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-T5: Determine, implement, document and verify corrections, corrective actions and preventive actions in proportion to risk, without adverse effect on finished devices

What does C3-T5 require?

Corrections, corrective actions and preventive actions must be decided, carried out and recorded, checked for effectiveness, confirmed not to harm finished devices, and scaled to the risk of the actual or potential nonconformity. Clauses: ISO 13485:2016 8.2.1, 8.2.5, 8.3.1, 8.5.2, 8.5.3; TG(MD)R Sch 1 Pt 1 EP 2, Sch 3 Pt 1 cl 1.4(3) and (5); RDC 665/2022 Arts 18 to 20, 116, 120; MO169 Arts 55-1, 57, 60-1, 63, 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