GHTF · International guidance
GHTF/SG3/N19:2012
QMS Nonconformity Grading System for Regulatory Purposes and Information Exchange
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/N19:2012
- Published (source metadata)
- November 2, 2012
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About this guidance
QMS Nonconformity Grading System for Regulatory Purposes and Information Exchange
Harmonized system for grading QMS nonconformities during regulatory inspections. Enables consistent evaluation and information exchange between regulatory authorities.