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-T19-T20: Identify product status so only product that passed inspection is dispatched, used or installed, and identify, verify, protect and safeguard customer property including patient and confidential health information

What does C6-T19-T20 require?

Product status identification must make sure nothing is dispatched, used or installed unless it has cleared the inspections and tests it needs. Customer property supplied for use or incorporation, including intellectual property and patient or confidential health information, must be identified, verified, protected and safeguarded. Clauses: ISO 13485:2016 7.5.8, 7.5.10; RDC 665/2022 Arts 108, 113; MO169 Arts 47, 51.

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