GOST R 55747-2013 Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 5. Audits of manufacturer control of suppliers
GOST ISO 13485-2011 Medical devices. Quality management systems. System requirements for regulatory purposes
GOST ISO 9000-2011 Quality management systems. Fundamentals and vocabulary
GOST R 54881-2011 Guidelines for auditing of quality management systems of medical device manufacturers to conform to requlating requirements. Part 3. Audit report*, 2023-12-21 Update
GOST R 55748-2013 Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 4. Multiple site auditing
GOST R 55747-2013 history
2013GOST R 55747-2013 Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 5. Audits of manufacturer control of suppliers