Maps to
FDA QMSR (Part 820): §820.30(i)
ISO 13485: ISO 13485 §7.3.8 / 7.3.9
Requirement text
Design changes shall be identified, reviewed, verified, validated as appropriate, and approved before implementation.
Atomic constraints
- •Design changes must be identified and documented
- •Impact of changes must be assessed
- •Changes must be reviewed and approved before implementation
- •Change records must be maintained
Evidence signals
- •
FILE_EXISTS
(Design.*Change|Change.*Control|Change.*Order|ECO|ECN)
- •
CONTENT_MATCH
Does this document describe a process for managing design changes, impact assessment, or change approval?
Audit defense
Design change control for [your product] is governed by [your document ID]. All design changes are documented via an engineering change order, assessed for impact, and reviewed and approved before implementation per QMSR 820.30(i).