ISO 15189 for Clinical Laboratory services

Particular requirements for quality and competence specify 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 the 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.