[Effect of ISO15189 accreditation in Clinical Laboratory Center of Toyama University Hospital]

Abstract

Quality, cost, risk, and knowledge control are essential in clinical laboratory management. In addition, a benchmark set by a third party is important. However, it is very difficult to develop these systems without a guideline and an authoritative body to set the benchmark. ISO15189 issued in 2003 is an international standard of "medical laboratories--particular requirements for quality and competence". This international standard is superior as a guideline. ISO15189 specifies quality and competence particular to medical laboratories. Also, it can be used by medical laboratories to develop their quality management systems and assess their own competence, and by accreditation bodies to confirm or recognize the competence of medical laboratories. In Japan, the Japan Accreditation Board for Conformity Assessment (JAB) is an accreditation body of ISO15189. We were awarded ISO15189 accreditation on July 31, 2008. In this report, we summarize the preparations for ISO15189 accreditation and the effects on our laboratory.