This International Standard specifies requirements for a quality management system where an organization: a) needs to demonstrate its ability to consistently provide product or service 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. All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. NOTE 1 In this International Standard, the terms product or service only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements