ISO 9001:2026 was published on 16 September 2026. It keeps the ten-clause structure of ISO 9001:2015, keeps the process approach, PDCA and risk-based thinking, and adds no new mandatory procedures. What it does change is specific and countable: one new sub-clause (6.1.3), seven new list items spread across Clauses 4 to 9, a dozen re-worded requirements that raise the bar in small but auditable ways, a Clause 3 that now defines its own terms, a merged Clause 10, a rewritten Annex A and a deleted Annex B. This page lists every one of them against the ISO 9001:2026 standard, not the draft.
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Key facts
- Published by ISO on 16 September 2026 as the sixth edition; 36 pages; ISO catalogue stage 60.60.
- Cancels and replaces ISO 9001:2015 and incorporates Amendment 1:2024 (climate change) into the main text.
- Structure unchanged: Clauses 1 to 10 under the Harmonized Structure; Annex A is now informative clause-by-clause clarification; Annex B has been removed.
- New requirements: sub-clause 6.1.3 (actions to address opportunities) plus new items 4.2 c), 5.1.1 i), 6.3 e), 6.3 f), 6.3 g), 7.3 e) and 9.3.2 c).
- Raised expectations inside existing requirements: risks and opportunities must now be analysed and evaluated, not just determined (6.1.2, 6.1.3); leadership must promote opportunity-based thinking (5.1.1 k)); the quality policy must take the organisation’s context into account and support its strategic direction as a requirement of its own (5.2.1 e), previously folded into the 2015 wording of 5.2.1 a)) and must be implemented, not only understood and applied (5.2.2 d)); organisational knowledge must be retained, applied and shared (7.1.6).
- No new mandatory documents or records. The “maintain / retain documented information” wording of 2015 is replaced throughout by “shall be available as documented information” and “documented information shall be available as evidence of” (explained in Annex A.2 e)).
- Transition: set by Global ACI (Global Accreditation Cooperation Incorporated, which took over the roles of IAF and ILAC on 1 January 2026) in Global ACI-TECH-3-TR 2029-09-30 (M), Transition Requirements for ISO 9001:2026, published on 16 September 2026: a three-year period ending 30 September 2029, with accreditation bodies ready by 31 March 2027, certification bodies’ transition declarations by 30 June 2027, accreditation decisions by 30 September 2027, and initial certifications only to the 2026 edition from 31 March 2028. ISO 9001:2015 certificates remain valid until 30 September 2029. Details on the transition deadline and timeline page.
How to read this register
Three labels are used throughout. New means a requirement that did not exist in ISO 9001:2015 in any form. Changed means an existing requirement whose wording now asks for something more, something different or something more specific, so an auditor can reasonably expect different evidence. Editorial means renumbering, re-ordering, a new informative NOTE or a change of words with no change in what has to be done. Where a NOTE has changed, it is listed as editorial, because NOTEs do not contain requirements; they do, however, tell you what auditors have been told to expect, so several are worth reading.
ISO’s own Foreword lists six “main changes”. They are the right headline, but they are written at the level of themes. The register below goes to the level of the list item, because that is the level at which a gap analysis, an internal audit checklist and a certification audit actually operate.
The six changes ISO itself lists, and where each one lands
| Change named in the Foreword | Where it appears in the requirements |
|---|---|
| Core management-system terms and definitions included in Clause 3 | 3.1 to 3.20 (23 entries including 3.4.1, 3.5.1 and 3.6.1). ISO 9000 remains the normative reference. |
| Quality culture and ethical behaviour introduced | 5.1.1 i) and NOTE 2; 7.1.4 NOTE; 7.3 e); Annex A.5.1 and A.7.3; ISO 10010 added to the Bibliography for guidance. |
| Risks and opportunities separated | 6.1.1 (determining both), 6.1.2 (actions to address risks), 6.1.3 (actions to address opportunities); consequential splits in 9.1.3 e) and f) and 9.3.2 g) and h); “opportunity-based thinking” in 0.3.1 and 5.1.1 k). |
| Management of change strengthened | 6.3 grows from four considerations to seven: a) to g). |
| Annex A expanded | A.1 to A.10, one section per clause, plus the term clarifications in A.2. |
| Annex B removed | References to the other ISO/TC 176 standards now sit in Annex A and the Bibliography. |
Not listed in the Foreword, but included in the text: the climate-change sentences from Amendment 1:2024 now sit permanently in 4.1 and 4.2, and the normative reference to ISO 9000 is now undated, so the current edition of ISO 9000 applies whenever it is revised.
The clause-by-clause register
Introduction and Clauses 1 to 3
| Reference | ISO 9001:2015 | ISO 9001:2026 | Label |
|---|---|---|---|
| 0.3.1 Process approach | Risk-based thinking named as the supporting concept | Adds “opportunity-based thinking” alongside risk-based thinking, pointing to A.6.1.2 and A.6.1.3 | Editorial (signals the 6.1 split) |
| 0.4 Relationship with other MSS | Refers to the high-level structure in Annex SL | Refers to the harmonized approach in the ISO/IEC Directives; PDCA figure retained | Editorial |
| 1 Scope | Applicability, Notes 1 and 2 | Unchanged | Editorial |
| 2 Normative references | ISO 9000:2015 (dated) | ISO 9000 (undated): the latest edition applies | Changed |
| 3 Terms and definitions | “Terms and definitions given in ISO 9000:2015 apply”; no terms listed | 23 defined terms across 3.1 to 3.20: organization, interested party, top management, management system, quality management system, policy, quality policy, objective, quality objective, risk, process, competence, documented information, performance, continual improvement, effectiveness, requirement, conformity, nonconformity, corrective action, audit, measurement, monitoring | Changed (no new requirement, but the definitions now bind the text; note that 3.15 records “conformance” as deprecated) |
Clause 4 — Context of the organisation
| Reference | ISO 9001:2015 | ISO 9001:2026 | Label |
|---|---|---|---|
| 4.1 | External and internal issues; climate-change sentence added by Amd 1:2024 | Climate-change determination is now part of the base text; Notes 1 to 3 retained | Editorial for anyone already working to the 2024 amendment; New for anyone who never applied it |
| 4.2 a), b) | Interested parties and their relevant requirements | Unchanged | Editorial |
| 4.2 c) | — | The organisation must determine which of those requirements will be addressed through the QMS | New |
| 4.2 NOTE | Climate-related requirements of interested parties (Amd 1:2024) | Retained in the base text | Editorial |
| 4.3 | Scope: boundaries, applicability, justification for non-applicability, “available and maintained as documented information” | Same substance; wording now “available as documented information” | Editorial |
| 4.4.1 | Lead-in sentence plus items a) to h) | The lead-in “determine the processes needed and their application” becomes item a); the list runs a) to i) with identical content | Editorial |
| 4.4.2 | a) maintain documented information to support processes; b) retain documented information for confidence processes are carried out as planned | “Documented information shall be available to the extent necessary” a) to support operation; b) as evidence processes are carried out as planned | Editorial |
Clause 5 — Leadership
| Reference | ISO 9001:2015 | ISO 9001:2026 | Label |
|---|---|---|---|
| 5.1.1 list | Ten items a) to j), accountability listed first | Twelve items a) to l), accountability listed last; “engaging” dropped from the item on directing and supporting persons | Editorial (re-ordering) |
| 5.1.1 i) | — | Top management shall promote quality culture and ethical behaviour; NOTE 2 explains these are reflected in shared values, attitudes, practices and actions | New |
| 5.1.1 k) | Promote the process approach and risk-based thinking | Promote risk-based thinking and opportunity-based thinking (process approach now sits in j)) | Changed |
| 5.1.2 | Customer focus a) to c) | Unchanged | Editorial |
| 5.2.1 a) to d) | a) appropriate to the purpose and context of the organisation and supports its strategic direction; b) framework for objectives; c) commitment to applicable requirements; d) commitment to continual improvement | a) is now “appropriate to the purpose of the organisation”; b) to d) unchanged | Editorial |
| 5.2.1 e) | Context and strategic direction sat inside a) with the verb “appropriate to” | A separate item: the policy shall take into account the context of the organisation and support its strategic direction. Under Annex A.2 b) “take into account” means the context must be included in the decision, not merely considered | Changed (separated and strengthened) |
| 5.2.2 | a) available and maintained as documented information; b) communicated, understood and applied; c) available to relevant interested parties | Four items: a) available as documented information; b) communicated within the organisation; c) available to interested parties as appropriate; d) implemented, understood and applied | Changed (“implemented” is a new expectation of evidence) |
| 5.3 | Five assigned responsibilities a) to e); reporting on performance and on opportunities for improvement combined in one item | Six items a) to f): reporting on QMS performance (b) and reporting on opportunities for improvement (e) are now separate assignments | Changed |
Clause 6 — Planning
| Reference | ISO 9001:2015 | ISO 9001:2026 | Label |
|---|---|---|---|
| 6.1.1 | Determine risks and opportunities to a) give assurance, b) enhance desirable effects, c) prevent or reduce undesired effects, d) achieve improvement | Same four purposes re-ordered: a) assurance, b) prevent or reduce undesired effects, c) achieve continual improvement, d) enhance desired effects | Editorial |
| 6.1.2 | One sub-clause covering actions for risks and opportunities together: plan actions and how to integrate and evaluate them; actions proportionate to the potential impact on conformity of products and services | Risks only. The organisation shall determine, analyse and evaluate risks that can have an undesired effect on its ability to provide conforming products and services and enhance customer satisfaction; plan actions and how to integrate and evaluate them; actions proportionate to the potential impact on the intended results of the QMS. NOTE 1 names the ability to deliver during and after a disruption; NOTE 2 lists risk-treatment options | Changed (“analyse and evaluate” is new; the proportionality test is now about the QMS’s intended results) |
| 6.1.3 | — | Opportunities in their own sub-clause: determine, analyse and evaluate opportunities that can have a desired effect; plan actions and how to integrate and evaluate them; actions appropriate to the organisation’s context and supportive of desired results; NOTE gives examples (new practices, products, partnerships, technologies) | New |
| 6.2.1 | Seven characteristics a) to g) plus a separate sentence requiring documented information on the objectives | Eight items a) to h): the documented-information requirement is now item g); relevance to conformity and customer satisfaction moves from d) to h) | Editorial |
| 6.2.2 | Planning a) to e) | Unchanged | Editorial |
| 6.3 a), b), d) | Purpose and consequences; integrity of the QMS; allocation of responsibilities | Unchanged | Editorial |
| 6.3 c) | Availability of resources | Availability of resources and information | Changed |
| 6.3 e) | — | The communication of the changes | New |
| 6.3 f) | — | How the effectiveness of the changes will be monitored and evaluated | New |
| 6.3 g) | — | How the results of the changes will be reviewed | New |
Clause 7 — Support
| Reference | ISO 9001:2015 | ISO 9001:2026 | Label |
|---|---|---|---|
| 7.1.1, 7.1.2 | Resources; people | Unchanged | Editorial |
| 7.1.3 | Infrastructure; NOTE lists buildings, equipment, transport, ICT | Requirement unchanged; NOTE now opens “for all types of work (e.g. on site, remote or a combination thereof)” | Editorial (remote and hybrid work acknowledged) |
| 7.1.4 | Environment; NOTE lists social, psychological and physical factors | Requirement unchanged; NOTE adds that some factors can be influenced by the organisation’s quality culture and ethical behaviour | Editorial |
| 7.1.5.1, 7.1.5.2 | Monitoring and measuring resources; traceability | Unchanged in substance; “retain” wording replaced | Editorial |
| 7.1.6 | Knowledge shall be maintained and made available to the extent necessary | Knowledge shall be retained, applied and shared to the extent necessary; NOTE lists forms of knowledge including knowledge held in documented information, digital systems and other media | Changed |
| 7.2 | Competence a) to d), with d) being the record | a) to c) with the evidence requirement as a closing sentence; no change in substance | Editorial |
| 7.3 a) to d) | Policy; objectives; contribution; implications of non-conformance | Same four items (objectives moves to d)) | Editorial |
| 7.3 e) | — | Persons shall be aware of the organisational quality culture and ethical behaviour | New |
| 7.4 | Communication a) to e) | Unchanged | Editorial |
| 7.5.1 to 7.5.3 | Documented information | Unchanged in substance; the NOTE on the meaning of “access” and the protection of evidence from unintended alteration are retained | Editorial |
Clause 8 — Operation
| Reference | ISO 9001:2015 | ISO 9001:2026 | Label |
|---|---|---|---|
| 8.1 | Planning items a) to e), with e) covering documented information | Items a) to e) re-cut so that documented information sits in two separate sentences (confidence that processes were carried out as planned; evidence of conformity of products and services); control of planned and unintended changes and of externally provided processes retained | Editorial |
| 8.2.1 a) to d) | Product information; enquiries, contracts and orders; feedback and complaints; customer property | Unchanged | Editorial |
| 8.2.1 e) | Establishing specific requirements for contingency actions, when relevant | Providing information related to contingency actions, when relevant, including any related to disruptions to the provision of products or services; a new NOTE recognises websites, publications, social media, FAQs and training as customer-communication channels | Changed |
| 8.2.2 to 8.2.4 | Determining, reviewing and changing requirements | Unchanged (NOTE on internet sales retained) | Editorial |
| 8.3.1 | Design and development process | Requirement unchanged; new NOTE says the process can include cycles of review, verification, validation and feedback, allowing an iterative approach | Editorial (agile and iterative development explicitly accommodated) |
| 8.3.2 | Planning considerations a) to j) | Unchanged | Editorial |
| 8.3.3 | Inputs a) to e) | Requirement unchanged; new NOTE says inputs are not always fully defined at the start and can evolve through repeated cycles | Editorial |
| 8.3.4 to 8.3.6 | Controls, outputs, changes | Unchanged | Editorial |
| 8.4.1 to 8.4.3 | Externally provided processes, products and services | Unchanged | Editorial |
| 8.5.1 to 8.5.6 | Production and service provision | Unchanged (the 8.5.3 NOTE still names premises, intellectual property and personal data as customer property) | Editorial |
| 8.6, 8.7 | Release; nonconforming outputs | Unchanged | Editorial |
Clause 9 — Performance evaluation
| Reference | ISO 9001:2015 | ISO 9001:2026 | Label |
|---|---|---|---|
| 9.1.1, 9.1.2 | Monitoring, measurement, analysis and evaluation; customer satisfaction | Unchanged | Editorial |
| 9.1.3 | Seven evaluation outputs a) to g); e) covers effectiveness of actions on risks and opportunities together | Eight outputs a) to h): e) effectiveness of actions to address risks; f) effectiveness of actions to address opportunities | Changed |
| 9.2.1, 9.2.2 | Internal audit; programme | Unchanged in substance; NOTE to ISO 19011 retained | Editorial |
| 9.3.1 | Management review at planned intervals for suitability, adequacy, effectiveness and alignment with strategic direction | Unchanged | Editorial |
| 9.3.2 c) | — (changes in interested-party needs were not a separately named input) | Changes in needs and expectations of interested parties relevant to the QMS are a named input | New |
| 9.3.2 d) 1) to 7) | Performance and effectiveness trends 1) to 7) | Same seven trend topics | Editorial |
| 9.3.2 g), h) | One input: effectiveness of actions to address risks and opportunities | Two inputs: g) effectiveness of actions to address risks (6.1.2); h) effectiveness of actions to address opportunities (6.1.3) | Changed |
| 9.3.3 | Outputs: improvement opportunities, changes to the QMS, resource needs; records | Unchanged | Editorial |
Clause 10 — Improvement
| Reference | ISO 9001:2015 | ISO 9001:2026 | Label |
|---|---|---|---|
| 10.1 | “General”: determine and select opportunities for improvement; actions a) improving products and services to meet requirements and future needs and expectations, b) correcting, preventing or reducing undesired effects, c) improving performance and effectiveness of the QMS | Retitled “Continual improvement” and merged with the former 10.3. The organisation shall continually improve the suitability, adequacy and effectiveness of the QMS; shall consider the results of monitoring, measurement, analysis and evaluation and of management review to determine opportunities, and shall address them. Actions shall include a) improving processes, products and services; b) addressing future needs and expectations; c) correcting, preventing or reducing undesired effects | Changed (structure and emphasis; “processes” and “future needs” are now explicit action areas) |
| 10.2.1 | React, evaluate causes, implement, review effectiveness, update risks and opportunities, change the QMS | Unchanged; a new NOTE says customer complaints can be a source of nonconformities | Editorial |
| 10.2.2 | Records of nonconformities and corrective action results | Unchanged | Editorial |
| 10.3 | Continual improvement as a separate sub-clause | Deleted; content absorbed into 10.1. Clause 10 now has two sub-clauses only | Changed (renumber any procedure, checklist or audit report that cites 10.3) |
Annexes and Bibliography
| Reference | ISO 9001:2015 | ISO 9001:2026 | Label |
|---|---|---|---|
| Annex A | A.1 to A.8: clarification of the new structure, terminology and concepts introduced in 2015 | A.1 to A.10: one section per clause with clarifications of intent; A.2 clarifies six pairs of words that auditors and implementers misuse (appropriate vs applicable; consider vs take into account; continual vs continuous; ensure; “shall be available as documented information” vs “as evidence of”; strategic direction); A.3 sets out applicability | Changed (informative, so no new requirements, but A.2 is now the reference for interpreting the text) |
| Annex B | Other ISO/TC 176 quality-management standards | Removed | Changed |
| Bibliography | Reference list of related standards and guidance | 26 entries, cross-referenced from the NOTEs in Annex A; they now point users to ISO 10010 (quality culture), ISO/TS 10020 (organisational change management), ISO 30401 (knowledge management systems), ISO 30201 (human resource management systems) and the 2025 ISO 9000 Glossary, alongside the long-standing ISO 10000-series guidance, ISO 19011 and ISO 31000 | Editorial |
Editorial changes that are not new requirements
Four families of change look bigger than they are. First, the documented-information verbs. ISO 9001:2015 used “maintain” for documents and “retain” for records; ISO 9001:2026 uses “shall be available as documented information” for the first and “documented information shall be available as evidence of” for the second. Annex A.2 e) states that the second phrase refers to the retention of objective evidence. Nothing has been added to or removed from the list of documents and records the standard asks for; the full list, with clause references, is on the documented information page.
Second, the renumbering. Several lists have been re-ordered (5.1.1, 6.1.1, 6.2.1, 7.3), and Clause 10 has lost a sub-clause. Any checklist, procedure or audit report that quotes an item letter from the 2015 edition needs to be checked against the 2026 letters before it is reused.
Third, the new NOTEs. Remote work in 7.1.3, iterative design in 8.3.1 and 8.3.3, communication channels in 8.2.1, complaints as a source of nonconformity in 10.2.1, and the link between working environment and culture in 7.1.4 are all informative. They add no requirement, but they tell you how ISO/TC 176 expects the requirements to be read in 2026 operating conditions.
Fourth, Annex A. It is informative and explicitly “does not add to, subtract from or in any way modify” the requirements. It is also, from now on, the reference a certification auditor will use when you and they disagree about what a word means.
What has not changed
The scope and intent of the standard are the same. The process approach, the PDCA cycle and risk-based thinking remain the organising ideas (0.3). The seven quality management principles from ISO 9000 are unchanged. Clause 8 (Operation), which carries most of the day-to-day requirements for planning, customer requirements, design, purchasing, production, release and nonconforming outputs, is substantively identical. The standard still does not require a quality manual, documented procedures, a management representative or a formal risk-management methodology (A.6.1.2 says so directly). Certification is still to the requirements in Clauses 4 to 10; Annex A and the Bibliography are informative.
How big is the move, really?
For an organisation with a functioning ISO 9001:2015 system, the transition work concentrates in five places: the quality policy (5.2.1 e), 5.2.2 d)), the separation and evaluation of risks and opportunities (6.1.2, 6.1.3, with knock-on updates to 9.1.3 and 9.3.2), the planning-of-change method (6.3 e) to g)), organisational knowledge (7.1.6) and the new culture-and-ethics expectations (5.1.1 i), 7.3 e)). Of these, only the last needs elapsed time rather than desk work, because auditors will test it through interviews and observed behaviour rather than a document. In Sterling’s transition engagements the desk work for an established small or medium-sized system typically runs to a few consultant-days; the culture element runs for weeks because it involves leadership briefing, a defined route for raising concerns and induction content that people can repeat back. A neglected 2015 system, or one that never applied the 2024 climate amendment, will need more.
What auditors will do with this register
Expect five lines of questioning that were not in a 2015 audit. Auditors will ask staff, not managers, what the organisation expects of them in terms of doing the job right and behaving ethically (5.1.1 i), 7.3 e)). They will ask for the analysis and evaluation behind the risk register, and for a separate view of opportunities (6.1.2, 6.1.3). They will take a recent change and ask how it was communicated, how its effectiveness was monitored and how the results were reviewed (6.3 e) to g)). They will ask leadership how the policy supports the strategy (5.2.1 e)). And they will look for changes in interested-party expectations as a management review input (9.3.2 c)). None of these needs a new document; all of them need evidence.
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Frequently asked questions
Is ISO 9001:2026 published? Yes. ISO published the sixth edition on 16 September 2026. It cancels and replaces ISO 9001:2015 and incorporates Amendment 1:2024.
Does the clause structure change between ISO 9001:2015 and ISO 9001:2026? No. Clauses 1 to 10 keep their titles and order. Inside the clauses, 6.1 is now split into 6.1.1, 6.1.2 and 6.1.3, and Clause 10 has two sub-clauses (10.1 and 10.2) instead of three, because the former 10.3 has been merged into 10.1.
What is the biggest change from ISO 9001:2015 to 2026? The explicit requirement for top management to promote quality culture and ethical behaviour (5.1.1 i)), supported by an awareness requirement for everyone doing work under the organisation’s control (7.3 e)). It is the only change that cannot be met by desk work alone.
Does ISO 9001:2026 add new mandatory documents? No. The set of documents and records required by the standard is the same as in 2015; only the wording used to require them has changed.
Is climate change new in ISO 9001:2026? Not if you applied Amendment 1:2024, which added it to ISO 9001:2015 in February 2024. The 2026 edition simply carries the same sentences into the base text of 4.1 and 4.2. If your system was certified before 2024 and never updated, it is new for you.
Are opportunities now mandatory? They always were part of 6.1, but they were bundled with risks. Under 6.1.3 you must determine, analyse and evaluate opportunities and plan actions for them, then evaluate the effectiveness of those actions (9.1.3 f)) and review it in management review (9.3.2 h)).
Will my ISO 9001:2015 certificate still be valid? Yes, until 30 September 2029, the end of the three-year transition period set by Global ACI in Global ACI-TECH-3-TR 2029-09-30 (M), Transition Requirements for ISO 9001:2026. From 31 March 2028 new certifications can only be issued to the 2026 edition, and a 2015 certificate must be transitioned by a transition audit before the period ends. The transition deadline page carries every milestone.
Do I need to buy the standard? Yes, if you are implementing or transitioning. This page paraphrases the requirements and gives their references; it does not reproduce the standard, which is copyright ISO and available from ISO or the Bureau of Philippine Standards.
Read next
The ISO 9001:2026 playbook for the full transition picture; the transition checklist; quality culture and ethical behaviour in depth; a gap analysis against the ISO 9001:2026 standard; and Sterling Revise™, the fixed-scope transition service.
Sources
ISO 9001:2026, Quality management systems — Requirements, sixth edition, 2026-09 (ISO catalogue, stage 60.60, published 2026-09-16). ISO news release, 16 September 2026. ISO 9001:2015 and ISO 9001:2015/Amd 1:2024 for the comparison. Global ACI-TECH-3-TR 2029-09-30 (M), Transition Requirements for ISO 9001:2026 (version 1.0, issued 4 September 2026, published by Global ACI on 16 September 2026; verified on global-aci.org on 18 September 2026).
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