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Supporting_the_Functioning_of_.pdf

European Research Studies Journal

Volume XXVIII, Issue 4, 2025

pp. 3-16

Supporting the Functioning of the ISO 9001:2015 Quality

Management System With Lean Management Principles Submitted 05/08/25, 1st revision 28/08/25, 2nd revision 17/09/25, accepted 15/11/25

Emil Ratter1

Abstract:

Purpose: The article compares the chapters (areas) of the ISO 9001: 2015 quality

management standard with the principles of Lean Management in order to identify

opportunities for enhancing quality management systems based on this standard, both in the

context of quality management and in the context of business process management.

Design/Methodology/Approach: The aim of the study was to identify common areas of

coexistence between Lean Management principles and the individual chapters (areas) of the

ISO 9001: 2015 standard. The theoretical and cognitive objective was to conduct a

substantive review of the literature and scholarly studies in the field of holistic quality

management. The analysis of the presented problem revealed previously unidentified

potential for applying Lean Management principles to improve the functioning of specific

areas of management structured within the ISO 9001: 2015 standard.

Findings: The conclusions drawn will enable enterprises operating based on the ISO 9001:

2015 quality management system to increase the likelihood of achieving both quality and

economic effectiveness in individual areas, as their functioning will be enhanced by the

incorporation of Lean Management principles.

Practical implications: The principles of Lean Management have been presented in a form

that enables their practical application in enterprises operating based on the ISO 9001: 2015

quality management system. The outcome of the conceptual work is a set of

recommendations for enterprises using the ISO 9001: 2015 quality management system

regarding the potential to enhance specific areas through principles derived from Lean

Management.

Originality/Value: The author presents opportunities for applying principles derived from

the Lean Management concept in enterprises operating based on the ISO 9001: 2015 quality

management system. The implementation of Lean Management principles requires actions

that lead to certain changes in the functioning of specific areas within an enterprise. These

changes can contribute to the widespread elimination of waste. An organizational culture

based on Lean Management principles also has the potential to support or foster the

development of effective and modern solutions in enterprises with an implemented and

structured quality management system.

Keywords: Defining value, value stream mapping, supply chain optimization, pull, pursuing

perfection, Lean Management, quality, quality management, ISO 9001.

JEL: L15, M11, M54.

Paper type: Research article.

1Vizja University, Poland, ORCID: 0000-0001-8872-3286, e-mail: [email protected];

Supporting the Functioning of the ISO 9001:2015 Quality Management System With Lean

Management Principles

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1. Introduction

The proposed support of the ISO 9001:2015 quality management system with Lean

Management principles may contribute to the discovery of previously unidentified

solutions that respond to the contemporary direction of changes observed in quality

management standards and norms. It seems that the evolution of quality

management systems is moving toward making them more realistic to market

realities.

Better alignment of quality management system requirements with aspects related to

economic profitability may lead to the development of practical guidelines for

enterprises that address not only quality improvement but also the enhancement of

business process profitability. Both the Lean Management concept and the ISO

9001:2015 system have evolved into universal approaches, and therefore, their

practical implications could be applied in enterprises across various business

profiles.

The purpose of the article is to analyze the requirements of the ISO 9001:2015

standard (with reference to its individual chapters) and to attempt to support the

fulfillment of these requirements using five Lean Management principles. The article

is conceptual in nature, and the research scheme is to correlate the chapters of ISO

9001:2015 with the five principles of Lean Management. The outcome of the

conceptual work is a set of efficiency-oriented recommendations for enterprises

operating based on the ISO 9001:2015 quality management system regarding the

possibility of supporting this system with Lean Management principles.

The proposed research framework enabled a clear presentation of the role of the five

Lean Management principles in increasing the likelihood of effective holistic

management in enterprises with an implemented ISO 9001:2015 quality

management system. This article is based on an extensive literature review covering

the functioning of quality management systems as well as Lean Management

(including Lean Manufacturing).

By identifying common ground between the ISO 9001:2015 standard and Lean

Management principles, it became possible to propose actions that not only help

meet the requirements outlined in the individual chapters of the standard but also

assist enterprises in achieving efficiency-oriented benefits in an economic context.

2. Characteristics of Lean Management Principles

Lean Management should be understood as a low-cost management approach

focused on eliminating waste and adding value to processes. Adding value can be

realized by simplifying internal structures and procedures across all departments of a

company (Janiszewski and Siemieniuk, 2012; Sivaram and Devadasan, 2012). The

essence of this concept lies in achieving high labor productivity, efficient

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management organization, high quality, and satisfactory economic performance. Its

goal is to adapt the enterprise to current market conditions through fundamental

transformations in organization, management, and operations (Asiński et al., 1999).

The term Lean Management first appeared in 1996 through Womack and Jones

(Womack and Jones, 1996). The authors defined this term as focusing on adding

value that enhances customer satisfaction and loyalty, which in turn allows the

company to maintain or increase its market share and strengthen its position in

shaping the pricing of its products. In the original version of the definition, the

authors also highlighted the significant benefits that can result from strengthening

cooperation with partners, as customer value can be created both at the interface of

the organization and beyond its boundaries.

The Lean Management concept demonstrates how to produce more with less

consumption of resources, less labor, time, equipment, and space, while

simultaneously maintaining an upward trend in customer satisfaction (Wójcik and

Kocoń, 2015). In addition, Lean Management makes it possible to improve

communication, increase health and safety, and reduce the negative environmental

impacts of the company and its products (Womack and Jones, 1996). Lean

Management aims to create an organizational culture focused on lean production

using Lean Management principles. Table 1 shows the five principles of the Lean

Management concept.

Table 1. Principles of Lean Management

No. Lean Management Principles

1.

Defining value occurs with the participation of consumers who validate the market

with their choices. Consumers are the final entities in logistics chains, and therefore,

the value created is aimed at meeting their expectations (Loane and Webster, 2014).

The decision on which tools to use during the implementation of a product or service

has a significant impact on risk, efficiency, and cost (Gonzalez-Zugasti and Otto,

1999).

2.

Value stream mapping enables more effective identification of process

inefficiencies and sources of waste. This principle makes it possible to identify areas

that require improvement, for example, by eliminating unnecessary activities. The

most common technique used in process mapping is Value Stream Mapping

(Manjunath and Shiva Prasad, 2014).

3.

Creating flow increases the efficiency, or the speed at which a company can produce

a product or service within a given unit of time (Little and Graves, 2008), of the

entire process, which is the main goal of Lean Management (Chatzopoulos, 2014).

Performance optimization has its roots in the Theory of Constraints (TOC), which

holds that a chain is only as strong as its weakest link. TOC views every organization

as a chain of interdependent processes, where the performance of each event (or

process) depends on the preceding one. Effective elimination of constraints and

bottlenecks is crucial for a company to perform well (Bahall, 2018).

4. Establishing pull, assumes producing exactly what the customer needs. Essentially,

a pull or push system refers to the flow of materials between production lines. An

Supporting the Functioning of the ISO 9001:2015 Quality Management System With Lean

Management Principles

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effective pull system will produce only what is consumed at the right time. Inventory

is maintained solely to meet minimum customer demand, which means this system

can help minimize overproduction (Jamaliah, Mohamad and Azianti, 2016).

5.

Pursuing perfection is a routine process of systematically seeking and implementing

new and improved work methods. The strategic objective behind launching industrial

production improvement initiatives is to build the capability to introduce

improvements quickly and effectively as part of the organization’s routine operations

(Butler and Szwejczewski, 2018).

Source: Own elaboration.

The concept of Lean Management involves improving the operation of the

production system by eliminating any kind of waste that may occur in enterprises

(Burnasheva, 2016; Pajak, 2007). By applying the five principles of Lean

Management, raw materials are delivered at the right time and in the right quantities,

while finished goods are delivered to customers just in time, creating added value

throughout the entire order fulfillment process (Al-Musawi et al., 2019). In addition,

the application of the five principles of the Lean Management concept makes it

possible to reduce the consumption of everything needed in the production process,

resulting in a product that is more in line with customer expectations (Sikorski,

1995).

Lean Management is a revolutionary concept that fundamentally transforms the way

organizations and their internal processes function. Enterprises that choose to

implement the five principles derived from Lean Management must be prepared for

changes affecting, among others, the internal and external supply chain, decision-

making processes, and human capital management (Borys and Rogala, 2012).

Today, the core assumptions of Lean Management (uninterrupted flow, customer

value, pull systems, waste minimization, etc.) have become a paradigm in many

organizations. The Lean Management concept should encompass the entire

organization, as only then is a comprehensive analysis of processes and

identification of both actual and potential losses possible (Šurinová, Daňo and

Saniuk, 2014).

3. Applying Lean Management Principles to Support the Implementation

of ISO 9001:2015

Both ISO 9001:2015 and Lean Management are aimed at improving the production

processes taking place in a company (Micklewright, 2010). Integrating Lean

Management with ISO 9001:2015 would enable the creation of a compatible quality

management system, the comprehensive implementation of which could help avoid

the duplication of certain activities (Gajendran and Sampath Kumar, 2011).

The ISO 9001 standard and Lean Management are among the most widely used

quality management approaches worldwide. Standardized quality management

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systems focus primarily on meeting the requirements defined in the standards on

which they are based, whereas the Lean Management concept emphasizes the

continuous improvement of value-adding activities and the elimination of waste

across all areas of an organization’s operations (Pepper and Spedding, 2010).

The main goal of integrating the ISO 9001:2015 quality management system with

the Lean Management concept is to achieve synergy resulting from the simultaneous

implementation and operation of both approaches. Lean Management principles

should be regarded as those that, when implemented, can transform non-value-

adding operations into value-adding ones.

It therefore appears that the potential for improving ISO 9001:2015 quality

management systems in enterprises depends on their ability to integrate with

individual Lean Management principles (Wirkus and Chmielarz, 2018). Regardless

of the integration capabilities of specific enterprises, it should be noted that Lean

Management principles have the potential to support companies operating based on

the ISO 9001:2015 quality management system (Khalili et al., 2017)

It should be noted that the structure of ISO 9001:2015 may lead to some difficulties

during the process of implementing Lean Management principles (Chiarini, 2011).

For the purposes of this study, the first three chapters of the ISO 9001:2015 standard

were not included in the analysis due to their general nature.

These chapters provide a general introduction to the standard. Their main task is to

clarify the scope and terminology used in the following sections of the document.

• Chapter 1: Scope - defines the scope of the standard, that is, the area in

which the requirements of ISO 9001:2015 can be applied. ISO 9001: 2015 is

applicable to companies, regardless of their type, size, or products and

services offered.

• Chapter 2: Normative references - includes references to other standards and

legislation that are relevant to understanding and applying ISO 9001:2015.

• Chapter 3: Terms and definitions - contains key terms and definitions used

in the standard. Standardization of terms is necessary to avoid confusion and

ensure a uniform understanding of the nomenclature used in the context of

the quality management system.

The subsequent chapters of ISO 9001:2015 (from chapter four to chapter ten) cover

specific requirements for a quality management system. Table 2 presents a

comparison of the chapters of the ISO 9001: 2015 standard with the principles of

Lean Management.

In Table 1, the chapters of the ISO 9001:2015 were juxtaposed with the principles of

the Lean Management concept. In my assessment, the individual principles of Lean

Supporting the Functioning of the ISO 9001:2015 Quality Management System With Lean

Management Principles

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Management have the potential to enrich and enhance all areas of operation in

enterprises that function based on the ISO 9001:2015.

Table 2. Comparison of ISO 9001: 2015 Chapters with the Five Lean Management

Principles

ISO 9001:2015 CHAPTER LEAN MANAGEMENT PRINCIPLE

4. Context of the organization First principle - Defining value

5. Leadership Fifth principle - Pursuing perfection

6. Planning Third principle - Creating flow

7. Support Fourth principle - Establishing pull

8. Operation Third principle - Creating flow

9. Performance evaluation Rule Two - Value stream mapping

10. Improvement Fifth principle - Pursuing perfection

Source: Own compilation based on ISO 9001:2015, Quality Management - Guidelines.

3.1 Defining Value as a Principle Supporting the Requirements of Chapter

Four: "Context of the Organization"

Defining value for a specific customer is not possible without a very good

understanding of your own organization and its processes. Conversely, without

strong engagement in the enterprise’s internal processes, the likelihood of failure in

the customer service process increases.

Every major enterprise is capable of defining its mission and vision; it is aware of its

competitive advantage and of what generates economic value (Collins, 2007).

Table 3. Subsections of Chapter Four, “Context of the Organization,” in ISO 9001:

2015 4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality management system and its processes

Source: Own compilation based on ISO 9001:2015, Quality Management - Guidelines.

The Lean Management culture is strongly customer-oriented; its goal is to meet

customer expectations by continuously delivering the highest possible value to them

(Beitelspacher et al., 2011).

By applying the first principle of Lean Management to the implementation and

maintenance of the requirements outlined in Chapter Four of the ISO 9001: 2015

standard, enterprises have the opportunity to increase their economic profits.

This is because value definition is highly significant to stakeholders and is closely

linked to the quality experienced by customers.

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3.2 Pursuing Perfection as a Principle Supporting the Requirements of Chapter

Five: "Leadership"

Pursuing perfection as defined by Lean Management can be defined as a never-

ending organization-wide process aimed at generating sustainable and effective

innovations (Bessant and Caffyn, 1997).

Leadership involves shaping the goals of a group or organization and motivating

behavior aimed at achieving those goals. Leaders are those who are accepted in this

role by their colleagues (Ciekanowski, 2011).

Table 4. Subsections of Chapter Five, “Leadership,” in ISO 9001:2015 5.1 Leadership and commitment

5.2 Policy

5.3 Organizational roles, responsibilities, and authorities

Source: Own compilation based on: ISO 9001:2015, Quality Management - Guidelines.

To achieve a high level of collaboration among employees, a key responsibility of

management is to create conditions that foster interaction between employees at

different levels, which enables the development of an appropriate level of trust

(Carter et al., 2013). Lower-level employees tend to have greater trust in their leader

when they experience more autonomy in performing their duties. Assigning specific

areas of responsibility to individual employees increases their engagement in the

work, giving them a sense of importance, which ultimately leads to better outcomes

in the context of pursuing perfection (Brajer-Marczak, 2014).

Modern leadership, of which pursuing perfection (the fifth principle of Lean

Management) is an essential component, is effective leadership. This is because full

involvement of top management in shaping quality policy fosters a culture of

excellence. Moreover, such an approach enables the effective implementation of

quality strategies, increases employee engagement at all levels, and improves the

likelihood of achieving the enterprise’s defined objectives.

3.2 Creating Flow as a Principle Supporting the Requirements of Chapter Six:

“Planning”

Planning is a systematic analysis involving the continuous making of a series of

decisions. Decisions made during the planning process should take into account the

risks to which the organization is exposed (Kulińska, 2012).

One of the fundamental assumptions of the Lean Management concept is the optimal

execution of activities (previously planned) aimed at improving the processes

functioning within the enterprise (Dias and Tenera, 2020).

Supporting the Functioning of the ISO 9001:2015 Quality Management System With Lean

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Table 5. Subsections of Chapter Six, “Planning,” of ISO 9001:2015 6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them

Source: Own compilation based on: ISO 9001:2015, Quality Management - Guidelines.

The use of the third principle of Lean Management (creating flow) to improve the

planning process makes the process in companies operating under the ISO 9001:

2015 becomes more efficient, because optimization of the planning process reduces

the risk of various types of waste, improves the flow of information, and harmonizes

the activities of various departments in the organization. An important effect of

creating flow optimization in the planning phase is improved risk analysis, which

contributes to greater organizational efficiency.

3.3 Establishing Pull - A Principle to Support the Requirements of Chapter

Seven “Support”

The fourth principle of the Lean Management concept (establishing pull) is to

produce/manufacture finished goods only when a contractor places an order for that

product. In other words, the production process depends on customer demand, and

the volume of component production is determined by previously established

minimum inventory levels (Spearman and Zazanis, 1992).

The economic viability of the pull system for enterprises results, among other things,

from producing finished goods in small batches and from the speed of response to

changes, that is, from flexibility in meeting customer orders. Moreover, organizing a

pull-based product flow is a principle designed, among other functions, to help

control workload distribution across different production sectors (Powell et al.,

2013). It therefore appears that this principle has relatively strong potential in

supporting the implementation and maintenance of the requirements outlined in

Chapter Seven of the ISO 9001:2015 standard.

Table 6. Subsections of Chapter Seven, “Support,” in ISO 9001:2015 7.1 Resources

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented information

Source: Own compilation based on: ISO 9001:2015, Quality Management - Guidelines.

Organizing a pull-based product flow has the potential to support the requirements

of all subsections comprising Chapter Seven of the ISO 9001: 2015 standard, as

production that begins only after a customer order is placed promotes resource

optimization and inventory minimization. It should also be noted that the

implementation of the fourth Lean Management principle in enterprises operating

under the ISO 9001:2015 standard may contribute to the improvement of

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communication processes (including those related to document flow) between

different departments of the organization, as well as to the broadening of employee

awareness in the context of production and warehousing processes. As a result of

increased awareness and improved communication processes, employee

competencies may also increase organically.

3.4 Creating Flow as a Principle to Support the Requirements of Chapter Eight

“Operation”

Operation concerns, either directly or indirectly, all actions related to the functioning

of an enterprise - from sourcing suppliers, ordering raw materials, and production, to

marketing, distribution of finished products, and after-sales service (Waters, 2001).

The Lean Management concept can be applied to a wide range of operational

activities taking place within a company. Examples of such activities include (Hame,

Kowang and Fei, 2017):

• organizational activities, such as planning research, managing ideas,

intellectual property management, human resource management, etc.

• Support-related activities, for example, project planning and monitoring, risk

management, managing cooperation with contractors, employee evaluation,

etc.

• decision-making activities, including modeling organizational concepts,

business analysis, product specification, product design, and development,

etc.

Table 7. Subsections of Chapter Eight, “Operation” in ISO 9001:2015 8.1 Operational planning and control

Source: Own compilation based on: ISO 9001:2015, Quality Management - Guidelines.

Creating flow has the potential to support the operational activities of enterprises

operating under the ISO 9001:2015 standard, as it emphasizes a holistic approach to

process improvement, which aligns with the spirit of ISO 9001:2015. Through more

effective analysis and planning, organizations can make their operational activities

more coherent and efficient, which in turn may contribute to better fulfillment of

customer expectations and market requirements. Moreover, creating flow can

enhance risk management effectiveness, which may improve responsiveness, which

is an increasingly critical capability in today's rapidly changing environment.

3.5 Value Stream Mapping as a Principle to Support the Requirements of

Chapter Nine, “Performance Evaluation”

As early as the early 1990s, one of the greatest modern authorities on quality

management, Peter Drucker, was of the opinion that one cannot manage something

that cannot be measured (Drucker, 1993).

Supporting the Functioning of the ISO 9001:2015 Quality Management System With Lean

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Value Stream Mapping (VSM) enables the graphical representation of the current

state of processes within an organization. Moreover, through its application, it

becomes possible to visualize the desired future state that the organization aims to

achieve.

Graphically representing both the present and future states of processes requires

personnel to measure the time of all activities performed at individual workstations

(Saboo et al., 2014). Value Stream Mapping can be applied continuously, as every

process within an organization can be subject to ongoing improvement.

Table 8. Subsections of Chapter Nine, “Performance Evaluation,” in ISO 9001:

2015 9.1 Monitoring, measurement, analysis, and evaluation

9.2 Internal audit

9.3 Management review

Source: Own compilation based on: ISO 9001:2015, Quality Management - Guidelines.

Value Stream Mapping highlights the importance of regular monitoring and analysis

of results in the context of continuous improvement of the quality management

system. The second principle of Lean Management can also be successfully applied

during periodic internal assessments conducted within an organization (such as

internal audits and management reviews), as it facilitates a detailed analysis of value

flow and more effective identification of waste.

3.6 Pursuing Perfection as a Principle Supporting the Requirements of Chapter

Ten, “Improvement”

The title of Chapter 10 of ISO 9001:2015 is identical to the fifth principle of the

Lean Management concept. When comparing these two approaches (ISO 9001:2015

and Lean Management), it becomes clear that implementing a culture of pursuing

perfection, or continuous improvement, has a universal character and supports the

development of more efficient, flexible, and resilient structures capable of

responding more rapidly to market changes and customer needs. Both approaches

also emphasize the importance of engaging all employees in matters related to

pursuing perfection.

An effectively implemented continuous improvement program should be

characterized by employee involvement in enhancing the quality and efficiency of

production and/or service processes (Lee, 2004). Continuous improvement is a

process that can only be successfully implemented with the participation of all

employees within the organization (Gatchalian, 1997).

Both approaches also emphasize the importance of detecting nonconformities as

early as possible and implementing improvement actions without delay (Poksinska,

2010; Habelman, 2015). The effective implementation of corrective actions plays a

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key role in eliminating waste and improving process efficiency – the systematic

analysis of processes leads to operational improvement and the ongoing

enhancement of organizational performance.

Table 9. Subsections of Chapter Ten, “Improvement,” in ISO 9001:2015 10.1 General

10.2 Nonconformity and corrective action

10.3 Continual improvement

Source: Οwn compilation based on: ISO 9001:2015, Quality Management - Guidelines.

Chapter 10 of ISO 9001:2015 and the fifth principle of the Lean Management

concept are complementary, together forming a comprehensive framework that

supports the development and maintenance of a culture of continuous improvement.

Organizations that apply both approaches simultaneously may benefit from the

resulting synergy, which in turn can lead to increased competitiveness and greater

customer satisfaction.

4. Conclusion

The implementation of both the ISO 9001: 2015 quality management system and the

Lean Management concept requires a broad range of actions and significant changes

to the way an organization operates. However, these efforts bring undeniable

benefits in both organizational and economic terms. All employees should be

involved in the implementation and maintenance of the quality management system

and Lean Management principles, as they are expected to perform their duties in a

specific manner once these approaches are adopted.

This conceptual study demonstrates that the principles of Lean Management do not

present obstacles to the implementation and maintenance of the requirements

outlined in ISO 9001:2015.

There are no provisions in the standard that prohibit organizations from:

• understanding what “value” means to their target customers;

• distinguishing between value-adding and non-value-adding activities within

processes;

• eliminating non-value-adding activities (e.g., bottlenecks) as quickly as

possible;

• producing finished goods in small batches, only after customer orders are

confirmed;

• continuously improving their processes and fostering a supportive

organizational culture.

The principles derived from the Lean Management concept appear to have

considerable potential in supporting organizations in the implementation and

Supporting the Functioning of the ISO 9001:2015 Quality Management System With Lean

Management Principles

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maintenance of the requirements found in the various chapters of ISO 9001:2015,

especially considering that some elements of Lean principles can be indirectly

identified within the standard (e.g., identifying customer value, continuous

improvement). Integrating the two approaches discussed in this paper may help

create a compatible quality management system that, through a synergy effect, could

enhance operational efficiency within enterprises.

It should be noted that research in this area ought to be reviewed periodically, as

updates to ISO 9001 occur irregularly. A new version of the ISO 9001 standard is

expected to be released in the near future (Kowalski, 2024).

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