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Return to ISO 9001.
ISO 9001:2000 specifies requirements for a quality management system where an organization:
1. Needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
2. 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.
All requirements of ISO 9001, an 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 ISO 9001 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.
In the early days the 'brief' summary of what ISO 9001 was:
"Say what you do,
Do what you say,
Prove that you did it."
The year 2000 revision changed that simplification by changing to emphasize a 'Process Approach' as opposed to the old "Do this and show me where and how you do it" basis.
ISO/TC 176 is the "umbrella" committee under which the ISO 9000 series of quality management and quality assurance standards are being developed.