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, certificat ion/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.
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.
All requirements of the International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot b e applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
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.