MDSAP Audit Approach (MDSAP AU P0002)
Chapter 1: Management – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C1-T9: Conduct documented management reviews at planned intervals covering the suitability and effectiveness of the policy, objectives and QMS against all regulatory requirements

What does C1-T9 require?

Management review must follow a documented procedure, take place at planned intervals and assess whether the quality policy, objectives and QMS remain suitable, adequate and effective in meeting all applicable regulatory requirements, with the required inputs and recorded outputs. Clauses: ISO 13485:2016 5.6; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(b)(iii)(f); RDC 665/2022 Arts 10 to 12; MO169 Arts 18 to 20.

Maintained by Gerard Blokdyk

Other controls in Chapter 1: Management – 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