ISO 9001:2026: What changes with the new version?

What changes with ISO 9001:2026?

ISO 9001:2026 does not change the basic logic of quality management, but it sharpens several requirements: top management must promote quality culture and ethical behaviour, risks and opportunities are considered separately, changes to the QMS must be planned in a more structured way, and the 2024 climate amendment is now a fixed part of the standard. Certified companies have until 30 September 2029 to transition.

The new edition was published on 16 September 2026 and replaces ISO 9001:2015, including the climate change amendment. The clause structure continues to follow the Harmonized Structure, which also underpins other management system standards such as ISO 27001. If you have maintained your QMS properly under the 2015 edition, you don’t need to rebuild it – you need to make targeted additions.

For an overview of all clauses, see our article ISO 9001 requirements for companies.

The key changes at a glance

Quality culture and ethical behaviour as a leadership responsibility

The most visible change: top management must actively promote quality culture and ethical behaviour (Clause 5.1.1). The topic also appears in employee awareness (7.3) and in the environment for the operation of processes (7.1.4).

In practice, this means quality can no longer be left solely to the quality manager. Auditors will look at how management demonstrates quality and integrity, for example through clear communication, training, an open approach to errors and codes of conduct.

Risks and opportunities are considered separately

Clause 6.1 has been restructured. Instead of treating risks and opportunities together, the standard now distinguishes between risks (6.1.2) and opportunities (6.1.3) and requires separate actions for each. The standard still does not require a formal risk management system according to ISO 31000.

For your QMS, this means: check whether your risk matrix has so far only touched on opportunities. Opportunities – such as new technologies, markets or process improvements – should be assessed in their own right and backed by actions.

Planning changes to the QMS in a more structured way

The requirements for planning changes (Clause 6.3) have been strengthened. Companies must not only plan changes to the QMS, but also communicate them, monitor their implementation and evaluate their effectiveness. This applies, for example, to new sites, new software, restructuring or changed processes.

Further adjustments

• Quality policy and strategy: The quality policy, objectives and actions should be more explicitly aligned with the long-term strategy.
• Organisational knowledge: Clause 7.1.6 is broader and linked to the intended results of the QMS.
• Internal audits: Audit objectives must now also be defined for the audit programme.
• Terms: Some terms now sit directly in the standard, aligned with the Harmonized Structure and ISO 9000:2026.
• Annex A: The guidance has been expanded to around 15 pages and explains clauses 4 to 10. It contains no additional requirements but helps with interpretation.

What does not change

In the run-up, there was a lot of speculation about artificial intelligence, digitalisation, sustainability and supply chains. The published standard contains no new specific requirements on these topics:

• No AI or digitalisation obligations: The standard remains technology-neutral. The use of AI or digital tools only needs to be considered where it is relevant to risks, opportunities or processes.
• No expanded sustainability requirements: Beyond the climate amendment in 4.1 and 4.2, there are no ESG requirements.
• No new supply chain clauses: The control of external providers (Clause 8.4) remains essentially unchanged.
• Same structure: Clauses 4 to 10 and the PDCA cycle remain in place.

Transition period: when do you need to switch?

• 16 September 2026: publication of ISO 9001:2026.
• Three-year transition period: certificates to ISO 9001:2015 remain valid until 30 September 2029. The binding transition rules are set by the international accreditation organisation.
• Transition audit: the transition usually takes place during a regular surveillance or recertification audit.
• New certifications: certification bodies first have to extend their accreditation to the new edition. Ask early when audits to ISO 9001:2026 will be available.

Checklist: how to prepare for the transition

1. Obtain the standard and carry out a gap analysis: compare your QMS clause by clause with the new edition.
2. Embed quality culture: define how management promotes quality culture and ethical behaviour, and include the topic in training.
3. Separate risks and opportunities: adapt your risk matrix and assess opportunities with their own actions.
4. Review your change process: make sure changes to the QMS are planned, communicated, monitored and evaluated.
5. Align quality policy and objectives: check the link to the company strategy.
6. Extend the audit programme: define audit objectives for internal audits.
7. Plan the transition audit: agree with your certification body in which audit the transition will take place.

Conclusion: evolution, not a fresh start

ISO 9001:2026 is an evolution of the 2015 edition. The biggest changes concern the role of leadership, the separation of risks and opportunities and the management of change. If you have maintained your QMS, a targeted gap analysis and a few adjustments will get you through the transition – and you have until the end of September 2029 to do it.

With the heyData compliance platform, you analyse the gaps to the new edition, adapt policies in a structured way and collect all evidence centrally.

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