[Development and Current Status of Quality Management Systems for Specimen Examination].

ISO 15189:2003 was published as an International Standard in 2003 by Technical Committee ISO/TC212 of the International Organization for Standardization (ISO). This international standard based on ISO 9001 specifies requirements for competence and quality that are specific to medical laboratories. With the publication of this standard, we will have to markedly change our concept. We have to adopt methods to manage the causes of errors in measurement processes rather than methods to manage only the results of measurements. The new concept of the Quality Management System (QMS) which manages the result of measurements is summarized. With the publication of ISO 15189, the definition of the quality assurance of examination results became clearer and stricter. This report describes the contents of ISO 15189 and the method of enforcing it.