US proposal for health care sector guide to ISO 9000

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ISO (International Organization for Standardization) has received a proposal from the USA for a guidance document on implementing the ISO 9000 quality management standards in the health care sector.

The proposal is made by the American Society for Quality (ASQ) and the Automotive Industry Action Group (AIAG). It concerns health care sector-specific guidelines based on ISO 9004:2000, Quality management systems - Guidelines for performance improvements, which could be published 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 structures.

ISO's Technical Management Board (TMB) is expected to discuss the proposal and take a decision at its meeting on 25-26 September 2000 in Geneva. If the proposal is accepted, the proposed workshop will take place in Warren, MI (Detroit), USA, on 26 and 27 October 2000 and the health care document may be published as early as December 2000, when it could reflect the provisions of the revised ISO 9004.

The new proposal is a spin-off of ISO's successful cooperation with the automotive industry in the United States and Europe to develop the ISO Technical Specification, ISO/TS 16949, which defines specific requirements for the implementation of ISO 9001 by automotive suppliers.

Among the prime movers of that specification were the USA's "Big Three" automobile manufacturers - Ford, Chrysler and General Motors - which, as major employers, have a strong interest in health care programmes and well run health care establishments.

In the United States, there are thousands of such establishments which are accredited by health care accrediting organizations. The Big Three have held discussions with several of these to have them consider using ISO 9001:2000 as the foundation for their criteria so that health care providers and programmes will no longer need multiple accreditations/certifications. The aim would be to improve the quality of care and patient safety while reducing cost.

ISO 9000 implementation guides for the health care sector, based on the 1994 versions of the standards, have been published in a number of countries and these were reviewed as part of the automotive industry's investigations. These include documents published in Australia/New Zealand, Ireland, Israel, Switzerland, the United Kingdom and the United States. However, it was felt that to some degree, these offer conflicting guidance which is counterproductive to the worldwide use of ISO 9000 in health care.

During the course of this year, working groups from ASQ and AIAG - the industry group which represents a large group of payers of health care services - were set up, independently of each other, to begin work on health care sector implementation guidance based on the ISO 9000:2000 revised standards now under development and due for publication by the end of the year. Once these 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.

The proposed guidelines document is not itself intended for use in third party certification, although it is envisaged that it could be used as one aid to improving a quality management system which may be certifiable to ISO 9001:2000.

In accordance with the ISO procedure for the establishment of Industry Technical Agreements, the TMB is invited to accept the proposal and assign a member body to work with the proposers in organizing a workshop where the ITA will be developed. In this case, the proposers are recommending that the assignment be given to the Standards Council of Canada/Canadian Standards Association (SCC/CSA), who hold the Secretariat of ISO/TC 176, Quality management and quality assurance, to ensure optimal coordination during finalization of the presently ongoing revisions of ISO 9001 and ISO 9004.

The automotive industry's ISO 9004 health care project specification quotes benefits experienced through the use of the QS-9000 sector-specific quality requirement, which includes ISO 9001 in its entirety. It states that use of the ISO 9000-based sector document has provided up to a 3:1 payback for all compliance-related costs, and a payback of nearly 17:1 for certification costs (source: 1997-98 ASQ/AIAG quality surveys). In addition, quality has improved by as much as 85 % over a five-year period (source: General Motors).


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