Maps to
FDA QMSR (Part 820): §820.20
ISO 13485: ISO 13485 §5.6
Requirement text
Top management shall review the organization's quality management system at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives.
Atomic constraints
- •Management reviews must be conducted at planned intervals.
- •Review inputs must include audit results, customer feedback, process performance, CAPA status, and changes that could affect the QMS.
- •Review outputs must include decisions on QMS improvement, resource needs, and updated requirements.
- •Records of management reviews must be maintained.
Evidence signals
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FILE_EXISTS
(Management.*Review|MR.*Minutes|QMS.*Review)
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CONTENT_MATCH
Does this document record a management review of the QMS including audit results, CAPA trends, customer feedback, and resource decisions?
Audit defense
Management reviews for our QMS are documented in [your document ID]. Each review follows a structured agenda covering all ISO 13485 §5.6.2 inputs, with documented decisions on resource allocation and QMS improvements traceable to subsequent actions.