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” applies only to a) product intended for, or required by, a customer, b) any intended output resulting from the product realization process. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.