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-T13-T14: Identify, calibrate, adjust and protect monitoring and measuring equipment, and assess and record the validity of earlier results and act on affected product when equipment is found out of specification

What does C6-T13-T14 require?

The organisation must decide which monitoring and measuring devices are needed to show conformity, identify them, calibrate or verify them, adjust and maintain them so they give valid results, and protect them from damage and deterioration. Where equipment turns out not to conform, it must assess and record whether earlier measurements were valid and take suitable action on the equipment and any affected product. Clauses: ISO 13485:2016 7.5.1, 7.6; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(e); RDC 665/2022 Arts 93 to 95, 102; MO169 Arts 40, 53.

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.

MCP endpointAll MDSAP Audit Approach (MDSAP AU P0002) controls