Maps to
FDA QMSR (Part 820): §820.20(d)
ISO 13485: ISO 13485 §7.1
Requirement text
Processes needed for product realization must be planned and developed. Planning must determine quality objectives and requirements, product-specific processes and documentation, required verification and validation activities, acceptance criteria at each stage, and records needed to provide evidence of conformity.
Atomic constraints
- •Quality objectives and requirements for each product must be planned and documented.
- •Required processes, documentation, and resources for product realization must be determined.
- •Verification, validation, monitoring, and inspection activities must be planned.
- •Acceptance criteria for each stage must be defined.
- •Records needed to provide evidence of conformity must be identified.
Evidence signals
- •
FILE_EXISTS
(Quality.*Plan|Product.*Realization|Development.*Plan|Project.*Quality)
- •
CONTENT_MATCH
Does this document define product-specific quality objectives, required processes, verification activities, and acceptance criteria for product realization?
Audit defense
Product realization for [your product] is planned in [your document ID]. The quality plan defines product-specific objectives, required processes and documentation, verification and validation activities, acceptance criteria, and required records per ISO 13485 7.1.