[ISO 15189, Up-To-Date Information and Prospective View].

"Accreditation Activities for Medical Laboratories in Japan" Audits for transition to ISO 15189:2012 continue to progress. Besides the continual increase of accreditations for medical laboratory testing and pathological examinations, preparations for the addition of physiological testing to the scope of accreditation have finally been completed. As a part of the revision to Japan's Medical Service Act, the external evaluation of medical laboratories is now a requirement to approve clinical trial core hospitals. Accordingly, the importance of third-party accreditation in medical laboratory testing is attracting a growing level of attention. World Accreditation Day 2015 "Accreditation: Supporting the Delivery of Health and Social Care" JAB is being used to make every effort to contribute to this system in order to improve the quality of healthcare in Japan and the health of its citizens.

[Team Medical Care Involving Biomedical Laboratory Scientists].

As medical care becomes'more advanced and complex, increasing importance is being attached to the im- plementation of team medical care that provides appropriate care while making use of the advances, mutually cooperating, and supplementing the high-level specializations of various branches of medicine in order to provide safe care with peace of mind. Planned team medical care is demanded in this era, and the Japanese Association of Medical Technologists is developing various projects as well as promoting the participation of biomedical laboratory scientists in team medical care. [Review].

[Update to ISO 15189:2012, and future prospects].

ISO (the International Organization for Standardization) is a worldwide federation of national standard bodies (ISO member bodies). The work of preparing international standards is normally carried out through ISO technical committees. ISO 15189 was prepared by Technical Committee ISO/TC 212, clinical laboratory testing, and in vitro diagnostic test systems. This third edition replaces the second edition (ISO 15189:2007), which was technically revised. Medical laboratory services are essential for patient care and, therefore, have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients.

[Current status of ISO 15189 accreditation system].

The Japan Accreditation Board (JAB) mainly involves the ISO 15189 accreditation system with support from the Japanese Committee for Clinical Laboratory Standards (JCCLS). The currently available procedure to obtain accreditation is as below. Firstly, it is necessary for applicants to prepare ISO 15189 and related documents in each laboratory. Then a JAB assessor will conduct a preliminary assessment to check if the applicant is ready to be accredited. Subsequently, a team consisting of one to five JAB assessors and/or technical experts will conduct the initial assessment, usually for two days. Finally, the team will make a recommendation to the JAB Accreditation Committee for Medical Laboratory on its evaluation for accreditation. If the Accreditation Committee approves the recommendation of the assessment team, the applicant will be granted accreditation and issued with a certificate of accreditation. According to EU data in February 2011, about 1,300 medical laboratories obtained the ISO 15189 accreditation. The numbers of accredited laboratories are 482 in Germany, 276 in England, 209 in France, 100 in Czechoslovakia etc. Similarly, the data for the Asia-Pacific region in June 2011 showed that the numbers of accredited laboratories are 638 in Australia, 287 in India, 220 in Canada, 160 in Taiwan etc. Although 59 laboratories are accredited in Japan, the ISO 15189 accreditation is not so widespread compared with other countries. It is now expected that the government and/or related bodies will have sufficient understanding of this accreditation system to further its development in Japan. [Rinsho Byori 60: 653-659, 2012]