Maps to
FDA QMSR (Part 820): §820.80 / 820.86
ISO 13485: ISO 13485 §8.2.4 / 7.4.3
Requirement text
Receiving acceptance activities shall be established. In-process acceptance activities shall be established. Finished device acceptance criteria and procedures shall be established. Only devices that have passed all required acceptance activities shall be released for distribution. Records of acceptance activities shall be maintained.
Atomic constraints
- •Receiving inspection procedures and acceptance criteria must be documented for incoming components and materials.
- •In-process inspection and test procedures must be established at defined production stages.
- •Finished device acceptance procedures and acceptance criteria must be documented.
- •Product shall not be released until all required acceptance activities are satisfactorily completed.
- •Acceptance records must identify the inspector and the acceptance criteria used.
- •Rejected or quarantined items must be identified and controlled per the nonconforming product procedure.
Evidence signals
- •
FILE_EXISTS
(Receiving.*Inspection|Incoming.*Inspection|Acceptance.*Procedure|Final.*Release|Finished.*Device.*Acceptance|In.Process.*Inspection|Release.*Checklist)
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CONTENT_MATCH
Does this document describe acceptance testing, receiving inspection, in-process inspection, finished device release criteria, or product release authorization procedures?
Audit defense
Acceptance activities for [your product] are documented in [your document ID]. Receiving inspection verifies incoming components against specifications before use. In-process inspections at defined production stages verify conformity throughout manufacturing. Finished device release is authorized only after review of all acceptance records per QMSR 820.80.