ISO13485 - 7.4.3 Verification of purchased product

7.4.3 Verification of purchased product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

Records of the verification shall be maintained (see 4.2.4).

Examples of verification

• Incoming inspection
  • 100% full inspection or
  • based on sampling plan (AQL) Acceptance Quality Limit as defined in ISO 2859-1
  • First article inspection or ….
  • Material certificates: evidence of conformity to supplier release tests
• Who has put the inspection flag on? And how is it un-flagged?
• Always again risk based
• What happens if does not conform? Corrective actions?

• Is the verification independent from assembly personnel?