Management system guidance
4.0 Context of the Organization
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4.1 Understanding the organization and its context
Determining the context of your organization
Determining organizational context was first introduced to ISO 9001 in the 2015 revision and remains a core requirement of ISO 9001:2026. It helps to underpin your organization’s quality policy and provides a road map for achieving its future goals.
Also known as contextual intelligence, this approach is not new to those familiar with business planning and strategic development, but it is new in terms of its specific inclusion into ISO management system standards.
Your organization is required to determine the internal and external issues that are relevant to its purpose and strategic direction and that could affect the ability of its quality management system (QMS) to deliver its intended results. It must also monitor and review information about those issues over time. You can read more about the different types of internal and external issues below.
What changed in ISO 9001:2026: your organization must now decide whether climate change is a relevant issue for its QMS. This requirement was first added by Amendment 1:2024 and now sits in the main text of Clause 4.1. The notes to the clause also list culture alongside values, resources, knowledge and performance as an internal issue to consider. The requirement to monitor and review information about internal and external issues is carried over from 2015.
We suggest that you use the context analysis template to help determine internal and external issues, relevant to your organization's strategic direction, that may affect its ability to achieve the intended result(s) of its management system.
Climate change is one of many issues that your organization needs to consider when analysing its internal and external context and when determining the requirements of customers and other relevant interested parties (Clause 4.2).
While some organizations may already address climate change issues, others will be considering it for the first time. If your organization determines that climate change is relevant, those issues will need to be addressed within the QMS, for example when planning actions to address risks and opportunities (Clause 6.1).
In all likelihood, most organizations will be affected by climate change in some way. Those affected businesses will, therefore, need to adapt to the challenges of climate change to continue to meet their objectives, strategy, and operational purpose.
You should develop an understanding of the key internal and external issues that influence your business, and set up processes to capture, monitor and review these issues. The following types of documents and tools often help to provide a source of contextual information:
- Policy statement(s) regarding your organization's purpose and strategic direction;
- Individual strategy documents underpinning your organization's policies that provide a road map to achieve its goals;
- Records of meetings where context is routinely discussed and monitored;
- Structured risk assessments of external and internal issues;
- Use of PESTLE template (Political, Economic, Social, Technological, Legal, Environmental) analysis tools for external issues;
- Use of SWOT template (Strengths, Weaknesses, Opportunities, Threats) analysis tools for internal issues;
- Documented information describing organizational context, included as part of a quality manual.
A review of organizational context could include interviews with senior management, questionnaires, surveys and research. Cross-functional input is essential for the specific expertise required to identify the full breadth of issues, such as finance, training, human resources, commercial, engineering and design, etc.
Not only will this ensure a broader appreciation of organizational context but also wider engagement, particularly with those functions not previously involved with the management system.
You will need to determine and understand the quality-related conditions, typically experienced in your type of organization, that could become internal or external issues with positive or negative effects. It is important to remember that Clause 4.1 'Understanding the organization and its context' interacts with the following clauses:
- Clause 4.3 - your internal and external issues must be considered when determining the scope of the QMS;
- Clause 5.1.1 - top management must ensure that the quality policy and quality objectives are established and compatible with the organization’s strategic direction;
- Clause 5.2.1e - the quality policy must take the context of the organization into account and support its strategic direction;
- Clause 6.1.1 - when planning the QMS, the issues identified under 4.1 are considered when determining the risks and opportunities that need to be addressed;
- Clause 9.3.2 - changes in external and internal issues relevant to the QMS are an input to management review.
If your organization operates an integrated management system, a single context analysis can serve more than one standard. Make sure, however, that the issues relevant to your QMS, i.e. those affecting the conformity of your products and services and the satisfaction of your customers, are clearly identified, because the focus of your QMS will differ from that of other management systems.
Identifying and analysing internal issues
To help understand your business's internal issues, at the micro-level, you need to understand its strengths and weaknesses and be able to identify relevant opportunities and threats. Undertake a SWOT analysis to review and evaluate current business strategies, the position and direction of your organization, business propositions and other commercial leads.
The SWOT analysis should be developed in such a way that its outputs become inputs to determining risks and opportunities. Internal issues might typically be influenced by the following:
- Organizational activities;
- The relevance and impact your operations have on climate change;
- Types of product and service;
- Strategic direction;
- Capabilities (people, knowledge, processes, systems);
- Working practices;
- Employment practices;
- Location and conditions;
- Worker knowledge;
- Organizational structure;
- Policy and objectives;
- Values;
- Strategy;
- Competence;
- Culture, including your organization’s quality culture and ethical behaviour;
- Knowledge;
- Performance;
- Quality-related conditions capable of affecting or being affected by your organization.
Sources of information relating to internal issues might include:
- Organizational structure, including the identification of roles and responsibilities and governance arrangements;
- External reports showing how well your business is performing;
- Statements relating to your organization's mission, vision and core values;
- Emphasis placed upon business ethics and organizational codes of conduct;
- Feedback obtained from employees through opinion surveys;
- Information management systems and processes for capturing and deploying knowledge and lessons learned;
- Organizational capability studies, identification of load/capacity and resource requirements to achieve demand;
- Register of identified internal risks and their treatment.
ISO 9001 does not require internal issues, or their monitoring and review, to be documented, so there might not be ‘lists of internal issues’ or records of reviews. However, information can be obtained via interviews with relevant top management in relation to your organization’s context and its strategic direction, the identified issues and conditions, and how these may affect the intended outcomes of your management system.
Ensure that your organization has determined whether climate change is, or is not, a relevant issue. The determination should be consistent with any statutory and regulatory requirements that apply to your products and services and with the contractual requirements of your customers and suppliers.
Identifying and analysing external issues
External issues might include political, financial or economic trends, customer demographics or emerging product developments. You should undertake a PESTLE analysis in order to establish a suitable understanding of these circumstances, and the market in which your business operates at the macro level.
PESTLE analysis provides a framework for measuring market and growth potential according to external political, economic, social, technological, legal and environmental factors. External issues might typically be influenced by the following:
- Cultural, social, political and regulatory;
- The relevance of the effects that climate change has on your operations;
- Innovation, technology, industry requirements, market requirements, suppliers and partners;
- Financial, economic, natural and competitive issues, whether international, national, regional or local;
- Quality-related conditions capable of affecting or being affected by your organization.
Sources of information relating to external issues might include:
- Reports relating to market environment, economic conditions, new technology, new markets, customer expectations;
- Reports relating to supplier intelligence, political considerations, investment opportunities, social factors etc.;
- Identification of factors relating to changes in legislation and regulation affecting your products and services;
- Feedback relating to product/service performance and lessons learned;
- Register of identified external risks and their treatment.
A workshop approach often allows ideas to be shared and provides an effective and efficient way of achieving a valuable outcome. The workshop could simply be a discussion identifying the issues that can be mapped out using Political, Economic, Social, Technological, Legal and Environmental (PESTLE) analysis. This method helps to structure the conversation and will also help to achieve buy-in to what is often seen as a peripheral or niche area.
Organizations should include climate change as an external issue in their PESTLE analysis and make a statement on its relevance. This should be discussed during management review meetings and recorded in the meeting minutes.
To demonstrate conformity, your organization should be able to show that it identifies its relevant internal and external issues and reviews them at periodic intervals. Although ISO 9001 does not require documented information defining organizational context, it is helpful to keep the following types of documented information to help demonstrate conformity:
- Business plans and strategy reviews;
- Quality manual;
- Competitor analysis;
- Economic reports from business sectors or consultant’s reports;
- SWOT template analysis output;
- PESTLE template analysis output;
- Risk and opportunity assessments;
- Statement contained within a Management System Manual;
- Minutes of management review meetings (that show decisions and actions relating to organizational context);
- Process maps, tables, spreadsheets, mind mapping diagrams.
To assess whether your organization has a high-level, conceptual understanding of the internal and external issues that affect, either positively or negatively, its ability to achieve its intended outcomes, you should describe the processes used by your organization to identify internal and external issues and make reference to all objective evidence, including examples of these issues.
We recommend that Clients consider whether climate change is, or is not relevant to their operational context. The relevance of climate change issues will vary greatly depending on the size and sector of your organization, the products and services provided, its position in the supply chain, its geography, and the scope of your organization’s quality management system.
There is no requirement for the outputs of Clause 4.1 to be documented. If you currently discuss and consider the requirements verbally during management review meetings, continue to do so. If your organization already retains documentation of the results of strategic planning via PESTLE analysis forms or Management Review Minutes, then climate change considerations may be captured in those documents.
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