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-T10-T11: Monitor and measure product conformity to a risk-based extent, and operate production within specified limits with production risk controls implemented, monitored and evaluated

What does C6-T10-T11 require?

Product characteristic monitoring and measurement must be able to show conformity to requirements, with the type and extent of monitoring based on product risk. Production and service processes must be controlled, monitored and run within set limits and documented in realization records, and the risk controls identified for production must be implemented, monitored and evaluated for effectiveness. Australia: see the Annex 1 expectations for technical documentation. Clauses: ISO 13485:2016 7.1, 7.5.1, 8.1, 8.2.5, 8.2.6; TG(MD)R Sch 1 Pt 1 EP 2, Sch 3 Pt 1 cl 1.4(5)(b)(e); RDC 665/2022 Arts 18 to 20, 64, 83, 128, 131; MO169 Arts 26, 40, 54, 57 to 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.

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