Provides guidance to organizations that provide health services, and to those involved in the health services sector, on the development and implementation of quality management systems based on ISO9001:2000. The application of each requirement is described in terms relevant to health services, and examples are included to assist in understanding their application. In addition, the major changes in ISO9001:2000 compared with ISO9001:1994 are identified and their impact highlighted.

This International Standard specifies requirements for a quality management system where an organization(a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and(b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.

First published as AS/NZS 3905.14;1998.Revised and redesignated as HB 90.8-2000.Reconfirmed 2016. Originated as AS/NZS 3905.14:1998. Revised and redesignated as HB 90.8-2000. Originated as AS/NZS 3905.14:1998. Revised and redesignated as HB 90.8-2000.