ISO 9001 - 4.0 Contexts of the Organization
ISO 9001 - Clause 4: 4.1-4.4
Do you need help getting a better understanding of ISO 9001 and how to best apply it to your own QMS? We’ve got you covered, follow along as we will go through each section and clause in ISO 9001:2015. Starting with an overview of each section, then getting into each clause in more detail. Starting with #4 The Context of the Organization is a foundational concept found in ISO 9001:2015, which is the international standard for Quality Management Systems (QMS). This section of the standard requires organizations to understand both the external and internal outcomes of their QMS.
The Context of the Organization consists of 4 clauses:
4.1 Understanding the Organization and Its Context
Understanding the Organization consists of External and Internal issues that could influence your QMS. Some External issue examples are things such as economic conditions, technological developments and market trends. Internal examples such as organizational structure, available resources and company culture. Internal processes and the effectiveness of employee communication can have a big impact on maintaining quality standards.
4.1 Standard Requirement (ISO 9001:2015):
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
The organization shall monitor and review information about these external and internal issues.
NOTE 1 - Issues can include positive and negative factors or conditions for consideration.
NOTE 2 - Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3 - Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.
Examples of real Internal issues for a business:
- Poor communication between departments or unclear organizational hierarchy can lead to inefficiencies and responsibilities.
- A business may struggle with a skills gap among employees, where existing staff lack the necessary training or expertise to perform tasks efficiently.
Examples of real External issues for a business:
- Businesses may face evolving government regulations that affect how they operate, such as new environmental laws or industry-specific standards.
- Shifting market trends or changes in customer expectations can impact on a business’s ability to remain competitive. For example, promoting something that is no longer needed or popular.
4.2 Understanding the Needs and Expectations of Interested Parties
Interested parties such as suppliers, customers, shareholders, employees and the community and understanding their needs and expectations. All of these different parties can have a significant impact on the organization’s success and quality objectives. Understanding these needs and expectations of interested parties are crucial for product quality and critical for compliance.
4.2 Standard Requirement (ISO 9001:2015):
Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their relevant requirements.
Interested parties – a few example may include suppliers, employees, and customers.
4.3 Determining the Scope of the QMS
Defining the scope of the QMS includes determining the boundaries of the QMS. This includes the organization’s products, service, operations and locations. Consider both Internal and External factors when defining the scope as well as requirements of interested parties.
Check out our blog post on How to determine your QMS Scope of Certification
4.3 Standard Requirement from Standard (ISO 9001:2015):
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
Below is a real example scope statement for a business certified to ISO 9001:2015:
Example Scope: ABC Manufacturing, situated in Paris, France, specializes in designing, producing, and distributing high-quality automotive components for clients in the European and North American markets.
4.4 Establishing the QMS and Its Processes
The ISO 9001 standard emphasizes a process approach. Organizations should establish, implement, maintain and continually improve the processes needed for the QMS. These should be focused on achieving your organization’s desired outcomes. Continual improvement is a main focus of Clause 4.4 as the organization is required to continually monitor and review its context to ensure that the QMS remains effective.
4.4 Standard Requirement from Standard (ISO 9001:2015):
4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
4.4.2 To the extent necessary, the organization shall:
a) maintain documented information to support the operation of its processes;
b) retain documented information to have confidence that the processes are being carried out as planned.
Why does it matter?
Understanding the context of the organization is crucial because the QMS is tailored to your specific needs and circumstances of the organization. The QMS will be better aligned with the intent of the ISO 9001:2015 standard and be more effective by considering the relevant internal and external factors and addressing them. In addition, aligning the needs of interested parties will lead to enhanced customer satisfaction and sustained success.
Related Blog Posts:
How to determine your QMS Scope of Certification
Improvement- The Seven Quality Management Principles
4 Steps to Achieving ISO 9001 Quality Management System Certification
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