Clause-by-clause comparison
ISO 9001:2026 vs ISO 9001:2015: every change explained
Published 16 September 2026. Eight changes to act on and very little renumbering. Here is each one against the 2015 text, what did not change, and what to do first.
Updated 13 October 2026 · 12 minute read
The short version
The 2026 revision of ISO 9001 is a measured one. The clause 4 to 10 structure, Plan-Do-Check-Act, the process approach and risk-based thinking are all retained, and the standard adopts the latest harmonized structure for ISO management system standards. A small number of requirements are new; elsewhere the change is mostly emphasis and wording. The 2026 edition gives culture and behaviour, not only documentation, a direct place in the requirements, where the 2015 text said almost nothing about them. The Foreword lists the main changes as core management system terms in clause 3, quality culture and ethical behaviour, separation of risks and opportunities, strengthened management of change, enhanced Annex A and removal of Annex B, and the edition incorporates the 2024 climate change amendment.
- 5.1.1, 7.3 and 7.1.4: top management promotes quality culture and ethical behaviour (5.1.1); people are aware of the organizational quality culture and ethical behaviour (7.3); a note to 7.1.4 says some factors in the process environment can be influenced by them.
- 4.1 and 4.2: the 2024 climate change amendment is incorporated, and 4.2 gains a requirement to determine which interested party requirements will be addressed through the QMS.
- 6.1: risks and opportunities are split into 6.1.1 to 6.1.3; each must be determined, analysed and evaluated, with actions planned in their own right.
- 6.3: planning of changes now also considers communication of the changes, how their effectiveness will be monitored and evaluated, and how their results will be reviewed.
- Annex A: expanded clarification of structure, terminology and clauses 4 to 10. Annex B is removed.
- Structure and terminology: continual improvement moves to 10.1 and nonconformity and corrective action stays at 10.2; clause 3 now defines the core management system terms; “maintain” and “retain” documented information give way to “available as documented information” and “available as evidence”.
ISO 9001:2015 certificates cease to be valid on 30 September 2029, whatever expiry date is printed on them. Expect your certification body to 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. The reasons generally given for the revision are these. 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, and Annex A was significantly expanded to give it.
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, and monitor and review information about them. The 2024 amendment added one sentence: determine whether climate change is a relevant issue. | Same requirements, with the climate change sentence now part of the standard itself rather than a separate amendment. The notes on external and internal context are slightly widened, for example to political and environmental issues and to strategic direction and resources. Annex A adds that issues change over time. |
| 4.2 | Determine the interested parties relevant to the QMS and their relevant requirements, and monitor and review information about them. A 2024 note said relevant interested parties can have climate-related requirements. | New item: determine which of those requirements will be addressed through the QMS. The climate change note is kept as a note. Annex A says climate expectations can influence requirements in areas such as regulatory compliance, customer requirements and organizational commitments. |
What to do. Record the climate change determination with reasoning, even when the answer is that it is not relevant; the standard does not demand a record, but an auditor will ask how you decided. Review customer supplier manuals and codes of conduct for climate clauses that were overlooked under 2015 and add them to the interested party analysis, then mark which requirements the QMS will address. Revisit both at the next context review. Clauses 4.3 (scope) and 4.4 (QMS and its processes) are unchanged in substance; 4.4.2 now uses the “available as documented information” wording.
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. | 2015 elements retained and relettered a) to l). New: promoting quality culture and ethical behaviour. Risk-based thinking is now paired with opportunity-based thinking, and improvement is now continual improvement. A new note says quality culture and ethical behaviour are reflected in shared values, attitudes, practices and actions. |
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 top management to promote quality culture and ethical behaviour, and auditors will look for evidence that they do. 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. Actions proportionate to the potential impact on conformity of products and services. In practice most organizations built risk registers and left opportunities implicit. | Three subclauses: 6.1.1 Determining risks and opportunities, 6.1.2 Actions to address risks, 6.1.3 Actions to address opportunities. Risks and opportunities are each determined, analysed and evaluated, with actions planned, integrated and checked for effectiveness. Risk actions are proportionate to the potential impact on the QMS's intended results; opportunity actions are appropriate to the organization's context. Opportunity-based thinking is named in 5.1.1. |
| 6.3 | Changes to the QMS carried out in a planned manner, considering purpose and consequences, QMS integrity, availability of resources, and allocation of responsibilities and authorities. Silent on what happens after the change is made. | 2015 items retained, with information added to resources. New items to consider: communication of the changes, how their effectiveness will be monitored and evaluated, and how their results will be reviewed. Annex A points to ISO/TS 10020 for guidance on managing change. |
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 in substance.
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 and the same social, psychological and physical examples in the note. The note adds that some of these factors can be influenced by the organization's quality culture and ethical behaviour, connecting the shop floor to 5.1.1. It is a note, not a new requirement. |
| 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, plus a fifth: awareness of the organizational 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 in substance; the 7.1.3 note now covers on-site, remote and hybrid work. 7.1.6 now says knowledge is retained, applied and shared to the extent necessary, and 7.5 is clarified in wording. The 2015 “maintain” and “retain” wording for documented information is replaced by “available as documented information” and “available as evidence of”, which Annex A explains.
Clauses 8, 9 and 10: largely carried over
Operational requirements were already mature and the 2026 edition leaves their substance largely as it was, with some wording changes and added notes. 8.1 now speaks of externally provided processes rather than outsourced processes, and Annex A confirms that the organization remains accountable for conformity even when provision is outsourced; expect auditors to test controls over outsourced processes more deliberately because of it. 8.2.1 now mentions contingency information related to disruptions, and new notes in 8.3 describe iterative design and development.
Clause 9 carries over largely in substance. 9.1.3 now lists the effectiveness of actions on risks and on opportunities as separate items. 9.2.2 is now titled “Internal audit programme”, and your programme must audit against the 2026 edition before the transition audit. Management review inputs in 9.3.2 add changes in the needs and expectations of interested parties and list risk and opportunity actions separately; 9.3.3 is retitled “Management review results”. In clause 10, continual improvement is consolidated into 10.1, combining the 2015 clauses 10.1 and 10.3, and nonconformity and corrective action stays at 10.2, with a new note that customer complaints can be a source of nonconformities.
Annex A: expanded, informative
Annex A, “Clarification of structure, terminology and clauses”, now runs from clause 4 to clause 10. It explains how words such as “appropriate” and “applicable”, “consider” and “take into account”, and “ensure” are used, describes the role of top management in promoting quality culture, says how climate expectations can shape interested party requirements, treats risks and opportunities as distinct and describes opportunity-based thinking, confirms that risk-based thinking does not require a formal risk management process, and expands on documented information, externally provided processes and organizational knowledge. It points to other ISO/TC 176 standards, the job Annex B used to do. Read it before writing or revising a procedure. It will settle most arguments with your auditor in advance. It is informative and says it adds no requirements: 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
- The clause 4 to 10 structure. Renumbering is limited to 6.1.1 to 6.1.3 and the consolidated 10.1, with 9.2.2 now titled and 9.3.3 retitled, so cross-reference matrices need only small updates.
- 4.3, 4.4, 5.1.2, 5.2, 5.3 and 6.2 in substance.
- 7.1.5, 7.2 and 7.4. 7.1.6 and 7.5 are clarified in wording.
- The substance of clause 8, with the externally provided process wording noted above.
- 9.1 and 9.2 in substance, 9.3 apart from the added input on interested parties, and corrective action in 10.2.
- PDCA, the process approach and risk-based thinking. Annex A confirms no formal risk management method is required.
- The overall approach to documented information, now expressed as “available as documented information” and “available as evidence of” instead of maintain and retain.
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. From 31 March 2028, new and initial accredited certifications are issued only to the 2026 edition. 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. Expect certification bodies to stop scheduling transition audits by early 2029 so that findings can be closed in time; ask yours for its date.
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 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.