This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization.

This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.

This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.

Scope – Health service additions

This document provides additional guidance for any health service organization (see 3.1.8) involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.

The definitions of terms such as patient/client, client, primary, ancillary, and specialty care vary by region within the health service community. The organization's processes for addressing these activities should be included in the quality management system. The recommendations and guidance in this document apply to anyone in the organization who could affect the quality of the organization's product(s) or service(s), including necessary support services (see 3.1.23).