ISO 9001:2015 specifies requirements for a quality management system where an organization
All requirements of ISO 9001:2015 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of ISO 9001:2015 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 9001:2015 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.
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