ISO 9000 / 9001 SET Historical

About ISO 9000:2005

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:

• organizations seeking advantage through the implementation of a quality management system;
• organizations seeking confidence from their suppliers that their product requirements will be satisfied;
• users of the products;
• those concerned with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators);
• 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);
• those internal or external to the organization who give advice or training on the quality management system appropriate to that organization;
• developers of related standards.

About ISO 9001:2008

ISO 9001:2008 specifies requirements for a quality management system where an organization

• needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
• 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 statutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 cannot be 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 ISO 9001:2008 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 statutory and regulatory requirements. See more