1 Scope
1.1 General ISO 9001:2008, Quality management systems requirements
1.1 General 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 statutory and 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 statutory and regulatory requirements.
NOTE 1 In this International Standard, the term “product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
This International Standard provides guidance for organizations in the application of ISO 9001:2008 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 9001:2008.
Annex A (informative) provides a table pointing to additional guidance in the implementation of ISO 9001:2008, available in ISO/IEC JTC 1/SC 7 and ISO/TC 176 International Standards.
The guidelines provided in this International Standard are not intended to be used as assessment criteria in quality management system registration/certification.
1.2 Application
ISO 9001:2008, Quality management systems requirements
1.2 Application
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 statutory and regulatory requirements.
The application of this International Standard is appropriate to software that is
— part of 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.
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