Quality - SOP - Management Review

Quality - SOP - Management Review

$250.00 AUD

The process outlined in this document will ensure that your company complies with the relevant clauses of ISO 13485 (5.6), 21 CFR (820.20), and EU MDR/IVDR.

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Purpose of Document

A quality management system must be reviewed at predefined intervals to ensure its continuing suitability, adequacy, and effectiveness. The purpose of this procedure is to provide instructions and to assign responsibilities for the scheduling, conducting, and recording of management reviews of the quality management system of Company to ensure its compliance with 21 CFR 820.20, ISO 13485 (5.6) and EU MDR/IVDR.

Scope of Document/s

This procedure applies to the periodic review of Company’s quality management system including its interaction and oversight of external vendor quality management systems (e.g. contract manufacturing) through quality/supplier agreements.

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