppliers an element of choice according to their circumstances while still maintaining the required level of assurance of conformity.

The conformity assessment modules cover : �� Self assessment by the manufacturer �� Type assessment by an independent

body (“notified body”) �� Quality assurance assessment by a

notified body �� Inspection of production items by a

notified body.

The Global Approach could be regard- ed as a conformity assessment system with the arrangements for each direc- tive being regarded as separate schemes.

For more on the EU system, see http :// ec.europa.eu/enterprise/newapproach/ index_en.htm

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Potential barriers to trade

The potential for conformity as- sessment systems, particularly those operated by regulatory authorities, to create barriers to trade has been recognized and the WTO/TBT Agree- ment was made in order to harmonize the regulations and conformity assess- ment practices in signatory countries (see Appendix 3).

Nevertheless, the procedures operated by conformity assessment bodies can inadvertently discriminate against sup- pliers from other countries. Regulatory authorities and bodies operating in the non-regulated sector are encouraged to ensure that the conformity assess- ment systems operate in an open and consistent manner. Bodies conforming to the requirements of the ISO/IEC standards for conformity assessment bodies are required to operate in an even-handed manner.

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Reference to ISO/CASCO tools

The ISO/CASCO standards and guides (se Appendix 1) define the characteris- tics for a number of different types of conformity assessment bodies. Some, such as testing laboratories and inspec- tion bodies can work as 1st, 2nd or 3rd party bodies, while certification can only be conducted as a 3rd party activity.

Where bodies act in a 3rd party capac- ity, an important feature is that they have to act in an impartial way so that the results of their work can be objec- tive and maintain the highest degree of confidence. The standards for certifica- tion bodies mentioned in the following sections set out the requirements for demonstrating and maintaining impar- tiality.

Testing laboratories

Requirements for testing and calibration laboratories For testing, the main internation- al standard that is used to specify the basic requirements against which com- petence is assessed is ISO/IEC 17025, General requirements for the compe- tence of testing and calibration labora-

tories. ISO/IEC 17025 has two types of requirements, namely : �� Management systems requirements �� Technical requirements.

While the management system re- quirements will be common to all lab- oratories, there is a need to apply the technical requirements to their specif- ic field of work. The potential need for such additional requirements is recog- nised in ISO/IEC 17025 where it in- cludes an informative annex (Annex B) on guidelines for establishing appli- cations for specific fields.

For example, medical laboratories have had to develop supplementa- ry criteria for medical sub-disciplines (such as biochemistry, microbiology etc). In fact, in this instance a separate standard for medical laboratories ISO 15189 has been produced, but it re- mains compatible with ISO/IEC 17025.

It is important for the laboratory to specify the scope of its testing work so that it can be confident that it has the people, equipment and facilities to carry out the work competently. In many cases, the laboratory will use standardized test methods and it is useful for the scope to be specified by

Chapter 4 – Conformity assessment bodies

60

reference to the standards. In this way, clients of the laboratory will be con- fident of its capability to perform the tests which they require.

When the laboratory seeks accredita- tion, the accreditation body will not only assess compliance with the gener- al standard and any field-specific sup- plements, but also their compliance with the technical requirements of spe- cific standard test methods for which the laboratory is recognised. In some cases this will also include specific re- quirements of regulators.

There thus becomes a hierarchy of cri- teria which laboratories may need to satisfy as shown in Figure 5.

The management systems and techni- cal requirements of sector specific stan- dards such as ISO 15189 for medical laboratories are compatible and cover similar issues. However, the language of ISO 15189 is more aligned to terminol- ogy used in clinical testing and includes some specific needs of such laboratories. The content of the management sys- tems requirements of both standards is aligned with the principles in ISO 9001, but again the language has been tai- lored to the needs of laboratories.

Figure 5 – Hierarchy of laboratory criteria

1 2

3

4

1. General requirements for all laboratories

2. Additional requirements for chemical laboratories (e.g. use of certified reference materials)

3. Additional requirements of specific test method (e.g. ISO xyz–controlled temperature limits)

4. Additional requirements of a regulator (e.g. specified reporting or labeling requirement)

ISO/IEC 17025

Supplementary field-specific

criteria (e.g. chemical)

Technical requirements of specific test methods and procedures

Regulatory requirements

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Inter-laboratory comparison testing and proficiency testing Testing laboratories may need to become involved in inter-laboratory comparison testing and in particular with proficien- cy testing. Inter-laboratory comparison testing may be used for a number of purposes including : �� Establishing the effectiveness and

comparability of new test or mea- surement methods and similarly to monitor established methods �� Identifying the reasons for differ-

ences in the results obtained by different laboratories �� Determining the performance of in-

dividual laboratories for specific tests or measurements and to monitor lab- oratories’ continuing performance.

Proficiency testing is the use of inter- laboratory comparison testing for the last of these items but it can also pro- vide information for other purposes in- cluding those listed above.

One of the tasks of ISO/CASCO has been to produce the guide and, more recently, the standard which applies to proficiency testing. Its ISO/IEC Guide 43 was expected to be replaced in 2009 by the new standard, ISO/IEC 17043, Conformity assessment – General re- quirements for proficiency testing.

Proficiency testing can be a powerful tool for the laboratories. Successful

performance can be a major risk man- agement tool, while any poor perfor- mance arising from their participation can be the catalyst to investigate the causes and take appropriate correc- tive action. Because competent profi- ciency testing is so critical to the confi- dence which accreditation bodies need in their recognition of the competence of testing and calibration laboratories, a number of accreditation bodies are now actively involved in accrediting proficiency testing providers.

Many proficiency tests also benefit other stakeholders, as the results of the inter-laboratory tests might also be used in determining values for certi- fied reference materials ; in improving standard test methods ; in re-assuring clients of laboratories, including regu- lators ; and as an educational tool for professional bodies. Figure 6 (see page 62) shows some of the stakeholders in proficiency testing.

Case study – Competence of laboratories in Pakistan The significance of access to credible testing and calibration laboratories to support trade development and access to foreign markets is well illustrated in a recently conducted programme for trade related technical assistance in Pakistan. This involved inputs from a number of agencies over the period 2004-2007, including a number of

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specific activities supported by UNIDO which were targeted at developing the capacity and competence of key test- ing and calibration laboratories and having their competence confirmed through accreditation by a well estab- lished foreign accreditation body.

While developing domestic testing ca- pabilities, the UNIDO inputs also in- cluded parallel upgrading of the capac- ity of Pakistan’s national accreditation body, to ensure the ongoing availability of a domestic resource to demonstrate

the competence of Pakistan’s testing and calibration services.

The specific needs for competent testing and calibration were first es- tablished through various assessments of constraints faced by Pakistan’s exporters in relation to supply side proof of conformity and market con- nectivity issues. These assessments in- cluded specific testing needs associat- ed with : �� Pakistan’s agro-based exports and

sanitary and phyto-sanitary com-

Figure 6 – Stakeholders in proficiency testing (PT)

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pliance (conducted as a joint World Bank-UNIDO initiative) �� Trade related challenges facing ex-

porters in Pakistan by 157 local firms. These included a focus on sec- tors such as textiles, leather, agro- based processing and fisheries (conducted as a joint initiative of UNIDO and the Pakistan Institute of Development Economics) �� A survey of the compliance issues

affecting enterprise clusters in the Punjab province of Pakistan. This covered 195 firms in sectors pro- ducing fans, cutlery, textiles and garments, mangos and tangerines. It included specific needs associat- ed with testing, certification, cali- bration and CE marking, labelling and branding (conducted jointly by UNIDO and the Small and Medium Enterprise Authority).

Exporters in Pakistan had historical- ly relied heavily on foreign testing of their products to achieve internation- al acceptance of their compliance. This was costly and time consuming and particularly for small exporters.

The testing capacity building achieve- ments in Pakistan resulted in : �� Strengthening the metrology infra-

structure through development sup- port of the National Physical and Standards Laboratory. This included upgrading of its calibration services

and their international traceability for mass, volume, length, temperature, pressure and electrical quantities �� Upgrading 19 key testing labora-

tories to achieve compliance with ISO/IEC 17025, including facilita- tion of their access to certified ref- erence materials and 35 internation- al proficiency testing schemes. The focus was placed on microbiological, chemical, textile, leather, and electri- cal testing �� Successful accreditation of 18 of

these laboratories by NA (Norwe- gian Accreditation).

Drivers and benefits for testing and calibration Examining first the drivers and benefits for calibration, it is critical to acknowl- edge that testing depends on the sup- port of competent calibration. If test equipment is not appropriately cali- brated, the results it generates will not be reliable. (Poor data leads to poor decisions based on that data.)

Some calibrations will not require a high level of expertise, and many calibrations may be performed rou- tinely by testing laboratories for their own needs. In these circumstances the calibration can be considered a rou- tine operation of the laboratory, rather than a conformity assessment activity. However, where special measurement expertise is required, laboratories usu-

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ally need to use the services of compe- tent calibration services.

The drivers and benefits for laborato- ries in using these services include the access they provide to traceability of measurement to international stan- dards and information on the mea- surement uncertainty of the devices and equipment calibrated for them. If a testing laboratory wishes to comply with standards such as ISO/IEC 17025, they need to have both measurement traceability and appropriate determi- nation of the measurement uncertainty of their own tests. So, the fundamental benefit and driver for such laboratories in using competent calibration services, is that calibration underpins most labo- ratory activities.

However, calibration is also a founda- tion for confidence in manufacturing, telecommunications, construction, de- fence, aviation, meteorology, mining, health services, general commerce and many other facets of life where decisions are based on measurement. Where the measurements concerned, or the decisions based on those mea- surements, are critical, it is essential that those performing the measure- ments and calibrations are competent to do so.

In some cases, the calibrations may be performed by the organizations them-

selves. In other cases, the use of special- ized, independent calibration services may be needed. For the most accurate measurements needed in a country, they are usually provided by a national measurement institute.

The primary drivers and benefits for testing are similar to those for calibra- tion. Many decisions in society require the availability of data and information which can only be obtained through testing. Testing is therefore an essen- tial feature of daily life. The primary drivers and benefits for testing depend on the criticality of the decisions being made. Judgment on the costs of testing and the levels of expertise needed for their conduct will vary depending on individual circumstances. Some testing may only need to be indicative, while other tests may require highly devel- oped expertise. The degree of benefits derived from testing will thus depend on the needs of individual users, as will the levels of risk taken in choosing appropriate testing services.

Inspection bodies

Requirements for inspection bodies The CASCO standard relevant to in- spection bodies is ISO/IEC 17020, General criteria for the operation of various bodies performing inspec- tion. It was adopted as an Interna-

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tional Standard after originally being produced as EN 45004 by CEN (the European Committee for Standard- ization) and CENELEC (the Euro- pean Committee for Electrotechnical Standards).

The structure of ISO/IEC 17020 is sim- ilar to the standards for laboratories and management systems certification bodies, but it has some unique features. One of these is the classification system it uses for the different types of bodies in- volved. That system is described in three Annexes to the standard, as follows :

Type A inspection bodies These bodies provide third-party ser- vices and are expected to be : �� Independent of the parties involved �� Not involved in the design, manu-

facture, supply, installation, use or maintenance of the items inspected, or similar competitive items �� Accessible to all parties interested

in their services �� Not subject to undue financial or

other conditions and be administered in a non-discriminatory manner.

Type B inspection bodies These bodies provide first-party servic- es to their parent body and are expect- ed to : �� Be a separate and identifiable part

of the organization involved in the design, manufacture, supply, instal-

lation, use or maintenance of the items it inspects �� Have clear separation of the respon-

sibilities of the inspection personnel from those personnel employed in the other functions with established organizational identification and re- porting methods for the inspection body within the parent organization �� Ensure the body and its staff does not

engage in activities that may conflict with their independence of judgement in respect to their inspection activi- ties, including involvement in design, manufacture, supply installation, use or maintenance of the items inspect- ed, or similar competitive items �� Only provide inspection services

to the organization to which the in- spection body belongs.

Type C inspection bodies These bodies are first-party inspec- tion bodies which may also provide inspection services to other organiza- tions, which are not their parent orga- nization. They may be involved in the design, manufacture, supply installa- tion, use or maintenance of the items they inspect. They are expected to : �� Provide safeguards within the or-

ganization to ensure adequate seg- regation of responsibilities and ac- countabilities in the provision of inspection services through their organizational structure and docu- mented procedures.

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The requirements to be met by inspec- tion bodies, as specified in ISO/IEC 17020 include : Administration – Be legally identifiable ; be properly identifiable within a parent organization ; document its functions and scope of its technical competence ; have adequate liability insurance or be protected by national laws ; document its business conditions ; and have inde- pendently audited accounts

Independence, impartiality and integrity – Comply with the obligations for Type A, Type B or Type C inspection bodies Confidentiality – Ensure confidentiality of information obtained during inspec- tion ; and protect proprietary rights

Organization and management – Operate to maintain capability to per- form its technical functions ; define and document responsibilities and report- ing structure, including any relation- ship with its testing or certification functions ; employ a permanent, qual- ified and experienced technical man- ager ; provide effective supervision ; nominate deputies for inspection man- agers ; and provide job descriptions specifying required education, training, technical knowledge and experience

Quality system – Documented quality policy and objectives ; operate a system appropriate to type, range and volume of work performed ; fully documented

system, including a quality manual con- taining the information required by the standard ; designate person authorized and responsible for quality assurance and the quality system ; maintain doc- umentation control ; conduct planned and documented internal audits with auditors independent of functions audited ; and conduct and record man- agement reviews

Personnel – Sufficient personnel with expertise required ; inspection staff with appropriate knowledge, training, experience and specific knowledge of the inspections performed, with abili- ty to make professional judgment and knowledge of the manufacturing tech- nology, manner inspected items are used and defects which may occur ; operate a documented training system ; provide guidance for the conduct of staff ; and ensure remuneration is not directly dependent on the numbers of inspections performed and the results of such inspections

Facilities and equipment – Use suitable equipment and facilities ; rules for use of and access to specified equipment and facilities ; ensure continued suitability ; properly identify equipment ; maintain equipment according to documented procedures ; where appropriate, ensure calibration and re-calibration of equip- ment ; ensure applicable measurements are traceable to national and inter-

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national standards of measurement ; reference standards used only for refer- ence ; maintain in-service checks ; proce- dures for selection of qualified suppli- ers, purchasing documents, inspection of received materials and storage facil- ities ; monitor deterioration of stored items ; ensure computers and automat- ed equipment and software are ade- quate, data is protected, equipment maintained ; security of data main- tained ; and records of equipment iden- tification, calibration and maintenance

Inspection methods and procedures – Use methods and procedures defined to demonstrate conformity ; document- ed instructions for inspection planning, sampling, and inspection techniques ; document any non-standard methods or procedures ; keep up to date and accessible all instructions, standards or written procedures, worksheets, check-lists, and reference data ; oper- ate a contract or work order control system ; timely recording of inspection data ; checking of calculations and data transfers ; and documented instructions for safe performance of inspections

Handling of inspection sample and items – Unique identification of items and samples ; note suitability for inspection ; appropriate preparation of the item ; and documented procedures and facilities to avoid damage or dete- rioration of inspection items

Records – Maintain appropriate system and comply with applicable regula- tions ; include sufficient information for satisfactory evaluation ; and safe storage, while secure and confidential unless otherwise required by law

Inspection reports and inspection certif- icates – Ensure retrievable inspection reports or certificates ; include results and determination of conformity with any additional information needed for understanding and interpretation ; identify any work performed by sub- contractors ; appropriate signatures or other approvals by authorized staff ; and details and justifications recorded for any corrections or additions to in- spection reports or certificates

Subcontracting – Demonstrate com- petence of subcontractors ; advise clients of their use ; ensure client approval ; record results of investiga- tions of subcontractors’ competence ; maintain a register of subcontracting used ; ensure access to qualified, expe- rienced and independent persons used for specialized activities ; and main- tain responsibility for conformity with requirements subject to inspection

Complaints and appeals – Documented complaints and appeals procedures ; and maintain records of all complaints and actions taken by the inspection body

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Cooperation – Exchange experience with other inspection bodies and con- tribute to standardization processes as appropriate.

Case study – Use of inspection for compliance with European Directives Under the “New Approach” Directives established by the European Commis- sion, use is made of “Notified Bodies” which are designated by the Member States of the European Union as com- petent bodies for confirming compli- ance of products with specific regula- tions (Directives). Member States are expected to accept the outputs of noti- fied bodies in other States without the need for separate testing, certification, inspection etc.

These Directives provide a number of Modules which may be used to de- termine compliance with the essential safety or other requirements applicable to a regulated product. When a product is evaluated by a notified body using an appropriate Module, a supplier can confidently label its products with the “CE” Marking to demonstrate com- pliance with the relevant Directive. (There is a separate EC Directive on use of the “CE” Marking. For some products, the compliance Modules for the Directives do not require the intervention of a “notified body”, and suppliers can use manufacturers’

declarations of conformity to assign the “CE” Marking to their products.).

For some Directives, a Notified Body may use inspection as the means of determining compliance with the essential requirements of the Directive. One such directive is the “Measuring Instruments Directive 2004/22/EC”.

To assist consistency in the use of inspection by Notified Bodies involved with the Measuring Instruments Directive, a guide has been produced by the European cooperation in legal metrology (WELMEC). It is enti- tled Measuring Instruments Directive 2004/22/EC – Assessment of Notified Bodies Designated for module F based on EN ISO/IEC 17020 : WELMEC 8.7, Issue 1, May 2008. (Details on WELMEC can be accessed through www.welmec.org).

The guide is intended to provide manu- facturers of measuring instruments and the notified bodies determining their conformity with WELMEC’s view on best practice in this sector. It provides a useful clause-by-clause guide on ISO/ IEC 17020 and a table of the roles of inspection under the various Modules relevant to measuring instruments.

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Drivers and benefits for inspection The drivers and benefits for inspec- tion are similar to those for testing and product certification. As with other forms of conformity assessment, in- spection provides an objective assess- ment of whether or not an inspect- ed item meets the specified needs of a manufacturer, purchaser, retailer, reg- ulator, exporter, importer, designer or other end-users.

In the case of inspection, the deter- mination of conformity may also be based on the professional judgment of people with demonstrable expertise in the technology, utility and limitations of the items under inspection.

This should provide additional confi- dence to the end user, as the competence of the inspection performed is not only based on the overall competence of the inspection body itself, but also on the competence of its inspection personnel.

Inspection is often an essential risk management tool. Many plants, equip- ment and installations require periodic inspections to ensure their safe opera- tion and use. One of the major benefits of many such inspections is that they are performed on-site. This provides an im- mediate opportunity to inform clients if there are any harmful or costly deficien- cies found in the items inspected.

In the context of exports of major ship- ments, early detection of deficiencies through inspection could provide the supplier with an opportunity to rectify the problems before shipment and save both cost penalties and possible rejec- tion in the intended market.

Other “ determination ” bodies

In line with the flexibility of conformi- ty assessment, there are other bodies than testing laboratories or inspec- tion bodies which carry out determi- nation activities. As new fields requir- ing conformity assessment emerge, such as environmental issues relating to energy efficiency and greenhouse gas emissions or food chain supervi- sion, so new techniques are developed. Terms such as “verification” and “vali- dation” may cover different techniques or may simply be colloquial names for the more established techniques such as inspection and testing.

Certification bodies

In the following sections, we consider bodies engaged in three types of cer- tification activity but the list is not ex- haustive : �� Product certification �� Management system certification �� Personnel certification.

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The principles of conformity assess- ment can be applied to other bodies which are independent and impartial and which carry out selection, deter- mination, review and attestation activ- ities.

Product certification bodies

Product certification bodies and their activities Product certification is a comprehen- sive activity in both developed and developing countries and has a much longer history than management sys- tems certification. It is also perhaps the most visible form of certification, as so many products carry the various marks of conformity issued by product certi- fication bodies. Some products, such as electrical appliances and telecommu- nications equipment, often carry mul- tiple marks to satisfy regulators and consumers in different markets.

For the general public and consum- ers this form of certification is perhaps the most recognized and understood. However, many consumers will not necessarily understand the purposes of individual product standards, and thus the significance of their certification. For example, some product standards might only address safety aspects, or only durability. Other standards might cover a combination of performance and safety characteristics.

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The purposes of a product stan- dard may have other features, such as health and environmental impacts, compatibility, energy efficiency etc. Whichever purpose is intended to be covered by a standard, there are two fundamental objectives of such certifi- cation, namely : �� Assisting consumers and end-users

to make better-informed decisions about products in the marketplace �� Assisting suppliers of the products

to achieve marketplace acceptance.

Requirements for product certification bodies The requirements for product certi- fication bodies are specified in ISO/ IEC Guide 65, General requirements for bodies operating product certifica- tion systems. This Guide is expected to be replaced on completion of the pro- posed new standard, ISO/IEC 17065, under preparation by ISO/CASCO. It should be recalled that “product” in this context includes services and processes.

The basic purpose of Guide 65 is to spec- ify the requirements that should be met by a product certification body to dem- onstrate that it is competent and reliable. The Guide is structured to cover the fol- lowing aspects of management and oper- ation of a product certification body : General requirements – Uncondition- al accessibility ; non-discriminatory administration ; products evaluated

against specific standards ; and scope- specific

Organization – Impartial structure ; responsibility for decisions ; person- nel responsibilities for testing, inspec- tion, appraisal, certification, policy for- mulation, decisions, finances, authority delegation, and technical basis for cer- tification ; documented legal identity and structure ; independence of certi- fication decision-making staff ; liability protection ; financial stability ; sufficient trained and knowledgeable staff ; ade- quate quality system ; freedom from undue influences ; rules and structures for appointment of certification com- mittees ; maintenance of impartiali- ty, confidentiality and objectivity from any related body activities ; and com- pliant, appeals and dispute handling

Operations – Use of specific product standards for conformance ; specifica- tion of the basis for the specific type of product certification system used ; and suitability of the bodies or persons un- dertaking testing, inspection and certi- fication

Subcontracting – Documented agree- ments ; responsibility for contracted work ; no delegation of certification functions ; competence and indepen- dence of subcontracted bodies and per- sons ; and applicant’s agreement to use of subcontractor

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Quality system – Responsibilities for policy ; system effective and relevant to type of work performed ; and docu- mented manual and procedure

Conditions and procedures for certifi- cation – Specified conditions and pro- cedures for granting, maintaining and extending certification, and for sus- pending or withdrawing certifica- tion ; and procedures for assessing the effects of significant changes in product design or specification, or in the owner- ship or administration of the product’s supplier

Internal audits and management re- views – Periodic internal audits ; timely

corrective action ; documented results ; and management reviews and associat- ed record

Documentation – Authority for certi- fication body’s operation ; statement of system’s rules and certification pro- cedures ; evaluation procedures used ; financial support and certification fees ; rights and duties of suppliers of certi- fied products, including use of marks ; complaints and appeal procedures ; directories of certified products and their suppliers ; and authorization and control of documents.

Records – Complying with regulations ; demonstrating effective fulfillment

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of certification procedures ; properly identified, managed, retained, disposed of and maintaining integrity and confi- dentiality of the process

Confidentiality – Meeting applica- ble laws ; including confidentiality of body’s own personnel, committees, and external bodies ; and written consent of suppliers for information disclosure

Certification body personnel – Com- petent for functions ; qualification cri- teria ; contracted to comply with rules ; and records of qualifications, training and experience

Changes in requirements – Due notice to interested parties ; and timely adjust- ment by suppliers

Appeals, complaints and disputes – In accordance with procedures ; and re- cords, including remedial actions and their effectiveness

Application for certification – Informa- tion on the certification procedure ; and product suppliers’ compliance and co- operation

Preparation for evaluation – Require- ments clearly defined ; capability to perform the certification ; planning ; and access to appropriate working doc- uments

Evaluation – Conducted against the required standards ; and using criteria specified in the rules of the certification procedure

Evaluation report – Report of findings on conformity ; and prompt provision to applicant and details of any noncon- formities requiring attention

Decision on certification – Based on evaluation findings ; not delegated to outside bodies or persons ; formalized in relevant certification documents ; effective date of certification, scope of products certified and the relevant product standards ; and actions needed for amendments

Surveillance – Documented procedure ; responsibility of suppliers to advise of changes to products, production pro- cesses and quality system ; records of surveillance activities ; and periodic re- evaluation of marked products to con- firm continuing compliance

Use of licences, certificates and marks of conformity – Control over ownership, use and display ; guidance on their use ; and action on misleading use

Complaints to suppliers – Required to be recorded ; appropriate action taken and documented ; and deficiencies rec- tified

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Case study – Product certification of electrical equipment for international acceptance of regulated products Within the Asia Pacific Economic Co- operation (APEC), a number of multi- government agreements have been developed to facilitate acceptance of regulated products amongst member economies, without the need for dupli- cation of conformity assessment activ- ities, such as testing and certification.

One such agreement is the APEC Electrical and Electronic Equipment Mutual Recognition Agreement (EE MRA). While not mandatory for all APEC member economies, it does provide a framework for countries’ regulators to establish processes for acceptance of products from other economies which have agreed to join the MRA.

The EE MRA has three parts available for participation : �� Part 1 : Information Interchange �� Part 2 : Acceptance of Test Reports �� Part 3 : Acceptance of Certification.

The MRA is intended to cover both pre-market and post-market regula- tory compliance needing to be demon- strated through testing or certification. Each economy signing the MRA is expected to designate competent test-

ing and/or certification bodies in their economy.

Where certification is the basis for reg- ulatory compliance, the MRA signa- tories’ designated certification bodies are expected to comply with ISO/IEC Guide 65, the relevant international criteria for product certification bodies.

The overall objective is to facilitate acceptance of regulated products in multiple markets though a single com- pliance process, thus reducing costs for manufacturers and exporters.

Drivers and benefits for product certification As discussed earlier, the two basic drivers for product certification are the provision of information to assist consumers of products and services to make better-informed choices on prod- ucts and to assist suppliers of certified products to achieve market acceptance.

There are, however, a number of other similar drivers and benefits associated with product certification. Product cer- tification often has an important role to play with products that may be sub- jected to technical regulations, (for ex- ample for safety, compatibility, energy efficiency, environmental impact, con- servation, and quarantine). The avail- ability of products with clearly labeled marks, showing their compliance with

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a mandatory standard set by regula- tors, assists regulatory bodies in their market surveillance of products cov- ered by their responsibility.

Additionally, manufacturers may be as- sisted in their selection of components for their own products, if such compo- nents carry marks of conformity with the standards required by the manufac- turers’ end products. The availability of product-certified components might also play a role in facilitating subse- quent certification of the manufactur- ers’ own assembled products.

Retailers have a tool for additional con- fidence in the products they sell, if they are supported by appropriate prod- uct certification. Both importers and exporters also have similar marketing advantages if the products and services they deal with, are certified to facilitate their acceptance in multiple markets.

Management system certification bodies

Management systems certification bodies and their activities The ISO 9000 series of standards are among the best known of the more than 18 000 standards published by ISO. They are utilised worldwide, not only by the countless organizations operating quality systems, but also as

the basis for certification of such or- ganizations’ compliance with the stan- dard. It should be noted that, in line with ISO’s neutrality policy, certifica- tion is not a requirement for conformi- ty with these standards.

The phenomenon of quality systems certification to ISO 9001 is well known in most countries. Such certification is the major activity of those certification bodies accredited by the members of the International Accreditation Forum (IAF), and most countries have multi- ple providers of management system certification. Another feature of this conformity assessment activity is that many of the certification bodies active in this area operate on a multi-nation- al basis.

Apart from ISO 9001, there are other management system standards which are used as the basis for certification, including the environmental man- agement system standard, ISO 14001. There are also emerging demands for certification to other, sector-specific standards, aligned with the quality and environmental system standards, such as ISO/IEC 27001 for information se- curity management systems,

Another significant management system certification activity relates to food safety management, addressed by the ISO 22000 series.

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A significant feature of management system certification is that the stan- dards affected by this form of con- formity assessment are produced, not only by ISO, but by many consortia and companies. For example, many major retail organizations and groups have developed management system crite- ria, against which they expect compli- ance by all of their suppliers. (Some of these are a combination of manage- ment system and product certification requirements).

While some retailers use their own second-party assessments against their proprietary standards, many use the services of recognised third-party certi- fication bodies to demonstrate compli- ance by their suppliers. Bodies accred- iting such certification bodies usually make provision within their accredi- tation scopes to accredit against both ISO management system standards and the proprietary standards of com- panies and groups.

Many companies also expect that bodies certifying against their crite- ria must be accredited to do so. An example is the British Retail Consor- tium (BRC) Food Technical Standard. This is used to evaluate manufactur- ers of retailers’ own brand food prod- ucts. (See www.brc.org/uk/standards/ default.asp).

From a developing country perspec- tive, it is critical to appreciate that the conformity assessment bodies in their countries (or used by their countries) may need to comply with such non- ISO standards. For example, many of the requirements for these standards affect suppliers of fresh foods, agricul- tural commodities, textiles, toys, etc, which are likely to be sourced from de- veloping countries.

Apart from ISO 22000, there are a number of proprietary food man- agement systems related to HACCP (Hazard Analysis Critical Control Point) systems. Some of these criteria for certification have been developed directly by certification bodies as part of their range of conformity assess- ment services.

Requirements for management system certification bodies ISO/CASCO has prepared the fol- lowing standard as the basic criteria for operation of management system auditing and certification bodies : �� ISO/IEC 17021, Conformity assess-

ment – Requirements for bodies pro- viding audit and certification of man- agement systems.

The standard provides a basis for in- ternational consistency for such certi- fication and is thus the base standard used by accreditation bodies when

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assessing the competence of manage- ment systems certification bodies. It replaced two previous ISO/CASCO Guides (ISO/IEC Guide 62 and ISO/ IEC Guide 66).

Implementation of this standard relies also on the availability and use of other critical standards including : �� ISO 9000, Quality management sys-

tems – Fundamentals and vocabu- lary

�� ISO 19011, Guidelines for quality and/or environmental management systems auditing.

While referring to quality and environ- mental auditing, it is intended that ISO/ IEC 17021 and ISO 19011 apply to all forms of management system auditing.

Examining ISO/IEC 17021 in more detail, it is important to note that there are three main features of certifica- tion bodies that the standard address- es in its principles and requirements, namely : �� Competence �� Consistency �� Impartiality.

The standard has a series of principles, general requirements and a number of operational clauses which are expect- ed to be met by certification bodies. In outline, their content is as follows :

Principles – Impartiality, competence, responsibility, openness, confidentiality, and responsiveness to complaints

General requirements – Legal and con- tractual, management of impartiality, liability and financing

Structural requirements – Organization- al structure and top management, com- mittee for safeguarding confidentiality

Resource requirements – Competence of management and personnel, per- sonnel involved in certification, exter- nal auditors and technical experts, per- sonnel records, outsourcing

Information requirements – Public documents, certification documents, directory of certified clients, reference to certification and use of marks, con- fidentiality, information exchange with clients

Process requirements – Initial audit and certification, surveillance activities, re- certification, special audits, suspending, withdrawing or reducing certification scopes, appeals, complaints, records of applicants and clients

Management system requirements for certification bodies – Providing two options, either in accordance with ISO 9001, or general management system requirements.

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The certification process Certification bodies will typically use specialist auditors to undertake their assessments of the management sys- tems of their clients. Such auditors will normally require training in auditing practices and principles (such as those embodied in ISO 19011) as well as being qualified by auditor certification bodies (itself a form of personnel cer- tification).

This should include examination of the auditors’ knowledge of the rele- vant management systems standards. Prior to their recognition as compe- tent auditors, they will be expected to participate in a number of audits in various roles as observers and, pro- gressively, under the supervision of experienced auditors.

It is also necessary for the audit team to include expertise relevant to the technical area in which the client or- ganization works. Such expertise could relate, for example, to the design fea- tures of a product, its means of produc- tion, the ways in which it is used and re- lated legislation and industry codes of practice. It is not uncommon for certi- fication bodies to use external techni- cal auditors as part of the assessment teams to complement the expertise of their own auditors.

Figure 7 outlines a typical sequence in the process of seeking and obtaining certification.

There may be a number of addition- al steps in the above process if, for example, a follow up assessment visit is required to confirm that deficiencies found in the initial assessment visit, have been rectified.

An important component in the pro- cess is the need for ongoing surveil- lance of the certified quality system’s continuing compliance. The frequen- cy of visits and off-site surveillance will vary, and details of these cycles should be publicly available from all certifica- tion bodies.

Case study – Establishment of a management system certification body in Bangladesh A recent UNIDO Technical Assistance project illustrates the ability of existing infrastructures to be used effectively to extend the conformity assessment capabilities in a developing coun- try. In Bangladesh, the lack of a local body for management system certifica- tion was considered a gap, but assessed as an activity with great potential for growth to upgrade the functioning of exporting enterprises and to increase Bangladesh’s share in the international market.

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Figure 7 – Typical certification process

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Creating a totally new structure was considered to be both costly and time consuming. Accordingly, the develop- ment assistance was directed towards the existing Bangladesh Standards and Testing Institution (BSTI), which was already engaged in product certifica- tion, and was found to have an appro- priate structure to also operate as a management system certification body.

Assistance was provided from an expert in a neighboring country with practical experience in the establish- ment and operation of a management system certification body. The expert was mandated to design, establish and implement the system. The scheme was also expected to achieve accreditation as a certification body in a short time- frame to enable it to award certifica- tions with appropriate credibility. The work was divided into documentation, training, implementation, and accredi- tation phases.

Documentation of the system was duly completed in accordance with ISO/ IEC 17021 and implementation of the system started shortly after. All rele- vant committee members and certifi- cation personnel were provided with intensive training on ISO/IEC 17021 requirements.

Early applications for certification were received after public announce-

ment of the new management systems certification scheme, and these ap- plicant bodies later provided valued opportunities for the new conformity assessment service to gain operation- al experience.

The project’s second phase had start- ed with creation of a pool of auditors and technical experts from amongst the trained officers of BSTI for their deployment in the certification pro- cess. Assistance in gaining auditing training and experience was also pro- vided by UNIDO experts. This includ- ed use of experienced UNIDO audi- tors to lead initial audits for three of the applicant organizations. This con- stituted part of the on-the-job training of the new scheme’s auditors and tech- nical experts.

On completion of a full cycle of audits of the early applicants for certification, it is expected that the scheme should have gained sufficient expertise and experience to seek to complete the final phase of the project by applying for independent accreditation.

Drivers and benefits for management system certification ISO/IEC 17021 notes that certification is one means of providing assurance that an organization has implemented a system for the management of rele-

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vant aspects of its activities in line with its policy. Additionally, certification of such a system provides an independent demonstration that the certified system conforms to specified requirements ; is capable of consistently achieving the stated policies and objectives of the or- ganization ; and is effectively imple- mented.

In many cases, the stated requirements for an organization to comply with a management systems standard (and to have that confirmed through third-par- ty certification), will be specified by cus- tomers of that organization. In these cir- cumstances, the driver for compliance may be a business necessity. However, another driver and benefit is often the value that certification of such systems provides internally. For staff of certified organizations, an external confirmation that their organization meets an inter- nationally accepted standard can pro- vide both motivation and satisfaction.

For the organization’s top manage- ment, also, the implementation of a certified system should ensure that they have an ongoing framework for sharing their organization’s objectives (for quality, environment, safety etc) with both internal stakeholders and external parties such as their clients, regulators, etc. It should also ensure that their organization has a consistent and updated source of information on

the processes and resources it needs to meet its policies and objectives.

As with other forms of conformity as- sessment, certification also provides additional benefits, such as a marketing opportunity to inform stakeholders of an organization’s certified status. In a global marketplace, where compliance with management systems standards may be either a requirement or an ad- vantage, the use of certification may be a necessity to trade. This acceptance, in many cases, will be enhanced if the cer- tification body is itself accredited by a body that is a signatory of the MLAs of IAF and/or its regional co-operations. Depending on the type of management system being implemented, (and certi- fied) there are a number of other driv- ers and benefits. These may include, for example, the continual improve- ment opportunities that are available through the inputs of external audi- tors ; additional customer confidence ; reduction in waste ; and management of enterprise risk related to produc- tion, the environment, worker safety, and organizational reputation.

Personnel certification bodies

Personnel certification bodies and their activities Personnel certification bodies have the objective of recognizing the com-

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petence of individuals to fulfill specific requirements. Often the need for such certification is driven by the lack of specific qualifications being available through other means, such as formal qualifications from educational or pro- fessional institutes.

Many personnel certification schemes are related to support for other con- formity assessment activities. Bodies involved in management system cer- tification activities need processes to establish the competence of auditors for various specialized assessments. For example, there are a number of person- nel certification schemes for : �� Auditors of ISO 9001 systems �� Auditors of environmental manage-

ment systems �� Auditors for food safety (e.g. ISO

22000 and HACCP) �� Auditors for occupational health

and safety systems, etc.

Some professional bodies also operate personnel certification schemes, such as, for example, recognition of the com- petence of welding operators using the process defined in the ISO 9606 series of standards.

The relevant ISO/CASCO standard for personnel certification bodies is ISO/ IEC 17024, Conformity assessment – General requirements for bodies oper- ating certification of persons. The stan-

dard includes an informative annex on development and maintenance of a certification scheme for persons. For the purposes of this standard, there are a number of definitions which assist in differentiating certification of persons from other forms of certification. In particular, the following definitions are of relevance :

Clause 3.3 (of ISO/IEC 17024) Certification process All activities by which a certification body establishes that a person fulfils specified competence requirements, including application, evaluation, decision on cer- tification, surveillance and recertification, use of certificates and logos/marks.

Clause 3.4 Certification scheme Specific certification requirements re- lated to specified categories of persons to which the same particular standards and rules, and the same procedures apply.

Internationally, the forum for person- nel certification bodies is the Inter- national Personnel Certification As- sociation (IPC), which previously operated as IATCA. Background on the organization can be accessed at (www. ipcaweb.org). One of the criteria for full membership of IPC is that the

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personnel certification scheme is cov- ered by an accreditation body that is a member of IAF or one of IAF’s region- al body members. IAF has also recently resolved to extend its MLA to include accreditation of personnel certification bodies complying with the appropriate standard, as discussed below.

One other differentiating feature in this standard is the use of examinations with objective criteria for competence and scoring.

Requirements for personnel certification bodies The major requirements to be satisfied by personnel certification bodies to comply with ISO/IEC 17024 are : Organizational structure – Assure interested parties of its competence, impartiality and integrity ; assume responsibility for certification deci- sions ; identify management with key responsibilities ; documentary confir- mation of its status as a legal entity ; documented structure ensuring impar- tiality and participation of balance of interested parties ; appoint a scheme committee ; have appropriate financial resources ; have policies distinguish- ing certification of persons from other activities ; ensure related bodies do not affect its confidentiality and impartial- ity in certification ; not offer training or preparation unless such is indepen- dent of the evaluation and certifica-

tion of persons ; define complaints and appeals policies, including their resolu- tion in an independent and unbiased manner ; and employ or contract suffi- cient people with requisite skills under responsible management

Development and maintenance of a certification scheme – Define meth- ods to evaluate competence of can- didates ; implement a process for de- velopment, maintenance, review and validation of the certification schemes by the scheme committee ; manage and inform interested parties of scheme changes ; ensure criteria for compe- tence defined to meet the standard, supported where needed by explana- tory documents developed by experts, endorsed by the scheme committee and published ; ensure candidates not restricted by undue financial or other limiting conditions ; evaluation of the methods of examination of candidates, ensuring they are fair, valid and reli- able ; and reaffirm annually, with any identified deficiencies rectified

Management system – Operate a suit- able, documented and effective man- agement system meeting the standard ; maintain and ensure understanding of the system at all levels ; and implement document control, internal audits, man- agement review, and provisions for im- provement, and corrective and preven- tative actions

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Subcontracting – Use documented agreement with subcontractors ; do not subcontract certification decisions ; take full responsibility for subcon- tracted work ; ensure subcontractors are competent, comply with the stan- dard, and are independent and impar- tial ; maintain a subcontractor list ; and monitor their performance

Records – Maintain records complying with laws and confirming the status of certified persons ; demonstrate process effectively fulfilled ; properly identified, managed and disposed of, to ensure integrity of the process and confiden- tiality ; and retained for appropriate periods

Confidentiality – Maintain confidenti- ality for all information by all parties involved ; and only disclose to unau- thorized parties with written consent

Security – Ensure security of examina- tions and related items.

Requirements for employees and con- tractors – Define their competence requirements ; contracted to comply with certification rules ; documented duties and responsibilities ; appropri- ately qualified, experienced and tech- nically competent ; maintain qualifica- tion records ; ensure examiners meet relevant competence standards, are fa- miliar with the schemes, with thorough

knowledge of methods and documents for examinations, have written and oral fluency and are free of undue interests

Certification process – Provide full de- scription of the certification process including any codes of conduct expect- ed of certified persons ; use of formal application document ; use of appro- priate written, oral, observational or other examination means ; use of planned and structured examinations with documented evidence to confirm competence of candidates ; appropri- ate reporting of the performance and results of examinations ; decision on certification by persons independent of the examination or training of the candidates ; and provide certificates but maintain their sole ownership

Surveillance – Define the process to monitor certified personnel’s ongo- ing compliance with the schemes pro- visions ; have the procedures and con- ditions for maintenance of certification endorsed by the scheme committee ; and ensure impartial evaluation to con- firm continuing compliance

Recertification – Define recertification requirements ; and have the conditions endorsed by the scheme committee, in- cluding impartial evaluation

Certificates, logos and marks – Docu- ment conditions for use and manage

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the rights for usage ; require certified persons to sign agreement to comply with provisions of the scheme, includ- ing those related to use of certificates ; and address any misleading use of cer- tificates, marks or logos.

Drivers and benefits for personnel certification The availability of an international standard for certification of persons provides a number of benefits. Firstly, it provides a consistent framework and set of requirements to allow the rec- ognition of the competence of people within, and between, countries. This should facilitate employment of cer- tified personnel in various locations, while also providing employers with a benchmark for appointment of staff requiring defined competencies. There are other benefits also, including the reassurance provided when certi- fication may need to be updated (and re-examined) as requirements for com- petence change or there are changes in the processes and technologies need- ing certified personnel.

As with other types of conformity as- sessment, the confidence provided by personnel certification may be further enhanced if the bodies concerned are accredited for their own competence. The proposed extension of the IAF MLA to cover such certification bodies should facilitate the greater portability

of certifications of persons across na- tional boundaries.

Qualification of conformity assessment bodies There are several ways in which the competence and impartiality of con- formity assessment bodies can be as- certained. The bodies could form a mutual recognition group such as the IECEE system for electro-technical product certification bodies or ILAC for laboratory accreditation bodies. The bodies could be assessed by an in- dependent body, generally known as an accreditation body or they might be appointed for specific tasks by a regu- latory authority. These alternatives are discussed below.

Recognition arrangements and agreement groups

In order to facilitate cross-border ac- ceptance of conformity assessment re- sults, conformity assessment bodies have for many years established recip- rocal recognition arrangements with each other. The arrangements have in- cluded the assessment of each other’s facilities and competence so as to pro- vide confidence in the conformity as- sessment results. In some cases these arrangements have extended to in- clude conformity assessment bodies from other countries, forming multi- lateral agreement groups. By using a

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peer assessment process, such as that discussed in Chapter 2, these groups have been able to share the cost of the assessments and to promulgate good practice in their field.

ISO/IEC Guide 68 provides guidance on setting up arrangements for the rec- ognition and acceptance of conformity assessment results. The guide provides information on the elements of an agreement and advice on setting up an agreement group, stressing the impor- tance of using internationally agreed criteria such as those in the CASCO toolbox. It mentions peer assessment and accreditation as methods for es- tablishing the basis for confidence in the results produced by the members of the group.

The guide also advises that these two techniques can be used in a comple- mentary way as, for example, where accreditation can provide assurance on the organization and management systems of the members while peer assessment can concentrate on the technical aspects.

Accreditation bodies

Accreditation is the term applied to the third party assessment of the con- formity of conformity assessment bodies with the relevant standards. It is defined in ISO/IEC 17000 as :

Clause 5.6 Accreditation

third party attestation (5.2) related to

a conformity assessment body (2.5) conveying formal demonstration of its competence to carry out specific tasks

The key words in this definition are competence and specific conformity as- sessment tasks. It is important to note that recognition of competence is the principal objective of accreditation and such recognition is for specific tasks. Some accreditation bodies have specif- ic capabilities, such as accreditation of the competence of laboratories, for ex- ample, or for accreditation of certifica- tion bodies. Some accreditation bodies are multi-functional and cover a broad range of conformity assessment bodies and others are more narrowly focussed on speciality areas.

Accreditation bodies are often ap- pointed by national governments and hold an important position in the con- formity assessment hierarchy. They provide confidence in the impartiality and competence of conformity assess- ment bodies. The criteria for accred- itation bodies are specified in ISO/ IEC 17011. As accreditation bodies are at the top of the confidence pyramid, there is no higher level body to assess their conformity with the require- ments. Instead, accreditation bodies

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from different countries have formed multi-lateral agreements through which they carry out peer assessments on each other as described in Appen- dix 2.

Role of accreditation in support of governments There are many ways in which ac- creditation can support and inter- act with governments. Governments themselves are often the operators of their economy’s national accreditation bodies. Some governments also view accreditation as a public interest activi- ty and have proposed that there should be no forms of commercial competi- tion between accreditation bodies. This view is strongly evident, for example, in the European Commission’s develop- ment of its policy on accreditation in its revision of its “New Approach” techni- cal regulations.

In other economies and regions there may be a mixture of government and non-government accreditation bodies, or solely non-government bodies. Many of the non-government accred- itation bodies also operate on a not- for-profit basis, and may have formal government support and recognition of their roles on behalf of government.

Within national quality infrastructures, governments often accept responsibil- ity for national systems for legal me-

trology, provision of standards of mea- surement (national measurement institutes) and accreditation servic- es. Where commercial bodies deliver some or all of a particular service, gov- ernments often accept the responsibil- ity for the appropriate delivery of the service. These services are rarely com- mercial and often require government financial support.

Some of the specific ways in which accred- itation supports governments include :

�� As a client of accreditation services Governments may operate their own laboratories, inspection activities, and certification systems. This provides the clients (or other affected parties) of government laboratories, certifi- cation systems, etc, and the public at large, with reassurance that the govern- ment’s own conformity assessment ca- pabilities are independently evaluated and recognised for their technical com- petence.

�� As a user and/or purchaser of servic- es from accredited facilities

Governments are significant users of non-government services, including goods and services requiring confor- mity assessment. Accreditation of the bodies which carry out conformity as- sessment provides governments with additional confidence for their pur- chasing needs that compliance with

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their specifications has been confirmed by competent bodies.

�� As a specification body for confor- mity assessment services

Government departments, regulato- ry authorities and agencies will often specify the use of accredited bodies. References to accredited bodies may be found in their public policies, gov- ernment specifications and regulations. This again provides governments with additional confidence that consumers and society in general have been pro- tected by the use of competent bodies in determining compliance with laws, regulations and specifications.

�� For underpinning government-to- government mutual recognition agreements for conformity assess- ment activities

As discussed in Appendix 2, some gov- ernments have recognized (or des- ignated) their national accreditation bodies as the bodies which will dem- onstrate competence of conformity as- sessment activities in their economy, relevant to specific regulated sectors covered by government-to-govern- ment MRAs.

�� For liaison on trade and technical barriers to trade

Some governments work closely with their accreditation bodies, at various levels of formality, in their negotiation

of trade and technical barriers to trade issues with foreign governments. The availability of a well-established ac- creditation body also provides govern- ments with a resource to demonstrate that their economy has a process avail- able to achieve the objectives of accep- tance of foreign conformity assessment certificates and data as sought in the WTO Agreement on Technical Barri- ers to Trade.

Role of accreditation in support of private sector Accreditation also supports the private sector in many ways. Firstly, for accred- ited conformity assessment bodies oper- ating in the private sector accreditation provides the following support :

�� As a benchmark for performance Many conformity assessment bodies operate in isolation from their peers. By being subjected to assessments by experts for compliance with accredi- tation criteria, these bodies are able to have independent confirmation that they are operating at levels that others have judged to be competent. Where deficiencies are revealed, through the accreditation process, the bodies also have the opportunity to initiate correc- tive action and thus improve their on- going performance.

�� As a recognition of competence Accreditation provides a public-

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ly available recognition of the spe- cific competencies of the accredited conformity assessment bodies. This enhances the acceptance of the out- puts of accredited bodies by regula- tors, suppliers, purchasers, consumers, etc., including both the direct clients of the conformity assessment bodies, and other parties which may have an inter- est in their reports, certificates, qualifi- cations of personnel, etc.

�� As a marketing advantage Accreditation can provide a market- ing advantage for conformity assess- ment bodies. Customers of conformity assessment bodies that are accredited should have more confidence, know- ing that such bodies have been subject- ed to independent evaluation of their competence through the accreditation process.

�� For international recognition Where conformity assessment bodies are accredited by bodies which are signatories to the MLAs of IAF, ILAC, or their regional Cooperation Bodies (APLAC, EA, ILAC, PAC and SADCA), they have access to interna- tional recognition as competent bodies in multiple foreign markets.

Secondly, other groups in the private sector, which do not operate their own conformity assessment activities, should also receive support from the accredi-

tation process. These include :

�� Private sector specification and pur- chasing bodies

Such bodies reduce their risks if they use accredited conformity assessment bodies. They may also avoid costly re-testing, inspecting or certifying if a non-accredited body’s results are not acceptable. Use of accredited bodies should also enhance the purchaser’s own customers’ confidence in their goods and services.

�� Importers and exporters Exporters may be able to reduce costly duplication of conformity assessment of their exported goods and services if their compliance with foreign require- ments is provided by accredited con- formity assessment bodies. Similarly, importers may be able to accept imported goods and services with addi- tional confidence if they are covered by foreign conformity assessment bodies that are accredited. This often will be facilitated even more if the foreign ac- creditation body is a signatory to the ILAC or IAF MLAs.

�� Trade associations, industry bodies, professional bodies and consumer associations

Trade associations, and bodies repre- senting industry groups, professional societies, and consumer associations, may be supported by accreditation in

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a variety of ways. Often, for example, such bodies may be represented on the governing bodies, and the advisory and technical committees of accreditation bodies. They therefore have opportu- nities to contribute to the operations of accreditation bodies and to have their own members’ interests consid- ered in the delivery of appropriate ser- vices by the accreditation bodies and the conformity assessment bodies they accredit. (ISO/IEC 17011 requires ac- creditation bodies to ensure that there are appropriate balances of interests in their governance).

Governmental appointment

Where governmental regulations require conformity assessment to be carried out by 3rd party bodies, those responsible for the regulations should specify the criteria which the bodies should meet. The most universally acceptable criteria are those found in the CASCO toolbox (see Appendix 1). The criteria could include a require- ment for the bodies to be accredited by a specified body or by, for example, a signatory to one of the international mutual recognition arrangements such as IAF or ILAC. In some cases those implementing the regulations could make a direct appointment of the bodies based either on the assessment of their competence by the regulatory authorities or by a body nominated by them.

Where there is an urgent need for conformity assessment arrangements to be set up, the regulatory authori- ties could decide to directly assess and appoint bodies. However, the basis of the assessment might not be clear and it could be difficult for the bodies and their certificates to gain recognition in other countries.

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UNIDO’s approach to sustainable industrial development

UNIDO, the United Nations Industri- al Development Organization, holds a special place in the United Nations system as the only organization that supports sustainable industrial devel- opment as a way of creating wealth and alleviating poverty.

With its portfolio of trade capacity building projects, the largest in the UN, it helps developing countries and econ- omies in transition to better integrate with the world economy. It mobi- lizes knowledge, skills, information and technology to promote produc- tive employment, create competitive economies and ensure a sound envi- ronment ; and it further enhances the value of its work by promoting coop- eration among international develop- ment agencies, public institutions and the private sector at global, regional, national and sectoral levels.

UNIDO’s primary focus is on sup- porting international competitive- ness in the small and medium enter- prise (SME) sector, the key generator of wealth in most developing countries

– and here setting up a quality infra- structure with conformity assessment at its core is an essential foundation – but it also supports environmental sus- tainability, playing a leading role in im- plementing the Montreal Protocol for the elimination of ozone-depleting substances (ODSs) and the Stockholm Convention for the elimination of per- sistent organic pollutants (POPs).

UNIDO’S thematic priorities UNIDO has focused its development efforts on three inter-related thematic priorities : �� Poverty reduction through produc-

tive activities �� Trade capacity building �� Energy and environment.

UNIDO services supporting the themat- ic priority of poverty reduction through productive activities improve the busi- ness environment and lay the policy and institutional foundations for the devel- opment of a vibrant private sector. They promote domestic entrepreneurship, es- pecially development of the entrepre- neurial skills of disadvantaged groups. They link domestic enterprises to in- ternational investment and technol- ogy flows, and they facilitate access to the resources and support services that

Chapter 5 – What UNIDO can contribute to setting up a quality infrastructure

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small and medium enterprises require to become more competitive.

The thematic priority of trade capaci- ty building combines services that, on the one hand, build the supply-side capacities that enable enterprises to manufacture products with high-ex- port potential in the quantities and quality required by the markets and, on the other hand, build the quality infra- structure capacities that enable these enterprises to prove that their products conform to international standards or private buyer technical requirements.

Services supporting the thematic prior- ity of energy and the environment are rural energy for productive use (with an emphasis on renewable energy) ; energy efficiency, including support to the Kyoto Protocol (climate change, greenhouse gasses) ; cleaner and more sustainable production, including National Cleaner Production Centres ; water management ; and support for the Montreal Protocol and the Stock- holm Convention.

Partnerships with other UN agencies UNIDO is an active supporter of the UN “Delivering as One” initia- tive launched in 2007. Also known as “One UN”, its aim is that the UN family deliver its services in a more co- ordinated way at the country level. A

consolidated UN presence – with one programme, one budgetary frame- work and an enhanced role for the UN Resident Coordinator – that builds on the strengths and comparative advan- tages of the different UN agencies, will ensure faster and more effective de- velopment operations. This will reduce duplication and transaction costs so that the UN can use its resources more effectively to support partner countries achieve their development goals.

UNIDO’s approach to trade capacity building – the 3Cs

The development of industrial exports is a multidimensional process. It requires effective policies and gover- nance systems that will create a stim- ulating environment for trade, and a wide diffusion of knowledge, informa- tion, skills and technologies across eco- nomic agents and institutions to ensure that export growth is diversified and sustainable and contributes to the cre- ation of an equitable society.

To effectively address the many com- plex factors underlying successful in- dustrial exports, UNIDO has adopted a holistic approach to trade capaci- ty building that takes into account the whole “product to market” chain. It has dubbed this its “3C” approach : com- pete, conform, connect (see Figure 8). The first two links, “compete” and

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“conform”, are at the core of UNIDO’s mandate and address, respectively, the capacity shortfalls of supply and proof of conformity with standards. The third link, “connect”, addresses short- falls in connecting to the market and is primarily the domain of other develop- ment partners.

Supplying the market : “ Compete ” Shortfalls in supply-side capacity render developing country industry unable to produce goods that are attractive to the market and meet the requirements of quantity, price, delivery time and in- ternational quality standards (safety, health and environmental).

UNIDO helps countries to compete by strengthening their capacity to

produce competitive goods. Its proj- ects are based on a rigorous analysis of competitive potential at product and sub-sector level and of supply-side con- straints. Its services focus on SMEs and include the creation of a policy environ- ment that stimulates trade, the upgrad- ing of industrial activities (including clus- ter and export consortia development) and the creation of capacity to meet in- ternational standards, client require- ments and environmental regulations.

Proving conformity with standards : “ Conform ” Shortfalls in proving conformity with standards arise when a country’s qual- ity infrastructure does not meet interna- tional conformity assessment stan- dards. These standards are exacting. Non-compliance can be due to an

Figure 8 – The 3Cs : Compete, Conform, Connect

Compete Conform Connect

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inadequate or non-existent quality policy, the unclear legal status of the in- frastructure, unsuitable premises, or problems with management structure, staff or equipment. The bottom line is that the country’s laboratory results and audit certificates are not recog- nized and its exports not fully accepted internationally.

UNIDO helps countries prove confor- mity by upgrading their quality infra- structure so that they can develop and harmonize standards and ensure that their domestic laboratories have the sampling and testing capacity to cer- tify products and enterprise systems. With the increased effectiveness and reduced costs resulting from an im- proved quality infrastructure, larger shares in export markets may be cap- tured and local customers are better protected from sub-standard products.

Connecting to the market : “ Connect ” In many developing countries, the cus- toms procedures, mechanisms and doc- umentation flows may be cumbersome and slow ; roads, ports and other utili- ties are non-existent or in bad repair ; knowledge of the multilateral trading system is poor ; there is insufficient in- volvement in negotiating international trade agreements ; and access to devel- oped country markets is hampered by quotas, tariffs and customs duties.

Activities to help countries connect with markets include infrastructure projects, such as improving roads and ports, developing capacities to facili- tate cross-border transactions, increas- ing the countries’ understanding of in- ternational trade rules and helping them to play an effective role in inter- national trade negotiations and agree- ments. Several international organi- zations, including UN agencies, work towards improving such infrastruc- tures.

The WTO TBT and SPS Agreements : additional conformity challenges Though standards and regulations may enhance the free flow of goods and services, experience has shown that they can also be used to create unnec-create unnec- essary obstacles to trade and protec- and protec- protec- tionism, often particularly disadvan- taging developing countries.

In order to prevent countries from ex- ploiting standards as unnecessary bar- riers to trade, the WTO, as the global organization dealing with the rules of trade between nations, requires its members to adhere to the WTO Agreement on Technical Barriers to Trade (TBT) and to the WTO Agree- ment on Sanitary and Phytosanitary Measures (SPS).

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Delivering services at the national, regional and sub-regional levels Developing the quality infrastruc- ture needed to achieve a competent conformity assessment system, which also satisfies the requirements of the TBT and SPS Agreements, is a high- cost venture for a developing coun- try. Such an infrastructure needs to provide access to the full set of stan- dards and adequate capacities in test- ing, calibration, legal metrology, certi- fication, accreditation, inspection and traceability. A regional or sub-region- al approach to trade capacity building will ease costs and may also have other advantages.

From its practical experience, UNIDO has, in fact, determined that address- ing trade capacity issues at the sub-re- gional level stimulates greater market integration and can lead to the pene- tration of global markets that would lie beyond the reach of individual countries. Sub-regional development projects can also be more cost-effective – one common accreditation body may, for example, be sufficient for a group of countries.

Indeed, due to the existence of an in- creasing number of regional econom- ic cooperation and trade agreements (sometimes with overlapping member- ship), the regional harmonization of standards and conformity assessment

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procedures has now become a necessi- ty. And regional programmes can also help developing countries to prepare a common position in trade negotiations and effectively voice their quality in- frastructure needs.

UNIDO has a long experience in building and strengthening capaci- ty at the regional level, most particu- larly in Africa where it has three re- gional programmes under way. The first, for the West African Economic and Monetary Union (UEMOA), is in its second phase while the second, for the Economic Community of West Af- rican States (ECOWAS), is in its first phase. The third, for the East African Community (EAC), is being finalized. Elsewhere, it has technical assistance programmes under consideration or already developed for Central America and the Andean Communi- ty, the Mekong Delta countries and the South Asian Association for Regional Cooperation (SAARC), and the Middle East, the latter in cooperation with the Economic and Social Com- mission for Western Asia (ESCWA) and the Arab Industrial Development and Mining Organization (AIDMO).

Forming partnerships to build trade capacity Partnering with other agencies in trade capacity building is an important di- mension of UNIDO’s developmental

work. Its 3C approach to trade capacity building embodies an integrated multi- agency response with other multilater- al organizations and agencies, national agencies and professional institutions, where it has entered into a number of strategic partnerships to increase effi- ciency and effectiveness and to avoid duplication.

UNIDO concentrates its own efforts on developing competitive supply ca- pacity and setting up quality infrastruc- tures that comply with standards and technical regulations in accordance with the WTO SPS and TBT Agree- ments. On connecting to the market and the multilateral trading system, it looks to other organizations and agen- cies, such as the WTO, the ITC and UNCTAD, for specialized knowledge. This approach is in line with the recom- mendations of the WTO Aid for Trade Task Force, the 2005 Paris Declaration on Aid Effectiveness and the UN sys- tem-wide coherence goals.

Some of the strategic partnerships that support UNIDO’s specialized role in trade capacity building are : �� The Standards and Trade Develop-

ment Facility (STDF). The STDF co- ordinates technical cooperation, the mobilization of funds, the exchange of experience and the dissemination of best practice to assist developing countries enhance their expertise

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and capacity to analyze and imple- ment international SPS standards. Members are the WTO, the ITC, UNCTAD, the Food and Agricul- ture Organization (FAO), the World Bank, the World Health Organiza- tion (WHO), the World Organization for Animal Health (OIE), the Inter- American Institute for Cooperation on Agriculture (IICA), and UNIDO �� The Joint Committee on Coordi-

nation of Assistance to Developing Countries in Metrology, Accredita- tion and Standardization (JCDC- MAS). The participating bodies are ISO, UNIDO, the ITC, the Interna- tional Electrotechnical Commission (IEC), the International Bureau of Weights and Measures (BIPM), the International Organization for Legal Metrology (OIML), the In- ternational Laboratory Cooperation (ILAC), the International Accredi- tation Forum (IAF) and ITU-T (the Telecommunications Standardiza- tion Sector of ITU, the Internation- al Telecommunication Union) �� The Enhanced Integrated Frame-

work (EIF). The EIF helps the least developed countries (LDCs) en- hance their trade development ca- pacity and integrate with the multi- lateral trading system. Members are the IMF, the ITC, the World Bank, UNCTAD, UNDP, the WTO and UNIDO (as a full implementing partner)

�� The Multi-Agency Support Team (MAST), comprising the FAO, the IMF, the ITC, UNIDO, the World Bank, the WTO and the Organiza- tion for Economic Co-operation and Development (OECD). MAST was established by the UNCTAD Sec- retary-General’s Group of Emi- nent Persons on Non-Tariff Barriers to work on better defi nition, classi- on better definition, classi- fication and quantification of non- tariff measures (NTMs) that con- stitute barriers to trade, and to help policy makers and trade negotiators in developing countries, especially in LDCs, build their capacities in deal- ing with non-tariff-barrier-related negotiating issues at the multilater- al forums.

And last, but definitely not least as partners, are the key donors to UNI- DO’s trade capacity building activities : the European Union, Austria, France, Italy, Japan, Norway, Switzerland and the United Kingdom.

Building a quality infrastructure : UNIDO’S approach

Building a quality infrastructure that will enable developing country enter- prises to meet the demands of a multi- lateral trading system – to ensure and to prove that their products conform to international standards, both of private

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buyers and of regulatory authorities – is a complex challenge that has to be met in several organizational dimensions. The typical building blocks of a quality infrastructure are standards, metrolo- gy and conformity assessment. The last, conformity assessment, includes the key components of inspection, testing, certi- fication and accreditation.

Developing a quality policy Experience suggests that there is a log- ical path for developing a quality in- frastructure. The best start is that the government develops and approves a quality policy giving details of the qual- ity infrastructure components and their relevant responsibilities. This would fa- cilitate a proper division of work. The quality policy should also detail the rela- tionship of the quality infrastructure with the country’s technical regulations, e.g. if it provides services related to the tech- nical regulations. No developing coun- try can afford to duplicate resources in two parallel systems, one for the market place and another for the regulatory au- thorities.

Establishing key organizations Once the quality policy is approved, the government takes a leading role in establishing key quality infrastructure organizations. In developing econo- mies, this government involvement in the early stages is essential. It gives the quality infrastructure organizations a

semblance of authority, both with regu- latory agencies and in the marketplace, and it provides the necessary finances since industry is not yet in a position to do so. Some quality infrastructure ser- vices will, however, always be funded totally or in large part by the govern- ment. These include fundamental me- trology, standards development, stan- dards information and accreditation. This is a very real sustainability issue for all UNIDO projects.

Meeting the costs When industry can afford to pay market prices for these services, the quality infrastructure organizations, especially those providing conformity assessment services (inspection, test- ing and certification), typically trans- form from government organizations providing subsidized services to com- mercial organizations providing ser- vices on the “user pays” principle at market prices. This is a very healthy de- velopment and UNIDO supports it in its projects, as far as is practicable.

However, even with the private sector paying market prices for conformity assessment services, the cost of main- taining a fully fledged national quali- ty infrastructure at the advanced level needed to ensure that development and trade are sustained is still often prohibitive. One solution is that parts of the quality infrastructure are jointly

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owned or shared by one or more coun- tries, as is in fact the case in some de- veloped countries where one country may rely entirely on another for spe- cific services. Agreement to such re- gional or bilateral services is a policy decision to be taken by governments themselves and, though bringing net benefits in economies of scale, will re- quire ongoing political and financial commitment.

Taking an integrated approach The building of a quality infrastructure should be based on a thorough needs assessment of all parts of the economy and should recognize that there is no ready-made model. The specific needs, once identified, must be considered carefully and the quality infrastructure planned and built in phases, with par- ticular attention to ensuring that it is sustainable – which will, of course, re- quire a clear government commitment to provide the necessary resources and finance.

The success of any intervention de- pends on coordination and collabora- tion between the government minis- tries and development agencies. The Joint Committee on Coordination of Assistance to Developing Countries in Metrology, Accreditation and Stan- dardization (JCDCMAS) is the forum for coordination of developing-country issues related to quality infrastructure.

In the broader context of trade capacity building, which includes building quality infrastructure capacity, an effort to improve coordination and collab- oration has been made by twenty-one organizations and five inter-agency bodies under the auspices of the UN Chief Executives Board. The fruit of their efforts has been published in the 2008 Interagency Resource Guide on Trade Capacity Building (available at http ://www.unido.org/fileadmin/media/ documents/pdf/TCB/TCB_Inter-agency _Resource_Guide_2008.pdf).

This guide has been developed to make it easier for developing countries and local UN country teams to draw on the wealth of UN-wide expertise when designing technical assistance pro- grammes. The guide is also intended to facilitate collaboration between UN agencies.

UNIDO’s capacity evaluation and needs assessment tools A UNIDO project to build quality in- frastructure capacity is broadly based. It begins with context-specific desk research and field missions to identify challenges at four levels : government policy and the regulatory framework, national quality infrastructure, sectors and value chains, and enterprises. Alertness is maintained for opportu- nities to cooperate with other bilateral and multilateral organizations in needs

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assessment and project development and implementation.

A project can call on a number of UNIDO tools to deploy in its desk and field research. These relate to trade challenges at the enterprise level, key export sector supply-side constraints, quality infrastructure constraints and product refusals / notifications.

Data on trade-related challenges at the enterprise level. Enterprise-level chal- lenges are identified using data from a UNIDO designed survey on “Trade- Related Challenges Faced by Export- ers” which has profiled a range of geo- graphical areas, levels of economic development and economic structures.

UNIDO’s Trade and Industry Com- peti tiveness Analysis Tool is used to profile supply side constraints in a number of ways : �� A nation-wide assessment of trade

and industry competitiveness anal- yses the factors that drive national manufacturing growth �� A value chain analysis of key stra-

tegic sectors identifies high value- added stages in the production pro- cess where a country can benefit from specialized export markets �� A product analysis methodology for

trade negotiations helps negotiators identify potential winning and vul- nerable products in trade agreements

�� The costs of doing business presents the factors that influence investment decisions in key strategic sectors �� An industrial observatory gives on-

line access to all indicators of trade and industry competitiveness so that a country can benchmark its per- formance against competitors, role models and global threats.

Data on quality infrastructure con- straints. UNIDO has compiled data to identify the gaps and assess the spe- cific needs of quality infrastructures (Figure 9) in 32 African countries. This African data is continually updated, and the scope and geographic cover- age has been extended to include Asia, the Pacific Island States and the Arab region. The data is valuable in projects targeting the harmonization of stan- dards and technical regulations at the regional level.

Product refusals/notifications tool. Also helpful for needs assessment is UNIDO’S “Enhanced classifica- tion of Non-Tariff Measures (NTMs) / Non-Tariff Barriers (NTBs) to Trade”. The tool was developed by the Multi- Agency Support Team (MAST), com- prising the FAO, the IMF, the ITC, the OECD, UNIDO, the World Bank and the WTO.

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Quality infrastructure building blocks Standards : A standards institution publishes standards – formal docu- ments, generally developed by con- sensus, containing the requirements that products, processes or services should comply with. Standards are, in themselves, voluntary, i.e. suppliers can choose whether to use them or not. It is only when they form part of a contract, for example, or are referenced in tech- nical regulation, that compliance with them becomes legally binding.

Typical standards institutions are a na- tional standards body (NSB), sectoral standards development organizations (SDOs) and industry-based standards organizations. Although most nation- al standards bodies are public organi- zations, there are a few private ones. A public national standards body is usu- ally a monopoly, and a private one has an agreement with the government to similar effect. Standards development organizations are mostly private.

Figure 9 – Quality infrastructure

QUALITY INFRASTRUCTURE

CONFORMITY ASSESSMENT

proof that technical requirements are met :

testing, inspection, certification

METROLOGY measurement

standards underpin testing & calibration

ACCREDITATION assures

competence

STANDARDS specific technical

requirement of product or system

S U

P P

L IE

R

C U

S T

O M

E R

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ISO/CASCO is responsible for devel- opment of joint ISO and IEC stan- dards and guides on conformity assess- ment. To date, a total of 27 standards and guides have been generated. Ap- pendix 1 contains a full listing of these standards and guides.

Metrology is the technology or science of measurement. It can be subdivid- ed into scientific metrology (the high- est level of measurement standards), legal metrology (the assurance of the correctness of measurements that affect the transparency of trade, law enforcement, health and safety) and industrial metrology (the satisfacto- ry functioning of measurement instru- ments used in industry, production and testing).

Typical metrology institutions are a na- tional metrology institute (NMI), a na- tional calibration service, calibration laboratories (public or private) and a legal metrology department (LMD). The national metrology institutes are invariably public organizations as are, by definition, the legal metrology de- partments. Calibration laboratories may be public or private.

Conformity assessment The following items are the most common conformity assessment activities.

Inspection is the examination of a prod-

uct design, product, process or installa- tion and the determination of its con- formity with specific requirements or, on the basis of professional judgment, with general requirements. Inspection is often conducted on consignments, for example import inspection, to ensure that the whole consignment is equiva- lent to the product sample tested.

Typical inspection institutions are import inspection agencies and gen- eral inspection agencies. These can be public or private agencies and normally compete in the market place.

Testing is the determination of a prod- uct’s characteristics against the re- quirements of the standard. Testing can vary from a non-destructive eval- uation (e.g. X-ray, ultra sound, pres- sure testing, electrical, etc., after which the product is still fit for use) to a to- tally destructive analysis (e.g. chemi- cal, mechanical, physical, microbiolog- ical, etc., or any combination of these), after which the product is no longer fit for use.

Typical testing institutions are test lab- oratories, pathology laboratories and environmental laboratories. These can be public or private laboratories and normally compete in the marketplace.

Certification by a certification body formally establishes, after evaluation,

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testing, inspection or assessment, that a product, service, organization or in- dividual meets the requirements of a standard.

Typical certification institutions are product certification organizations and system certification organizations. These can be public or private orga- nizations. Competition in the market place is the norm.

Accreditation provides independent attestation of the competence of an individual or an organization to offer specified conformity assessment ser- vices (e.g. testing, inspection or certifi- cation).

The typical accreditation institution is the national accreditation organiza- tion. This is usually a public body with a defined monopoly.

There are a few conflicts of interests that have to be considered when estab- lishing a quality infrastructure : �� The accreditation function cannot

be carried out by an organization that also provides conformity assess- ment, i.e. inspection, testing and cer- tification �� The national standards body may

also become the national accredita- tion body, but then it may not pro- vide any conformity assessment ser- vices

�� Although fundamental metrolo- gy and accreditation is not per se a conflict of interest (as defined by the BIPM, ILAC and the IAF) it is considered close to being one, and hence UNIDO encourages devel- oping countries to avoid this combi- nation. In particular, a body which accredits calibration laboratories cannot itself provide calibration ser- vices.

Building a standards infrastructure

Definition of a standard There are two commonly used defini- tions of a standard. ISO/IEC Guide 2 defines a standard as a document estab- lished by consensus and approved by a recognized body, which provides, for common and repeated use, rules, guide- lines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. The WTO TBT Agree- ment, on the other hand, defines a stan- dard more restrictively, highlighting aspects important for the Agreement, namely the notion that standards are voluntary and are limited to products. Hence, from a quality infrastructure perspective, the ISO definition is more useful, but the fact that standards in themselves are considered voluntary, as defined in the WTO TBT Agreement, should always be kept in mind.

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Typical standards institutions The typical standards institution is the national standards body.

Hierarchy of standards An important consideration in develop- ing projects on standards is the hierar- chy of standards as shown in Figure 10. At the top we have international stan- dards, published by international stan- dards organizations, of which there are quite a few. For manufactured goods these include the top tier organizations, ISO, the IEC and the ITU. In food and agro-processing we have the Codex Al- imentarius Commission (CAC), the International Plant Protection Con- vention (IPPC) and the Office Inter- national des Epizooties (OIE). For trade, the metrology- related standards published by the International Organi- zation for Legal Metrology (OIML) are also very important. It is international standards that developing economies would normally adopt as their nation- al standards. At the next level we have regional standards. These are very im- portant for economies that belong to regional economic structures, such as the European Union (EU), the East African Community (EAC), the Eur- asian Economic Community (EurA- sEC), the Association of Southeast Asian Nations (ASEAN) and others. These regional standards are often the basis for technical regulation in the region, and hence are very important

for trade. Where a developing econo- my is part of a regional trade block, the adoption of such regional standards is obligatory under the regional treaty or similar agreement.

At the base of the hierarchy we find standards published by national stan- dards bodies. These national stan- dards have a specified legal stand- ing and are freely available in local languages. There are also standards de- veloped by industry groupings or mul- tinational certification bodies, which are of economic importance. These include standards in the petroleum industry (API), the cell phone indus- try (GSM), testing (ASTM), pressure vessels (ASME), food security (Glo- balgap, BRC) and many, many others. The standards landscape is therefore a multi-facetted one.

Obtaining copyright to standards It is important to understand that de- veloping economies are generally stan- dards “takers”, rather than standards “makers” – international standards are developed by only a few of the major industrialized countries. Nevertheless, projects should not aim to establish mechanisms to develop “indigenous” standards, but rather find efficient ways to adopt international standards.

However, some of the major interna- tional standards are protected by copy-

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right, e.g. ISO and IEC standards, and cannot simply be adopted as nation- al standards and applied at will. Full membership of such bodies is the most cost-effective way to obtain the copy- right of international standards. Once transferred, though, the copyright must be protected at national level. Where a copyright does not exist, e.g. OIML Recommendations, some restrictions on their use still have to be honoured.

Accessing standards In developed economies, standards are usually available on-line, though pay-

ment is required to download them. In developing economies, where access to the Internet is not always available, CD-ROMs are a useful electronic al- ternative, though the standards should be in a format that is not easily altered, e.g. PDF rather than MS Word or simi- lar. Standards, however, will often have to be delivered in hard copy, and here a “print-on-demand” system is the best way to minimize costs and provide the latest edition – establishing a big print- ing press is not a good idea.

Figure 10 – Hierarchy of standards

ISO, IEC,

CAC, IPPC, OIE, OIML

EN, SADC, EAS, GOST Interstate

ANSI, BS, DIN, ES, SANS, TS

BRC, Globalgap, UL

API, ASME, ASTM, GSM, JPEG

International standards

Regional standards

National standards

Certification body standards

Industry association standards

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Financing standards bodies An analysis of ISO membership data shows that approximately 30% of the member bodies at the time of the analy- sis are totally dependent on government funding, a similar number for more than 50% of their funds, and less than 30% for 20% or less of their funding.

In developed economies with very strong industries, the sale of standards provides a major part of the income of standards bodies, but in developing economies this covers 5% at most of their running costs. Governments must therefore make a formal long-term commitment to financing their national standards bodies if they are to be sus- tained. This is an issue that UNIDO’s projects need to address.

Joining regional and international standards organizations Membership of regional and interna- tional standards organizations is im- portant on two counts : first, the needs of the country have to be represented ; and second, knowledge gained in such forums about major trends in region- al and international standards develop- ment can be quickly passed on to in- dustry and the authorities. This means, however, that members should not only attend annual general meetings, but must participate actively in techni- cal committees. Both, membership and

active participation, are an important issue for UNIDO projects. To ensure that membership is maintained, the government has to commit to provid- ing long-term financial support.

Involving private industry in national standards bodies In many developing economies, nation- al standards bodies have long been es- tablished. Many, however, are governed only by government representatives, with perhaps one or two representa- tives from industry or business asso- ciations, which does not encourage in- dustry to accept the national standards body. UNIDO projects should ensure that industry leaders, people with a real power base, form the bulk of the gover- nance structure, whether this is a coun- cil or a board of directors. Additionally, the council or board of directors should have real fiduciary and strategy author- ity over the body even if they are ac- countable to the relevant minister – nor should the minister attempt to micro- manage the body.

The essential components of a standards infrastructure project The components to be considered in a standards infrastructure project are listed below. Each component has one or more project outputs and related project outcomes. To some extent, the sequence of the list provides a logical

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development path, even though many of the components can and should be dealt with in parallel.

1. National policy 2. National coordination 3. Legal status 4. Financial policy 5. Independence 6. Legal entity 7. Director 8. Management structure 9. Personnel 10. Premises 11. Equipment 12. Standards development 13. Technical committees 14. Public relations 15. Standards experts 16. Standard for a standard 17. Committee drafts 18. Public enquiry 19. National standard 20. Information experts 21. Standards information 22. WTO TBT enquiry point 23. Training system 24. Training courses 25. Board of directors 26. Associations 27. Authorities 28. Metrology and accreditation 29. ISO / IEC / CAC 30. Regional standards organizations.

Building a metrology infrastructure

Typical metrology institutions The typical metrology institutions are : �� A national metrology institute �� A national calibration service �� Calibration laboratories, public or

private) �� A legal metrology department.

Metrology : a basic necessity Metrology is the science of measure- ment and has been part and parcel of everyday life since antiquity. Today me- trology is the foundation of industrial quality control – in most modern indus- tries, measurements constitute 10-15% of production costs. In Europe, weigh- ing and measuring costs the equivalent of 6% of the combined GDP. The au- thorities, too, are dependent on weights and measures to set off alarms if mea- surements fall outside regulated limits. And, of course, science is complete- ly dependent on measurements. The metrology infrastructure is therefore a basic necessity without which few if any of the other quality infrastructure activities would be possible. It is a fun- damental and necessary precondition for any of the UNIDO projects.

Choosing an organizational structure for metrology From a purist’s perspective, the na- tional metrology infrastructure con-

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sists of three distinct and separate or- ganizations representative of the three categories of metrology : the nation- al metrology institute, responsible for scientific metrology, the legal metrol- ogy department, responsible for legal metrology, and the national calibration service, covering industrial metrology.

This is often how it is organized in developed economies, e.g. Germa- ny with the Physikalisch-Technische Bundes anstalt (PTB) as the national metrology institute at the federal level, various Eichämpter responsible for legal metrology at the provincial level, and the Deutscher Kalibrier Dienst (DKD) at the federal level for indus- trial metrology.

However, developing economies fre- quently cannot afford three differ- ent organizations, so the metrology in- frastructure has to be combined in a single organization or, quite common- ly, is attached to the national standards body. Many variations are possible, and each one carries risks and advantages.

Some examples : a. The national metrology institute is

attached to the national standards body, which is also responsible for calibration services. Legal metrol- ogy is a separate government de- partment, often called “Weights and Measures”, denoting its limited scope

b. The weights and measures depart- ment is made responsible for the national measurement standards, and provides calibrations in both the regulated and the non-regulat- ed metrology domains

c. The national metrology institute is a separate department attached to a scientific institution, and legal me- trology is a separate government department or is attached to the national standards body.

All of these constructs can be made to work, but there is always the risk that one or more functions will be relegat- ed to a lower level of activity. UNIDO projects therefore endeavour to have at least two separate metrology insti- tutions set up, the national metrology institute with added responsibility for industrial metrology and a legal metrol- ogy department – the optimum solution for developing countries. The reason for this split is very simple : national me- trology institute personnel are scientists, whereas legal metrology inspectors are basically regulators. The type of per- sonalities and functional approaches of these two are completely different even though the technology is very similar.

Setting up a national metrology institute The national metrology institute is designated by national decision, e.g. by legislation, to develop and main-

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tain national standards for one or sev- eral quantities. Although not required by definition, most developing coun- tries will operate a centralized metrol- ogy organization, designating only one national metrology institute.

The metrology institute’s mandate The mandate of the national metrology institute should be to : �� Establish and maintain nation-

al measurement standards demon- strably traceable to international metrology definitions/standards for the relevant metrology quantities needed by the country �� Ensure that a national calibration

system is established and main- tained to diffuse metrology stan- dards to industry, the authorities and society �� Represent the country at the inter-

national level, e.g. at BIPM �� Represent the country in regional

metrology structures such as AFRI- MET (Africa), APMP (Asia Pacific), COOMET (Euro-Asia), EUROMET (Europe), SIM (Americas), etc. �� Represent the country at the na-

tional metrology institutes of other countries.

In many countries, the national metrol- ogy institute also conducts the type ap- proval testing of measuring equipment that falls within the scope of legal me-

trology regulations. The final approval of this equipment for use in the market place, however, should remain with the legal metrology department.

Ensuring the sustainability of the metrology institute To establish a fully working and sus- tainable national metrology institute, UNIDO must carefully consider the following major issues in the design of a fundamental metrology project : Legal certainty regarding the institute, its mandate and the supremacy of the national measurement standards in the calibration hierarchy of the coun- try. The best way to achieve this is to ensure that the legislation is developed in accordance with international best practices (e.g. OIML D1, Elements for a Law on Metrology) and promulgat- ed by the highest legislative authority in the country.

Funding certainty for the establish- ment and short and long-term mainte- nance of the national metrology insti- tute functions. The government will be the only source of long-term financing, so the UNIDO project must get its commitment to provide this.

Appropriate laboratory space and en- vironmental control. Metrology labo- ratories are subject to some very spe- cific requirements (e.g. OIML G13, “Planning of Metrology And Testing

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Laboratories”). They also need to have strict environmental controls (e.g. tem- perature, humidity and dust) operat- ing 24 hours per day, 7 days per week throughout the year (which requires consistency of electrical supply), other- wise measurement accuracy will be se- riously compromised. Equipment should only be provided when there is proper metrology laboratory space and environmental controls. Dust, for example, may not be an issue in de- veloped economies, but in developing economies it is often a major concern, especially if roads are not tarred. National primary or secondary stan- dards. These are the metrology stan- dards that should be the most accurate in the country. Primary standards are extremely expensive to establish and

to maintain and will be found only in the most advanced national metrolo- gy institutes. In developing economies, national secondary standards are quite adequate, provided that their accuracy is aligned with the demonstrated needs of industry and the authorities.

Training metrology personnel. Fun- damental metrology is highly techno- logical, so well-trained personnel are vital for its sustainability. Training can be provided by international experts coming to the country or by the at- tachment of personnel to recognized national metrology institutes, or pref- erably both. Retention of highly skilled personnel will affect long term sustain- ability.

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Establishing calibration and mea- surement capabilities (CMCs). The rules for establishing CMCs and their acceptance through peer reviews can be obtained from the BIPM. Having the national metrology institute’s CMCs accepted and published by the BIPM ensures that the country’s mea- surements will be acceptable to the international markets, and is therefore a high priority.

Setting up a legal metrology department Some metrology processes need to be regulated by the government to ensure a transparent and fair measurement regime. These would include : �� Type approval, calibration and ver-

ification of measuring equipment used in trade to ensure that purchas- ers obtain the quantities of goods they pay for, e.g. weighing scales, petrol pumps, tot measures, etc. �� Control over pre-packaging opera-

tions for the same reasons, e.g. with butter, milk, beer, wine, cereals, etc. �� Type approval, calibration and

verification of measuring equip- ment used in health and safety to ensure that decisions are made on the basis of correct measurements, e.g. thermo meters, blood pressure meters, noise meters, etc. �� Type approval, calibration and ver-

ification of measuring equipment used in law enforcement to ensure a

fair enforcement regime, e.g. speed traps, alcohol meters, axle load weighing equipment, etc.

The main function of legal metrology is therefore a regulatory one, albeit on the basis of metrology technology, so the organization responsible should have regulatory powers. It must therefore be a government department, agency or regulatory authority vested with such powers through legislation. This is not a function that can be privatized easily.

Legal metrology requirements come under technical regulations and should therefore comply with the WTO TBT Agreement requirements. Fortunate- ly, a vast body of international recom- mendations and standards for legal metrology have been developed and published over many years by the In- ternational Organization for Legal Metrology (OIML). These are avail- able as free downloads from the OIML Website (http ://www.oiml.org).

The legal metrology department should also be responsible for managing re- gional and international relationships. Because legal metrology is a regula- tory function, many regions are in the process of harmonizing legal metrology rules, actively supported by the OIML, so involvement in regional organiza- tions is critical. These include APLMF (Asia Pacific), COOMET (Euro-Asia),

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EMLMF (Euro-Mediterranean), SAD- CMEL (Southern Africa), SIM (Ameri- cas), WELMWEC (Europe), etc.

Ensuring the sustainability of a legal metrology department A fully functional legal metrology in- frastructure has an immense impact on society and hence is often the first com- ponent of the quality infrastructure to be established in developing econo- mies. Some have already had one for over a century. However, these long- established institutions have not been subject to a proper review for decades and often leave much to be desired.

Projects to modernize them, or to extend the scope of the original weights and measures department (dealing only with measurements in trade) to that of modern legal metrology, are therefore still very relevant. In designing a legal metrology project, UNIDO needs to carefully consider the following sus- tainability issues.

Legal metrology legislation. The most efficient way to promulgate legal me- trology legislation is to do it in two or more levels. The primary legislation (i.e. a law approved by parliament) has to provide legal certainty about the man- date of the legal metrology department, the powers of search and seizure of the registered inspectors, the metrology standards used, the system of type

approval and verification, the system of pre-packaging control, and sanctions.

Subsidiary legislation (i.e. regulations promulgated when necessary by the minister so empowered by the prima- ry legislation) would contain the tech- nical details and could refer to OIML, ISO, IEC and other standards. Exist- ing legislation should be reviewed, and amended or revised as appropriate.

Funding certainty is needed for the es- tablishment and short and long-term maintenance of the legal metrology department. The bulk of the finances will have to be provided by the gov- ernment, even though users of measur- ing equipment can and should pay for calibration and verification work. The income from this source would certain- ly not be enough to cover all expendi- ture, and commercial pressures should not unduly influence the activities of the inspectorate. Hence the project must engage with the government to secure their long term commitment.

Laboratory and equipment for type approval. Although the requirements for these laboratories may not be as stringent as for fundamental metrolo- gy, the same basic sustainability issues apply. In many cases, measuring equip- ment will be brought into the country with OIML test reports, in which case no retesting should be required.

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Presence in all the major centres. Legal metrology is mostly about market sur- veillance, hence it is very important that the legal metrology department has an appropriate physical presence in all the major centres of economic activity in the country. A legal metrology infrastructure with a head office supported by regional, provincial or city offices, as demonstrably required, is probably the most effective option for developing economies.

Calibration and verification equip- ment. The department needs mea- surement standards to be able to cali- brate and verify measuring equipment that comes within the scope of the regulations. The accuracy class of this equipment has to meet the regulato- ry requirements, and there should be enough equipment for inspectors to be able to cover the whole of the coun- try within reasonable time limits. This equipment needs to be regularly cali- brated against departmental standards or against the national standards.

Trained and registered legal metrology inspectors. In the first instance, legal metrology inspectors need to be trained in metrology. Secondly, they need to be trained in their legal re- sponsibilities, because they have to un- derstand their immense legal powers. Thirdly, they need to be properly reg- istered and issued with identity cards to present when entering premises.

Obviously, once they are no longer em- ployed by the legal metrology depart- ment, these identity cards should be withdrawn.

Proper application of sanctions. The legal metrology regime will only be as effective as the way in which sanc- tions are applied. It is therefore very important that a system of administra- tive sanctions be developed and imple- mented, and where this does not bring about the required behaviour, then the courts of law must be utilized.

Setting up a national calibration system Measurements will only be accepted world-wide if the measuring equipment is properly calibrated, i.e. it is part of an un- broken traceability chain that ends with the primary national metrology standard. There are three main reasons for this : �� To ensure that readings from the in-

strument are consistent with mea- surements from other instruments �� To determine the accuracy of the in-

strument readings �� To establish the reliability of the in-

strument.

A national calibration system is the most effective way to provide a coun- try’s industry and authorities with such a calibration service. Although cali- bration services can be provided by the national metrology institute or

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the legal metrology department, the usual case in developing economies, it is much better if calibration laborato- ries are eventually established so that the national metrology institute and the legal metrology department can then focus their energies on their main mandates. Figure 11 shows the national metrology infrastructure and indicates the traceability chain from the mea- surements to, ultimately, the definition of the unit.

A national calibration system should be established by the national metrol- ogy institute in close cooperation with the national accreditation body. The es- tablishment of calibration laboratories is usually a private industry initiative, and hence outside the scope of UNIDO projects. However, if calibration labo- ratories are to be established as a proj- ect outcome, then sustainability issues as discussed for the national metrolo- gy institute should be addressed, albeit without the legislative requirements and CMCs. The calibration laboratories must, however, be accredited against ISO/IEC 17025 and their reference standards traceably calibrated against the national standards.

Essential components of a metrology infrastructure project The components to be considered in a metrology infrastructure project are listed below. Each of the project com-

ponents has one or more project out- puts and related project outcomes. To some extent the sequence of the list provides a logical development path, even though many of the components can and should be dealt with in parallel. 1. NQI policy on metrology 2. Legislation 3. Financial policy 4. Legal entity 5. Director 6. Management structure 7. Personnel 8. Premises 9. Environmental controls 10. Equipment 11. Quality documentation 12. NMI : Metrologist

LMD : Legal metrology inspectors 13. Training system 14. NMI : Inter-laboratory comparison

LMD : Type approvals 15. NMI : Calibration service

LMD : Verification 16. NMI : Peer review

LMD : Market surveillance 17. NMI, CMCs

LMD : Sanctions 18. Council 19. Associations 20. Client organizations 21. NMI : AFRIMET, APMP,

COOMET, EUROMET, etc. LMD : APLMF, SADCMEL, WELMEC, etc.

22. NMI : BIPM LMD : OIML.

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Building an accreditation infrastructure

Typical institutions The typical accreditation institution is a national accreditation body.

The role of accreditation The increase in trade over the past few decades demands more certainty across borders about the integrity of conformity assessment results. Accreditation is one means of providing this assurance. It is an independent attestation that a confor- mity assessment body is operating in an impartial and technically competent way. This can greatly enhance the value of the conformity assessment body’s output –

its test or inspection reports, calibration certificates, and system or product cer- tificates. Accreditation has played a role in the elimination of technical barriers to trade in many areas.

The confidence that accreditation provides is valuable in both support- ing economic progress and protect- ing public interests – in both the non- regulatory and the regulatory domains. Its benefits can assist with : �� The establishment of internation-

ally recognized conformity assess- ment services �� The opening of export markets to

national industries �� The underpinning of industrial

Figure 11 – The national metrology infrastructure

NMI

Calibration laboratory

Enterprises

End users

BIPM

Legal metrology department

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development through strengthened competition �� The creation of transparency in the

markets by the clear description of competency scopes and inter-labo- ratory comparisons �� The implementation of anti-corrup-

tion measures through the traceabil- ity of results, annual surveillance audits, on-site assessments, peer evaluations and management of the records of every step in a process.

It is no wonder that governments in many developing economies feel com- pelled to establish an international- ly recognized national accreditation body to support their industrial devel- opment and to create certainty in the implementation of technical regula- tions.

Getting international recognition At the international level, the Inter- national Laboratory Cooperation (ILAC) and the International Accred- itation Forum (IAF) are the main or- ganizations in the development of ac- creditation practices and procedures ; additionally, they manage mutual recognition arrangements (MLAs) amongst their members. They divide their responsibilities thus : �� Laboratories (ILAC) �� Certification bodies (IAF) �� Inspection bodies (both).

The MLAs between participating members facilitate the international acceptance of test data, calibrations, inspection reports and certificates (system and product). Any UNIDO project to establish a national accred- itation body should ultimately support the body in becoming a signatory of the MLAs.

NOTE : The ultimate aim in the estab- lishment of a national or regional ac- creditation body is for it to become a signatory of the ILAC and/or IAF MLA.

Choosing organizational structures Accreditation bodies come in a va- riety of shapes and sizes : some coun- tries have only one, some have many, and in others it is part of a bigger or- ganization, such as the national stan- dards body. The tendency now, though, is for countries with many accredita- tion bodies to merge them into one or at most two, reflecting the ILAC and IAF division of responsibilities. At the same time, most countries realize that these bodies need to be independent of and separate from other quality in- frastructure organizations to avoid any actual or perceived conflict of interest. UNIDO, too, must ensure that any ac- creditation body it establishes is impar- tial, independent and devoid of conflict of interest.

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Funding an accreditation body The authorities in most developing economies have no idea of the real costs of a national accreditation system. They commit to funding the start-up phases, believing that accreditation fees will quickly cover expenditure. The re- ality is different. It is highly unlikely that fees in developing countries will ever cover total expenditure. To reach break-even point a body must accredit 200 to 250 organizations, an impossible target in many developing countries. The government will therefore have to continue providing the bulk of long- term funding. And even if the magic number of 200 can be reached, the gov- ernment will still have to fund interna- tional and regional obligations, such as IAF and ILAC membership fees. This is an area that needs to be carefully considered during the design phase of UNIDO projects.

Setting up regional accreditation bodies Due to their financial and human re- source constraints, some regions have begun the long journey towards a re- gional accreditation body, e.g. SADC. There are serious issues that the member states need to agree on. These include : �� The organizational form and statutes

of the regional accreditation body �� The registration of the body in one

of the member states, and its gover-

nance structures and professional li- ability �� The joint short-term and-long term

funding mechanisms �� The appointment of a full-time di-

rector and staff �� Recognition of the regional accred-

itation body as equivalent to a na- tional accreditation body, especial- ly in the administration of technical regulations �� Acceptance of the regional accredi-

tation body as representing the indi- vidual states in international accred- itation forums and as a signatory of the mutual recognition arrange- ments of the IAF and ILAC �� The establishment of liaison struc-

tures, i.e. an accreditation desk, in the responsible ministry in each member state to facilitate the as- sessment and accreditation of orga- nizations at the national level by the regional accreditation body �� Training and registration of lead and

technical assessors in each of the participating member states.

The establishment of such a region- al accreditation body is undoubtedly worthwhile, but there should be no illu- sions about the difficulties. It would be a long term project, with a time frame of six to eight years before it is finally a signatory of the IAF and ILAC multi- lateral recognition arrangements.

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NOTE : Establishing a regional accred- itation body requires a tremendous political will from all the governments involved. Resolving the legal and ad- ministrative issues and gaining interna- tional recognition will take as long as eight years.

Complying with ISO/IEC 17011 The accreditation body has to comply with ISO/IEC 17011, the standards used by the peer evaluation group of either IAF or ILAC or their recog- nized regional groupings, before it can become a signatory of their multilater- al recognition arrangements. This peer evaluation will look at the accredita- tion body’s performance in three broad categories, structure quality, process quality and outcome quality. The pro- cess is shown in Figure 12.

Ensuring the sustainability of an accreditation infrastructure The accreditation body is in many ways the pinnacle of the conformity assur- ance pyramid in a country. It would therefore seem best to have just one national accreditation body which all ministries and regulatory agen- cies would agree to support and use. A number of developed economies have established more than one accreditation body, particularly where they cover dif- ferent fields such as testing and certifi- cation.

NOTE : For developing economies the optimum situation is to establish a single, national accreditation body that is accepted by all industry and especial- ly all ministries and authorities.

This situation is acceptable where the economy can support more than one accreditation body, but for developing economies it is usually not economi- cally or technically viable. Problems can arise where developing economies have established several bodies, each within a different ministry and sup- ported by a different donor organiza- tion with the result that their activities can overlap. The best way to avoid this problem is to pass legislation estab- lishing a single, national accreditation body.

Financing. The government has to sup- port the accreditation body financially as a long term commitment, even if it is established by donor funding – this was discussed earlier as a fundamental project consideration. This unequiv- ocal commitment by the government is of vital importance for the sustain- ability of the accreditation body, and has to be obtained before a project is launched.

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NOTE : Accreditation will not pay for itself in the short term, and it is doubt- ful whether it will do so in the long- term in developing economies, even if the magic number of 200 accredited organizations can be reached. Hence the government must recognize that it will need to support the accreditation body financially, and long-term, if it wishes to have one.

Ensuring the impartiality of an accreditation body The accreditation body’s assessment and decision making processes should not be subjected to any undue influ- ence from within the accreditation body itself or outside, especially from ministries or their agencies. Continued

and demonstrable compliance with ISO/IEC 17011 is essential.

Multilateral recognition arrangements of IAF and ILAC Ultimately, the accreditation body has to become a signatory to the multi- lateral recognition arrangements (MLAs) of IAF and ILAC. Without this, none of the conformity assessments accredited by it will be accepted in the international markets.

Essential components of an accreditation infrastructure project The components of an accreditation infrastructure project are listed below. Each component has one or more

Figure 12 – Evaluation pyramid for compliance with ISO/IEC 17011

Evaluation by Examples

Out- come quality

Process quality

Structure quality

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project outputs and related project outcomes. To some extent the sequence provides a logical development path, even though many of the compo- nents can and should be dealt with in parallel. 1. NCAI policy on accreditation 2. National coordination 3. Legal status 4. Financial policy 5. Independence 6. Legal entity 7. Director 8. Premises 9. Management structure 10. Personnel 11. Equipment 12. Quality documentation 13. First scope 14. Public relations 15. Technical committees 16. Proficiency testing 17. Metrology, standards 18. Board of directors 19. Associations 20. Client organizations 21. Lead assessors 22. Technical assessors 23. Training system 24. Special courses 25. Pre-assessments 26. Working groups 27. Joint accreditations 28. Pre-evaluation 29. MLA/MRA

Building an inspection infrastructure

Typical institutions �� Trade inspection agencies �� Engineering inspection agencies �� Regulatory inspection agencies.

In Chapter 2 we saw that inspection is defined as “Examination of a prod- uct design, product, process or instal- lation and determination of its confor- mity with specific requirements or, on the basis of professional judgement, with general requirements”. Bearing in mind that “product” can include hard- ware, software, service or processed material, the potential field for inspec- tion can be seen to be very wide. It is also a technique which is applied at dif- ferent levels in the economy, including inspection of, for example : �� Food on the farm or products in the

factory �� Safety and integrity of vehicles,

buildings and process plant �� Items used in trade, such as weigh-

ing and measuring equipment �� Quality and quantity of traded goods.

The requirements against which the inspections are carried out are equal- ly diverse. They could, for example, be specified in contracts for the supply of goods or services or could be laid down in legislation regarding health, safety or fair trade.

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All of these factors mean that before contemplating the establishment of an inspection infrastructure it is vital that the purpose(s) are clearly defined and that the intended benefits and likely costs are understood.

The nature of inspection can vary from carrying out repetitious and simple counting or measuring operations to highly complex technical examinations and calculations for which a high level of professional expertise is needed. The range of inspection bodies described in Chapter 4 includes those which are independent, referred to as Type A bodies, and those which carry out in- spections for the organization of which they are a part, referred to as Type B bodies.

There is also a hybrid status, known as a Type C body, where inspection may be carried out for both the parent orga- nization and others. The underpinning requirement is for the work to be car- ried out with integrity and in a system- atic manner.

Fundamental project considerations : Inspection infrastructure

Purpose The purpose of the inspection infra- structure could be limited to the facilitation of the development of trade

and industry but could also cover such areas as the protection of the health, safety and well-being of people. Pro- vided that the inspection infrastruc- ture is being designed as part of the overall national quality infrastructure, the national priorities should already have been considered and will provide a good basis for determining the scope of the inspection infrastructure.

The nature and level of inspection which is required will be related to the need for confidence in the confor- mity of items with the expectations of the parties involved. As mentioned in Chapter 3, an important part of the in- frastructure design process is an assess- ment of the risks associated with non- conformity. In what ways might items not conform? How likely is it that they would not conform? What could be the consequences if they did not conform? How much effort is it sensible to apply to the prevention of nonconformity?

Where legislation requires, either di- rectly or by inference, inspection to be carried out, it is important to take account of the economic impact. Inspectors have to be paid, and delays waiting for an inspector to be available and to carry out the inspection can cost money. Legislators are strongly ad- vised to apply the conformity risk as- sessment process when considering the introduction of regulatory inspection.

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Inspection is not the only technique which can be employed to manage the many and varied risks in everyday life. The basic philosophy of the quality ap- proach is to design quality in from the outset rather than trying to inspect it in afterwards. However, no process is per- fect and some degree of inspection will be needed.

An important consideration when de- signing an inspection infrastructure is to ensure that all other measures to prevent nonconformity are going to be in place. In that way the demands on the inspection operation can be kept within realistic and economic bounds.

Potential client base From the preceding discussions, it can be seen that the range of potential cli- ents for inspection is large. A number of different situations might exist.

A manufacturer could employ its own inspectors to check the quality of its products or it could buy in the services of inspectors on a sub-contracted basis if the need is infrequent or requires specialist expertise. In either case, the manufacturer would bear the cost of the inspection.

A purchaser could employ its own in- spectors to check the quality and quan-

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tity of the products which it is buying. Inspection could be carried out at its premises or at the manufacturer’s premises prior to shipment. Again, these inspections could be carried out by a sub-contracted agency. In these cases it is usual for the purchaser to bear the cost of the inspection.

A regulatory authority could employ its own inspectors to check whether items comply with legislative requirements or an independent agency could be ap- pointed to carry out the work. In either case, the cost of the inspection could be borne by the authority or, as is becom- ing more common in some economies, the person or organization responsible for the items might be expected to pay some or all of the cost. Vehicle inspec- tion is an example of an area where the owner of the vehicle is required to pay for periodic regulatory inspection.

The inspection infrastructure plan will need to take account of the type, number and size of client organiza- tions and of the nature of their in- spection needs. Unlike testing, much of which takes place in laboratories at fixed locations, inspection tends to take place where the items to be in- spected are located. Thus a wide geo- graphic spread of clients will add con- siderably to the time taken in carrying out inspections due to the time spent traveling between clients.

There will also be the travel costs and, possibly, accommodation and subsis- tence costs for the inspectors. If the in- spection work is highly specialized and requires only a few days a year, it could be more economical to bring in an in- spector (or team) from another coun- try rather than going to the trouble and expense of creating a specific element of the inspection infrastructure for this work.

On the other end of the scale, where there is a more or less continuous need for inspection, the agency could sta- tion one or more inspectors at the site. Extra care is needed with this kind of arrangement because inspectors might become too familiar with the people at the site and lose their objectivity.

Conformity requirements Having defined the purposes, and there- by the scope, of the inspection infra- structure and ascertained the needs of the potential clients, the requirements against which the inspectors will be de- termining conformity can be defined. Where possible, existing standards, par- ticularly those adopted at international level, should be used, whether in com- mercial contracts or in legislation.

The main benefits of this approach are that the standards represent cur- rent good practice in the technical sub- ject and that it will be easier to find

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inspectors with expertise in those sub- jects. If standards do not exist or are not suitable, then inspection schedules will need to be created in consultation with the clients. One feature of inspection, as stated in the definition given above, is that requirements might be general in nature and the inspectors might be required to exercise professional judg- ment in determining the conformity of the object which is being inspected.

However, the consistency of the con- duct and results of inspections will be improved if the inspectors work to common procedures. Occasional meet- ings of all inspectors in a given technical area can help to promote a consistent approach ; they can also assist in main- taining a sense of corporate identity amongst people who are often working on their own away from headquarters.

Resources The main resource required for inspec- tion is people who are expert in the relevant technical areas. In some cases, measuring or testing equipment could be needed and it is helpful for an in- spection agency to have an office even if the majority of the work is carried out in the field. Each of these items is considered in more detail below.

People The key resource of an inspection agency is its team of inspectors who

are likely to be people with a high level of competence in the fields in which the agency is offering its servic- es. The scope of inspection work to be undertaken will determine the range of competences to which the inspec- tion agency will need to have access. It might not be necessary for all of the inspectors to be employed as full time staff if people with the necessary com- petence can be brought in on a con- tract basis when needed.

Generally speaking, there will be a break-even point in the volume of work above which it becomes more economical to employ full time staff. The agency would need to ensure that contracted-in inspectors work within its management system and that their work is properly monitored. Such re- quirements and the likelihood that many of its full time inspectors are working away from headquarters em- phasize the need for strong manage- ment within the agency.

Above all, a high degree of professional integrity must be maintained to ensure that the inspectors carry out their work free from any commercial, financial and other pressures which might affect their judgment. Procedures must be im- plemented to ensure that people or or- ganizations external to the inspection agency cannot influence the results of inspections carried out.

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Equipment The inspection agency must have avail- able to it suitable equipment to permit all activities associated with the inspec- tion services to be carried out. It is not always necessary for the agency to have its own equipment if it has arrangements for the use of equipment belonging to another organization, for example a test- ing laboratory. Whichever arrangement it uses, the inspection agency is responsi- ble for ensuring that the equipment : �� Is used only by people authorized to

do so �� Is used in the intended manner �� Is and remains suitable for its in-

tended use �� Is properly and unequivocally iden-

tified so that the results of any mea- surements or tests for which it is used are traceable �� Is properly calibrated and main-

tained, bearing in mind that it is likely to be used in the field and sub- ject to adverse transport and storage conditions.

Premises Although the majority of the inspec- tion work is likely to be carried out in the field, the inspection agency will need some accommodation for head office functions such as overall man- agement, client interface, maintenance of records and storage, maintenance and calibration of equipment, if nec- essary. The inspectors might also need

some office facilities for some aspects of their work. Overall, the aspect of premises is probably the least critical in the plans for setting up the inspec- tion infrastructure.

Accreditation Since the key feature of an inspection agency is the competence of the in- spectors, accreditation may not be as important in the inspection sphere as it is in others. The inspection agency should, in any case, be set up to comply with ISO/IEC 17020 as the interna- tionally agreed set of criteria for in- spection bodies. Two main reasons for gaining accreditation to that standard would be : �� Providing objective evidence that

the agency does in fact comply with the standard and is therefore most likely to provide the required level of inspection service �� The acceptance in another country

of the inspection reports produced by the agency, where the inspection work relates to items exported to that country.

Because accreditation represents an ongoing expense for the inspection agency, the commitment to accredita- tion should only be made where it has been properly considered and justified.

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Sustainability issues : Inspection infrastructure

Financial stability Provided that the inspection agency can gain access to the appropriate inspectors, initially on a contracted basis, the entry cost for providing an inspection service is relatively low. The key feature is a tech- nically sound business manager who can maintain a high degree of client satisfac- tion by building up inspection capacity in line with the growth in demand.

Staff retention As with other elements of the quality infrastructure, the inspection agency must be able to recruit, develop and retain the necessary technical staff.

As most of the business assets of the agency will reside in the people it em- ploys, the agency will be vulnerable to the loss of people to competitors.

It will be important to maintain good employment conditions, including re- muneration, but also, because many inspectors will be working away from head office, it will be vital for the man- ager to keep in good communications with them so as to retain their motiva- tion and commitment.

Essential components of an inspection infrastructure project The components that need to be considered in an inspection infrastruc- ture project are listed below. Each of

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the project components has one or more project outputs and related proj- ect outcomes. To some extent the se- quence of the list provides a logical development path, even though many of the components can and should be dealt with in parallel. 1. Board decision 2. Legal status 3. Financial policy 4. Legal entity 5. Inspection scope 6. Director 7. Management structure 8. Personnel – inspectors and support 9. Premises 10. Equipment 11. Client interface and marketing 12. Quality documentation 13. Training and development system 14. Board of directors 15. Associations 16. Client organizations 17. Pre-assessment (optional) 18. Assessment and accreditation

(optional).

Building a testing infrastructure

Typical institutions The typical institutions in a testing in- frastructure are : �� Test laboratories �� Pathology laboratories �� Environmental laboratories.

The functions of a test laboratory A test laboratory conducts tests to de- termine the characteristics of a prod- uct or commodity. These characteristics are then evaluated against the require- ments of a standard, and the test labo- ratory produces a test report or a test certificate with the results. The scope of testing is immense, covering mechani- cal, electrical, metallurgical and civil engineering, biological and chemical sciences, food technology, fibre tech- nology and many, many more.

Testing can be destructive or non-de- structive, mundane or extremely com- plex, routine, state of the art or cutting edge. In short, testing can be anything you want it to be. Hence any UNIDO project to establish test capacity will require very careful thought, otherwise it will very quickly become a black hole into which project funds disappear without trace.

Assessing testing needs The immense scope of testing has pro- found implications for project design. Perhaps more than in any other quali- ty infrastructure component, an assess- ment of a country’s testing needs has to be absolutely thorough. In devel- oping economies, where the state has to establish and maintain most testing facilities, such an assessment is even more relevant because every ministry

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tends to establish their own test labo- ratories.

This fragmentation is, unfortunate- ly, encouraged by donors, who each have one ministry as a counterpart. An overall assessment of current laborato- ry capacity, whether latent or active, is therefore essential in developing a new testing capacity project, as is a govern- ment policy on the allocation of staff.

Providing appropriate accommodation Many testing laboratories are subject to some very specific accommodation requirements. Different functions, for example, have to be separated to pre- vent cross-contamination of samples, and laboratory space and offices need to be separated to ensure that person- nel only spend testing time in the labo- ratories. In addition, most product test- ing requires consistent temperature, humidity, test speed, test force, test se- quence, number of test cycles, etc.

Testing textiles and polymers, for example, requires an environment of 20 ± 2° C and 65 ± 2% relative humidity, while paper and many rubber products require 23 ± 1° C and 50 ± 2% relative humidity. On the other hand, most me- chanical and electrical engineering testing can be conducted between 15° C and 30° C with a relative humid- ity not exceeding 70%. Continuity of

electricity supply (24 hours per day, seven days per week) is of critical im- portance when tight environmental controls have to be maintained. These requirements must be kept in mind when new premises are being built or old ones refurbished.

Another issue that is very often over- looked in laboratory design is the ori- entation of the windows. In the north- ern hemisphere the sun comes from the south, so main windows are orien- tated north to avoid direct sunlight. In the southern hemisphere, this situation is reversed. Architects appointed from northern donor countries have to be aware of this.

Choosing testing equipment Before any testing equipment is pro- cured, the testing methodology has to be chosen. This is to ensure that the equipment fully meets the methodolo- gy requirements, and not just the pref- erences of the testing staff. The equip- ment’s test results must be reproducible, under similar conditions, with those of other laboratories, as must the consum- ables required in testing, for example the quality of gases, chemicals, etc.

A second major issue is the availability of maintenance and technical support for a particular make of testing equip- ment. It is often better to buy a slightly more expensive piece of testing equip-

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ment, but one for which maintenance is available, rather than a less expen- sive option for which there is no tech- nical backup, either in the country or in neighbouring states.

Electricity supply is also relevant to equipment performance. In many de- veloping economies, electricity does not meet the generally accepted stabil- ity criteria in developed economies, e.g. ± 5% variance on voltage. Their vari- ance can be as much as ± 15% inter- spersed with frequent supply failures. Additional voltage stabilizers and UPS equipment may need to be provided ; otherwise equipment may not perform to expectations.

Calibrating testing equipment The proper calibration of test equip- ment is an important consideration. This presupposes a functioning me- trology infrastructure within the coun- try, or access to one in a neighbouring country. In addition, the calibration of some test equipment requires certified reference materials that are frequent- ly only available from limited sourc- es. The project has to assure the long term availability of such materials, often more an issue of scarce foreign exchange than anything else.

Training and retaining staff Modern product and food testing equipment is becoming very sophis-

ticated, using, for example, atomic absorption spectrophotometers, gas chromatographs, high performance liquid chromatographs, etc. Staff must therefore have both sound theoret- ical training and adequate practical experience. This is best achieved by their placement for an extended period of time in a working test laboratory.

The remuneration of staff is also an important issue. If at all possible, the project should ensure that fully trained staff are paid enough to keep them in the organization.

Achieving accreditation to ISO/IEC 17025 Depending on the type of testing per- formed by a laboratory, there may be a requirement from the customer or the regulator that the laboratory be accredited as an independent means of verifying the technical competence of the laboratory for the specific scope of testing. Where this is necessary, the laboratory should be accredited to ISO/IEC 17025.

Where there is no specific customer re- quirement for accreditation, the labora- tory should operate in compliance with ISO/IEC 17025. One means for a labo- ratory to demonstrate their competence is to be accredited to ISO/IEC 17025. This will add to the confidence in the test results produced by the laboratory.

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However a UNIDO project establish- ing competent test capacity has the accreditation of the test laboratory as its final outcome. It will choose the ac- creditation body early in the project implementation phase, since accredi- tation bodies have significant differ- ences of approach, and the choice will influence some of the project activities. When choosing an accreditation body the following criteria need to be kept in mind : �� Language �� Proximity to the country, to keep

down travel costs (assuming that the country does not yet have its own accreditation body) �� Accreditation costs (broad budget

figures can be obtained from most accreditation bodies) �� That the accreditation body is a

member of the ILAC Multilateral Recognition Arrangement (MLA) �� That the accreditation body sup-

ports programmes for inter-labora- tory comparisons or proficiency test- ing schemes in the disciplines that the test laboratory wishes to be ac- credited for.

Ensuring the sustainability of the testing infrastructure Initiatives to ensure sustainability are closely aligned with those for establish- ing testing capacity, detailed above, but because of their importance are briefly recapped below.

Financial stability. Since most testing laboratories in developing economies find it very difficult to cover costs from earned income, the government has to commit to providing long-term finan- cial support.

Appropriate premises are a funda- mental requirement, but long term en- vironmental control can be particular- ly problematic. Proper maintenance of air-conditioning units and the uninter- rupted supply of electricity are vital sustainability issues.

Calibration facilities and equipment maintenance. The accuracy of testing and measuring equipment degenerates with time, so equipment has to be calibrated at regular intervals. Whether calibration is provided by a national

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calibration service, or certified refer- ence materials, the fundamental princi- ple remains the same. Without such cal- ibration facilities, the sustainability of the testing capacity will be compro- mised. This also applies to maintenance and, in anticipation of equipment breakdown, to having a technical backup. Maintenance and backup services are essential to sustainability.

Accreditation support. The project may provide financial and technical support for obtaining initial accredita- tion to ISO/IEC 17025, but long term financial and managerial support to maintain such accreditation needs to be assured.

Retaining staff. Well-qualified staff are in short supply in developing econ- omies. Laboratories need to have remuneration packages and other in- centives to keep their trained staff from being poached, as well as train- ing programmes to develop new staff.

Multilateral recognition arrangements of IAF and ILAC Ultimately, the accreditation body has to become a signatory to the multi- lateral recognition arrangements (MLAs) of IAF and/or ILAC. With- out this, none of the conformity assess- ment it has accredited will be accepted in international markets.

Essential components of a UNIDO testing infrastructure project The components that need to be considered in a testing infrastruc- ture project are listed below. Each of the project components has one or more project outputs and related project outcomes. To some extent the sequence provides a logical develop- ment path, even though many of the components can and should be dealt with in parallel. 1. Board decision 2. Legal status 3. Financial policy 4. Legal entity 5. Testing scope 6. Director 7. Management structure 8. Personnel 9. Premises 10. Environmental controls 11. Equipment 12. Marketing 13. Quality documentation 14. Scientists 15. Training system 16. Inter-laboratory comparison 17. Calibration service 18. Board of directors 19. Associations 20. Client organizations 21. Pre-assessment 22. Assessment and accreditation.

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Building a certification infrastructure

Typical institutions The typical certification institutions are : �� Product certification organizations �� System certification organizations �� Personnel certification organiza-

tions.

The growth of system certification System certification is the success story of ISO 9001. Certification to this stan- dard is still experiencing a remarkable growth, and is now considered a basic requirement for any company wishing to export large orders or land big con- tracts.

ISO policy with regard to sector man- agement system standards is not to en- courage the unnecessary proliferation of management system standards by the individual economic/industry sec- tors. However, ISO would accommo- date the development where the sector has identified a real need for a sector standard. Today there are many exam- ples of such documents :

ISO 22000, Food safety management systems – Requirements for any organi- zation in the food chain.

ISO/IEC 27001, Information technol-

ogy – Security techniques – Informa- tion security management systems – Re- quirements

Getting appropriate, affordable accreditation System certification is a multi-billion dollar business worldwide with a large number of private and public orga- nizations providing certification ser- vices at various levels of competence. Accreditation was introduced to pro- vide a means for these organizations to independently demonstrate their tech- nical competence.

Today, most certification service pro- viders are accredited against ISO/ IEC 17021, though there are still some issues with branch offices of certifica- tion organizations in countries other than those where their main offices are located. These branch offices frequent- ly operate under the umbrella of the accreditation of their head office and are assessed by the head office’s ac- crediting body based on a number of criteria, one of which is the activities performed by the branch office. The IAF and ILAC have implemented a cross-frontier policy which addresses the accreditation and assessment of branch offices by the accreditation body. The policy came into effect in 2007. This policy is aimed at reducing problems of branch offices not comply- ing fully with accreditation criteria.

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In developing economies where mul- tinational certification organizations operate through less satisfactory local subsidiaries or are very expensive, small and medium-sized enteprises (SMEs) can find it very difficult to gain affordable, internationally recognized certification. This has led many gov- ernments and/or standards authorities in developing economies to put a high priority on establishing a national cer- tification organization to support local industry, especially SMEs.

One of the requirements for accredi- tation is that the certification body has already conducted a minimum number of successful audits and issued certif- icates, the current minimum usually being two per scope of accreditation. This number needs to be checked out early in the project to ensure that there are no unpleasant surprises. Certifica- tion bodies, however, may have diffi- culty getting this number because few industrial organizations want to be cer- tified by a new certification body that is not yet accredited – a classic chicken and egg situation.

A useful strategy in this case is to offer to help a few industrial com- panies towards certification, provid- ed they agree to be audited and cer- tified by the new certification body as well as by an established accredited certification company. The industrial

company would then obtain two cer- tificates, one from the established cer- tification body and one from the new body. Once the new body has been ac- credited, the established body trans- fers the certified companies totally to the new body.

Meeting organizational requirements The international standard ISO/IEC 17021 has detailed requirements, shown in Figure 13 (see page 134), for the governance and organizational structure of a certification body. These have to be carefully considered when the body is being established, other- wise its accreditation will be seriously compromised.

Choosing an accreditation body The certification body in a developing economy should be accredited ; other- wise it may not be sustainable. This means that it has to demonstrate com- pliance with ISO/IEC 17021 as well as with the relevant IAF mandatory doc- uments. The accreditation body should be chosen fairly early in the project im- plementation phase, as it will have an influence on some of the project activi- ties – the various accreditation bodies do have differences in approaches that matter.

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Issues that need to be considered when choosing an accreditation body include the following : �� Language �� Proximity to the country to keep

down travel costs (assuming that the country will not yet have an accredi- tation body of its own) �� Accreditation costs (broad budget

figures can be obtained from most accreditation bodies) �� That the accreditation body is a

member of the IAF Multilateral Recognition Arrangement (MLA) �� That the accreditation body sup-

ports programmes for newly estab- lished certification bodies, i.e. a pre-

assessment to determine gaps in processes and procedures before the full assessment.

Ensuring the sustainability of a certification body Financing. Anecdotal evidence indi- cates that it takes about three years to establish a system certification body, develop the internal procedures, train and register assessors, and conduct a number of trial audits, leading, hope- fully, to accreditation. During this time the certification body is not fully func- tional, lacks international recognition and, being without customers, will have

Figure 13 – Typical organizational structure of a certification body

CERTIFICATION BODY

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difficulty covering costs. It is only in the fourth year of operation that most cer- tification bodies break even or start to make a profit.

The founding organizations, whether government, the national standards body or a private-public partnership, will have to make good this shortfall. The total operating and capital costs for three years are estimated to be in the region of USD 500 000 to USD 600 000 per year, including accred- itation costs and annual fees, while income is unlikely to exceed USD 150 000, creating a shortfall of USD 350 000 to USD 450 000. This is a seri- ous sustainability issue that UNIDO must factor into any project proposal.

Choosing specific certification ser- vices. Accreditation is an expensive business, and is given only for those standards and sectors for which the certification body is shown to be com- petent. There is no blanket accredita- tion so the target market requirements need to be carefully researched and the system certification body’s scope of ac- creditation defined accordingly before it is established. Within each of the var- ious standards, there are also sectoral groupings that need to be considered, i.e. agriculture, fishing, textiles, machin- ery, etc. Complete details can be found in the relevant IAF guidelines.

Achieving accreditation is very often not an option. Without accreditation, certificates issued by a certification body in a developing economy have very little chance of being accepted in developed markets.

Essential components of a certification infrastructure project The components that need to be con- sidered in a certification infrastructure project are listed below. Each of the project components has one or more project outputs and related project outcomes. To some extent the sequence of the list provides a logical develop- ment path, even though many of the components can and should be dealt with in parallel. 1. Board decision 2. Legal status 3. Financial policy 4. Legal entity 5. Director 6. Management structure 7. Personnel 8. Premises 9. Equipment 10. First scopes 11. Quality documentation 12. Marketing 13. Certification committee 14. Lead auditors 15. Auditors 16. Training system

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17. Auditor registration 18. Pre-assessment 19. Assessments 20. Certification 21. Impartiality 22. Board of directors 23. Impartiality committee 24. Associations 25. Client organizations 26. Pre-evaluation 27. Accreditation.

For more detailed information on UNIDO and its range of activities, including those associated with con- formity assessment, see its Website at www.unido.org.

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This chapter presents case studies of the building of quality infrastructures, both individual conformity assessment infra- structures – testing laboratories, certifi- cation bodies, inspection bodies, metrol- ogy institutes and accreditation bodies – and integrated quality infrastruc- tures that bring all of these components together.

The first part, “Building the components of a quality infrastructure”, describes the variety of resources that UNIDO de- ploys and the wide range of activities it undertakes in building each of these in- frastructures, illustrated with brief ac- counts of its experience in several de- veloping countries, typical of the many countries that have built similar infra- structures, and the West African Eco- nomic and Monetary Union (UEMOA).

The second part, “Building an integrat- ed quality infrastructure”, exempli- fies, particularly in the case of Guyana, the urgency of having a quality infra- structure that meets the challenges of global competitiveness and, in the cases of UEMOA, where UNIDO played a key role, and the Caribbean Communi- ty (CARICOM), gives detailed accounts of the experience of setting up fully in- tegrated quality infrastructures in these two sub-regions.

Building the components of a quality infrastructure

Testing laboratories Technical assistance for testing lab- oratories has always been an impor- tant component of UNIDO’s support for quality infrastructure development – whether establishing new laborato- ries or upgrading existing ones. First, UNIDO assists the authorities, the board of directors or top management to evaluate market requirements and make an informed decision on the type of testing capacity they need.

At the same time, it ensures from the outset that the legal status of the lab- oratory is clear, that medium and long term funding is available, and that the scope of testing is well defined and specifies precisely the equipment, environmental controls, calibration instruments, maintenance, etc., that will be needed.

There are of course many other im- portant activities that a UNIDO project supports to ensure that the laboratory contributes to industrial competitiveness and, ultimately, be- comes accredited to ISO/IEC 17025 : choosing a competent, qualified direc- tor ; setting up a suitable management

Chapter 6 – Case studies

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structure and recruiting or develop- ing technically qualified, able person- nel ; finding suitable accommodation ; running a promotion campaign ; pre- paring quality documentation accept- able to the accreditation body ; intro- ducing an appropriate training system for scientists in an established tertiary education centre ; organizing inter- laboratory comparison to establish the laboratory’s proficiency ; and setting up a properly constituted and fully func- tional board of directors.

As well as direct technical assistance, UNIDO has prepared guidance docu- ments and training on the operation of proficiency testing programmes, on the significance of certified reference ma- terials, and on the various guides on this subject produced by by the ISO policy development committee for ref- erence materials, ISO/REMCO.

UNIDO has also contributed to the establishment of LABNET, a valu- able Web-based information source for testing laboratories, which covers accreditation, reference materials, pro- ficiency testing, etc. A joint venture by UNIDO and WAITRO, the World Association of Industrial and Tech- nological Research Organizations, LABNET can be accessed online at : www.labnetwork.org.

Sri Lanka The UNIDO “Integrated Industrial Development Support Programme for Sri Lanka” assisted five laboratories that supported the agro-food, textile and gar- ment sectors to comply with internation- al standards. In the agro-food sector, the target commodities were tea and shrimps, both of export significance for Sri Lanka.

Specifically, UNIDO assisted two micro biology laboratories, two chem- ical laboratories and a textile-testing laboratory to pursue accreditation for their export-significant tests by a well- established foreign accreditation body. The five laboratories succeeded in achieving accreditation for compliance with ISO/IEC 17025 from the Swedish Board for Accreditation and Confor- mity Assessment (SWEDAC).

UNIDO’s technical assistance also ensured domestic calibration support for the accredited laboratories by up- grading six of the Industrial Metrology Institute’s metrology centres, covering dimensional, volume, mass, thermom- etry, pressure and electrical calibration services. These services were also ac- credited by a foreign accreditation body.

The measurable benefits of this assis- tance included : �� The demand for accredited over

non-accredited testing and calibra- tion services increased significantly

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�� Reliance on government funding for the laboratories was significantly re- duced �� More small and medium enterpris-

es were able to enter export markets on the basis of the accredited labo- ratories’ compliance testing �� Local compliance testing costs were

much less than those of foreign lab- oratories �� A lot of the testing was delivered

faster �� Valuable experience gained in the

programme was passed on to people and institutes in other developing countries.

Certification bodies

UNIDO has provided comprehen- sive development assistance for certi- fication activities for many years. This focuses on management systems cer- tification (including quality, environ- mental, food safety, and occupational health and safety), product certifica- tion, and personnel certification, both for enterprises and for certification and accreditation bodies.

It has assisted enterprises by working with local industry and institutes or in- dustry associations to build the capaci- ty of either of the latter to provide cer- tification services. As well as projects to develop the certification infrastruc- ture, UNIDO conducts national and

regional seminars, workshops and training programmes to raise aware- ness of certification criteria and prac- tices, and to assist certification auditors qualify to perform specific types of cer- tification audits.

It has assisted certification bodies by conducting projects to help them de- velop the institutional structures, sys- tems and personnel they need to carry out specific types of certification, some- times culminating in their independent accreditation.

Like other quality infrastructure proj- ects, certification infrastructure proj- ects need to have a competent director, a management structure, personnel, premises, marketing services, quality documentation, etc., but they also have their own specific and critical needs : an established and fully functional certi- fication committee acceptable to the accreditation body ; a pool of trained and registered lead auditors, both on the staff of the certification body and available for sub-contractual work ; a pool of trained and registered auditors, both within and outside the organiza- tion, appropriate for the accreditation scopes of the certification body ; an es- tablished, fully functional and recog- nized training system for auditors and lead auditors ; an established and inter- nationally recognized national auditor and lead auditor registration system ; a

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fully functional pre-assessment system in accordance with ISO/IEC 17011 and IAF Guidelines for certification of companies ; a fully functional assess- ment process in accordance with ISO/ IEC 17011, ISO 19011 and IAF guide- lines for the certification of companies ; a certification process compliant with ISO/IEC 17021 and acceptable to the accreditation body ; a certification body whose impartiality is acceptable to the accreditation body ; a fully function- al board of directors with terms of ref- erence acceptable to the accreditation body ; a fully functional impartiality committee acceptable to the accredita- tion body ; industry and business asso- ciations fully aware of the services of the certification body ; active participa- tion of client organizations on the im- partiality committee ; and a success- ful pre-assessment of the certification body by the accreditation body.

Nepal In 2003, Nepal joined the World Trade Organization as part of a process of economic liberalization and faster de- velopment. This included a transition to full compliance with all the obli- gations of a member state by 2007. UNIDO was asked to assist in bring- ing the country’s conformity assess- ment procedures in line with the re- quirements of the WTO Agreement on Technical Barriers to Trade. It helped strengthen and upgrade Ne-

pal’s product certification infrastruc- ture to a level where it could be accred- ited, thereby increasing acceptance of Nepal standard mark products in the international market.

A valuable contribution was made by a certification expert with wide practical experience in product certification who assisted the Nepal Bureau of Standards and Metrology (NBSM) implement ISO/IEC Guide 65, General require- ments for bodies operating product certification systems. To achieve accred- itation the entire documentation had to be completed in accordance with Guide 65 and supporting ISO stan- dards within the existing legal frame- work, the Nepal Standards (Certifica- tion Marks) Act, 1980.

As well as document preparation, com- prehensive training was provided on im- plementing the documented system and auditing and inspecting under it. This in- cluded training on auditing techniques based on ISO 19011, on the accredita- tion requirements of the International Accreditation Forum, and on the modus operandi of the accreditation system.

Sri Lanka UNIDO is currently implementing a project to enhance and build certifi- cation capacities in Sri Lanka for both training and conformity assessment de- livery. It is :

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�� Supporting and promoting the establishment of private-public non- profit partnerships for certification, based on international certification practices and standards �� Building national capacities by qual-

ifying certified national auditors and trainers against international prac- tices and standards �� Developing training capacities by

qualifying the certification body as an accredited training centre and support- ing the development of customized training support tools and materials �� Supporting national accreditation

initiatives to ensure credible certifi- cation activities by, and fair compe- tition amongst, certification bodies �� Implementing pilot interventions in

certification and training activities through the use of nationally trained and accredited personnel �� Promoting national conformity

marks for specific sectors as focus areas for the certification bodies.

Inspection bodies

Apart from developing the inspection functions associated with legal me- trology bodies, UNIDO has only had occasional requests in recent years to undertake capacity building of inspec- tion bodies (see example below from the UEMOA Region) but does have access to expertise to assist further de- velopments in this area.

Potential areas where UNIDO can provide awareness and capacity build- ing for inspection activities include : �� General seminars, workshops, train-

ing and awareness programmes on inspection body issues, such as : − Inspection standards, including

ISO/IEC 17020 − Training and qualification of

inspection body auditors − Accreditation of inspection bodies − Meeting inspection requirements

for specific regulations or speci- fiers.

�� Capacity building of specific inspec- tion bodies that are needed to assist local industrial or service bodies fa- cilitate the acceptance of inspected materials, products, commodities or services in foreign markets �� Training of inspection body personnel �� Facilitation of the accreditation, by

foreign or local accreditation bodies, of inspection bodies who need this to gain access to markets or to sup- port local industrial development.

UEMOA As part of a multi-faceted project in the eight countries of the West African Economic and Monetary Union (UEMOA), UNIDO commis- sioned a regional evaluation of regu- latory inspection capacity in the fields of plant and animal health, processed foodstuffs and the analysis of pesticide residues.

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The objectives of this evaluation were to identify gaps in regulatory inspec- tion in the region ; to determine needs for analytical equipment to support the regulatory function ; and to identify in- stitutions that needed strengthening.

Subsequent elements of the project involved : �� Training phytosanitary inspectors �� Training animal health inspectors �� Discussing the harmonization of

inspection criteria and techniques �� Developing guidance documents

on modernizing food sanitary in- spection and promoting agricultur- al products.

Metrology institutes

A significant part of UNIDO techni- cal assistance in developing quality in- frastructures has been directed at es- tablishing and building the capacity of national metrology institutes, bringing international experts from different branches of metrology (mass, temper- ature, electrical, pressure, dimensions, etc.) to oversee the development of fa- cilities, personnel and equipment.

Its technical assistance has ranged from establishing instrument repair and maintenance support to provid- ing measurement traceability of cal- ibration standards to international standards of measurement. Projects

involve surveys of users’ needs for various types of calibration and mea- surement and the levels of accuracy required to support industrial testing and other needs. International metrol- ogy experts conduct seminars, work- shops and other training activities, and fellowships are provided for staff to be trained abroad in measurement tech- niques.

Two recent UNIDO technical assis- tance projects, in Tanzania and Viet- nam, are typical of the numerous projects UNIDO has undertaken over many years to develop metrology ser- vices in developing countries.

Tanzania As with many UNIDO projects, assis- tance for the development of metrol- ogy capabilities in Tanzania was only one component of a broader project to enhance the quality infrastructure so that it would ensure the delivery of globally accepted metrology, test- ing, quality and certification services in compliance with TBT and SPS require- ments.

After identifying local needs for me- trology services and obtaining fund- ing commitments, a variety of activities were undertaken to enhance metrol- ogy capabilities. These included pre- paring metrology facility blueprints, specifying equipment needs, installing

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equipment, training staff, conducting inter-laboratory comparisons, prepar- ing laboratories for accreditation, re- viewing the legal metrology system and associated laboratories, establishing a repair and maintenance facility, and developing a mobile calibration facility.

Progress to date includes the deliv- ery and installation of equipment for pressure, dimensional measure- ments and electrical calibrations, and the training of staff. Additionally, the Tanzanian Bureau of Standards’ Me- trology Laboratory has successfully maintained accreditation by the South African National Accreditation System (SANAS), and the mobile calibration unit is operational with trained staff and measurement instruments.

Viet Nam A UNIDO project is underway in Viet Nam to assist the country gain better market access by strengthening its ca- pacities in metrology, testing and con- formity assessment. UNIDO has assist- ed three metrology laboratories in the Directorate for Standards and Quality (STAMEQ) and the Viet Nam Metrol- ogy Institute (VMI) to provide precise and recognized calibration services to industry, and has upgraded metrolo- gy facilities in Ho Chi Minh City and Hanoi with international accreditation for their mass and temperature calibra- tion services.

The specific activities include : �� Preparing a framework for strength-

ening metrology laboratories, includ- ing the Viet Nam Metrology Institute

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�� Identifying the equipment and phys- ical facilities required to meet the spectrum of measurements needed to cover industries’ needs �� Installing equipment �� Providing training in calibration �� Securing overseas fellowships for

key staff �� Assisting in establishing laboratory

management systems that comply with ISO/IEC 17025 �� Assisting metrology services to gain

international accreditation.

With Viet Nam joining the WTO in January 2007, a second-phase project is now underway to assist it to comply with its TBT and SPS obligations.

Accreditation bodies

Over recent years UNIDO has un- dertaken numerous technical assis- tance projects to establish or enhance the capacities of national accreditation bodies, including helping them to reach the entry level of the mutual recogni- tion arrangements of ILAC or IAF, or a regional recognition arrangement. Both ILAC and IAF offer candidates for entry to their MRA or MLA the opportunity to take part in a trial peer- evaluation, or “pre-evaluation”, by a small team of experienced evaluators from foreign accreditation bodies. Any deficiencies are highlighted and assis- tance given to rectify these before a

formal evaluation takes place. UNIDO has provided pre-evaluation assistance to a number of accreditation bodies and helped them gain entry to these recognition arrangements.

UNIDO has made experts available to assist in establishing and enhancing ac- creditation bodies. They have advised on technical, policy, and governance issues. Understanding the latter can be important for meeting the impartiality requirements of ISO/IEC 17011, essen- tial for entry into the ILAC MRA and IAF MLA. Often the assistance on gov- ernance issues includes inputs to the content of draft legislation or regula- tions that effect the establishment and roles of national accreditation bodies.

UNIDO has also facilitated the at- tendance of personnel from develop- ing country accreditation bodies at various ILAC and IAF meetings, and helped them understand the technical and policy issues that affect accredita- tion bodies internationally, including issues relevant to joining their recogni- tion arrangements. Other typical assis- tance includes awareness seminars and workshops for potential clients. Among the many assistance projects conducted by UNIDO for the devel- opment and recognition of accredita- tion bodies are recent projects in Mon- golia and the West African Economic and Monetary Union (UEMOA).

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Mongolia The development of Mongolia’s ac- creditation capacity is part of an over- all project aimed at reducing poverty by developing a competitive and sus- tainable export-oriented agro-industri- al sector.

The project commenced with a review of the existing documentation of the Mongolian Accreditation Scheme for compliance with ISO/IEC 17011. Weaknesses were identified and an action plan was drawn up to implement an effective management system, de- velop its quality manual and operation- al procedures, develop its accreditation criteria and its structure, and bring it to a level where it can achieve signa- tory status in a mutual recognition ar- rangement and become a member of APLAC, ILAC or IAF.

This project highlights a number of issues critical to the smooth imple- mentation and success of projects of this type in any country. Perhaps most significant is the effort sometimes re- quired to establish structural arrange- ments that ensure an accreditation body is impartial and has no conflicts of interest. This is an essential require- ment of ISO/IEC 17011 and a neces- sary pre-condition if an accreditation body is to achieve signatory status in the MRAs of ILAC and IAF and their regional cooperation bodies.

In Mongolia, like many other develop- ing countries, the initial development and operation of accreditation activi- ties was assigned to a single national organization with a number of func- tions : operating as the national stan- dards body ; performing the role of the national measurement institute ; oper- ating testing laboratories (particular- ly in support of product certification) ; and conducting third party certifi- cation for management systems and products.

While this may be a practical central- ization of resources in a developing country, it places the accreditation body in a position of potential conflict of in- terest where doubts may be cast on its impartiality. If an organization is oper- ating testing, calibration and certifica- tion services together, its credibility in accrediting other organizations’ labora- tories, inspection bodies or certification bodies is seriously compromised.

Such situations have arisen in a number of countries and have led projects to recommend the separation of accredi- tation functions into independent agen- cies or departments, usually within the government sector. This often requires legislative or regulatory changes since accreditation may be the subject of na- tional laws or regulations. UNIDO has on occasion assisted in drafting such legislation.

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UEMOA UNIDO’s assistance with an accredi- tation infrastructure for UMEOA has most of the elements of a classic inte- grated approach, the project’s planned output being a system for accreditation, standardization and quality promotion for the eight UEMOA countries.

In accreditation, the immediate aim is a regional accreditation system for UEMOA and ultimately a West Af- rican Accreditation System (SOAC) that is recognized internationally. A number of the activities undertaken to establish the accreditation system were supported by the parallel development of the region’s laboratory and inspec- tion capacities.

The project’s objectives included facil- itation of access for agricultural food products, fishery products and cotton to regional and international markets ; improvement of sanitary and hygiene conditions ; better consumer aware- ness of hygiene and quality standards ; increased use of standards and confor- mity assessment processes in public purchasing arrangements ; and im- provement in the quality of, and in- creased revenue from, sales of agri- cultural food products, both within UEMOA and internationally.

Specific project activities to develop re- gional accreditation included support

from the French accreditation body, COFRAC, to design and assist the op- eration of the West African Accredi- tation System (SOAC) ; joint accredi- tation assessments by COFRAC and SOAC ; preparation of the operation- al and technical documents for com- pliance with international standards by SOAC ; establishment of a database of approximately 150 laboratories in the UEMOA sub-region ; training of groups of laboratory assessors ; train- ing in the management systems of lab- oratories according to ISO/IEC 17025 ; provision of foreign calibration sup- port for incubators used by microbio- logical laboratories in the region ; and harmonization of analytical methods for testing food products in the region.

A more detailed account of the UEMOA programme is given in the following section on building integrat- ed quality infrastructures.

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Building an integrated quality infrastructure

Guyana Guyana, like other developing coun- tries, finds itself unprepared for inte- gration into an open or global market place and, with its limited resourc- es, recognises that the challenges of global competitiveness are becoming extremely complex and difficult.

The drive for economic development in the country is closely associated with its ability to export locally man- ufactured products. As a result, it has been involved for the last decade in ne- gotiating many multilateral and bilat- eral trade agreements. However this increase in exports will only be possi- ble if Guyana can provide assurance to the marketplace that these products meet the requirements stipulated in standards/regulations and/or are being produced under management systems that are recognized by and acceptable to the marketplace.

At the same time, there is a movement from commodities-based exports to more value added or consumer prod- ucts. This means that the requirements for conformity assessment are becom- ing more pronounced, since the com- modities-based products were being supplied for reprocessing whilst the consumer products are for direct con-

sumption. Conformity assessment ac- tivities such as testing, inspection and certification offer an opportunity for that assurance to be provided to the marketplace. The requirements for these activities are all stipulated in the trade agreements negotiated. Recognising that conformity assess- ment activities can either expedite or seriously hinder the free flow of goods in international commerce, these trade agreements establish procedural re- quirements for conformity assessment schemes aimed at preventing unnec- essary obstacles to trade. They specify that conformity assessment procedures be prepared, adopted and applied so that like products originating from other countries (which are signatories to the agreement) are granted no less favourable conditions than those pro- duced nationally or originating in an- other country, and encourage the use of international standards in this whole process.

Conformity assessment activities in Guyana, as in the majority of other de- veloping countries, are primarily the functions of the government regulato- ry agencies. This practice is not in con- formance with that of developed coun- tries and has led to their results being questioned by the marketplace. The credibility of these agencies’ results will continue to be an issue until a third

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party provides assurance that they are operating to the relevant international standard. The recognized standards are ISO/IEC 17020 for inspection bodies, ISO/IEC 17025 for laboratories con- ducting testing and calibration, and ISO/IEC Guide 65 for bodies involved in certification.

These agencies need to ensure that their operations are aligned to interna- tional practices so that their results will be accepted by all the markets and the export of locally manufactured prod- ucts facilitated. They would then, too, be better able to protect local consum- ers from substandard imports.

For Guyana to achieve the level of in- ternational trade, market access and investment that will drive its economic development, it needs to consider the principles outlined for free trade in the various trade agreements and put the necessary infrastructure in place to ad- dress them.

For this purpose, the National Com- mittee for Conformity Assessment (NCCA), consisting of a number of or- ganizations from government and the private sector, was established in Jan- uary 2004 with the declared goal of : “Improving the quality of life for all Guyanese through the development of an internationally recognized na- tional system of conformity assess-

ment in Guyana”. This committee is in the process of implementing actions to achieve this goal.

(This Guyana case study has been taken from the website of the Guyana National Bureau of Standards : http :// www.gnbs.info/NL%20conf%20ass. htm)

UEMOA

Consensus on quality The West African Economic and Mon- etary Union (UEMOA) compris- es eight member states, Benin, Burki- na Faso, Côte d’Ivoire, Guinea Bissau, Mali, Niger, Senegal and Togo. The UEMOA Commission, based in Oua- gadougou, Burkina Faso, was UE- MOA’s technical arm in implementing the UEMOA Quality Programme. The UEMOA countries also form part of the Economic Community of West Af- rican States (ECOWAS) whose other members are Cape Verde, Gambia, Ghana, Guinea, Liberia, Nigeria and Sierra Leone.

The UEMOA Common Industrial Policy aims at a lasting industrial de- velopment process underpinned by technology upgrading and quality im- provement as decisive economic suc- cess factors. In line with this policy, the member states of UEMOA ad- opted and implemented a comprehen-

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sive “Programme for the setting-up of a system for accreditation, standard- ization and quality promotion” from 2002 to 2005. Also referred to as the UEMOA Quality Programme, it was implemented by UNIDO on behalf of the UEMOA Commission, with fund- ing from the European Union to the tune of 14 million Euros. A second phase of the programme has now been implemented for the UEMOA coun- tries as of 2007 and, in parallel, the programme was extended to the non- UEMOA ECOWAS countries and Mauritania.

The Conference of African Ministers of Industry (CAMI), at its meeting held in Cairo in June 2006, re-assert- ed the need to strengthen the African standardization and conformity assess- ment infrastructure and increase the harmonization of standards in Africa at the national, regional and continen- tal levels.

The conference took note of the achievements of the UEMOA Quality Programme and invited development partners to build on this experience. In fact, a side-event of the 2006 CAMI was the signing of an agreement be- tween the Commission of the African Union and UNIDO which renewed co- operation between the two organiza- tions in various fields, including trade and production capacity building with

a strong emphasis on quality, standards and conformity assessment.

There is, therefore, a clear consensus at the highest political level on the need to boost quality infrastructures across the whole African region in order to support industrialization. The expe- rience gained in implementing the UEMOA Quality Programme consti- tutes an invaluable asset for similar programmes which will inevitably be set up in other sub-regions of Africa.

The UEMOA Quality Programme The main objective of the UEMOA Quality Programme was to build and/ or reinforce all the steps of a quality infrastructure for the UEMOA sub-re- gion and to ensure its recognition at in- ternational level through the process of accreditation. The programme has as- sisted UEMOA countries in their goal of meeting the provisions of the WTO TBT Agreement, thus enhancing their capacity to participate with added con- fidence in international trade.

Highlighted below are some of the most important characteristics of the UEMOA Quality Programme as a re- gional approach to implementing a set of quality management, standardization and conformity assessment activities across a wide spectrum of beneficiaries in a group of countries with very dispa- rate institutional quality infrastructures.

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Several constraints weighed heavily on the execution of the programme, but at the same time many critical suc- cess factors contributed to project re- sults that were much appreciated by the beneficiaries.

Constraints The following constraints were noted at the beginning of the programme : �� National quality policy and infra-

structure were practically non-exis- tent in most countries of UEMOA �� Two of the eight countries did not

have a national standards body (NSB) and the national standard bodies of several of the others were non-operational due to lack of human and material resources ; most national standards bodies were not members of ISO, which meant that they did not have international and foreign national standards available for economic operators �� There was little demand for stan-

dards by industry, consumers and other major players like public pur- chasing organizations �� Only one private testing laborato-

ry was accredited in the whole sub- region ; other laboratories did not work according to the accreditation standard ISO/IEC 17025 and there was a serious lack of modern labora- tory testing equipment and training ; �� Only one national standards body

operated a product certification

body and few certifications were granted �� Only about 30 enterprises were cer-

tified to ISO 9001 in all eight coun- tries, and local consultancy support for enterprises was available in only two countries.

Success factors There were several critical success factors, listed below with several de- scribed in more detail in subsequent paragraphs : �� Project activity formulation ; use of

an external specialised agency like UNIDO for project execution �� Efficient financial and administra-

tive arrangements for fund transfer and use, impacting on the lead time for mobilising international consul- tancy and the procurement of goods or services �� A supranational regional organisa-

tion for anchoring the central proj- ect execution team and for following up on individual governments’ com- mitments �� A legal framework for sustaining

post-project results �� Private sector participation �� An adequate number of technical-

ly competent project coordinators at both national and regional levels �� The flexibility during implementa-

tion to take immediate and urgent conformity assessment issues on board

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�� Partnerships with foreign national and international technical organi- zations.

External specialized agency. One of the reasons that the involvement of a specialized agency like UNIDO is considered a critical success factor is that it was able to take part in both the formulation and execution of the project. UNIDO collaborated with the UEMOA Commission right from the project formulation stage. The choice of the programme’s strategy and tech- nical focus drew on UNIDO’s long ex- perience in the field, thus ensuring that quality factors at design level were ap- propriately included. The huge techni- cal expertise that UNIDO could bring to bear on the programme, including its roster of independent consultants, greatly increased its effectiveness. It is noteworthy that, at the beginning of project implementation, UNIDO had secured 66 % of the total funds needed during the whole lifetime of the proj- ect, and for the final two years of im- plementation this proportion had risen to 86%. UNIDO actually carried out activities valued at 87 % of its share of funds by the end of the project’s lifes- pan.

Supranational regional organization. It was a great asset that a suprana- tional regional organization like the UEMOA Commission hosted the re-

gional project coordination team and liaised with member governments. Both the project coordination team and UNIDO were limited in their ca- pacity to convey instructions or guid- ance on project execution directly to governments.

Often, national beneficiary organiza- tions have to be given deadlines, for example for preparing laboratory ac- commodation before equipment can be supplied, and there may also be fi- nancial implications. The UEMOA Commission was very effective in get- ting government ministries responsible for the programme at the national level to put pressure on the national benefi- ciary organizations (laboratories in this example) in order to meet deadlines.

Legal framework. In order to strength- en regional cooperation in accredita- tion, certification, standardisation and metrology, UEMOA had to harmonise its policies and set up regional coordi- nation mechanisms through an appro- priate legal framework. The UEMOA Commission took the lead in formulat- ing such a framework and consequent- ly a regulation (UEMOA Quality Regulation 2005) was adopted by the UEMOA Statutory Council of Minis- ters on 4 July 2005.

The regulation provides for the set- ting up of a Regional Coordination

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Committee on Quality (CRECQ) and three permanent regional structures which will ensure the sustainability of the programme, namely the West Af- rican Accreditation System (SOAC) ; the Regional Secretariat of Standar- disation, Certification and Quality Promotion (NORMCERQ) ; and the West African Secretariat for Metrolo- gy (SOAMET). In this case as well, the essential role played by the UEMOA Commission is clear.

Private sector participation at all levels of project coordination was critical. Under UNIDO guidance, the UEMOA Commission therefore required the ministers in charge of the programme in each country to set up national steer- ing committees composed of represen- tatives from the public and private sec- tors in equal proportions.

The positions of chair and vice-chair were shared between these two sectors. The fact that the sole Regional Steering Committee was composed of the chair and vice-chair of the national steering committees ensured that private sector inputs to the coordination of the pro- gramme reached the highest level.

Technically competent coordinators. The need to have high-level technical experts on a permanent basis at the level of central coordination, especial- ly when such a complex programme is

being implemented for the first time at a regional level, cannot be over-empha- sized. The project coordination team consisted of four full-time internation- al consultants : a chief technical advis- er, who was an expert in accreditation ; an expert in standardization ; another in quality promotion ; and one in consum- er affairs and communication.

The experts not only managed the pro- gramme but also advised the UEMOA Commission on policy choices that had a long-lasting impact. Such an adviso- ry function, for example, was critical in framing the UEMOA Quality Reg- ulation 2005 and for subsequently en- suring its acceptance at various levels of UEMOA, namely the Commission itself, the Committee of Ministers of In- dustry and finally the statutory Coun- cil of Ministers. Such an expert team is also essential in managing internation- al consultants and guiding their work since the latter very often know little about the regional context and issues when they begin their mission.

In each country, the coordination was effected by a national technical coordi- nator, who was a national of the coun- try concerned and who also acted as secretary to the national steering com- mittee. Both the project experts and the national technical coordinators were recruited directly by UNIDO after con- sultation with the UEMOA Commis-

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sion and were supervised by a UNIDO project director based in Vienna.

The latter also coordinated project support activities in other UNIDO di- visions, for example the Human Re- sources Branch responsible for consul- tant recruitment and the Procurement Division responsible for equipment purchase. In all, UNIDO recruited and supervised the missions of 132 nation- al consultants and 88 international con- sultants who contributed on different technical aspects of the programme.

Flexibility. The programme was asked, in response to urgent issues that ap- peared in certain sectors during the

course of execution, to undertake actions that had not initially been planned. Here, it is worth noting the as- sistance provided to the fisheries and cotton sectors, described in the follow- ing paragraphs.

The fishery sectors in Togo, Benin, Côte d’Ivoire and Guinea-Bissau have been strengthened. The assistance pro- vided under the programme improved the quality of exported fishery prod- ucts and helped the fisheries industry to meet the sanitary and normative re- quirements of the market. The labora- tory equipment provided through the programme for Togo and Benin was mostly directed to this sector.

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In Benin, the technical support was particularly timely as it enabled the country to resume exports of fish- ery products to the European Union. During the life of the programme, there was a fundamental change in the EU’s regulations on food safety : these became stricter with the adop- tion by the European parliament of several regulations on hygiene and of- ficial food controls. One of the regula- tions specifically requires official food control laboratories to be accredited to ISO/IEC 17025.

The programme also responded to the needs of the cotton sector. Several ini- tiatives were taken : cotton graders from

six UEMOA countries were trained, and high volume instruments (HVI) for automated testing of cotton fibre delivered to selected countries ; cotton standards for West African cotton were prepared for the first time, and these are expected to enable cotton produc- ers to negotiate the true price for their cotton in the international market ; and a manual covering topics such as quality standards, trade and ginning practice for cotton was prepared for the economic operators in the sector.

Cotton production and transforma- tion has gradually become a critical sector for many UEMOA countries – UEMOA has even adopted an Agenda

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on Cotton with the aim of strengthen- ing all aspects of this sector.

Partnerships. The main partner- ship agreement concluded under the programme was signed between the UEMOA Commission and the French Committee for Accreditation (COFRAC). COFRAC is to support SOAC, the UEMOA regional accred- itation body, to become operational and achieve international recognition.

Collaboration was also undertaken with organizations like the Physika- lisch-Technische Bundesanstalt (PTB – the German National Metrology In- stitute) in the area of metrology ; the Association Française de Normalisa- tion (AFNOR) and the Internation- al Organization for Standardization (ISO) in the area of standards ; and the international consumers’ organisation (OIC).

The programme has paid subscription dues to enable all eight member States of UEMOA to become members of ISO (one member body and seven cor- respondent members). Two of the coun- tries participate in the international technical work of ISO and all eight na- tional documentation centres are con- nected to the ISO intranet system.

These partnerships provide the neces- sary link towards international recog-

nition and are crucial for UEMOA’s development of standardisation, con- formity assessment and accreditation systems. The programme also sought to ensure that necessary budget allo- cations were made to meet future ISO subscription dues.

The power of a regional approach Although the final beneficiaries of the programme, the productive sectors and the population at large, are at country level, UEMOA has taken a region- al approach that targets both regional and national levels in order to build a robust standardization and conformity assessment infrastructure, since most of the UEMOA countries do not have the critical mass of conformity assess- ment needs to justify purely national approaches. The programme has there- fore opted to create a unique regional accreditation body, SOAC, to provide accreditation services to all laborato- ries, certification and inspection bodies in the sub-region.

In laboratory strengthening as well, equipment has been provided to 46 lab- oratories in the eight countries with the objective of creating centres of ex- cellence in different countries. In the notable example of pesticide residue analysis, it is clear that each UEMOA country cannot expect to have a full- fledged laboratory capable of testing

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all the pesticides used in the sub-region. The material and human resources are simply not there. The same logic applies to other types of analysis, such as myco- toxin analysis. Certain laboratories have therefore been provided with equip- ment that will enable them to take on a regional role, e.g. by becoming regional reference testing laboratories.

The same approach has been adopted for the development of sectoral tech- nology centres in the fields of fruits and vegetables, meat and milk prod- ucts, and building and civil engineering. Nine existing institutions have been se- lected in four countries and provided with equipment and training to enable them to act as regional centres for the dissemination of technology-based in- formation and training.

Another area where there is no alter- native but to adopt a regional approach is the preparation of regional standards or the harmonization of national stan- dards. In implementing this approach, the role of the UEMOA Commission has been critical in responding to que- ries by countries which had not been chosen to host a regional centre. The Commission could arbitrate in this way precisely because of its supranational status. This again highlights its value in dealing with governments, something no other project coordination entity could effectively accomplish.

CARICOM Regional Organisation for Standards and Quality (CROSQ)

The CARICOM Regional Organ- isation for Standards and Quality (CROSQ) was established in February 2002 as an inter-governmental agency to facilitate the development of region- al standards, represent the interests of the sub-region in global standards work, promote the harmonization of metrology systems and support the sus- tainable production and trade of goods and services in the Caribbean Commu- nity (CARICOM) Single Market and Economy (CSME).

The Headquarters Agreement, signed with the Government of Barbados in January 2007, provides a permanent base for CROSQ in Barbados, where the Secretariat has been located since 2003. All member states of CARICOM are members of CROSQ, with Haiti becoming the latest addition when it signed the CROSQ Intergovernmen- tal Agreement on 8 May 2009.

The Executive Secretary (Chief Exec- utive Officer) manages the Secretariat and interfaces with the national stan- dards bodies via the CROSQ Council. The Council, comprising all directors of the national standards bodies of the member states, guides CROSQ activi- ties and reports on them to the Council

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for Trade and Economic Development (COTED) of CARICOM.

In keeping with its mandate, CROSQ has been pursuing, within the last two years, the goal of developing a strong regional quality infrastructure in tandem with national quality in- frastructures and has received sup- port from a range of externally funded projects. In keeping with this effort, the project and staff complement at the Secretariat has tripled since 2007.

From standards development... In the early years, CROSQ focused mainly on the development of region- al standards. A Technical Management Committee, comprising volunteers from among the national standards

bodies, met and continues to meet 3-4 times a year to coordinate the devel- opment of the standards following ISO guidelines. Regional technical commit- tees (RTCs), comprising experts in rel- evant sectors and coordinated by one or more national standards bodies, de- velop the committee drafts (CDs).

The drafts are then circulated to the member states for public comments, which are returned to the RTC to be dealt with. Following editing and final formatting, the standards are submit- ted to the CROSQ council for approv- al and then to the Council for Trade and Economic Development for ratification. The Technical Management Committee currently has a portfolio of more than 50 standards under development.

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Of these, 34 normative documents are being developed under a 2005–2009 project, co-funded by the Inter-Amer- ican Development Bank (IDB), aimed at increasing the competitiveness of small and medium-sized enterpris- es. A two-year extension has been re- cently approved in order to meet the project goals and objectives. Other components of the project include awareness-raising, training small and medium-sized enterprises and setting up a regional information system.

...to regional quality infrastructure In recent years, globalisation has shifted attention to the development of other regional quality infrastructure elements (metrology, inspection, testing, calibra- tion, certification, accreditation). This is the focus of the second IDB-funded project for 2007-2011, which aims to im- prove market access and competitive- ness in the production and trading of re- gional goods and services. The German Physikalisch Technische Bundesanstalt (PTB) has provided valuable technical and financial assistance to conduct base- line studies and needs assessments on the current status of the regional quali- ty infrastructure in order to enhance re- gional capabilities. With the signing of the Economic Part- nership Agreement in October 2008, the German Ministry for Economic Cooperation and Development (BMZ)

approved a complementary technical assistance project, channeled through the PTB, in December 2008. A regional planning workshop for a third project, also funded by the BMZ, was recent- ly concluded and will address metrolo- gy and accreditation as well as enhanc- ing the capacity of CROSQ to meet its mandate. CROSQ’s role is to bring complementarities to all three projects in order to maximize scarce resources and avoid duplication of efforts.

Metrology A recently developed concept is that of the regional Caribbean Reference Laboratories (CARLs). These lab- oratories will provide efficient and cost-effective traceability to prima- ry quantities at the international level for working standards at the national level. Quantities to be developed in- clude mass, volume, time and frequen- cy. The capabilities of two advanced na- tional laboratories are currently being upgraded so that they can take on the role of CARLs.

In 2008, CARIMET (the regional arm of the Sistema Interamericana Metro- logia – SIM) became a Technical Com- mittee of CROSQ. It is anticipated that the implementation of subsequent re- gional quality infrastructure projects through CARIMET will further facili- tate the integration of CARIMET into CROSQ.

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Tradecom is providing technical as- sistance to CROSQ for the hiring of a metrology officer to implement these projects and to hold three seminars (calibration methodologies, uncer- tainty estimation, and development of quality management handbooks) during 2009-10.

Inspection and certification A conformity assessment survey is cur- rently underway to assess the status of inspection and certification bodies in all the member states of CROSQ. In- formation from the survey will help es- tablish how best to harmonise region- al inspection and certification. The use of a single regional standards mark is also being considered, together with an annual regional quality awards pro- gramme.

Accreditation Phase II of the Caribbean Labora- tory Accreditation Services (CLAS) Project (9th European Development Fund- sponsored) is currently being im- plemented (to April 2010). This aims to assist laboratories achieve accreditation through regional cooperation and the establishment of an overarching region- al accreditation cooperation mechanism. At present, two national accreditation bodies, one each in Trinidad & Tobago (Trinidad & Tobago Laboratory Ser- vices – TTLABS) and Jamaica (Jamai- ca National Agency for Accreditation

– JANAAC), operating in conformi- ty with ISO/IEC 17011, are prepar- ing for international recognition. Both are associate members of the Inter- American Accreditation Cooperation (IAAC) and affiliate members of the International Laboratory Accredita- tion Cooperation (ILAC).

In countries without a national ac- creditation body, national accredita- tion focal points have been formed to fill this need and provide the necessary information and support for accredita- tion activities. A major part of the work of the Caribbean Laboratory Accredi- tation Services is to network member states which do not have emergent na- tional accreditation bodies in order to continue the development of national accreditation focal points.

The regional cooperation for labora- tory accreditation is to be established through the implementation of the Statement of Technical Co-opera- tion between the national accredita- tion bodies and support for the devel- opment of the national accreditation focal points. Mechanisms are being es- tablished for the harmonization of pro- cesses and procedures in accordance with international standards and guide- lines and for the development of a re- gional approach to the basic require- ments for laboratories.

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Human resource capacity building is being pursued to ensure that labora- tory personnel, accreditation body and focal point personnel and assessors are provided with the necessary knowl- edge and skills to serve the needs of the accreditation system. The sustain- ability of the accreditation service is to be assured through advocacy for and marketing of accreditation, mobilisa- tion of resources and maintaining a cadre of certified assessors.

In addition, the accreditation system will be continually improved by en- suring the establishment and mainte- nance of feedback mechanisms and systems for updating personnel and criteria. To this end, Caribbean Lab- oratory Accreditation Services is to conduct pilot studies on the accredita- tion of laboratories within the region, share best practices and assess the need for enhanced regional accredita- tion capacity.

Other projects The Caribbean Development Bank (CDB) is funding a 30-month project, aimed at developing regional build- ing standards based on the Interna- tional Code Council (ICC) Codes. The main output of the project is the Carib- bean Application Documents and the promotion of their use regionally. The project comes to an end in mid-2010.

The Canadian International Devel- opment Agency (CIDA – via TDV Global / Wren Group) is supporting the strengthening of CROSQ’s proce- dures and processes, in particular the development of a quality management system (QMS) in accordance with ISO 9001.

Next steps Going forward, the sub-region faces new trade agreements that will pro- vide new opportunities for the export of goods and services. The recent slow- down in the global economy, on the other hand, could impede the rate of development in the region. In response, manufacturers need to consciously shift their focus from cost leadership to product and service differentiation on quality parameters, including and in particular the added value of brand imaging.

At the national level, this would re- quire a shift in emphasis from import inspections against mandatory stan- dards to export-led growth using inter- national voluntary standards bench- marked against international best practices. CROSQ has a pivotal role to play in the process by realigning itself, widening its scope of operation and developing its capacity to help region- al business move from a strategy of price competitiveness to quality com- petitiveness. This can only be achieved

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by establishing the full range of quality infrastructure : �� Harmonization and implementation

of regionally relevant standards �� Development of metrology and con-

formity assessment capability, in- cluding accreditation �� Promotion of a regional quality cul-

ture.

CROSQ’s Three-year Strategic Plan (2009-2012) takes into account the new direction in which CROSQ is moving, setting up strategic themes as the pil- lars for developing regional quality in-

frastructure, with strategic objectives as the building blocks and business drivers of the future. It also takes into consideration the nec- essary human, technical and financial resources as well as projects and ac- tivities that will help the organization achieve the set targets. The plan has seven strategic themes – harmoniza- tion of standards, metrology capability, conformity assessment capability, ac- creditation cooperation, regional qual- ity culture, financial self-sustainability and organizational efficiency.

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Southern African Development Community

Formed on 17 August 1992 in Wind- hoek, Namibia, the Southern African Development Community, SADC, comprises 15 member countries with a combined population of around 250 million people and a gross domestic product (GDP – 2006) of USD 375 bil- lion (Seychelles excluded).

SADC countries include Angola, Bo- tswana, Democratic Republic of the Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, United Republic of Tanzania, Zambia and Zimbabwe.

SADC’s vision is one of a common future within a regional community that will ensure economic well being and improvement of the standards of living and quality of life of its people. In its quest to achieve the above, SADC has identified trade as the main driver for regional integration and eco- nomic development. It was realized very early on that effective trade facili- tation and productive competitiveness required a robust regional quality tech- nical infrastructure.

To facilitate this, SADC member states agreed to put in place a technical reg- ulation framework whose objective

would be the identification, prevention and elimination of unnecessary techni- cal barriers to trade (TBTs) amongst the member states and between SADC and other regional and internation- al trading blocs through harmonized standards, technical regulations and conformity assessment procedures in order to facilitate and increase trade in goods and services. Regional coopera- tion structures were set up to facilitate harmonisation activities as follows : �� SADCSTAN – SADC Cooperation

in Standardization �� SADCMEL – SADC Cooperation

in Legal Metrology �� SADCMET – SADC Cooperation

in Measurement Traceability (In- dustrial and Scientific Metrololgy) �� SADCA – SADC Cooperation in

Accreditation �� SADCTRLC – SADC Technical

Regulations Liaison Committee �� SADCTBTSC – SADC Technical

Barriers to Trade (TBT) Stakehold- ers Committee �� SQAMEG – SADC SQAM Expert

Group.

These structures have been deliberate- ly formed to mirror the internation- al design of bodies dealing with TBT matters to enable ease of obtaining in- ternational recognition in the various areas.

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Standardization SADCSTAN is the regional coopera- tion structure tasked with the harmon- isation of standards based on interna- tional standards and the promotion of the use of common performance based standards rather than prescrip- tive standards as a basis for technical regulations.

In terms of the SADC technical regula- tion framework, all member states are required to withdraw conflicting stan- dards once harmonised text is avail- able. SADCSTAN has developed elab- orate procedures, based on ISO/IEC Directives, to facilitate its standards harmonisation work.

So far, approximately 100 standards have been harmonised and about 30 are in the process of being harmonised.

Work has also started to engage reg- ulators in the member states through SADCTRLC to identify and prioritise technical regulations that need har- monisation. It is the job of the SADC- TRLC to provide a forum for the identification of common technical regulations to be implemented in the region.

All SADC countries except Lesotho now have national standards bodies (NSBs) in place and Lesotho is working towards establishing its NSB. The fact that all countries now have NSBs is at- tributable to SADCSQAM (see Figure 14) and is one of SQAM‘s achievements.

The national standards bodies of Bo- tswana, Mozambique, Angola, Swazi- land and Namibia all fully developed after the start of the SADCSQAM

Figure 14 – SADCSQAM infrastructure mirrors the global TBT landscape

SADC 

GLOBAL 

TBT/Quality infrastructure

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Programme and these developments are in part due to the encouragement and moral support from SADCSQAM. All SADC countries are members of ISO and IEC. For the latter only South Africa is a full member of IEC whilst the rest of the countries are affiliate member bodies.

Metrology and conformity assessment The region has hundreds of private and public sector laboratories in areas which support industrial, mining, ag- ricultural, medical and food sectors’ requirements for voluntary and reg- ulatory testing and calibration. Tertia- ry education and research institutions also have test facilities that are fre- quently availed to industry.

The region has a significant number of certification and inspection bodies that offer services to the voluntary and reg- ulatory sectors. The SADCTBTSC was established as the forum through which these conformity assessment service providers can cooperate at regional level. SADCTBTSC advises the other SADCSQAM structures, in particular SADCSTAN and SADCTRLC, on pri- ority areas for inclusion in their work programmes and on any other issues that may affect the efficient operation of the SADCSQAM infrastructure and the technical regulatory framework of the region.

International recognition for con- formity service providers is achieved through measurement traceability and accreditation. The key pre-requisites for traceability and accreditation for laboratories include participation in proficiency testing (PT) schemes and the use of certified reference materials and calibrated equipment.

SADC has therefore put in place two metrology structures, SADCMET and SADCMEL, to support industry with traceability requirements through re- gional cooperation and also coopera- tion with international players outside of SADC itself. Within this context, SADCMET monitors the PT schemes that are being run in member states mainly in the area of water and food. Two regional PT schemes are being run in the area of water and food forti- fication supported by donor assistance. SADCMET plans to offer more PT schemes in the near future.

Access to reference materials (RMs) remains a major problem for conformi- ty assessment service providers (both private and public) in SADC. This is one of the areas that will receive donor support in a quality infrastructure sup- port project funded by the European Commission.

165

Accreditation Two countries in SADC have nation- al accreditation bodies, Mauritius and South Africa. The South Africa Na- tional Accreditation System (SANAS) is well established and has internation- al recognition.

On the other hand, the Mauritius Ac- creditation Service (MAURITAS) is fairly new and has only recently start- ed accrediting entities. SADCA, the re- gional accreditation cooperation struc- ture, noted that the process of setting up national accreditation bodies ordi- narily takes a long time and that some smaller economies in the region may not need to form national accreditation bodies as they do not have the econo- mies of scale to sustain them.

It was therefore decided to establish a regional accreditation body – SADC Accreditation Service (SADCAS) to offer accreditation services to the countries that do not have national ac- creditation bodies. It is also envisaged that SADCAS will offer its services to countries with national accreditation bodies but are unable to accredit in some scopes due to lack of expertise, for example, in that particular area.

SADCAS will offer accreditation pro- grammes for calibration and testing laboratories, certification bodies (man- agement system/product/personnel)

and inspection bodies. SADCAS office has been set up in Gaborone, Botswa- na. The first three members of staff took up their positions in SADCAS between April and July 2008.

SADCAS was officially launched on 23 April 2009 at a ceremony held in Gaborone, Botswana during which the SADC/SADCAS Memorandum of Understanding on general coopera- tion was signed.

National Accreditation Focal Points (NAFPs), who are the administrative link between SADCAS and SADC member states, have been established by the respective member states gov- ernments.

All NAFPs were officially launched by 2008. SADCAS was admitted as an affiliate member of the International Laboratory Accreditation Cooperation in November 2008. SADCAS is poised to start offering accreditation services in the latter half of 2009.

These services are aimed at support- ing regional and international trade, enhancing the protection of consum- ers and the environment as well as im- proving the competitiveness of SADC products and services both in the regu- latory and voluntary areas.

166

As shown in Figure 15, the ISO Com- mittee on conformity assessment is CASCO. It reports to the ISO Coun- cil and has the following terms of ref- erence and objectives : �� Study means of assessing the confor-

mity of products, processes, services, and management systems to appro-

priate standards or other technical specifications �� Prepare standards and guides re-

lated to the practice of testing, in- spection, and certification of prod- ucts, processes, and services and to the assessment of management sys- tems, testing laboratories, inspec-

Appendix 1

ISO/CASCO sets conformity assessment standards

Figure 15 – Structure of ISO

CENTRAL SECRETARIAT

167

tion, certification and accreditation bodies, and their operation and ac- ceptance �� Promote mutual recognition and

acceptance of national and regional conformity assessment systems, and the appropriate use of Internation- al Standards for testing, inspection, certification, assessment and related purposes.

Of ISO’s 151 members eligible for ISO/ CASCO membership, 107 are repre- sented in ISO/CASCO. That member- ship includes both developed and de- veloping countries, and 76 of the total are participating (P) members and 31 are observer (O) members.

ISO/CASCO’s outputs are both of a technical nature (standards, guides and other publications) and policy develop- ment. It has been structured to have a number of key advisory groups to com- plement the technical work undertak- en in the CASCO Working Groups developing the ISO/CASCO suite of standards and other publications. Those advisory groups and their func- tions are as follows (and as shown in Figure 16 – see page 168) :

Policy and support groups of ISO/CASCO

These are : Chairman’s policy and coordination

group (CPC), which reviews and up- dates ISO/CASCO’s action plan and technical work plan. This group also assists the ISO/CASCO Chair in iden- tifying strategic conformity assessment issues and in developing policy. The CPC has also recognized the need for a ISO/CASCO Interpretation Panel to provide a consistent approach to inter- pretation and maintenance of existing ISO/CASCO developed standards and guides.

Technical Interface Group (TIG), is a technically focused group which liaises with other ISO technical committees in order to ensure a consistent and har- monized approach to conformity as- sessment amongst all committees. It seeks to ensure ISO/CASCO confor- mity assessment policies are adhered to and understood, while also provid- ing internal advice within ISO on con- formity assessment issues.

Strategic Alliance and Regulatory Group (STAR) provides a mechanism for industry sectors and regulators to interact with ISO/CASCO (keeping abreast of activities in conformity as- sessment, promoting the ISO/CASCO toolbox, and providing a forum to dis- cuss conformity assessment needs and concerns).

Knowledge Management Group (KMG), which is a small group within

168

CPC that records historical decisions of ISO/CASCO.

The “ ISO/CASCO toolbox ”

The standards, guides and related pub- lications produced by ISO/CASCO form what is known as the ISO/ CASCO toolbox. They are the col- lected resources available to ensure that the various parties with an in- terest in conformity assessment have available the latest documents reflect-

ing the state of the art in internation- al conformity assessment practice. Dif- ferent user-groups will need to select those documents which are of most relevance to their needs, depending on whether they conduct conformity as- sessment activities or are one of the many potential end-users of such ser- vices.

Some of the tools are supported by other complementary tools. For example, the vocabulary and general principles of

Figure 16 – Supporting and working groups in the ISO/CASCO structure

Promotion Study and policy

Technical support Technical work

169

conformity assessment, contained in ISO/IEC 17000, should be of interest to both operators of conformity assessment and their users, such as regulators.

A laboratory using ISO/IEC 17025 as the basis of its operation may also have an interest in the toolbox elements dealing with selection and use of profi- ciency testing schemes (currently cov- ered in ISO/IEC Guide 43).

An accreditation body should not only be fully aware of the requirements for such bodies in ISO/IEC 17011, but also all of the relevant standards affecting the conformity assessment bodies they accredit, for example, ISO/IEC 17020, ISO/IEC 17021, ISO/IEC 17024, ISO/ IEC 17025 and ISO/IEC Guide 65.

A specifier may have an interest in issues related to marks of conformity, where ISO/IEC 17030 could be of value.

The various ISO/CASCO tools are listed in the table at the end of this appendix and are referred to in the appropriate places in this publication.

ISO/CASCO’s global outreach

ISO/CASCO promotes the ISO/IEC conformity assessment standards at the global level through interaction with developing countries and, through

the STAR group, with industry sectors and intergovernmental agencies (reg- ulators) that are involved in conformi- ty assessment. The strategy is to active- ly promote the conformity assessment standards and try to encourage their uptake and use.

Through this work, ISO/CASCO can engage with sector organizations with which ISO does not have a formal li- aison at the CASCO level but which have some global reach such as GFSI, IFOAM etc.

ISO/CASCO communicates with these organizations to make sure they are aware of the toolbox and how to use it to best effect. They are encouraged to become directly involved in the devel- opment of standards for conformity as- sessment activities particularly where the present contents of the toolbox are not suitable for the newly emerging sec- tors such as agri-food, climate change and supply chain risk management.

A list of the standards – either pub- lished or under development – making up the ISO/CASCO toolbox as of July 2009 appears on pages 170-174. (The latest information on publica- tions developed by ISO/CASCO can be accessed via links on the ISO Web site www.iso.org : click on Conformity assessment, then on Publications and resources, then on CASCO toolbox.)

170

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175

The roles of international and regional accreditation body forums

Accreditation is the top level in the quality infrastructure, providing a means of giving confidence in the work of conformity assessment bodies. Accreditation is intended to underpin the integrity, transparency and con- sistency of the work of these bodies. Within a national context where there is one accreditation body in any par- ticular field, this aim can be realized but when more than one accreditation body operates in a given technical area there can be inconsistencies in the way they operate.

The result can be that some conformity assessment bodies might be subject to a more restrictive regime than others according to which accreditation body they use. Such a situation can lead to distortions in the market and can affect those using the services of the confor- mity assessment bodies. As a result, confidence would be undermined and, for example, test reports or certificates issued in one country might not be ac- cepted in another.

In order to address these problems and to promote the widest possible accep- tance of the work of conformity assess-

Appendix 2 ment bodies, the accreditation bodies have formed regional and internation- al forums. The International Laborato- ry Accreditation Cooperation (ILAC) had its origins in 1977 and was formed to promote good practice in testing and calibration and the international ac- ceptance of the work of the laborato- ries carrying out this work.

The International Accreditation Forum (IAF) was formed in 1993 with similar aims in relation to certification (or registration) of quality manage- ment systems conforming to ISO 9001. Subsequently the work of IAF has ex- tended to cover other management systems such as those for environmen- tal issues covered by ISO 14001 and to product certification. ILAC and IAF are working together to cover the ac- creditation of inspection bodies con- forming to ISO/IEC 17020.

One of the driving forces which influ- enced the formation and development of these forums was the GATT (Gen- eral Agreement on Tariffs and Trade) Standards Code. Its purpose was to dis- courage the use of standards (techni- cal regulations and specifications) and conformity assessment (primarily test- ing and certification) as trade barriers. The GATT Standards Code has since been superseded by the establish-

176

ment of the World Trade Organization and its Agreement on Technical Bar- riers to Trade. That Agreement and its relevance to the roles of conformi- ty assessment in global trade are dis- cussed in more detail in Appendix 3.

The objectives of the two interna- tional accreditation forums are as fol- lows : International Laboratory Accreditation Cooperation (from ILAC Rules)

�� To define criteria and standards and harmonize practices to build consis- tency in accreditation of testing and calibration laboratories and inspec- tion bodies for the purposes of trade facilitation �� To develop and maintain arrange-

ments for the mutual recognition of calibration certificates and test and inspection reports issued by labo- ratories and inspection bodies ac- credited by Signatories to the ILAC multilateral Mutual Recognition Arrangement (MRA) �� To ensure that such arrangements

are relevant to the needs of users of such reports and certificates �� To promote the international rec-

ognition of such arrangements by users of calibration certificates and test and inspection reports �� To strive to ensure that the interna-

tional accreditation infrastructure meets the needs of all interested parties seeking competent calibra-

tion, testing and inspection services �� To encourage and assist accredi-

tation bodies to satisfy the needs of their domestic markets and to achieve full international recogni- tion of calibration certificates, test reports and inspection body reports prepared by accredited laboratories and inspection bodies �� To foster the development of ap-

propriate Regional Cooperation Bodies as the means of ensuring that laboratory and inspection bodies throughout the world have adequate opportunities to participate in the work of laboratory and inspection body accreditation and the raising of standards of laboratory and inspec- tion body performance �� To conduct seminars and conferenc-

es and to encourage research into relevant aspects of conformity as- sessment �� To collaborate with regional and in-

ternational bodies having comple- mentary objectives.

International Accreditation Forum (from its Memorandum of Understand- ing)

�� To ensure that accredited conformi- ty assessment activities are effective in adding value to the facilitation of global trade �� To facilitate world trade by :

− promoting common application of the requirements for inspec-

177

tions, certifications and/or regis- trations, or similar programmes of conformity assessment ;

− promoting the equivalence of ac- creditations granted by Accredi- tation Body Members of inspec- tion programmes, certification and/or registration programmes, or similar programmes of confor- mity assessment

− providing technical assistance to emerging economies that are de- veloping conformity assessment accreditation programmes

�� To establish and maintain confi- dence in the accreditation pro- grammes operated by Accreditation Body Members and in the activities of conformity assessment bodies ac- credited by them by : − participation by Accreditation

Body Members and Regional Groups in the worldwide Multi- lateral Recognition Arrangement (MLA)

− exchange of information − participation in IAF activities − participation in regional group-

ings where they exist. �� To support the implementation by

accreditation and conformity assess- ment bodies of those international standards and guides which are en- dorsed by IAF, and to contribute to their development as necessary �� To harmonize the application of cri-

teria for the operation of the Accred-

itation Body Members’ accreditation schemes, based on IAF endorsed in- ternational standards and guides, and publicly available IAF guid- ance documents on the application of those standards and guides �� To establish and maintain an MLA

based on the equivalence of the Accreditation Body Members’ ac- creditation programmes verified through peer evaluation and/or re- evaluation among Accreditation Body Members, such that all par- ties have confidence in the declared equivalence �� To promote the international accep-

tance of the MLA, and of regional group MLAs, on the equivalence of the operation of their accreditation programmes, and the internation- al acceptance of conformity assess- ment results from bodies accredited by Members of the MLA �� To open and maintain channels for

the interchange of information and knowledge between Accreditation Body Members and other relevant bodies.

How the international forums work

Because of their different origins and the different fields they are address- ing, there are some differences between ILAC and IAF in the way that they are organized and operated. However, both

178

have multilateral recognition arrange- ments through which the individual accreditation bodies are evaluated for their conformity with ISO/IEC 17011 and the particular rules of the relevant forum.

The ILAC arrangement is known as the Mutual Recognition Arrangement (MRA) while that of IAF is called the Multilateral Recognition Arrangement (MLA). For more details on how these arrangements work, see the forums’ websites : �� ILAC : http ://www.ilac.org �� IAF : http ://www.iaf.nu

The evaluation is carried out by a team of assessors from other accreditation bodies using peer assessment techniques such as those specified in ISO/IEC 17040. The results of the assessments are reviewed by a special committee which makes the decision on whether or not the body meets the requirements. Re- evaluations are carried out periodically to ensure that the accreditation bodies maintain the standard of their work.

Through the peer evaluation process confidence in the accreditations car- ried out by ILAC and IAF members is enhanced and the international accep- tance of the work of the accredited lab- oratories and certification bodies is fa- cilitated.

The membership categories of IAF are as follows : �� Accreditation Body Members –

Open to bodies accrediting other bodies which certify* quality sys- tems, products, services, personnel, environmental management systems or similar programmes of conformi- ty assessment. Such accreditation bodies declare a common intention to join the IAF MLA to recognize the equivalence of other members’ accreditations to their own. (* IAF uses “register” and “registration” as equivalent words to “certify” and “certification”) �� Association Members – Open to

other organizations involved in the use or implementation of certifica- tion systems �� Special Recognition Organizations-

Regional Accreditation Groups – Open to regional groupings of accreditation bodies whose aims in- clude the maintenance of Regional MLAs.

The membership categories of ILAC are : �� Full Members

− Open to accreditation bodies that meet the requirements for Asso- ciates (below) and have also been accepted as signatories to the ILAC Mutual Recognition Ar- rangement. To do this, the signa- tory must :

179

− Maintain conformance with ISO/ IEC 17011, related ILAC guidance documents, and a few, but impor- tant, supplementary requirements,

− Ensure that all its accredited lab- oratories comply with ISO/IEC 17025 and related ILAC guidance documents.

These signatories have, in turn, been peer-reviewed and shown to meet ILAC’s criteria for competence. �� Associates

− Open to accreditation bodies that, while not yet signatories to the ILAC Arrangement : − Operate accreditation schemes

for testing laboratories, cali- bration laboratories, inspec- tion bodies, and/or other ser- vices as decided from time to time by the ILAC General As- sembly

− Can provide evidence that they are operational and comply with : − Requirements set out in rel-

evant standards established by appropriate international standards writing bodies such as ISO and IEC and ILAC ap- plication documents

− Obligations of the ILAC Mu- tual Recognition Arrangement

− Are recognized in their economy as offering an accreditation ser- vice.

�� Affiliates − Open to accreditation bodies that

are : − Currently operating, being de-

veloped or intended to be de- veloped for testing laboratories, calibration laboratories, inspec- tion bodies, and/or other servic- es as decided from time to time by the ILAC General Assembly

− Declare their intention to op- erate their accreditation pro- grammes in compliance with the requirements set out in relevant standards established by appropriate international standards writing bodies such as ISO and the IEC and ILAC application documents.

�� National Coordination Bodies – Open to formally established na- tional bodies with responsibility for the coordination of laboratory and/ or inspection body accreditation ac- tivity in particular economies. �� Regional Cooperation Bodies – Open

to formally established regional ac- creditation co-operations with objec- tives similar to and compatible with ILAC, which are committed to the obligations of the ILAC Mutual Rec- ognition Arrangement and which con- sist of formally nominated represen- tatives of the accreditation interests from at least four economies (Recog- nized Regional Cooperation Bodies are those whose regional Mutual

180

Recognition Arrangements (MRA/ MLA) have been successfully peer- evaluated by ILAC). �� Stakeholders – Open to representa-

tive international, regional and na- tional organizations having an inter- est in the work of ILAC and include bodies such as associations of labo- ratories, associations of laboratory practitioners, inspection body asso- ciations, purchasing organizations, regulatory authorities, consumer as- sociations and trade organizations.

Both ILAC and IAF are organized in such a way that the accreditation body

members determine the policies of the organizations while specialist commit- tees work on different aspects such as the development of guidance material for members or promotion of accredi- tation. Stakeholders in the outcome of accreditation such as associations of testing laboratories and certification bodies, end users and regulatory au- thorities are allowed to participate in the work of the forums but their voting rights are limited.

The structures of the two internation- al bodies are as shown in the Figures 17 and 18 :

Figure 17 – IAF

181

Coordination of ILAC and IAF Activities

There are a number of ILAC commit- tees and groups shown which operate jointly with IAF. Many accreditation bodies are members of both organiza- tions and ILAC and IAF now sched- ule their annual meetings (and some other meetings of various committees) alongside each other.

Additionally, there is one conformity assessment activity where both ILAC

and IAF are active, namely accredita- tion of inspection bodies. In the longer term it is expected that there will be a joint IAF/ILAC multilateral MRA for accredited inspection bodies.

Regional accreditation forums

While ILAC and IAF are able to pro- vide a global forum for harmonization of accreditation activities, the more specific needs of different regions are being met by regional forums. Exam-

Figure 18 – ILAC

Advisory Committees

182

ples of these regional accreditation forums are : �� Asia Pacific Laboratory Accredita-

tion Cooperation (APLAC) (www. aplac.org) – ILAC Regional Coop- eration Body member �� European cooperation for Accredi-

tation (EA) (www.ea-accreditation. org) – ILAC Regional Cooperation Body member ; and IAF Regional Accreditation Group member �� Inter-American Accreditation Co-

operation (IAAC) (www.iaac.org. mx) – ILAC Regional Cooperation Body member ; and IAF Regional Accreditation Group member �� Pacific Accreditation Coopera-

tion (PAC) (www.apec-pac.org) – IAF Regional Accreditation Group member �� Southern Afr i can Deve lop -

ment Community Accredita- tion (SADCA) (www.sadca.org) – ILAC Regional Cooperation Body member ; and IAF Regional Body member.

Multiple beneficiaries of MRAs

There are a number of potential bene- ficiaries of regional and global MRAs. They include : �� Accredited conformity assessment

bodies �� Accreditation bodies �� Regulators and trade officials

�� Importers, exporters and consumers �� National infrastructures.

For accredited conformity assessment bodies benefits from MRAs include : �� International recognition of their

certificates and data �� Access to new markets �� Exposure to foreign standards and

regulations �� Access to support from other accred-

ited conformity assessment bodies, such as, for example, specialist cali- bration services.

For accreditation bodies, their benefits from MRAs include : �� Benchmarking against best practice

codes through the peer evaluation process �� Opportunities to share experiences

and improvements through the peer evaluation process �� Enhanced reputation internation-

ally (greater acceptance of their ac- credited bodies’ certificates and data �� Enhanced reputation domestically

(providing reassurance to domes- tic stakeholders and users that they maintain the standards and disci- pline required by their international counterparts).

For regulators and trade officials the benefits include : �� Access to multiple providers of

compliance data ( from both foreign

183

and local conformity assessment bodies) �� Reduced needs for governments

to undertake their own compliance testing, inspection and certification �� Opportunities to reduce technical

barriers to trade within their economy �� Prompts to harmonize their techni-

cal requirements with other coun- tries’ or to accept their equivalence �� Reduced tensions with importers

and exporters by provision of mul- tiple sources for compliance assess- ment.

For importers, exporters and consum- ers the MRA benefits include : �� Reduced duplication and cost (one

certificate for many markets) �� Opportunities for new markets �� Greater confidence in foreign data

(for consumers) �� Expanded network for information

on competent providers of confor- mity assessment (through, for exam- ple, the listings of accredited facili- ties available from signatory bodies to the MRAs) �� A mechanism for dispute resolution

when faced with conflicting data from different sources.

For national infrastructures, benefits include : �� Mutual support (for example the

CIPM MRA for national measure- ment institutes and the ILAC MRA

have complementary roles in dissem- inating measurement traceability) �� Prompting the adoption of inter-

national standards for conformi- ty assessment activities in domes- tic economies, while also providing experiences and inputs to devel- opment of appropriate standards, codes of practice etc by bodies such as CASCO �� Sharing of scarce technical resourc-

es for example by providing access to foreign experts for assessment, audits etc.

Current scopes of the IAF MLA and the ILAC MRA

As of mid-2009, the IAF MLA covered : �� Accreditation of certifiers of quality

management systems �� Accreditation of certifiers of envi-

ronmental quality systems �� Accreditation of product certifica-

tion bodies.

As of mid-2009, the ILAC MRA cov- ered : �� Accreditation of test and calibration

laboratories to ISO/IEC 17025 �� Accreditation of medical laborato-

ries to ISO 15189 or ISO/IEC 17025.

As mentioned earlier, IAF and ILAC are working together to establish a joint MLA for inspection body ac- creditation. ILAC has taken in prin-

184

ciple resolutions to include accredita- tion of reference material producers and proficiency testing providers in the ILAC MRA after appropriate process- es for their inclusion have been agreed. IAF has resolved to extend its MLA to cover personnel certification bodies.

At the regional level, bodies such as EA, IAAC and APLAC have already implemented expansions of their MLAs to include accreditation of in- spection bodies. APLAC has recent- ly established the first group of signa- tories to an expansion of the APLAC MRA to cover accreditation of refer- ence material producers.

185

Conformity assessment and the WTO Agreement on Technical Barriers to Trade

The TBT Agreement has 15 articles which are binding on member gov- ernments. Five of those articles deal exclusively with conformity assessment procedures and Article 6.1 requires that member central government bodies :

“…shall ensure, whenever possible, that

results of conformity assessment pro-

cedures in other Members are accept-

ed, even when those procedures differ

from their own, provided they are sat-

isfied that those procedures offer an

assurance of conformity with applica-

ble technical regulations or standards

equivalent to their own procedures. It

is recognized that prior consultations

may be necessary in order to arrive at

a mutually satisfactory understanding

regarding, in particular :

6.1.1 adequate and enduring techni-

cal competence of the relevant con-

formity assessment bodies in the ex-

porting members, so that confidence in

the continued reliability of their con-

formity assessment results can exist ;

in this regard, verified compliance, for

instance through accreditation, with

relevant guides or recommendations

issued by international standardizing

bodies shall be taken into account as an

indication of adequate technical com-

petence ;

6.1.2 limitation of the acceptance of

conformity assessment results to those

produced by designated bodies in the

exporting Member.”

Further, in Article 6.3 “Members are encouraged, at the re-

quest of other Members, to be willing to

enter into negotiations for the conclu-

sion of agreements of the mutual recog-

nition of results of each other’s confor-

mity assessment procedures…”

While Article 6 deals with the respon- sibilities of central government bodies, Article 8 requires Member govern- ments to

“..take such reasonable measures as may

be available to them to ensure that non-

governmental bodies within their territo-

ries which operate conformity assessment

procedures comply with the provisions of

Articles 5 and 6 [of the TBT]…”

The significance of this Article is that it also obliges member governments to seek to ensure that voluntary-sec- tor providers of standards, conformi- ty assessment and accreditation do not create technical barriers. Article 7 has similar provisions for central govern- ments to have local government bodies follow the same principles.

Appendix 3

186

The WTO TBT Agreement makes spe- cial mention of the difficulties develop- ing countries may face in administering and establishing standards, technical reg- ulations and conformity assessment sys- tems. In this regard Article 11 is entitled Technical Assistance to Other Members. The Article places particular emphasis on technical assistance being provided to developing country members and with priority for least developed countries.

Article 12 (Special and Differen- tial Treatment of Developing Country Members) has quite detailed provisions for taking into account the special fi- nancial and trade needs of developing countries, including the protection of indigenous means of production.

Conformity assessment and the WTO Agreement on the Application of Sanitary and Phytosanitary Measures

Apart from the WTO Agreement on Technical Barriers to Trade, Member governments of the WTO are also required to comply with the WTO Agreement on the Application of San- itary and Phytosanitary Measures.

That Agreement deals with food safety and animal and plant health regulations and their potential for being used in a discriminatory manner. The Agreement encourages WTO Members to use har-

monized measures and to base them on international standards, guidelines and recommendations, where they exist.

Article 8 and Annex C of the Agree- ment covers Control, Inspection and Approval Procedures, and notes that such procedures include sampling, test- ing and certification.

As with the WTO Agreement on TBT, the SPS Agreement also makes special provisions for developing countries with its Article 9 covering technical as- sistance and Article 10 dealing with special and differential treatment for developing countries and particularly least-developed country Members.

The WTO website (www.wto.org) pro- vides access to the text of the WTO SPS Agreement and through the “Resourc- es” tab of its website provides access to interactive training modules on both : �� The Agreement on SPS Measures �� SPS Handbook : How to apply the

transparency provisions of the SPS Agreement.

Global and regional relationships, interactions and cooperation

Since the mid-1990’s there has been a steady growth in the development of co- operation amongst a number of the key international and regional bodies which

187

have an impact on conformity assess- ment activities. As discussed in earlier Chapters, all of the international infra- structure bodies have well-established relationships with their regional coun- terparts (including ISO, BIPM, OIML, IAF and ILAC). Many of the interna- tional bodies, also, use their region- al co-operations as major contributors to their standardization, accreditation, and metrology activities, including im- plementation of their respective MRAs.

At the regional level there are also re- gion-to-region memoranda of under- standing (MOUs) which have emerged amongst some of these bodies. (For ex- ample, to cooperate on mutual train- ing needs and proficiency testing as set out in the MOU between IAAC and APLAC.)

There are also now well established formal and informal linkages between the international and regional infra- structure bodies. These linkages often include mutual participation at the var- ious bodies’ annual technical and policy meetings as well as through formal MOUs outlining specific cooperation activities.

Some of the relevant MOUs include those between : �� ISO/IAF/ILAC �� CIPM/ILAC �� IAF/OIML/ILAC

Details of these MOUs can be accessed through the bodies’ Websites as listed earlier.

From a developing country perspective, it is noteworthy that UNIDO has also developed MOUs with ILAC and IAF and there is also a forum for a number of these international bodies to collaborate jointly on developing country issues. This is through JCDCMAS (Joint Committee on Coordination of Assistance to Devel- oping Countries in Metrology, Accredi- tation and Standardization), where the participating bodies are BIPM, OIML, IAF, ILAC, ISO, IEC, UNIDO, the Inter- national Trade Centre (ITC) and ITU-T, the Telecommunications Standardiza- tion Sector of ITU (International Tele- communications Union).

Mutual acceptance of conformity assessment certificates

The World Trade Organization’s (WTO) World Trade Report 2005, Trade, Standards and the WTO (page 56), discusses conformity assess- ment and its relevance to world trade as follows :

“Exporters are often faced with having

to test or certify their products in each

of the countries to which they are ex-

porting. Even if countries rely on in-

ternationally harmonized standards or

accept as equivalent another country’s

188

standard, they may not rely on an ex-

porting country’s conformity assess-

ment results. This can substantially in-

crease costs of exports in a number of

ways. First of all, exporters incur the

costs of redundant testing and certifi-

cation for each of the destination mar-

kets. Second, they face the risk of higher

transportation costs if the goods are re-

jected by the importing country after

shipment. Third, there is a cost in terms

of time required for complying with ad-

ministrative requirements and inspec-

tions by the importing country’s author-

ities. For some time-sensitive products,

such as textiles and clothing, the time

delays associated with product testing

and certification in the importing coun-

try can severely impact on profitability

and the ability to penetrate the market.

“In order to reduce such costs, a number

of conformity assessment recognition

agreements have been negotiated be-

tween and among countries bilateral-

ly. Obviously, these agreements do not

have an influence on the standards and

technical regulations themselves. The

impact of such agreements on the trade

of participating countries is clearly pos-

itive due to a reduction in costs gener-

ated by the avoidance of duplicative

tests, as well as lower transport and ad-

ministrative costs, as handling time and

uncertainty of delivery are reduced.

Mutual recognition requires confidence

in the competence of one another’s con-

formity assessment bodies and in the

methods employed to assess conformi-

ty. For this reason, agreements are often

limited to accepting conformity assess-

ment results from bodies that are recog-

nized by the parties concerned, and do

not extend to self-certification arrange-

ments such as suppliers’ declarations of

conformity.”

The World Trade Report 2005, Trade, Standards and the WTO also notes (on page 118) :

“A lot of international cooperation is

taking place to establish confidence

in the work of conformity assessment

bodies in other countries. An efficient

way forward seems to be the conclu-

sion of mutual recognition agreements

(MRAs) between accreditation bodies

such that the results of any laboratory

or other conformity assessment body

accredited by one of the parties are ac-

cepted in any other country. In order

for this to happen, it is important that

common standards on best practices

are adhered to, giving other parties con-

fidence in the work of their partners.”

Accreditation bodies themselves do not use the data and certificates from foreign bodies accredited by their counterparts in the MRAs of ILAC, IAF and their regional bodies. The accreditation bodies’ role is to pro- mote to regulators and other potential users of data and certificates in their

189

own countries, the equivalence of for- eign, accredited conformity assessment bodies, to their own accredited bodies.

It is important to note that the IAF and ILAC MRAs are in the voluntary sector. As such, they are not formal- ly binding on governments. Howev- er, many governments and their reg- ulators do use the voluntary-sector MRAs of ILAC, IAF and their region- al cooperation bodies to accept foreign conformity assessment certificates and data.

A number of governments have also established their own government-to- government MRAs for conformity as- sessment. Some of these MRAs are on a bilateral basis, such as that between the Singapore and Australian Govern- ments. Others are multi-lateral, such as the APEC Electrical and Electron- ic goods MRA.

Some governments have also formally designated their voluntary-sector accreditation bodies as the bodies which will be used to achieve mutual acceptance of conformity assessment certificates in their regulated sectors. This is also one of the pathways for acceptance under the APEC electri- cal MRA, where governments can use the APLAC voluntary-sector MRA to accept foreign results. In Europe also, the European Commission is en-

couraging the use of the EA voluntary sector MRA as support for their confi- dence in accredited conformity assess- ment bodies acting in a wide range of regulated sectors.

Internationally, there are other forms of mutual acceptance of test and cer- tification results, such as direct accep- tance at the conformity assessment body level. This is the purpose of the conformity assessment schemes of the International Electrotechnology Com- mission (IEC) administered by its Conformity Assessment Board. Their schemes involve the testing and certi- fication of safety of electrical products, electrical products used in hazardous environments and electronic com- ponents and products. Full details of their schemes can be found at the IEC Website (www.iec.ch).

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