2. What are the new requirements?
The truly new requirement concerns the explicit separation of risks (§ 6.1.2) and opportunities (§ 6.1.3), each introduced by a requirement with the same sentence structure.
“The organization shall identify, analyze, and evaluate risks (and opportunities, respectively) that may have an undesirable (or desirable, respectively) effect on its ability to consistently and continuously provide conforming products and services and to improve customer satisfaction.”
This wording of the requirement specifies the minimum framework for addressing risks and opportunities, focusing on:
the conformity of products and services;
increasing customer satisfaction.
Note the consistency with the scope of ISO 9001.
Furthermore, the 2026 version clarifies the necessary link between implementing actions...
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What are the new requirements?
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