ISO 9000 internal and external issues relevant to its purpose and strategic direction (section 4.1). The organization must demonstrate how the standard’s requirements are being met, while the external auditor’s role is to determine the quality management system's effectiveness. More detailed interpretation and implementation examples are often sought by organizations seeking more information in what can be a very technical area. International Organization for Standardization (ISO) does not certify organizations itself. Numerous certification bodies exist, which audit organizations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as "ISO 9000" certification, the actual standard to which an organization's quality
ISO 15189 section on laboratory information management. ISO 15189 ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 "General requirements for the competence of testing and calibration laboratories". This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test