This International Standard describes fundamentals of quality management systems, which form the subject of the ISO 9000 family, and defines related terms.
This International Standard is applicable to the following:
a) organizations seeking advantage through the implementation of a quality management system;
b) organizations seeking confidence from their suppliers that their product requirements will be satisfied;
c) users of the products;
d) those concerned with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators);
e) those internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies);
f) those internal or external to the organization who give advice or training on the quality management system appropriate to that organization;
g) developers of related standards.
The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems.
— ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems.
— ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfil customer and applicable regulatory requirements and aims to enhance customer satisfaction.
— ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system. The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties.
— ISO 19011 provides guidance on auditing quality and environmental management systems.
Together they form a coherent set of quality management system standards facilitating mutual understanding in national and international trade.