An update on ISO 9001 and ISO 13485 - harmonization of the medical device quality standards: the evolution of ISO 13485

摘要

This presentation will begin with a short background into the origins of ISO 13485 and ISO 13488 and how these standards relate to existing international and regional standards for quality system management. The reason such additional standards were needed will be presented, as well as the importance of ISO 13485/8 to the process of global harmonization of quality management standards for medical device manufacturers, who are subject to regulatory requirements. The particular relationship of ISO 13485/8 standards to the ISO 9000 series of quality management standards will be emphasized, in order to show how changes that took effect in ISO 9001:2000 necessitated revisions to ISO 13485:1996. The most significant differences between ISO 13485:2003 and ISO 9001:2000, and between ISO 13485:1996 and ISO 13485:2003 will be defined. The rationale as to why changes in ISO 9001:2000 were, or in some cases were not, carried into ISO 13485:2003 will also be examined. Additional information regarding the fate of ISO 13488:1996, and the revision process for the ISO 13485:2003 guidance document, ISO/TS 14969:2003, will also be presented.