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-T3-T4: Investigate the root causes of nonconformities and potential nonconformities where possible, with depth proportionate to the risk

What does C3-T3-T4 require?

Investigations must seek the underlying cause of detected nonconformities and of potential nonconformities where possible, and the depth of each investigation must match the risk the nonconformity poses. Clauses: ISO 13485:2016 8.5.2 and 8.5.3; TG(MD)R Sch 3 Pt 1 cl 1.4(3) and (5), Sch 1 Pt 1 EP 2; RDC 665/2022 Arts 116 and 120; MO169 Arts 63 and 64.

Maintained by Gerard Blokdyk

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

Query this from an agent

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