MDSAP Audit Approach (MDSAP AU P0002)
Chapter 7: Purchasing – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C7-T1-T3: Plan purchasing (what to buy and outsource, requirements, records, resources, acceptance and risk management) and document procedures ensuring purchased product meets requirements

What does C7-T1-T3 require?

Purchasing planning must identify products to buy and processes to outsource, the requirements they must meet, purchasing documentation and record needs, resources, acceptance activities, and how risk management shapes supplier choice and buying, and documented procedures must ensure purchased product conforms to purchasing requirements. Clauses: ISO 13485:2016 4.1.2, 4.1.3, 4.1.5, 7.1, 7.4.1 to 7.4.3; TG(MD)R Sch 1 Pt 1 EP 2, Sch 3 Pt 1 cl 1.4(5)(d)(ii); RDC 665/2022 Arts 18 and 21; MO169 Arts 5-2, 5-3, 5-5, 26, 37 to 39.

Maintained by Gerard Blokdyk

Other controls in Chapter 7: Purchasing – 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.

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