ConfirmedISO 9001:2026 publishes 16 September 2026. FDIS approved 7 August 2026.What it means →
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ISO 9001: 2015 vs 2026

Every clause of ISO 9001, compared across the two editions. 8 clauses changed in substance and have a full side-by-side breakdown; the remaining 41 carried over, and are listed here so you can see at a glance that nothing was missed.

Cut against the approved final draft — not a guess

ISO/TC 176/SC 2 approved ISO/FDIS 9001 on 7 August 2026 and fixed publication at 16 September 2026. The clause numbering and text are frozen at this stage, so this comparison is built on what the standard will actually say — not on an early draft that still moves. See the dated update.

Changed in 2026 — 8 clauses

3Terms and definitions

A selection of core QM terms is defined inside clause 3 itself; ISO 9000 stays as the full vocabulary. 'Opportunity' remains undefined in both.

4.1Understanding the organisation and its context

Same requirement, plus: determine whether climate change is a relevant issue and record a conclusion either way (already in force via the 2024 amendment).

4.2Understanding the needs and expectations of interested parties

Same, with explicit recognition that parties can have climate-related requirements — considered and captured where real (in force via the 2024 amendment).

5.1.1Leadership and commitment — general

The list now explicitly includes promoting a quality culture and ethical behaviour, with a light evidence trail expected.

6.1Actions to address risks and opportunities

Restructured: risk and opportunity are documented and pursued distinctly; 'opportunity-based thinking' arrives alongside risk-based thinking. 'Opportunity' itself remains undefined — define it yourself.

6.3Planning of changes

Same, plus plan up front: communication of the change, monitoring and evaluation of its effectiveness, and review of its results — the loop closes.

7.3Awareness

Extended to the quality-culture and ethical-behaviour expectations of 5.1.1 — the culture requirement reaches the whole workforce.

Annex AGuidance on the use of this standard (new, informative)

A new informative Annex A gives clause-by-clause application guidance for clauses 4–10 — no new requirements, but it will steer auditor interpretation.

Carried over unchanged — 41 clauses

Carried over — determining the scope of the QMS is unchanged in substance. Verify wording at publication.

Carried over — the process approach and QMS requirements are unchanged; the process model remains the backbone. Verify wording at publication.

Carried over — customer focus unchanged in substance; note the adjacent 5.1.1 culture/ethics addition colours leadership interviews. Verify at publication.

Carried over — policy requirements unchanged; a policy referencing culture/ethics commitments will read naturally against the new 5.1.1 but is not required. Verify at publication.

Carried over — roles, responsibilities and authorities unchanged in substance. Verify at publication.

Carried over — quality objectives and planning unchanged in substance; objectives arising from distinctly-managed opportunities (new 6.1) are a natural link auditors may follow. Verify at publication.

Carried over — resources and people requirements unchanged in substance. Verify at publication.

Carried over — infrastructure unchanged in substance. Verify at publication.

Carried over — process environment unchanged in substance. Verify at publication.

Carried over — monitoring and measuring resources unchanged in substance. Verify at publication.

Carried over — organisational knowledge unchanged in substance. Verify at publication.

Carried over — competence requirements unchanged in substance; competence for newly-planned changes (strengthened 6.3) is the practical link. Verify at publication.

Carried over — communication unchanged in substance; note new 6.3 explicitly expects change communication to be planned. Verify at publication.

Carried over — documented information philosophy ('keep what you need') carries straight over from 2015. Verify at publication.

Carried over — operational planning and control substantively unchanged; clause 8 sees only minor wording tweaks across the board. Verify at publication.

Carried over — customer communication unchanged in substance; climate-related customer requirements (4.2) may surface here in practice. Verify at publication.

8.2.2–8.2.4Clause 8.2.2–8.2.4

Carried over — requirements determination and review unchanged in substance. Verify at publication.

Carried over — design and development planning unchanged in substance. Verify at publication.

Carried over — design inputs unchanged in substance. Verify at publication.

Carried over — design controls unchanged in substance. Verify at publication.

Carried over — design outputs unchanged in substance. Verify at publication.

Carried over — design changes unchanged in substance; the strengthened 6.3 loop is the adjacent discipline. Verify at publication.

Carried over — control of external providers unchanged in substance. Verify at publication.

Carried over — type and extent of control unchanged in substance. Verify at publication.

Carried over — information for external providers unchanged in substance. Verify at publication.

Carried over — control of production and service provision unchanged in substance. Verify at publication.

Carried over — identification and traceability unchanged in substance. Verify at publication.

Carried over — property of customers/external providers unchanged in substance. Verify at publication.

Carried over — preservation unchanged in substance. Verify at publication.

Carried over — post-delivery activities unchanged in substance. Verify at publication.

Carried over — control of (production) changes unchanged in substance, but read together with the strengthened 6.3: the effectiveness-and-review discipline now runs through both. Verify at publication.

Carried over — release of products and services unchanged in substance. Verify at publication.

Carried over — control of nonconforming outputs unchanged in substance. Verify at publication.

Carried over — monitoring and measurement unchanged in substance. Verify at publication.

Carried over — customer satisfaction unchanged in substance. Verify at publication.

Carried over — analysis and evaluation unchanged in substance. Verify at publication.

Carried over — internal audit unchanged in substance; scope your transition audits to cover the five changed areas. Verify at publication.

Carried over in structure — management review unchanged in substance; expect inputs to exercise the new ground (climate in context, culture signals, effectiveness of actions on risks AND opportunities, change reviews per 6.3). Verify input list wording at publication.

Carried over — improvement (general) unchanged in substance; distinctly-managed opportunities (6.1) feed it more visibly. Verify at publication.

Carried over — nonconformity and corrective action unchanged in substance. Verify at publication.

Carried over — continual improvement unchanged in substance. Verify at publication.

49 clauses covered in total.

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Based on the approved final draft of ISO 9001:2026 (ISO/FDIS 9001, approved 7 August 2026). Qlause provides interpretive guidance only and is not a substitute for the standard — refer to your licensed copy of ISO 9001:2026 for the authoritative text.