GHTF Guidance - Risk management principles and activities within a Quality Management System

• Date: October 04, 2010
• Source: www.ghtf.org

This document is intended to assist medical device manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples.

A basic understanding of quality management system requirements and a basic knowledge of quality management system terminology are assumed in this guidance document.

This document is based on general principles of a quality management system and general principles of a risk management system and not on any particular standard or regulatory requirement.

This document also:

• Has general applicability to quality management systems for manufacturers providing medical devices;
• Discusses risk management related to medical device safety, rather than financial or other business risks;
• Does not suggest a particular method of implementation; and
• Does not include requirements to be used as the basis of regulatory inspection or certification assessment activities

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