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-T25: Review customer requirements before committing to supply, and keep the distribution records regulators require (consignee, product, quantity, date and control numbers; Canadian retention for device life or two years)

What does C6-T25 require?

Customer requirements, including purchase order terms, must be reviewed before committing to supply, and the distribution records regulators require must be kept. Australia: sponsors carry distribution-record duties as conditions of ARTG inclusion and may specify, as customers, what the manufacturer must provide (ISO 13485:2016 7.2.1(a)). Brazil: records must include or reference the consignee's name and address, product identification and quantity shipped, dispatch date and any control numbers used (RDC 665/2022 Art 112). Canada: records must allow complete and rapid withdrawal and be kept retrievable for the longer of the device's projected useful life and two years after shipment (CMDR 52 to 56). Clauses: ISO 13485:2016 4.2.1, 5.2, 7.2.2, 7.5.9; MO169 Arts 6, 11, 28, 48, 49.

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.

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