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ISO 9000 AND TOTAL QUALITY:

THE RELATIONSHIP

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What does ISO mean?

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a. Industrial Systems Order

b. Illegal Substances Online

c. ISO Glad that Dallas Beat Philly Sunday…!

d. International Organization of Standards

What is ISO 9000? ISO 9000 is a family of standards and

guidelines related to the quality management system (QMS).

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What is QMS? A quality management system (QMS) is a set of policies, processes and procedures required for

planning and execution (production/development/service) in the core

business area of an organization (i.e., areas that can impact the organization's ability to meet customer

requirements).

4 https://the9000store.com/iso-9001-2015-requirements/what-is-iso-9001-quality-management-system/

What is ISO 9000? ⬜ It’s not one thing—it’s a family of standards

and guidelines related to the QMS.

⬜ Its purpose is, through the organization’s QMS, to: ◼ Improve customer satisfaction by fulfilling customer

requirements ◼ Achieve continual improvement of organizational

performance and competitiveness. ◼ Continually improve processes, products, and

services ◼ Comply with regulatory requirements.

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Eight Principles of ISO 9000

1. Customer Focus 2. Leadership 3. Involvement of People 4. Process Approach 5. System Approach to Management 6. Continual Improvement 7. Factual Approach to Decision Making 8. Mutually Beneficial Supplier Relationships

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PDCA Cycle

Plan

Do

Check

Act

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Applying ISO 9000 to an Organization

Once registered, the organization must: ⬜ Apply QMS to its operations according to the

standards and exactly as the QMS states ⬜ Continually assess the effectiveness of the QMS

and make changes to improve it ⬜ Conduct periodic internal QMS audits ⬜ Submit to external (3rd party) surveillance

audits at least annually by the registrar ⬜ Submit to a new registration audit every third

year by a registrar

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The ISO 9000 definition of QMS: Quality Management System

⬜ Composed of all the organization’s policies, procedures, plans, resources, processes, and delineation of responsibility and authority, all deliberately aimed at achieving product or service quality levels consistent with customer satisfaction and the organization’s objectives. When these policies, procedures, plans and so forth are taken together, they define how the organization works and how quality is managed.

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The QMS will include: ⬜ A quality policy

◼ Organizational statement about approach to quality ⬜ The quality manual

◼ Addresses each clause of ISO 9001 standard ⬜ Quality objectives

◼ Goals which must align with policy ⬜ Quality procedures

◼ How goals are attained, how ISO 9001 clauses are met ⬜ Forms, records, and so on…

◼ Proof of activities for the firm and auditors

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Authority flow for ISO 9000

Organization seeking certification

Certification Body (Registers Organizations)

Accreditation Body (Accredits Certification Bodies)

International Accreditation Forum (Assesses Certification Bodies)

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ISO 9000 Total Quality

⬜ ISO 9000 can be considered a subset of TQM. ⬜ First released in 1987 by the ISO ⬜ ISO 9000 is concerned only with QMS for the

◼ Design ◼ Development ◼ Purchasing ◼ Production ◼ Installation ◼ Servicing … of products and services

⬜ Total quality encompasses EVERY aspect of an organization

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Motivations for ISO 9000 certification

⬜ Improving operations ⬜ Creating or improving a QMS that will be

recognized worldwide ⬜ Improving quality or the consistency of quality ⬜ Improving customer satisfaction ⬜ Improving competitive posture ⬜ Conforming to the requirements of a major

customer

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Break

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PROBLEM SOLVING AND DECISION MAKING

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Problem solving v. Decision making

⬜ Problem solving deals with solving something in the present, typically something that impacts the organization or its customers in some way, usually negatively.

⬜ Decision making impacts the organization in some significant, tangible way. For example, decisions that affect the future path of the organization—its mission, staffing, culture, environment, equipment, or training.

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Problem Solving in Total Quality

⬜ A problem is only solved when its recurrence has become impossible or significantly less probable.

⬜ Existent problems: ones that already exist that demand immediate attention.

⬜ Latent problems: ones that have yet to occur but could.

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The Deming Cycle

Plan

DoCheck

Act

• Define the problem • Gather information • Identify the root cause • Develop alternatives • Weigh alternatives • Select the best solution

• Implement the planned solution

• Monitor the implemented solution

• Gather and analyze data

• If the results do not match the planned outcome, determine the needed adjustment or change

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The Toyota Model Perceive the

initial problem

Clarify the problem

Observe with an open mind

Compare the situation to the

standard

Variance exists?

No

Yes

Determine the POC

Set an improvement objective

Prioritize

More than 1

Variance?

Yes

Determine the Root Cause

Develop & Implement a

Countermeasure

No

Change the standard

Yes

Counter- measure effective?

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Decision Making Process

⬜ The decision-making process is a logically sequenced series of activities through which decisions are made.

Identify or anticipate the

situation

Gather the facts

Consider alternatives

Choose the best alternative

Implement

Monitor and adjust

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Two Types of Decision Making

⬜ Objective Decision Making ◼ Logical, orderly, step-by-step ◼ Assumes managers have time ◼ Assumes complete and accurate information ◼ Assumes freedom to select the best choice

⬜ Subjective Decision Making ◼ Based on intuition and experience ◼ Under pressure, short on time ◼ Limited information

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Factors that contribute to objective decision making

Time

Complete, accurate

information

Freedom to select the best

alternative

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The Scientific Approach

⬜ Juran’s 85/15 Rule

⬜ Complexity ◼ Errors and Defects ◼ Breakdowns and Delays ◼ Inefficiency ◼ Variation ▫ Common-cause variation ▫ Special-cause variation

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Employee Involvement

● Advantages: ○ It can result in a more accurate picture of what the

problem is. ○ It can help managers do a better job of evaluating

alternatives and selecting the best one. ● Potential Problems:

○ Time you don’t have ○ Time away from the employees’ regular jobs ○ Conflict ○ Does not necessarily lead to the best decision due to

democratic compromise.

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Information & Data

Information: Data that are relevant to the decision-making process that have been converted into a usable format.

Data that are relevant are the ones that might have an impact on the decision.

GIGO: “Garbage In/Garbage Out”

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In-Class Activity

● Discussion Assignment 16-1 "Why It is Important to Ask Why"

● Discussion Assignment 16-2 "Defective Steel in New Aircraft"

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