GOST R 57451-2017
Medical devices. Quality Management System. Requirements for competence and maintaining competence for audit organizations that audit medical device manufacturers for regulatory purposes

Standard No.

GOST R 57451-2017

Release Date

2017

Published By

RU-GOST R

Latest

GOST R 57451-2017

GOST R 57451-2017 Referenced Document

• ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
• ISO/IEC 17000:2004 Conformity assessment - Vocabulary and general principles
• ISO/IEC 17021-1:2015 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements
• ISO/IEC TS 17021-3:2013 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 3: Competence requirements for auditing and certification of quality management systems

GOST R 57451-2017 history

• 2017 GOST R 57451-2017 Medical devices. Quality Management System. Requirements for competence and maintaining competence for audit organizations that audit medical device manufacturers for regulatory purposes