Maps to
FDA QMSR (Part 820): §820.50
ISO 13485: ISO 13485 §7.4
Requirement text
The organization shall evaluate and select suppliers based on their ability to supply product meeting requirements. Criteria for selection, evaluation, and re-evaluation shall be established. FDA-Plus: Purchasing controls must include quality agreements defining quality requirements. Verification of purchased product must be documented. Supplier performance must be monitored and re-evaluated at defined intervals.
Atomic constraints
- •Supplier evaluation and selection criteria must be documented.
- •An approved supplier list must be maintained.
- •Purchasing data must adequately describe the product ordered.
- •Verification of purchased product must be performed and documented.
- •Quality agreements must define quality requirements for critical suppliers.
- •Supplier performance must be monitored and re-evaluated periodically.
Evidence signals
- •
FILE_EXISTS
(Supplier|ASL|Approved.*Supplier|Vendor|Purchasing|Quality.*Agreement)
- •
CONTENT_MATCH
Does this document describe supplier evaluation criteria, approved supplier management, purchasing controls, incoming inspection, and supplier re-evaluation procedures?
Audit defense
Supplier management for [your product] is controlled through [your document ID]. All suppliers on our ASL have been evaluated against defined criteria, with quality agreements in place for critical suppliers. Incoming inspection results and supplier performance metrics drive periodic re-evaluation.