"General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization??s quality management system is influenced by a) its organizational environment@ changes in that environment@ and the risks associated with that environment@ b) its varying needs@ c) its particular objectives@ d) the products it provides@ e) the processes it employs@ f) its size and organizational structure It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked ""NOTE"" is for guidance in understanding or clarifying the associated requirement. This International Standard can be used by internal and external parties@ including certification bodies@ to assess the organization's ability to meet customer@ statutory and regulatory requirements applicable to the product@ and the organization's own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard."