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ISO 9001:2000, Quality management systems — RequirementsGeneral
This International Standard specifies requirements for a quality management system where an organization
- needs to demonstrate its ability to consistently provide product that meets customer and applicable 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 regulatory requirements.
This International Standard provides guidance for organizations in the application of ISO 9001:2000 to the acquisition, supply, development, operation and maintenance of computer software and related support services. It does not add to or otherwise change the requirements of ISO 9001:2000.
Annex A (informative) provides a table pointing to additional guidance in the implementation of ISO 9001:2000 available in ISO/IEC JTC 1/SC 7 and ISO/TC 176 standards.
The guidelines provided in this International Standard are not intended to be used as assessment criteria in quality management system registration/certification.
ISO 9001:2000, Quality management systems — Requirements
All requirements of this 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 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 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.
The application of this International Standard is appropriate to software that is
- part of a commercial contract with another organization,
- a product available for a market sector,
- used to support the processes of an organization,
- embedded in a hardware product, or
- related to software services.
Some organizations may be involved in all of the above activities; others may specialize in one area. Whatever the situation, the organization's quality management system should cover all aspects (software related and non-software related) of the business.