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-T22-T23: Identify, control and dispose of nonconforming product according to risk, and rework only under approved procedures that assess adverse effects, document results and re-verify the product

What does C6-T22-T23 require?

How nonconforming product is identified, controlled and dispositioned must suit the risk the nonconformity poses. Where rework is needed, the organisation must work out whether reworking could harm the product, perform it to an approved procedure, document the results and re-verify the reworked product. Clauses: ISO 13485:2016 7.5.8, 8.3, 8.3.4; TG(MD)R Sch 1 Pt 1 EP 2, Sch 3 Pt 1 cl 1.4(5)(b); RDC 665/2022 Arts 115, 116, 119; MO169 Arts 47, 60-1 to 60-4.

Maintained by Gerard Blokdyk

Other controls in Chapter 6: Production and service controls – 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