Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers

This document has been prepared by Study Group 4: Auditing which was convened by the Global Harmonisation Task Force. The members of this group were auditing experts from, or acting on behalf of, regulatory bodies and representatives of the medical device manufacturing industries from Australia, Canada, Europe, Japan and the USA. A list of the organisations represented on the Study Group can be found in Annex A. The incorporation of quality system requirements, based on ISO 9001/9002/9003, into regulations applicable to manufacturers of medical devices, provides the opportunity for developing mechanisms that would lead to global harmonisation.