Which clauses changed in ISO 9001:2026?

ISO 9001:2026 changes clauses 4.2, 5.1.1, 6.1, 6.3, 7.1.4, 7.1.6, 7.3, parts of clause 8, 9.2.2, 9.3.2 and 10.1. The biggest shifts are quality culture and ethical behavior, separate handling of risks and opportunities, expanded planning of changes and broader organizational knowledge. The process approach and PDCA are unchanged.

The revision is moderate. The process approach, customer focus, PDCA and the clause structure carry over from ISO 9001:2015, and the 2024 climate amendment is folded into the new text. What changes is the depth of several requirements, and those are the places a certification body will probe at your transition audit.

In leadership and support, clause 5.1.1 now requires top management to promote quality culture and ethical behavior, and the theme reappears in 7.1.4 on the environment for operating processes and in 7.3 on awareness. Clause 7.1.6 widens organizational knowledge from what is needed to deliver products and services to what the whole QMS needs to achieve its results, and makes retaining, applying and sharing that knowledge explicit.

In planning, clause 6.1 is split into 6.1.1 to 6.1.3 so that risks and opportunities are determined and addressed separately, and clause 6.3 extends planning of changes to communicating the change, monitoring it and reviewing its results. Clause 4.2 asks you to decide which relevant requirements of interested parties the QMS will address, and 9.3.2 adds changes in those needs to management review inputs.

In operation and evaluation, clause 8.2 adds communication of contingency actions to customers and evidence that changed requirements were reviewed and passed on, 8.5.1 stresses current instructions at the point of use, and 8.3 refines design and development inputs and outputs. Clause 9.2.2 requires an objective for every internal audit, and continual improvement is consolidated in 10.1. Clause 3 now lists the harmonized structure terms, and the informative Annex A is expanded but adds no requirements. For the timeline and business context, see our ISO 9001:2026 guide.

Related Information

  • 5.1.1, 7.1.4, 7.3: quality culture and ethical behavior
  • 6.1.1 to 6.1.3: risks and opportunities handled separately
  • 6.3: planning of changes through to results
  • 7.1.6: organizational knowledge for the whole QMS
  • 4.2 and 9.3.2: interested party requirements and review inputs
  • 9.2.2: an objective for every internal audit

“Most quality systems already do half of what the new clauses ask. The work is proving it with records an auditor can sample, and closing the half you don't.”

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