Quality - SOP - Management Responsibility

Quality - SOP - Management Responsibility

$250.00 AUD

The process outlined in this document will ensure that your company complies with the relevant clauses of ISO 13485 (5.5), 21 CFR (820.20), and MDR (2017/745)/IVDR (2017/746).

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Purpose of Document

A robust and effective quality management system requires Top Management to play a key role in its development, implementation, and ongoing management. This procedure outlines the management responsibilities which ensure that Company Top Management takes responsibility for the effectiveness of the QMS and to ensure that it is aligned with the company’s strategic goals. 21 CFR 820 (Section 820.20), ISO 13485 (Clause 5.5) and the MDR (2017/745)/IVDR (2017/746) regulations and customer requirements.

Scope of Document/s

This procedure sets out the responsibilities of Company’s Top Management, which ensures that a robust and effective quality management system is in place.

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