ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2

(see ).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received

(see ).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

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The committee responsible for this document is Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 1, Concepts and terminology. This fourth edition cancels and replaces the third edition (), which has been technically revised.


This International Standard provides the fundamental concepts, principles and vocabulary for quality management systems (QMS) and provides the foundation for other QMS standards. This International Standard is intended to help the user to understand the fundamental

concepts, principles and vocabulary of quality management, in order to be able to effectively and efficiently implement a QMS and realize value from other QMS standards.

This International Standard proposes a well-defined QMS, based on a framework that

integrates established fundamental concepts, principles, processes and resources related to quality, in order to help organizations realize their objectives. It is applicable to all

organizations, regardless of size, complexity or business model. Its aim is to increase an organization’s awareness of its duties and commitment in fulfilling the needs and expectations of its customers and interested parties, and in achieving satisfaction with its products and services.