1. Scope 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 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 regulatory requirements. NOTE - In this International Standard, the term product applies only to the product intended for, or required by, a customer.
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 regulatory requirements.