MDSAP Audit Approach (MDSAP AU P0002)
Chapter 3: Measurement, analysis and improvement – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C3-T2: Identify and analyse all relevant quality data sources under a documented procedure, using valid statistical methods where appropriate

What does C3-T2 require?

The organisation must identify the sources of quality data and analyse them under a documented procedure, using valid statistical techniques where appropriate, as input to measurement, analysis and improvement: complaints and other customer feedback, service and returns data, internal and external audit results, findings from regulatory inspections, and monitoring data on products, processes, nonconforming product and suppliers. Clauses: ISO 13485:2016 7.5.4, 8.1, 8.2.1, 8.2.6, 8.4; TG(MD)R Sch 3 Pt 1 cl 1.4(3) and (5); RDC 665/2022 Arts 120 I and 131; MO169 Arts 43, 54, 55-1, 58, 59, 61.

Maintained by Gerard Blokdyk

Other controls in Chapter 3: Measurement, analysis and improvement – 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