GHTF · International guidance
GHTF/SG3/N15R8:2005
Risk Management Principles and Activities within a QMS
International Medical Device Regulators ForumGHTF/IMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- GHTF/IMDRF
- Reference
- GHTF/SG3/N15R8:2005
- Published (source metadata)
- May 20, 2005
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About this guidance
Risk Management Principles and Activities within a QMS
Integration of risk management principles into quality management systems. Addresses risk-based approach to QMS processes aligned with ISO 14971.