Competence and Training Requirements for Auditing Organizations

Titel:
Competence and Training Requirements for Auditing Organizations
Herkunft/Verlag:

IMDRF

Inhalt:
This document applies to recognized Auditing Organizations conducting audits of a medical device manufacturer for regulatory purposes. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of manufacturers by ensuring that Auditing Organization personnel have the necessary commitment, competence, experience, and training before conducting an audit or undertaking a decision making function.

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