By Jackie Stapleton

A fellow auditor recently shared a story with me about an audit that had gone off track.

The conversation with the auditee had started with clause 4.1 of ISO 9001 (as amended in 2024) and the requirement for the organization to determine whether climate change was a relevant issue.

The auditee was openly skeptical about climate change and made it clear that they did not believe it was relevant to their organization.

Rather than bringing the conversation back to the quality management system (QMS), the discussion became increasingly personal. The auditor pushed harder. The auditee pushed back.

Before long, they were no longer discussing the organization’s context or its ability to achieve the intended results of its quality management system.

They were arguing about climate change.

When the auditor told me the story, what stood out was not which person was right or wrong in their personal views. It was that the audit had moved away from the audit criteria.

In ISO/FDIS 9001:2026, clause 4.1 states:

“The organization shall determine whether climate change is a relevant issue.”

At first glance, that wording seems simple. But it leaves an important question unanswered:

Relevant to what?

Read on its own, it almost sounds as though the organization is being asked to decide whether climate change is relevant in general.

That is not the purpose of clause 4.1.

The real question is whether climate change is relevant to the organization’s context and its ability to achieve the intended results of its QMS.

That is a very different conversation.

It is almost like asking whether rain is relevant.

The answer will be different if you are planning a picnic, pouring concrete, or operating a data center. The issue may be the same, but its relevance can only be determined within the circumstances in which it is being considered.

Climate change is no different.

Clause 4.1 is not asking the organization to form a general opinion about climate change. It is asking the organization to determine whether climate change could affect its context or its ability to achieve the intended results of its quality management system.

This example points to something broader about the changes to clause 4 in ISO/FDIS 9001:2026.

The wording may appear straightforward, but how it is interpreted and applied will determine whether clause 4 supports meaningful decision-making or becomes another conformance exercise.

So, what has changed in clause 4, and what will those changes mean for organizations, auditors, and consultants?

“Seek first to understand, then to be understood.”

That principle, from Stephen R. Covey, matters in auditing. Before reaching a conclusion, we need to understand the organization, its circumstances, and the evidence supporting its decisions.

This is also reflected in guidance published by the ISO 9001 Auditing Practices Group on auditing climate change issues.

The guidance explains that the overall intent of clause 4.1 and clause 4.2 has not changed. Organizations have always been required to identify the internal and external issues that could affect the intended results of their QMS. The addition of climate change does not prescribe what conclusion an organization must reach. It requires climate change to be considered as part of that process.

For auditors, the task is therefore not to decide on behalf of the organization that climate change is relevant. It is to evaluate whether the organization has considered the issue, whether its conclusion is reasonable within its context, and whether relevant climate-related requirements have been addressed through the QMS.

Looking at the whole of clause 4

Climate change is only one part of the clause 4 conversation.

What this example really highlights is the importance of interpreting each requirement within the broader purpose of clause 4.

Clause 4 is where the organization establishes the foundation for its QMS. It considers the issues that may affect the organization, identifies the interested parties and requirements that matter, defines the scope of the QMS and determines the processes needed to make the system work.

The changes in ISO/FDIS 9001:2026 do not completely rewrite clause 4, but they do sharpen several expectations across clauses 4.1, 4.2, 4.3 and 4.4.

Taken together, the changes ask organizations to be clearer about:

• Which internal and external issues are relevant
• Which interested-party requirements will be addressed
• How the scope reflects the organization’s context
• How QMS processes are determined, applied, and maintained

So, while climate change may be the most visible change in clause 4.1, it should not distract us from the broader question:

Does the organization genuinely understand the context in which its quality management system operates?

How clause 4 turns context into a working QMS

Clause 4 still follows a clear logic. The organization considers what matters, who matters, what the QMS covers, and how its processes will operate. The graphic below shows that flow and highlights where the 2026 revision introduces a clearer expectation, where the wording has been refined, and where the intent remains largely unchanged.

Clause 4.1 Understanding the organization and its context

Clause 4.1 still requires the organization to determine the internal and external issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of the QMS.

The most visible point is the explicit reference to climate change.

The organization is required to determine whether climate change is a relevant issue. That does not mean the conversation needs to begin with the words “climate change,” particularly if those words are likely to pull the discussion into personal views or debate.

Sometimes it is more useful to begin with what the organization has already experienced, rather than asking people to speculate about what might happen.

Useful questions include:

• “Has the organization experienced floods, storms, bush fires, heat waves, or other extreme weather events?”
• “Did any of those events affect operations, employees, suppliers, customers, or delivery?”
• “Have weather-related disruptions changed insurance, infrastructure, resource availability, or customer requirements?”
• “What did the organization learn, and has anything changed in the QMS as a result?”

These questions keep the discussion practical and evidence based. They also help the organization determine relevance without turning the conversation into an argument about climate change itself.

The requirement does not prescribe the answer. It requires the organization to consider the issue and reach a reasonable conclusion.

4.2 Understanding the needs and expectations of interested parties

Clause 4.2 continues to require the organization to determine:

• The interested parties that are relevant to the QMS
• The relevant requirements of those interested parties

The wording places clearer emphasis on deciding which interested-party requirements will be addressed through the QMS.

This matters because many organizations create a list of interested parties, record a few broad expectations, and stop there. The real decision is not simply who is interested in the organization. It is which requirements are relevant to the QMS and which of those the organization will address.

The note in clause 4.2 also reminds organizations that relevant interested parties can have requirements related to climate change.

As with clause 4.1, the conversation does not need to begin with climate change as a broad topic. It may be more useful to look at what interested parties have already asked for, changed, or introduced.

Useful questions include:

• “Have customers introduced new environmental, resilience, or supplier requirements?”
• “Have insurers changed conditions, exclusions, or evidence requirements?”
• “Have regulators, landlords, funding bodies, or parent companies introduced new expectations?”
• “Have any of these requirements affected products, services, operations, or the QMS?”
• “Which of these requirements has the organization decided to address through the QMS?”

These questions keep the discussion practical and evidence based.

The organization is not expected to treat every expectation from every interested party as a QMS requirement. It should be able to explain why an interested party is relevant, which of its requirements matter, and how those requirements are being addressed through the QMS.

4.3 Determining the scope of the quality management system

There does not appear to be a significant change to the intent of clause 4.3.

The organization still needs to determine the boundaries and applicability of its QMS by considering:

• The internal and external issues identified under clause 4.1
• The relevant interested-party requirements identified under clause 4.2
• The organization’s products and services

The scope should describe what the QMS actually covers.

It should not be treated as wording produced only for the certificate. It needs to reflect the organization’s activities, locations, products, services, and operational boundaries.

A useful test is simple:

“Would someone reading the scope understand what this quality management system genuinely applies to?”

The context and interested-party analysis should lead into the scope. If those activities change, the scope may also need to be reviewed.

4.4 Quality management system

The process-based intent of clause 4.4 remains substantially the same.

The organization still needs to establish, implement, maintain, and continually improve its QMS, including the processes needed and their interactions.

This includes determining matters such as:

• Process inputs and expected outputs
• The sequence and interaction of processes
• Criteria and methods for effective operation and control
• Resources
• Responsibilities and authorities
• Risks and opportunities
• Process evaluation
• Changes needed to achieve intended results

The important point is that the context work in clause 4.1 to clause 4.3 must eventually show up here.

If an issue is genuinely relevant, an interested-party requirement matters, or the scope establishes a particular boundary, there should be some effect on how the QMS is designed or operated.

Otherwise, clause 4 risks becoming a collection of registers sitting beside the system rather than shaping it.

Next steps for you

1. Review what has already happened

Start with evidence, not assumptions.

Look back at:

• Weather events or disruptions that affected operations, suppliers, employees, or delivery
• New requirements introduced by customers, insurers, regulators, or other interested parties
• Changes in the organization’s context that may affect the intended results of the QMS

This gives the organization a practical basis for deciding what is relevant.

2. Update the clause 4 decisions

Review clause 4.1 to clause 4.4 together, rather than as four separate exercises.

Confirm:

• Which internal and external issues are relevant
• Which interested parties and requirements matter to the QMS
• Whether the QMS scope still reflects the organization
• Whether the required processes address those decisions

The aim is not to create more documents. It is to make clearer decisions.

3. Check that the QMS reflects those decisions

Trace the outcomes of clause 4 into the working system.

Look for evidence in:

• Risks and opportunities
• Objectives and plans
• Operational controls
• Supplier management
• Emergency or business continuity arrangements
• Process responsibilities and resources
• Management review

If the decisions made in clause 4 cannot be seen anywhere else in the QMS, they are probably sitting in a register rather than shaping the system.

About the author

Jackie Stapleton is the director of Auditor Training Online and holds multiple Exemplar Global certifications.

A version of this article first appeared on the Lead the Standard blog and is published here with permission.