NATIONAL SCHOOL OF APPLIED SCIENCES-MPSI -GEI-QUALITY MANAGEMENT PROJECT-2023

Unveiling the flaws of ISO 9001 2015’s

Context of organization:
Mohammed Yassine MKADMIN, Mohamed BOUGHABA
Adnane ELAMIRI, Samya GHARBAOUI
1
National Schools of Applied Sciences, N.S.A.S Achakar’s road, BP 1818 Principal Tangier Morocco.

Abstract:

Context: The fourth clause of ISO 9001:2015, Context of the Organization, is a crucial aspect of quality
management system implementation. This paper aims to provide an overview of the fourth clause, its
requirements, benefits, and challenges.
Methods: The study utilized a literature review approach to gather information on the fourth clause of ISO
9001:2015. Relevant sources were identified through online databases and search engines. The information
was analyzed and synthesized to provide a comprehensive understanding of the topic.
Results: The study found that while the fourth clause is essential for quality management system
implementation, it has several potential drawbacks. These include a lack of specific guidance, limited scope,
subjectivity, overemphasis on risk, and time-consuming implementation. To mitigate these drawbacks,
organizations must strive to interpret and implement the standard in a way that balances risk management with
other important considerations.
Discussion: Organizations can effectively implement the fourth clause by taking a broad view of their internal
and external issues, seeking guidance from quality management experts, and allocating sufficient resources to
the process. By doing so, they can improve the overall effectiveness of their quality management system.
Conclusion: In conclusion, while there are challenges associated with implementing the fourth clause of ISO
9001:2015's Context of Organization standard, organizations can overcome them by adopting best practices in
interpreting and implementing this standard. Doing so will help them achieve their quality objectives while
ensuring compliance with industry standards.
Keywords: - ISO 9001:2015, Context of the Organization, Quality management system, Implementation, Requirements, Benefits,
Challenges, Flaws, Internal and external issues, Risk management, Resources allocation, Regulatory requirements, Customer preferences, Market
trends, Quality objectives.

Introduction:
Quality management systems (QMS) have become increasingly important for organizations seeking to
improve their competitiveness and meet customer expectations. One internationally recognized standard for
QMS is ISO 9001:2015, which outlines requirements for organizations to identify, document, and measure the
effectiveness of their quality management processes.
The fourth clause of ISO 9001 specifically focuses on the organization's management system and
requires them to identify and document the processes that make up their QMS, measure their effectiveness in
meeting customer requirements, and continuously improve the system. Implementing this clause can provide
numerous benefits for organizations, including increased customer satisfaction, enhanced risk management,
and improved decision-making.
However, the fourth clause of ISO 9001:2015, which pertains to the context of the organization, has
several potential flaws that organizations should be aware of.
In the following article, we will identify and analyze the limitations and weaknesses of the fourth clause
of ISO 9001:2015, and propose a set of viable solutions to address these issues.
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1. The 4th clause of ISO9001:2015

ISO 9001 is an international standard that outlines requirements for a quality management system. The
fourth clause of ISO 9001 focuses on the organization's management system and the processes it uses to ensure
quality. It requires the organization to identify the processes that make up its quality management system,
document them, and measure their effectiveness in meeting customer requirements.
1.1 Implementation of the 4th clause:
Organizations can take these following steps to implement this clause:
• Define the scope of the QMS: Identify the boundaries of the QMS and the processes that will be
included in it.

• Define the quality policy and objectives: Establish a quality policy that outlines the organization's
commitment to quality and sets out the objectives for the QMS.

• Identify and document processes: Identify the processes that are necessary for the QMS and
document them in a way that is easy to understand and implement.

• Establish controls and procedures: Establish controls and procedures to ensure that the QMS is
implemented and maintained effectively.

• Define roles and responsibilities: Clearly define the roles and responsibilities of all personnel
involved in the QMS.

• Provide training: Provide training to all personnel involved in the QMS to ensure they understand
their roles and responsibilities and the requirements of the QMS.

• Implement monitoring and measurement: Implement monitoring and measurement of the QMS to
ensure its effectiveness and identify areas for improvement.

• Continual improvement: Continually improve the QMS by identifying areas for improvement and
implementing corrective and preventive actions.

• Conduct internal audits: Conduct internal audits to ensure the QMS is operating effectively and
meeting the requirements of ISO 9001:2015.

• Management review: Conduct regular management reviews of the QMS to ensure it remains effective
and continues to meet the organization's needs.

1.2 Benefits of Implementing the 4th Clause:

Some of the benefits of implementing the 4th clause of ISO 9001:2015 include:

• Improved understanding of the organization's environment: By considering the internal and

external context, an organization can gain a better understanding of the factors that impact its
operations, such as market trends, regulatory requirements, and customer preferences. This
understanding can help the organization identify new opportunities and risks, and develop strategies
to address them.

• Increased customer satisfaction: By considering the needs and expectations of interested parties,
including customers, an organization can develop products and services that better meet their
requirements. This can lead to increased customer satisfaction and loyalty.
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• Enhanced risk management: Understanding the context of the organization can help identify
potential risks and opportunities that may arise in the future. This can help the organization develop
effective risk management strategies and take proactive measures to mitigate risks and exploit
opportunities.

• Improved decision-making: By considering the internal and external context of the organization,
decision-makers can make more informed and effective decisions. This can lead to better allocation of
resources and improved business performance.

• Increased stakeholder confidence: By demonstrating a commitment to understanding and addressing

the needs and expectations of interested parties, an organization can build trust and confidence among
its stakeholders, including customers, employees, and regulatory bodies.

1.3 Challenges of Implementing the 4th Clause:

Implementing the fourth clause of ISO 9001 can be challenging for organizations. It requires them to identify
and document their processes, measure their effectiveness, and identify areas for improvement. It also requires
organizations to invest in training employees, updating processes, and introducing new technologies.

2. Criticizing the fourth clause of ISO 9001:2015

While this clause is an essential part of the standard, some critics argue that it is not specific enough and can
be interpreted in various ways, making it challenging for organizations to implement the requirements
effectively. In addition, some critics argue that the clause does not provide adequate guidance on how to
identify and manage the risks and opportunities related to the organization's context.

2.1 The lack of guidance:

The fourth clause of ISO 9001:2015 is titled "Context of the Organization" and requires the organization to
determine the internal and external issues that are relevant to its purpose and strategic direction and to consider
them when establishing, implementing, maintaining, and continually improving its quality management system
(QMS).

The clause does not provide specific guidance on how to identify or evaluate these issues, leaving it up to the
organization to determine its own approach based on its unique circumstances. This can be challenging for
organizations that are new to ISO 9001 or do not have a lot of experience with management system standards.

A small business may find it difficult to determine their internal and external issues without more specific
guidance. For example, they may not know how to identify their stakeholders or how to prioritize their needs
in relation to their quality management system.

2.2 Limited scope:

The limited scope flaw in the fourth clause of ISO 9001:2015 refers to the fact that the clause only requires
organizations to identify and manage processes that directly impact the quality of their products or services.
This means that some processes that may be important for the overall success of the organization, but that do
not have a direct impact on product or service quality, may not be included in the QMS.
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This limited scope can be problematic for organizations because it may result in them overlooking important
processes that could impact their overall effectiveness and efficiency. For example, a manufacturing company
may have a process for managing employee training and development that does not directly impact the quality
of its products, but that is critical to maintaining a skilled and productive workforce.

An organization that produces environmentally hazardous products may focus solely on quality
management and overlook the impact of their products on the environment. They may not consider
the environmental impact of their products to be relevant to their quality management system.

2.3 Subjectivity:

Another potential flaw in this clause is the subjectivity involved in determining which issues and requirements
are relevant to the organization's context. Since different organizations may have different perceptions of what
constitutes their context, it can be challenging to define a universal set of issues and requirements that apply
to all organizations equally.

Moreover, the interpretation of what constitutes an "issue" or "requirement" may vary depending on the
perspective of the organization, its industry, and the regulatory environment in which it operates. This
subjectivity can lead to inconsistencies in how organizations implement and comply with the requirements of
this clause.

Two organizations in the same industry may interpret the fourth clause differently and prioritize issues in
different ways. For example, one organization may prioritize customer satisfaction as the most important issue,
while another may prioritize employee satisfaction.

2.4 Overemphasis on risk:

Overemphasizing risk can be a problem because it can lead to a culture of fear and avoidance, where the
organization's primary concern is to avoid mistakes or failures at all costs. This can be counterproductive
because it can stifle innovation, creativity, and progress. Instead of taking calculated risks that can lead to
improvements and advancements, the organization may become overly cautious and miss out on opportunities
for growth and development.

Another potential issue with overemphasizing risk is that it can lead to a narrow focus on compliance rather
than on the broader goals of quality management. Organizations may become so preoccupied with meeting
regulatory requirements and avoiding penalties that they lose sight of their customers' needs and preferences.
This can result in a decline in customer satisfaction and a loss of market share.

An organization in a highly regulated industry, such as healthcare, may become overly cautious in their risk
management approach. They may prioritize risk mitigation to such an extent that it impacts the effectiveness
of their quality management system or even their ability to provide quality services.

2.5 Time consuming:

One more potential flaw with this clause is that the process of identifying and analyzing the internal and
external issues, as well as the interested parties and their requirements, can be time-consuming and resource-
intensive. This is especially true for larger organizations or those with complex operations.

Some organizations may find it challenging to identify all the relevant internal and external issues, as well as
interested parties and their requirements. This can lead to an incomplete or inaccurate understanding of the
organization's context, which can, in turn, impact the effectiveness of its QMS.
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Additionally, the ongoing monitoring and review of the internal and external issues, as well as the interested
parties and their requirements, can also be time-consuming. Organizations must regularly assess whether any
changes in the context require a review or update of their QMS.

A large organization with complex operations may find it time-consuming to determine their internal and
external issues. For example, they may have multiple business units, each with their own stakeholders and
issues to consider. This could require significant resources and delay the implementation of the standard.

3. Improvement suggestions:
3.1 The lack of guidance:

One way to address this challenge is to include additional guidance or best practices in the organization's QMS
documentation. For example, the organization can document its approach to identifying internal and external
issues, including the methods used, such as SWOT analysis or stakeholder analysis. The organization can also
document its process for evaluating and prioritizing these issues and how it uses this information to develop
and implement its QMS.

Additionally, the organization can seek guidance from a consultant or experienced ISO practitioner to help
them identify and evaluate their internal and external issues. The consultant or practitioner can provide
expertise and guidance on best practices for identifying and evaluating internal and external issues, as well as
how to integrate this information into the organization's QMS.

3.2 Limited scope:

To address the limited scope flaw in the fourth clause of ISO 9001:2015, one approach would be to expand the
definition of "quality" to include not just the quality of products or services but also the quality of all
organizational processes. This would require organizations to identify and manage all processes that contribute
to their overall effectiveness and efficiency, not just those that directly impact product or service quality.

Another approach would be to require organizations to consider the potential impact of all processes on
customer satisfaction, rather than just the impact on product or service quality. This would ensure that
organizations are taking a more holistic approach to quality management and considering the broader
implications of their processes on customer satisfaction and organizational success.

Alternatively, the fourth clause could be revised to explicitly require organizations to identify and manage all
key processes, regardless of whether they directly impact product or service quality. This would ensure that
all processes that are critical to the organization's success are included in the QMS.

3.3 Subjectivity:

To address the potential subjectivity involved in determining relevant issues and requirements for an
organization's context, the following additions or clarifications could be made to clause 4 of the ISO 9001
standard:

Include examples of potential issues and requirements that organizations may need to consider based on their
context, such as regulatory compliance, supply chain risks, or emerging technologies.

Encourage organizations to seek input and feedback from internal and external stakeholders, such as
employees, customers, suppliers, and regulators, to ensure a more comprehensive understanding of their
context.
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3.4 Overemphasis on risk:

One approach could be to incorporate a risk management process that takes a holistic approach to risk,
considering both the potential negative impacts of risk and the potential positive impacts of taking risks. This
approach would encourage the organization to identify and assess risks, but also to evaluate the potential
benefits of taking calculated risks that could lead to growth and innovation.

Additionally, the organization could establish a culture of continuous improvement, where employees are
encouraged to identify areas for improvement and take initiative to implement changes. This can help to foster
a culture of innovation and creativity, while also addressing potential risks.

Finally, the organization could incorporate a customer-centric approach to quality management, where the
needs and preferences of customers are at the forefront of decision-making. This approach can help to balance
the focus on compliance and risk management with a broader focus on customer satisfaction and long-term
success.

3.5 Time consuming:

For example, organizations can consider:

Providing specific guidance on how to identify and analyze internal and external issues, as well as interested
parties and their requirements. This guidance can include tools, techniques, and templates that can help
organizations to systematically and comprehensively identify and analyze relevant factors.

Establishing a clear process for involving relevant stakeholders in the analysis process, such as through
consultations, surveys, or focus groups. This can help to ensure that all perspectives are considered and that
the organization's QMS is aligned with the needs and expectations of interested parties.

By including these additional requirements or guidelines, organizations can strengthen their approach to
identifying and analyzing internal and external issues, interested parties, and their requirements, and ensure
that their QMS remains effective and relevant over time.

4. Conclusion:
In conclusion, the fourth clause of ISO 9001:2015 is an essential aspect of quality management system
implementation, but it has several potential drawbacks, including a lack of specific guidance, limited scope,
subjectivity, overemphasis on risk, and time-consuming implementation. To mitigate these drawbacks,
organizations must strive to interpret and implement the standard in a way that balances risk management with
other important considerations, takes a broad view of their internal and external issues, seeks guidance from
quality management experts, and allocates sufficient resources to the process.

By doing so, organizations can effectively implement the fourth clause of ISO 9001:2015 and improve the
overall effectiveness of their quality management system.

References:
ISO 9001:2015. Quality Management Systems - Requirements. International Organization for Standardization, 2015.
https://www.iso.org/standard/68170.html

ISO 9001:2015 Quality Management System - Understanding the Requirements. American Society for Quality, 2019.
https://asq.org/quality-resources/iso-9001-2015