Purchasing and Supplier Controls
Purchasing and supplier controls ensure that externally provided products and services that affect device quality are controlled (ISO 13485:2016 Section 7.4).
Key requirements
- Approved supplier list (ASL) — maintained list of suppliers evaluated and approved
- Supplier evaluation criteria — defined criteria based on the supplier's ability to meet requirements
- Purchasing information — purchasing documents specify requirements clearly
- Verification of purchased product — incoming inspection or other verification activities
- Supplier monitoring — ongoing monitoring of supplier performance (re-evaluation at defined intervals)
- Critical suppliers — higher controls for suppliers of critical components or services
Special focus: sterile device manufacturers
For sterile devices, sterilisation service providers are treated as critical suppliers requiring more rigorous evaluation and monitoring.