How does ISO 9001:2026 change the treatment of risks and opportunities?

ISO 9001:2026 splits clause 6.1 into 6.1.1 to 6.1.3 so that risks and opportunities are determined, evaluated and acted on separately. Performance evaluation and management review must look at the effectiveness of actions on each. One planning tool can still cover both; two registers are not required.

Under ISO 9001:2015, clause 6.1 handled risks and opportunities in a single requirement, and many organizations treated opportunities as an afterthought on a risk register. ISO 9001:2026 separates them into subclauses 6.1.1 to 6.1.3, makes analysis and evaluation explicit, and expects leadership to promote opportunity-based thinking alongside risk-based thinking.

The change carries through the system. Performance evaluation and management review now distinguish the effectiveness of actions taken on risks from actions taken on opportunities, so a review agenda that reports only on risk treatment leaves a gap. The expanded informative Annex A gives guidance on applying the clause but adds no requirements.

The standard does not prescribe a method, a scoring model or separate registers. One planning tool is enough as long as it shows that opportunities were identified and evaluated in their own right and that the resulting actions were followed up. The common transition fix is to add an opportunity stream with its own evaluation and review fields, then feed both streams into management review.

Actions on opportunities often change processes, which brings in the expanded planning of changes in clause 6.3. See all ISO 9001:2026 clause changes for how this fits the wider revision.

Related Information

  • Clause 6.1 split into 6.1.1 to 6.1.3
  • Analysis and evaluation made explicit
  • Opportunity-based thinking promoted by leadership
  • Management review assesses actions on risks and opportunities separately
  • One planning tool allowed; no second register required

“An opportunity register with nothing in it is a finding waiting to happen. Auditors will ask what you decided not to pursue, and why.”

Browse all FAQs →

Full knowledge base

We use cookies to improve your experience

Necessary cookies are always active. You can accept, reject non-essential cookies, or customize your preferences.