Significance of clinical laboratory accreditation based on ISO 15189, and recent trend of international clinical laboratory accreditation program

ISO 15189 was first published in 2003, its second edition in 2007, and its third edition in 2012 by the ISO. Since 2003, through the approval of ILAC, ISO 15189 has been used for the accreditation of clinical/medical laboratories throughout the world, and approximately 5,000 clinical laboratories have now been accredited. In Japan, the JAB, in cooperation with the JCCLS, introduced the clinical laboratory accreditation program based on ISO 15189 in 2005, and 70 labs had been accredited by January 2014. It has been purely voluntary, without any governmental or regulatory involvement so far. However, it has been gradually accepted to be significant for maintaining quality management and for the improvement of clinical laboratory efficiency. The program will expand widely throughout the world in order to accomplish "one-stop testing" among clinical laboratories, at least regarding frequently-used routine laboratory tests.