these two management systems separately, it may be advantageous to integrate them as it could reduce costs, eliminate redundancies, and lead to a more effective management system.
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
The scope of the medical device manufacturer’s quality management system will define the applicability and extent of implementing risk management principles and activities.
Processes required by the quality management system and performed by suppliers to the manufacturer are the responsibility of the manufacturer. Risk management activities relating to any process within the quality management system are ultimately the responsibility of the manufacturer.
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