Laboratory News

ISO-15189 Gathering in British Columbia

Few of you in the laboratory medicine profession across the globe are aware of an event unfolding here in Vancouver, British Columbia this week. It is the ISO Technical Committee 212 conference. Their mission is to discuss, debate, and advance the work under way to update the standards for "ISO:15189 Medical Laboratories."

This is noteworthy because ISO:15189 is gathering momentum as a global standard for laboratory accreditation. Since ISO:15189:2003 was introduced five years ago, a surprisingly large number of countries have taken steps to evaluate ISO:15189 as the basis for a national laboratory accreditation program.

In North America, the Canadian Province of Ontario quickly accepted ISO:15189 as the basis for laboratory accreditation. Ontario mandates that both public hospital laboratories and private laboratory companies operating in the province must be accredited. Speaking at a pre-conference symposium, titled "Quality Conference Weekend Workshop" produced by the University of British Columbia, Gregory J. Flynn, M.D., Managing Director of the Quality Management Program for Lab Services at the Ontario Medical Association discussed the province's swift acceptance of ISO:15189-based accreditation. "By the end of 2008, there will be 200 laboratories in Ontario that are accredited under the ISO:15189 standard," he stated. "One consequence of the laboratory accreditation in Ontario is that a number of very small laboratory firms chose to close down rather than to comply with the requirements of accreditation."

Dark Daily is here in Vancouver as an invited observer to the ISO Technical Committee 212 conference. This is an international gathering of the committee members who are responsible for ISO:15189 and related standards. It is an opportunity to learn first-hand, about ISO:15189 from the laboratory professionals who are part of the technical committees tasked with updating and revising the standards that comprise ISO:15189.

The interesting question is whether ISO:15189 has potential to eventually become the basis for laboratory accreditation in countries such as the United States, which already have rigorous accreditation requirements for medical laboratories. In the short term, the likely path of acceptance for ISO:15189 will involve countries which currently lack a requirement for laboratory accreditation.

Related Articles:

"ISO 15189 Accreditation Program Offered by CAP" from The Dark Report, Volume XV, No.3, March 3, 2008