ISO 9000 guide for health sector set for January 2001

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The ISO (International Organization for Standardization) workshop to develop guidelines for implementing ISO 9000 quality management systems in the health care sector will be held in January 2001.

The exact date and location were expected to be announced during the next two weeks by the Standards Council of Canada (SCC), the ISO member which is hosting the workshop, and the Canadian Standards Association International (CSAI), to which SCC has delegated the detailed organization of the event.

A date in October 2000 had originally been put forward but ISO's Technical Management Board (TMB) felt that a postponement would allow more time for notifying interested parties and encouraging the widest possible participation.

The workshop is being held to develop health care sector-specific guidelines based on ISO 9004:2000, Quality management systems - Guidelines for performance improvements, and publishing them as ISO's first Industry Technical Agreement (ITA). The latter is one of the alternatives to fully fledged International Standards offered by ISO for cases where swift development and publication takes priority. A particularity of ITA's is that they are developed in open workshops rather than through ISO's technical committee structure.

The proposed guidelines document is not itself intended for use in third party certification, although it is envisaged that it could be used in the design or improvement of quality management systems in the health care sector, themselves certifiable to ISO 9001:2000.

The proposal to develop the guidelines was made jointly by the American Society for Quality (ASQ) and the Automotive Industry Action Group (AIAG), which is an industry association representing US automotive companies, including the "Big Three" - Ford, Chrysler and General Motors. As major employers, the Big Three deal with thousands of health care providers and spend substantial amounts on health care programmes. They see the generalized implementation of ISO 9000 quality management systems by the health care establishments that they deal with as a means of rationalizing client-supplier relationships and improving the quality of health care while reducing the costs.

Against this background, an AIAG working group was set up earlier this year to begin work on health care sector implementation guidance based on the ISO 9000:2000 revised standards now under development and due for publication in December. An ASQ working group had been set up for a similar purpose and once the two groups became aware of their common focus, agreement was reached to work together towards a single document. Since then, interest from other countries has led the combined group to request that the proposed document should be developed and published within the ISO system.

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