Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 5: Audits of manufacturer control of suppliers

Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 5: Audits of manufacturer control of suppliers

Leitlinie

This document gives guidance for the auditing of a manufacturer’s purchasing controls, including the audit of the suppliers when suppliers should be audited and what a supplier audit should cover,adding to the guidance given in GHTF/SG4/N28 and GHTF/SG4/N30.