Management Review for ISO 13485:2016

In this page, we discuss about one of the key process in the Quality Management System according to ISO 13485:2016 and 21 CFR 820 : the Management Review. Basically, it is a moment where the quality management system of the company is fully reviewed in presence of the top management.

Firstly, the input of the Management Review Process are well defined by the ISO 13485:2016 and includes feedback complaint handling; reporting to regulatory authorities; audits; monitoring and measurement of processes; monitoring and measurement of product; corrective action; preventive action; follow-up actions from previous management reviews; changes that could affect the quality management system; recommendations for improvement; applicable new or revised regulatory requirements. The review of risk management can also be performed during management review.

Secondly, the output are the following improvement needed to maintain the suitability, adequacy, and effectiveness of the quality management system and its processes; improvement of product related to customer requirements; changes needed to respond to applicable new or revised regulatory requirements; resource needs.

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