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ISO 13485/488 to be revised for adaptation to ISO 9001:2000
09.02.2000
The writing group made significant progress and produced an initial working draft revision of ISO 13485, which contains additional requirements for medical device quality systems. The ad hoc writing group is one of the first joint efforts under the new Memorandum of Understanding established between ISO/TC 210, Quality management and corresponding general aspects for medical devices, and the GHTF.
The primary objectives of the revisions to ISO 13485 and ISO 13488 are:
- to set out the requirements of quality management systems necessary to ensure the provision of safe and effective medical devices;
- to accomodate the various medical device regulatory schemes around the world; and
- to conform, as much as those objectives allow, to the text and format of ISO 9001:2000.
The convener of ISO/TC 210/WG 1, Ed Kimmelman, who also serves as the writing group leader, attended the September 1999 meeting of ISO/TC 176/SC 2, Quality systems, in San Francisco, where he participated in the drafting of ISO draft international standard (DIS) 9001:2000.
According to Kimmelman, "Although DIS 9001:2000 contains improvements from the previous draft, it still presents concerns for the regulated medical device industry. A significant focus of ISO/DIS 9001:2000 is on "customer satisfaction" and "continual improvement" of the quality system. These objectives are inappropriate for a quality system standard intended to serve as the basis for harmonizing quality system regulations around the world. More appropriate objectives for such a standard are "meeting customer requirements" and "maintaining the suitability of the quality system"".
Another consideration is that the ISO/DIS 9001:2000 clause, entitled "Permissible Exclusions", presents problems when trying to apply the standard to the regional "tiered" regulatory schemes (for example, the system of conformity assessment alternatives contained in the European Union Medical Device Directive: Annexes II, V and VI).
Kimmelman noted that "the objective of the Permissible Exclusions" clause is to allow for the compression of ISO 9001, 9002, and 9003 into one standard. It is more convenient and understandable for those who operate under the tiered regulatory systems to have two standards: The medical device equivalents of ISO 9001 and 9002."
As a result, the writing group decided to revise ISO 13488 rather than adopt the approach of Permissible Exclusions.
In addressing the content and format of the ISO 13485/13488 revision(s), the writing group retained as much of the ISO 9001:2000 text as possible. In addition, it organized the draft revisions using the "process approach" and the number systems used in ISO 9001:2000.
The ad hoc writing group will meet February 28 to March 1, 2000, in Tampa, FL, where they will review writing group comments on the initial working draft revision of ISO 13485. It is anticipated that the revisions of ISO 13485 and 13488 will be completed during 2001.
It should be noted that the current harmonized quality standard to the Medical Devices Directives are EN 46001 and 46002. Work by CEN on adopting the current standards ISO 13485 and 13488 into harmonized standards, was initiated last year by the EC Commission.
(This article was based on report from AAMI NEWS. January 2000).
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