Quality Management System for Medical Devices

Nonconformity Grading System for Regulatory Purposes and information Exchange

This document is intended for regulatory authorities and auditing organizations. It introduces a standardized nonconformity grading system for regulatory purposes with a Regulatory Audit In-formation Exchange Form providing consistent audit information in order to enable exchange among regulatory authorities. Currently, the significance of a nonconformity related to a medical device manufacturer’s Quali-ty Management System (QMS) may vary between regulatory authorities and auditing organiza-tions. All parties will benefit from the use of a standardized and transparent grading system of QMS nonconformities. This will build the confidence necessary for the potential mutual ac-ceptance of the results of a regulatory audit.
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