ISO 13485 for Medical Devices to be Revised

More than 70 delegates from 19 countries and international organizations gathered in Tokyo in April to attend the eighth meeting of ISO/TC 210, Quality management and corresponding general aspects for medical devices, which was hosted by the Japan Federation of Medical Devices Associations (JFMDA). The US delegation included 12 representatives of the Association for the Advancement of Medical Instrumentation (AAMI) member companies and the Food and Drug Administration (FDA).

One of the most significant developments in Tokyo was agreement to circulate a revision of ISO 13485 (Quality management systems – Medical devices – System requirements for regulatory purposes) as a committee draft for vote. The WG reviewed numerous comments received on a previous working draft revision and had the benefit of interaction with a representative from ISO/TC 176 (ISO 9000) in its deliberations.

Several years of very active communications between ISO/TC 210 and ISO/TC 176 appear to have paid off in the recognition by both sides that the medical device sector, given its regulatory imperatives, requires some modification to the generic standards.

The committee draft revision of ISO 13485, soon to be released for vote and comment in both ISO and AAMI, is a stand-alone document for the medical device sector that follows the format of ISO 9001:2000, but where necessary, with clear rationale, establishes requirements specific to this sector. Among the areas where TC 210 modified the language in ISO 9001:2000 are “customer satisfaction” and “continual improvement.” The view within TC 210 is that, while these concepts may be appropriate for a business excellence model, they do not belong in a baseline standard for a quality system that will become a regulation in many jurisdictions.

In addition, the new version of ISO 13485 will retain the same documented procedure requirements contained its 1996 version based on the ISO 9001:1994 standard. ISO 9001:2000 significantly reduces these procedure requirements.

An announcement will appear in the Standards section of the AAMI web site and in AAMI News when the proposed revision of ISO 13485 becomes available for public review. The document will be available for free download by AAMI members.