ISO 13485:2003 specifies requirements for a Quality Management System (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for QMSs. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 standard that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose QMSs conform to this standard cannot claim conformity to ISO 9001 unless their QMSs conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the QMS. These regulations can provide alternative arrangements that are to be addressed in the QMS. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.

This ISO 13485 set, containing a Quality Manual and approximately 60 procedures and forms will save you enormous time in developing a Quality Management System (QMS) for compliance with ISO 13485:2003 and ISO 13485:1996 standards Compliance with both revisions of ISO 13485 standard will allow you to have one QMS for the transition period. Our extensive template documentation set has helped companies to establish effective QMS quickly and easily. The template procedures and forms included in the set are in the same format as those shown in our "The Perfect Manual" preview version. They are easy to modify to your specific needs, and define a solid baseline system for compliance with ISO 13485:2003 and ISO 13485:1996.

Do not forget to download a free copy of ISO 9001:2000-ISO 13485:2003-21 CFR 820 Correspondence Matrix! which we offer with a permission of the author. Please be patient - it is a relatively large pdf file.