Maps to
FDA QMSR (Part 820): §820.20
ISO 13485: ISO 13485 §5.3
Requirement text
Top management shall ensure the quality policy includes a commitment to comply with requirements and maintain QMS effectiveness.
Atomic constraints
- •Quality policy must be documented
- •Policy must include commitment to compliance
- •Quality objectives must be established
- •Policy must be communicated and understood
Evidence signals
- •
FILE_EXISTS
(Quality.*Policy|Quality.*Objective|Quality.*Manual)
- •
CONTENT_MATCH
Does this document state a quality policy, quality objectives, or management commitment to compliance?
Audit defense
Our quality policy is documented in [your document ID]. The policy includes an explicit commitment to comply with applicable requirements and maintain QMS effectiveness. Quality objectives are established, communicated to all personnel, and reviewed at management review per ISO 13485 5.3.