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

MDSAP Audit Approach (MDSAP AU P0002) C1-T11: Top management demonstrates commitment to an effective QMS and communicates its effectiveness, as judged across management, measurement and improvement, design, production and purchasing

What does C1-T11 require?

At the end of the audit, and again for each primary process, the auditors decide whether top management has shown the commitment needed for a suitable and effective QMS and has communicated its effectiveness to staff: committing resources and attention to detecting and addressing nonconformities (Chapter 3 Task 16), to design and development (Chapter 5 Task 17), to production and service controls meeting specifications and objectives (Chapter 6 Task 29) and to purchasing (Chapter 7 Task 12). Clauses: ISO 13485:2016 4.1.1, 4.1.3, 4.1.4, 4.1.5, 5.1, 5.2, 5.5.1, 5.5.3, 8.1, 8.5.1; RDC 665/2022 Arts 4 to 9; MO169 Arts 5 and 10 to 17.

Maintained by Gerard Blokdyk

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