Is ISO 15189 going to fly?

The ISO 15189 standard was issued back in 2003 and has not received as much recognition as the ISO 17025 standard. Which countries have accreditation schemes in place to support the implementation of the standard?

United States
The United States does not seem as concerned with utilizing an international standard for medical labs when there are so many FDA requirements as well as being home to the Clinical and Laboratory Standards Institute

Australia
The National Association of Testing Authorities has a web page that gives you the process to be accredited for medical testing at:
http://www.nata.asn.au/index.cfm?objectId=AD74874A-933B-BBCB-A904EAE6169EF49A
They don't actually mention ISO 15189 on the page, but you will find a number of laboratories accredited to ISO 15189 if you do the search on their site.


Canada
Ontario has implemented a program for medical laboratory accreditation that can be viewed at:
http://www.qmpls.org/ola/ola.html
It doesn't state that it subscribes to any international standard, but does mention such things as ISO 9000 and ISO 15189 as starting points, but they have set about their own set of requirements.

Japan
Click here for an interesting link that TUV Rheinland Japan Ltd has posted.

TUV is usually recognized as an ISO 9001 registrar so it is interesting to see a private company initiate a programme rather than a government body / non-profit organization.

A couple decades ago when ISO Guide 25 came out there were just about as many standards used as there were countries and states for "accrediting" laboratories. It has been a long process to get to where we are at today, but at least ISO 17025 has been firmly established as the standard of choice for accrediting laboratories worldwide. It should be interesting to see if the medical laboratory accreditation community will take the same long road or continue to use their own spin on quality management systems.

We'll see!