ISO 9001 - Clause 4 Context of the organization

by Maya G

Organizations operate in a context that includes but is not limited to, factors such as stakeholder expectations, organizational culture, processes, resources, and external environment (e.g. market conditions, technology, legal and regulatory requirements).

The context of an organization can change, which can impact the ability of the organization to achieve its intended outcomes. The organization needs to be aware of these changes and determine how they impact the organization’s ability to achieve its quality objectives.

ISO 9001

When determining the context of the organization, the organization needs to consider?

  • The organization’s purpose, vision, values, strategy, objectives, and activities
  • The internal and external environment in which the organization operates, including
  • The organization’s stakeholders and their requirements, expectations, and perceptions
  • The organization's culture, including values, behaviours, and norms.
  • The organisation’s structure, including governance, responsibilities, and authority.
  • The organisation’s processes, including those for management, operations, and support.

Why is context important?

When implementing a quality management system (QMS), it is important to first understand the organization’s context. The organization’s context refers to the internal and external factors that can affect the organization’s ability to achieve its objectives.

Organizations operate in a constantly changing environment, so it is important to periodically review and update the context to ensure that the QMS is still relevant. The organization’s context can be divided into four categories:

  • Internal context: Factors that are within the organization’s control, such as policies, processes, and resources.
  • External context: Factors that are outside of the organization’s control, such as customer needs and market trends.
  • Organisational environment: The organization’s culture, values, and structure.
  • Regulatory environment: National and international regulations that the organization must comply with.

Understanding the organization and its context:

Organizations operate in a dynamic environment that comprises many internal and external factors that can affect their ability to achieve their objectives. An organization needs to monitor and understand its environment to be able to identify opportunities and threats that could impact its success.

ISO 9001 - Clause 4: Context of the organization is all about understanding the organization and its context. This clause requires organizations to establish, maintain and communicate a context for the quality management system. It also requires organizations to monitor and review the external and internal factors that could affect their ability to achieve their quality objectives.

 Monitor and review the context:

Organizations are increasingly required to demonstrate their commitment to quality and continuous improvement to meet the requirements of customers, regulators, and other stakeholders. One way to do this is to implement a quality management system (QMS) and seek certification to internationally recognized standards such as ISO 9001.

ISO 9001 is the world’s most popular quality management standard, and Clause 4.0 of the standard requires organizations to “monitor and review the context” within which they operate. This includes understanding the needs and expectations of customers and other interested parties, as well as the applicable legal and regulatory requirements.


Organizations must establish, implement, and maintain documented procedures for monitoring and reviewing their context. This is essential for ensuring that the QMS continues to be suitable, relevant, and effective in achieving the organization’s objectives.

The review of the organization’s context should include, as a minimum:

  • Identification of interested parties that could affect, or be affected by, the organization’s ability to achieve its objectives;
  • Evaluation of changes in the relevant external and internal issues that could affect, or be affected by, the organization’s ability to achieve its objectives; and
  • Identification of any opportunities or threats that could affect the organization’s ability to achieve its objectives.

The results of the review of the organization’s context should be used to support the planning of changes to the QMS, as needed.

When monitoring and reviewing the organization’s context, the following should be considered:

  • Relevant external and internal issues
  • Changes in these external and internal issues

ISO 9001