ISO 9000 Guidelines for the Health Care Sector

The guidelines for implementing ISO 9000 quality management systems in the health care sector have been published by ISO as its first “International Workshop Agreement”. IWA 1 was developed from an earlier draft jointly developed by the American Society for Quality (ASQ) and the Automotive Industry Action Group (AIAG).

IWA 1, Guidelines for Process Improvements in Health Service Organizations, is based on ISO 9004:2000, Guidelines for Performance Improvements. IWA 1 contains much of the text of ISO 9004:2000, supplemented by specific guidance for its implementation in the health care sector.

The IWA 1 document provides a framework for the design and improvement of process-based quality management systems by health care organizations. The guidelines are voluntary and they are not intended for certification or accreditation.

As a major employer, the automotive sector deals with thousands of health care providers and spends substantial amounts on health care programs. The generalized implementation of ISO 9000 quality management systems by health care organizations is seen as an opportunity to improve the quality of health care while reducing its costs.

An International Workshop Agreement is a new alternative to developing International Standards for cases where swift development and publication takes priority. Compared to the traditional ISO process of developing International Standards through the technical committee structure, IWA’s are developed in open workshops and organized by an ISO member body.

AIAG members can purchase IWA 1 for $10 by calling 248-358-3003 ($50 for non-members). ASQ members and non-members can buy IWA 1 for $40 at 800-248-1946.