Clause-by-clause comparison
ISO 9001:2026 vs ISO 9001:2015: every change explained
Published 16 September 2026. Eight substantive changes, no new clause numbers, no new mandatory documents. Here is each one against the 2015 text, what did not change, and what to do first.
Updated 6 October 2026 · 12 minute read
The short version
The 2026 revision of ISO 9001 is a measured one. The harmonized structure, the clause numbering, Plan-Do-Check-Act, the process approach and risk-based thinking are all unchanged. What changed is emphasis. The committee concluded that culture and behaviour, not documentation, decide whether a quality management system works, and the 2015 text said almost nothing about them.
- 5.1.1, 7.1.4 and 7.3: top management promotes a quality culture and ethical behaviour; the process environment supports them; everyone understands their contribution to them.
- 4.1 and 4.2: the 2024 climate change amendment is embedded in the body text with Annex A examples.
- 6.1: risks and opportunities are separated; opportunities must be determined and acted on in their own right.
- 6.3: planning of changes now includes communication, monitoring, evaluation and review.
- Annex A: expanded guidance for clauses 4 to 10.
- Terminology: documented information, outsourced processes and organizational knowledge clarified.
ISO 9001:2015 certificates cease to be valid on 30 September 2029, whatever expiry date is printed on them. Most certification bodies will stop scheduling transition audits months earlier.
Why the standard changed
ISO standards are reviewed on a cycle, and the committee could have confirmed the 2015 edition without change. It did not, for five documented reasons. Users reported that culture and behaviour determined effectiveness far more than documents did. High-profile quality failures and falsified test data made ethical behaviour a quality issue rather than only a compliance one. The 2024 climate change amendment, published as a separate sheet, needed to live in the body text. Risk-based thinking had become risk registers in practice, with opportunities rarely pursued deliberately. And changes to the QMS were planned but often not followed through. Users also asked for more guidance on intent, which is why Annex A was expanded rather than new requirements added.
Clause 4: context and interested parties
| Clause | ISO 9001:2015 | ISO 9001:2026 |
|---|---|---|
| 4.1 | Determine external and internal issues relevant to purpose and strategic direction. The 2024 amendment added one sentence: determine whether climate change is a relevant issue. | Same core requirement. Climate change relevance is part of the body text. Annex A gives examples of how it might be relevant: supply disruption, energy cost, regulation, customer demands, site exposure. |
| 4.2 | Determine interested parties relevant to the QMS and their relevant requirements. A 2024 note said interested parties can have climate-related requirements. | Same core requirement. Climate-related requirements of interested parties are referenced explicitly: customer supplier codes, investor expectations, regulation. |
What to do. Record the climate change determination with reasoning, even when the answer is that it is not relevant. Review customer supplier manuals and codes of conduct for climate clauses that were overlooked under 2015 and add them to the interested party analysis. Revisit both at the next context review. Clauses 4.3 (scope) and 4.4 (QMS and its processes) are unchanged.
Clause 5: leadership
| Clause | ISO 9001:2015 | ISO 9001:2026 |
|---|---|---|
| 5.1.1 | Accountability for effectiveness; policy and objectives aligned with strategy; integration into business processes; promote the process approach and risk-based thinking; resources, communication, engagement, support for other managers. | All 2015 elements retained. New: top management promotes a quality culture and ethical behaviour within the organization. Annex A describes culture as the shared values and behaviours that shape how quality is treated in practice. |
This is the headline change and the one auditors will probe hardest, because it is new and because it is about behaviour rather than documents. The standard does not mandate a culture officer, a signed code of ethics or a programme. It asks for promotion by leadership and for evidence that it happened. Evidence that stands up tends to include leadership communications that name quality and ethics, incentives and targets reviewed for conflicts with conformity, a visible route for raising concerns with examples of concerns acted on, and nonconformity records that show problems reported early rather than hidden. Clauses 5.1.2, 5.2 and 5.3 are unchanged in substance.
Clause 6: planning
| Clause | ISO 9001:2015 | ISO 9001:2026 |
|---|---|---|
| 6.1 | Risks and opportunities addressed together as a pair throughout the clause. In practice most organizations built risk registers and left opportunities implicit. | Risks and opportunities addressed in separate sub-requirements. Opportunities must be determined and acted on in their own right; opportunity-based thinking is named. Planning, integration and effectiveness evaluation apply to both. |
| 6.3 | Changes to the QMS carried out in a planned manner, considering purpose and consequences, QMS integrity, resources, and responsibilities and authorities. Silent on what happens after the change is made. | 2015 elements retained. Strengthened: changes communicated to those affected, implementation monitored, results evaluated and reviewed. Links to 8.1, 8.3.6 and 8.5.6 are clearer in Annex A. |
What to do. Add an opportunity log, or an opportunity section to your planning records, with owners, actions and review dates, and link it to quality objectives (6.2) and management review (9.3). Add communication and post-change review steps to your change procedure or form, and keep the records for every change made since the new edition. An empty opportunity column and a change form with no review step are the two most predictable transition findings. Clause 6.2 is unchanged.
Clause 7: support
| Clause | ISO 9001:2015 | ISO 9001:2026 |
|---|---|---|
| 7.1.4 | Determine, provide and maintain the environment needed for process operation. A note lists social, psychological and physical factors. | Same requirement. Social and psychological factors now explicitly include a culture that supports quality and ethical behaviour, connecting the shop floor to 5.1.1. |
| 7.3 | People are aware of the quality policy, relevant objectives, their contribution to QMS effectiveness, and the implications of not conforming. | Same four elements. Contribution to effectiveness now explicitly includes contribution to quality culture and ethical behaviour. |
What to do. Consider whether workload, targets, incentives or a blame culture undermine conformity, and treat them as process environment issues under 7.1.4. Update induction and awareness material so that people can say what quality culture and ethical behaviour mean in this organization, and what to do when asked to compromise. Clauses 7.1.5, 7.2 and 7.4 are unchanged. 7.1.6 and 7.5 are clarified in wording only, and the maintain versus retain distinction for documented information is explained more fully in Annex A.
Clauses 8, 9 and 10: unchanged in substance
Operational requirements were already mature and the 2026 edition leaves them alone. 8.1 is unchanged, with Annex A clarifying the link between QMS changes in 6.3 and operational changes in 8.1. 8.2, 8.3, 8.5, 8.6 and 8.7 are unchanged. 8.4 benefits from the clarified definition of an outsourced process, which confirms it stays within the QMS and that the organization keeps responsibility; expect auditors to test controls over outsourced processes more deliberately because of it.
Clause 9 is unchanged. 9.1.3 still requires evaluating the effectiveness of actions on risks and opportunities, which now means the separated opportunities too. Your internal audit programme under 9.2 must audit against the 2026 edition before the transition audit. Management review inputs under 9.3 are unchanged, and the new evidence on climate, culture, opportunities and change reviews fits under the existing headings. Clause 10 is unchanged.
Annex A: expanded, informative
Annex A now carries clarifications for every clause from 4 to 10, with examples. It explains quality culture and ethical behaviour and how leadership can demonstrate promoting them, gives examples of how climate change may be relevant, describes opportunity-based thinking and how it differs from risk mitigation, and expands on documented information, outsourced processes and organizational knowledge. Read it before writing or revising a procedure. It will settle most arguments with your auditor in advance. It is informative, not normative: a nonconformity must cite a requirement from the body of the standard, and if one cites Annex A, ask for the clause.
What did not change
- Clause numbering and the harmonized structure. Cross-reference matrices need no restructuring.
- 4.3, 4.4, 5.1.2, 5.2, 5.3 and 6.2.
- 7.1.5, 7.2 and 7.4. 7.1.6 and 7.5 are clarified in wording only.
- All of clause 8, with the outsourced-process clarification noted above.
- 9.1, 9.2, 9.3 and clause 10.
- PDCA, the process approach and risk-based thinking. No risk methodology is mandated.
- No new mandatory documents or records anywhere in the standard.
Dates and the transition audit
Published 16 September 2026. Three-year transition. 2015 certificates cease to be valid after 30 September 2029 regardless of printed expiry. Transition normally happens at a scheduled surveillance or recertification audit, with additional time for the changed clauses. Before the audit, certification bodies typically ask for the gap assessment, updated documents, and evidence of internal audit and management review against 2026. The 2026 certificate is issued only after any major nonconformities are closed. Most bodies stop scheduling transition audits in early 2029 so that findings can be closed in time.
Missing the deadline has no grace period. The certificate lapses, registers show it as lapsed, and regaining it means initial certification again: stage 1 and stage 2 at full cost, with no certificate until the decision. If a recertification audit falls in 2027 or 2028, that is the natural moment to transition. It reviews the whole system anyway, so transition adds the least incremental time, and a year remains to close findings.
What to do first
- Buy the standard and read Annex A before touching any procedure.
- Run a gap assessment against the eight changes above and record findings per clause.
- Document the climate change relevance determination, with reasoning, either way.
- Agree with top management how they will promote quality culture and ethical behaviour, and what evidence will exist.
- Create an opportunity log and add communication, monitoring and review to the change procedure.
- Update awareness material, then train internal auditors and audit the whole QMS against 2026.
- Hold a management review with the 2026 evidence, then book the transition audit with a year of margin.
The free guide below has this as a printable twelve-step checklist. The transition course turns it into a gap assessment template, a twelve-month plan and an internal audit module, in eight hours, with a verifiable certificate at the end.