MDSAP Audit Approach (MDSAP AU P0002) C7-T10-T11: Verify purchased product to a risk-appropriate combination of supplier controls, purchase requirements and acceptance, keep verification records, hold material until verified (Brazil), and use purchasing data as quality data

What does C7-T10-T11 require?

Verification of purchased product (inspection or other activities) must be enough to show requirements are met, using a combination of supplier controls, purchase requirements and acceptance activities proportionate to the risk that supply creates for the finished device, with records kept. Brazil: components, raw materials, in-process and returned product must stay in quarantine until the required inspections, tests or verifications are completed and documented (RDC 665/2022 Art 91). Data from supplier evaluation, verification and purchasing must feed measurement, analysis and improvement. Clauses: ISO 13485:2016 4.2.1, 7.1, 7.4.3, 8.4; TG(MD)R Sch 1 Pt 1 EP 2, Sch 3 cl 1.4(5)(e); RDC 665/2022 Arts 22, 41, 42, 89, 120; MO169 Arts 6, 26, 39, 61.