ISO 9001:2026 vs 2015: Clause-by-Clause Comparison

The ISO 9001:2026 Draft International Standard (DIS) was published August 2025. Final publication is projected for September 2026, with a three-year transition deadline around September 2029. Every organisation certified to ISO 9001:2015 must transition or lose certification.

This ISO 9001:2026 vs 2015 comparison covers the changes clause by clause. For the interactive version, use the clause comparison tool. For broader strategic context, read our pillar guide on the ISO 9001:2026 revision.

Five overarching changes

1. New 15-page Annex A. Unprecedented for ISO 9001. Provides non-normative interpretation guidance on risk-based thinking, documented information, externally provided processes, and organisational knowledge. Auditors will reference it.

2. Climate change in Clause 4.1. Per the ISO London Declaration (September 2021) and Annex SL Amendment 1 (February 2024), you must determine whether climate change is a relevant external issue. Even if your conclusion is "not material," you must document the assessment.

3. Expanded organisational knowledge (7.1.6). How you identify, capture, share, and protect knowledge needed for your processes — directly addressing key-person risk.

4. Digitalisation acknowledged. The standard remains technology-neutral but explicitly recognises digital tools, data-driven decisions, and cloud-based workflows as part of modern quality management.

5. Updated Annex SL alignment. The high-level structure shared by all ISO management system standards was revised in 2023. This means ISO 9001, 14001, 45001, and 27001 share even more common text — beneficial if you run an integrated system.

Clause-by-clause comparison

Clause 4 — Context of the organisation

Sub-clause	2015	2026 DIS change
4.1	Determine external/internal issues	Must now explicitly consider climate change
4.2	Determine interested parties	Must monitor for changes in requirements — not a one-off exercise
4.3	Define QMS scope	Minor clarifications
4.4	QMS processes	Stronger emphasis on process interactions, per-process risks, and knowledge requirements

Transition effort: Low to moderate. Add climate change consideration; review process interaction documentation.

Clause 5 — Leadership

Sub-clause	2015	2026 DIS change
5.1	Leadership and commitment	Clearer that top management cannot fully delegate QMS accountability
5.2	Quality policy	Minor wording updates for sustainability alignment
5.3	Roles and authorities	Must assign responsibility for organisational knowledge (7.1.6)

Transition effort: Low. If your MD is already engaged, minimal work needed.

Clause 6 — Planning

Sub-clause	2015	2026 DIS change
6.1	Risks and opportunities	More explicit methodology expectations — informal approaches no longer sufficient
6.2	Quality objectives	Clearer measurability requirements with defined measurement frequencies
6.3	Planning of changes	Must cover technology-driven changes (ERP migration, cloud adoption)

Transition effort: Moderate. Risk methodology documentation is the biggest item. Our gap analysis checklist covers what Clause 6.1 evidence auditors expect.

Clause 7 — Support

Sub-clause	2015	2026 DIS change
7.1.6	Organisational knowledge	Significantly enhanced — must identify, capture, share, and protect process knowledge
7.2	Competence	Updated for digital competencies (data analysis, software proficiency)
7.5	Documented information	Explicitly acknowledges cloud systems and digital workflows

Transition effort: Moderate to high. If you rely on experienced staff teaching newcomers verbally, you will need to formalise knowledge capture. Document critical processes. Create handover procedures. Identify single points of failure.

Clause 8 — Operation

Sub-clause	2015	2026 DIS change
8.1	Operational planning	Better integration with Clause 6 risk-based thinking
8.4	External providers	Enhanced oversight of externally provided processes — not just products. Outsourced design, testing, or logistics gets more scrutiny.
8.5	Production/service provision	Minor clarifications on post-delivery activities

Transition effort: Low to moderate. If your supplier management already includes ongoing monitoring, you are close.

Clause 9 — Performance evaluation

Sub-clause	2015	2026 DIS change
9.1	Monitoring and analysis	Greater emphasis on using data to drive decisions, not just collecting it
9.2	Internal audit	Clearer expectations for audit frequency, methods, and auditor competence. Your internal audit checklist should reflect these.
9.3	Management review	Climate/sustainability joins the required inputs list. Must review performance trends, not just current-period data.

Transition effort: Low for most well-run systems.

Clause 10 — Improvement

Sub-clause	2015	2026 DIS change
10.2	Corrective action	Stronger link to organisational learning — apply lessons across related processes, not just the one that failed
10.3	Continual improvement	Acknowledges innovation alongside traditional improvement

Transition effort: Low.

What to do now

Already certified to 2015:

1. Run a gap analysis using the clause comparison tool and our gap analysis checklist
2. Prioritise: knowledge management (7.1.6), climate consideration (4.1), risk methodology (6.1)
3. Book your transition audit early — during the ISO 27001:2022 transition, UKAS-accredited body slots filled 6-12 months ahead
4. Update your quality manual once the final standard publishes

Pursuing first-time certification:

Wait for the 2026 edition if you do not need certification before late 2026. Otherwise, certify to 2015 but build with the DIS in mind. Use the cost estimator to model either scenario. If also considering ISO 27001, the controls checklist helps you assess the information security side in parallel.

Practical takeaway checklist

1. The revision is evolutionary — your existing QMS provides 60-70% of the foundation
2. Three biggest changes: knowledge management (7.1.6), climate change (4.1), risk methodology (6.1)
3. Annex A is new and will shape auditor interpretation — read it when published
4. Plan your transition audit for 2027-2028 to avoid the 2029 deadline rush
5. Budget for the standard (from BSI), transition training, and documentation restructuring
6. Start your gap analysis now using the clause comparison tool

This article is for general informational purposes only and does not constitute legal, regulatory, or professional compliance advice. ISO certification requirements vary by scope, sector, and certification body. Always verify requirements with your UKAS-accredited certification body or a qualified consultant before making compliance decisions.