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

MDSAP Audit Approach (MDSAP AU P0002) C1-T4: Define the organisational structure, responsibilities and authorities, and provide the people, infrastructure, competence and training needed to design and make devices as planned

What does C1-T4 require?

The organisational structure and related documents must set out responsibilities and authorities (including the management representative), personnel, infrastructure resources, competence and training, so that staff can design and manufacture devices according to the planned arrangements and applicable regulations, and so that processes that assure quality are not compromised. Clauses: ISO 13485:2016 5.1, 5.5.1, 5.5.2, 6.1, 6.2; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(b); RDC 665/2022 Arts 8 and 13 to 17; MO169 Arts 10, 15, 16, 21 to 23.

Maintained by Gerard Blokdyk

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