Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 4: Multiple Site Auditing

Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 4: Multiple Site Auditing

Leitlinie

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers with multiple sites. This document should be read in conjunction with the Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers -- Part 2: Regulatory Auditing Strategy (GHTF/SG4/N30).