April 29, 2018

ISO 15189

During autumn 2008, College of Patolog America (CAP) launched a laboratory accreditation program based on ISO 15189:2007 for Medical Laboratory. ISO 15189 can be defined as a quality management standard system which is specifically designed for the accreditation of medical laboratory. This standard is conducted by the medical laboratory in term of quality management system improvement and competency value of the laboratory itself. Moreover, it is also explained about the risk management system for the result of laboratory and customer satisfaction.

ISO 15189 is a standard which has been recognized worldwide by organization of accreditation which conducted ISO15189 in 44 different countries. In several countries, this laboratory standard has been modified. Although this standard has not been formally used in USA, but CAP said that this standard will help the laboratory in achieving the best practice of quality management system.

 The accreditation of Medical Laboratory based on ISO 15189:2007 which has modified to SNI ISO 15189:2008 Medical Laboratory is an important guideline to acquire the recognition of quality and competency for the laboratory.

ISO 15189 and ISO 17025 are connected, because ISO 15189 is just the medical laboratory version of ISO 17025. Moreover, because of its connection with ISO 9001, ISO 15189 is a recognition for a medical laboratory competency, whereas ISO 17025 and ISO 9001 is only a recognition of competency and laboratory system management.

One of the main objectives of ISO 15189 is to ensure that the client knows about the procedure which supports the quality management system as well as to convince that the result is valid. ISO 15189 has several advantages for hospital laboratory system which includes the quality of health services, patient and employees’ satisfaction, cost of the treatment, and its delivery.