Maps to
FDA QMSR (Part 820): §820.198 / 820.100
ISO 13485: ISO 13485 §7.2
Requirement text
Product-related requirements must be determined — including customer requirements, statutory and regulatory requirements, and any additional requirements. Requirements must be reviewed before committing to supply. Customer communication processes must be established, including procedures for advisory notices and field safety corrective actions.
Atomic constraints
- •Customer and regulatory requirements for each product must be determined and documented.
- •Requirements must be reviewed before committing to supply and records maintained.
- •Customer communication processes must be established including for complaints and feedback.
- •Procedures for advisory notices and field safety corrective actions (FSCA/recalls) must be documented.
- •Records of contract or order review must be maintained.
Evidence signals
- •
FILE_EXISTS
(Advisory.*Notice|Field.*Safety|FSCA|Recall.*Procedure|Customer.*Requirement|Order.*Review)
- •
CONTENT_MATCH
Does this document describe customer requirements review, advisory notice procedures, recall procedures, or field safety corrective action communication?
Audit defense
Customer requirements and communication for [your product] are managed per [your document ID]. Product requirements are reviewed before commitment to supply, and procedures for advisory notices and field safety corrective actions define our communication process to customers and regulatory authorities per ISO 13485 7.2.