ISO 9001:2015 vs ISO 9001:2026

This is the headline change of the edition and it is a shall, not a note. The standard also defines it: an organization's quality culture and ethical behaviour are reflected in its shared values, attitudes, practices and actions. Reflected in, not consists of, which is what makes it auditable.

Clauses: 5.1.1 i) and Note 2, 7.1.4, 7.3 e). Guidance in Annex A.5.1 and A.7.3, which point to ISO 10010 and ISO 10018.

What to do: Expect interviews rather than document review. Be ready with dated examples of how top management promotes it, and check that people at any level can say what it means here in their own words.

The largest structural change. Risk and opportunity are now separate disciplines with parallel requirements. Risk actions must be proportionate to potential impact; opportunity actions must be appropriate to context and support desired results. Annex A.6.1.2 confirms this does not imply formal risk management methods.

Clauses: 6.1.1, 6.1.2, 6.1.3. Flows through to 9.1.3 e) and f) and 9.3.2 g) and h).

What to do: A combined register with the opportunity column left empty is now a likely finding. Separate the two, and evidence that opportunity actions were evaluated for effectiveness.

Clause 4.2 gains item c): determine which of these requirements will be addressed through the quality management system. Small wording, useful effect. It gives you a documented basis for deciding that a requirement sits outside the QMS, which the 2015 text did not.

Clauses: 4.2 c). Annex A.4.2 adds that climate expectations can influence interested party requirements.

What to do: Add a column to your interested party register recording whether each requirement is addressed through the QMS, and why.

Clause 6.3 grows from four considerations to seven. Item b) becomes the potential impact on the integrity of the QMS, item c) adds information alongside resources, and three new items cover communicating the change, monitoring and evaluating its effectiveness, and reviewing the results.

Clauses: 6.3. Annex A.6.3 points to ISO/TS 10020 on organizational change management.

What to do: A change record that stops at approval is no longer enough. Show the change was communicated, its effectiveness evaluated, and the results reviewed.

The list in 5.1.1 goes from ten items to twelve. New item i) is promoting quality culture and ethical behaviour. Items j) and k) split what was one item, and k) now covers opportunity-based thinking as well as risk-based thinking. Accountability moves from a) to l). Promoting improvement becomes promoting continual improvement.

Clauses: 5.1.1. Also 5.2.1, which grows from four items to five as context and strategic direction become their own item.

What to do: Map your leadership evidence against all twelve items. Most organizations have nothing on i), j) or k).

Clause 5.3 loses the word "Organizational" from its title, and the lead-in drops "and understood". The assigned responsibilities go from five to six, because reporting on QMS performance and reporting on opportunities for improvement are now separate duties.

Clauses: 5.3.

What to do: Check your role descriptions cover all six. The improvement reporting duty is the one usually missing.

Knowledge must now be retained, applied and shared, rather than maintained and made available. The purpose broadens from conformity of products and services to the intended results of the QMS. A new note lists four forms: experience held by people, knowledge from education and training, knowledge embedded in methods and products, and knowledge represented in documented information and digital systems.

Clauses: 7.1.6.

What to do: A knowledge register that nobody reads no longer satisfies the wording. Show knowledge being applied and shared.

Clause 9.1.3 grows from six evaluation inputs to eight, separating risk action effectiveness from opportunity action effectiveness and adding the effectiveness of planning implementation. Management review adds changes in the needs and expectations of interested parties, splits risk and opportunity, and 9.3.1 adds alignment with the strategic direction of the organization. Clause 9.3.3 is renamed from outputs to results.

Clauses: 9.1.3, 9.3.1, 9.3.2, 9.3.3. Also 9.2.2, which adds audit objectives and the word correction.

What to do: Update your management review agenda template. Three inputs are new or split.

The 2015 clauses 10.1 General and 10.3 Continual improvement merge into a single 10.1 Continual improvement. Clause 10.2 on nonconformity and corrective action is substantively unchanged.

Clauses: 10.1, 10.2. There is no 10.3.

What to do: Renumber any procedure, matrix or internal audit checklist that still references clause 10.3.

Clause 3 now carries the core terms rather than referring wholesale to ISO 9000. Annex A.2 also clarifies the meaning of appropriate versus applicable, consider versus take into account, continual versus continuous, ensure, and the difference between "shall be available as documented information" and "documented information shall be available as evidence of".

Clauses: Clause 3, Annex A.2.

What to do: The available versus evidence distinction decides whether you need a live document or a retained record. Worth reading before your next audit.

Annex A is expanded with new material on applicability, terminology, and clause-by-clause clarification. Annex A.5.1 and A.7.3 both point to ISO 10010 on organizational quality culture, A.7.3 also points to ISO 10018 on people engagement, A.6.1.2 confirms formal risk management is not implied, and A.6.3 points to ISO/TS 10020. Annex B, which listed other ISO quality management standards, is removed.

Clauses: Annex A. Annex B removed.

What to do: Annex A is informative, but it is where the drafters explain what they meant. Read A.2 and A.3 in particular.

Climate change was not in the original 2015 text. It was added by Amendment 1:2024 and carried into the 2026 edition unchanged. It reads as a standalone sentence, not as a qualifier inside the issues requirement: the organization shall determine whether climate change is a relevant issue.

Clauses: 4.1, and a note under 4.2. Annex A.4.2 expands on it.

What to do: If you already implemented Amendment 1:2024, nothing changes. If not, record a determination either way. A yes or no with reasoning is enough.