MDSAP Audit Approach (MDSAP AU P0002)
Chapter 6: Production and service controls – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C6-T21: Carry out and document acceptance activities for every incoming item and service, to an extent matched to the device risk, with statistically valid sampling for Brazil

What does C6-T21 require?

Acceptance activities must ensure conformity to specifications and be documented, covering every incoming component, sub-assembly or service whatever the commercial relationship with the supplier, with their extent matched to the device risk. Brazil: sampling plans must rest on a valid statistical rationale, with procedures keeping sampling methods fit for purpose and reviewed regularly in light of nonconformities, audits and complaints (RDC 665/2022 Arts 132 to 134). Clauses: ISO 13485:2016 4.2.1, 7.4.3, 7.5.8, 8.2.6; TG(MD)R Sch 1 Pt 1 EP 2, Sch 3 Pt 1 cl 1.4(5)(d); RDC 665/2022 Arts 88 to 90, 131; MO169 Arts 6, 39, 47, 58, 59.

Maintained by Gerard Blokdyk

Other controls in Chapter 6: Production and service controls – MDSAP Audit Approach (MDSAP AU P0002)

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll MDSAP Audit Approach (MDSAP AU P0002) controls