ISO 15189 Medical laboratories — Particular requirements for quality and competence 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 users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab’s role in the education and training of health care staff.
The first version was published in 2003, it was revised in 2007 and the third edition of the standard was published in 2012.
While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.