ISO 9000 Guidelines for the Health Sector

An ISO workshop to develop guidelines for implementing ISO 9000 quality management systems in the health care sector will be held in January 2001. The Standards Council of Canada (SCC) is the ISO member hosting the workshop.

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 the first Industry Technical Agreement. An ITA is an alternative to full-fledged International Standards when swift development and publication takes priority. An ITA is developed in open workshops rather than through the ISO technical committee structure.

The proposed guidelines document is not intended for use in third party certification, although it could be used in the design or improvement of quality management systems in the health care sector (and those systems could be certified 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). Ford, Chrysler, and General Motors deal with thousands of health care providers and spend substantial amounts on health care programs. They see the implementation of ISO 9000 quality management systems by the providers as a means of 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. 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 led the combined group to request the proposed document be developed and published within the ISO system.