Anyone have experience with ISO/IEC 15189 for medical laboratories?

Anyone have experience with ISO/IEC 15189 for medical laboratories?

I have the cross-reference to ISO/IEC 17025 and have an inquiry regarding accreditation.

Hershal

I know about it, I am no expert, by any means, but fire away.

Any idea how many labs are considering it? Any idea whether any accrediting bodies are working with it? The cross reference list I have (15189 to 17025) is put out by RvA.

There appear to be many more in depth technical requirements. Any idea how it crosses to Part 11?

Also, if your organization is already accredited to the standard, then we should chat more directly off-line.

I appreciate any help.

Hershal

We are not accredited, heck we are not even a lab. I was going to take a contract position with a company that was in your neck of the woods (Costa Mesa) so I did a lot of research on it, so I was up to speed.

I am attaching some documents I found very useful. As for the number of labs being registered I can not answer that and a quick serch of the ISO website for facts and figures offered no help.

Good luck and let me know if you need anything else

what type of information you have required

Yes we are accrederating on iso 15189, and many other accreditation bodies accredit medical labs on this standard. Actually this standard is derived from iso 17025, so it has many similarties with iso 17025.

"We" will be moving to ISO 15189:2007. Currently we are accreditied to CPA (clinical pathologists association) which is based on 15189. (but is is a british not an international standard). I am looking for a gap analysis or breakdown of the standard to check the boxes?
What are your experiences with different intereptations of the standard clauses?
Regards Stan

what type of help you have required, I am responsible for accreditation of medical labs in accordance with ISO 15189 from application to disposal.

Hi
What checks or audits do you do to show compliance?. I am looking for a clause breakdown/results sheet to show compliance and what types of evidence you provide.
Regards Stan

My client Medical Lab wants to apply ISO/IEC 15189 standard, I have experience about ISO 17025 implementation and auditing too.
Is there anyone or you, can assist me which Accrediation bodies we need to contact for auditing.

Thanks for all.
Jasminphyu