WHO: Draft Revision of its Guidelines on Quality Risk Management
WHO published a revised draft of its “WHO guidelines on quality risk management”. Working document QAS/26.994 is open for public comment until 15 November 2026.
The revision focuses on alignment with ICH Q9(R1). New sections address reducing subjectivity and risk-based decision-making. Knowledge management, transparent decision criteria and documented assumptions receive greater emphasis. The draft also clarifies the degree of formality and the planning of risk reviews.
The lifecycle approach, integration of QRM into the quality system and risk-based inspections were already included in the 2013 guidelines. The revision therefore builds on established principles.
Possible adoption is scheduled for October 2027; the document remains a consultation draft.
Source:
WHO: Draft working document for comments: WHO guidelines on quality risk management
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