[Osaka Medical Laboratory ISO15189 Study Group: History and Future Prospects of the Group]

The IS015189 "Medical laboratories: Specific requirements regarding quality and competence" is an international standard issued by the International Organization for Standardization (ISO) in February 2003. In October 2004, pilot surveys were initiated in Japan prior to accreditation surveys scheduled to be started in 2005. In September 2005, the first ever ISO15189-accredited facility was established in Japan. With the background of limited information about and few opportunities to study ISO15189 in 2004, we established the Osaka Medical Laboratory ISO15189 Study Group as a unique association that anyone interested in the ISO is able to join. Approximately 900 people have participated in group meetings, which have been held a total of 11 times. Thus, our group has played a major role in ISO development in Japan. To date, approximately 100 facilities have been ISO15189-accredited in Japan, suggesting the need to take new steps regarding its accreditation. As our group has achieved our initial objective, we are planning to work towards taking new steps, such as interaction with accredited facilities.