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ISO 15189:2003 - Standard for Medical Laboratories

A

akdoris

#1
:rolleyes:
There has been a set of standards applicable to laboratories which is known as 17025. It is not particularly applicalbe to CLINICAL LABORATORIES. In an effort to introduce a set of standards, ISO has created 15189, which is specifically made for clinical laboratories. It corellates well with the ISO 9001:2000 set. Is there any interest out there for cooperation in developing a quality manual based on that standard???
 
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S

SilverHawk

#2
Animal Laboratory

Our Malaysian Accreditation Body, Department of Standard (and Accreditation) Malaysia has adopted this ISO 15189 scheme together with the ISO 17025 accreditation scheme.

Who would really needs this accreditation scheme? Well, the private and government medical laboratory that conduct pathology tests, etc, and drugs. There are many private medical laboratory.

Our medical lab. for testing of dope during any international, regional and national sports events has been accredited by NATA, Australia under ISO 17025 but now our local govt. agency is not too happy.

I guess there is a gap and vacuum for this service industry. I can think of is the animal medical lab. especially those testing of dope during horse racing events. Horse racing is popular in Hong Kong and Macau and several other places.

ISO 15189 is applicable for not only human lab but also the animal lab. I am guess wondering should the animal lab testing H5N1 avian bird flu should seek this accreditation????
 
A

akdoris

#3
Iso 15189

This standard was approved by ISO TC212 in February 2003. It is not widely known or accepted in the US, since medical laboratories are regulated by CAP and FDA. However, it is has been widely accepted in Canada, Europe, and Asia. The purpose of this standard is to provide uniformity and the operations of a clinical laboratory, whether it is for humans or animals. Like any other standard, requires management commitment, and dedicated personnel. It takes about a year for implementation, and the end result is a very well managed, organized, and standardized laboratory. Looks like that this standard is going to become part of CAP checklists, so eventually it will be implemented in US labs. If anyone needs anything specific please email me. ISO 17025 for measurement and calibration labs is not suitable for medical laboratories, and ISO 15189 was developed based on ISO 9000, ISO 17025, FDA GMP's, and certain European standards not related to any ISO form.Please feel free to share any experiences you have with this standard.
Thanks.
Al K. Doris MBA,MT(ASCP)SC
 
A

akdoris

#4
ISO 15189-Veterinary Laboratories

Personally, I admire vet labs trying to implement ISO15189 in order to implement quality standards and management. It shows a high degree of dedication to their patients. There are few differences beetween human and animal laboratories, but ISO15189 implementation presents pretty much the same difficulties and capabilities in both. I have not been involved with vet labs standardization, but I find it fascinating, and I would love to, given the opportunity.
Al K. Doris MBA,MT(ASCP)SC
 
A

akdoris

#6
Iso15189:2003

Thank you Marc,
These two PDF files accompany the book "A Practical Guide to Accreditation in Laboratory Medicine" which I reviewd last October, and my review was published in the british journal "The Biochemist" last December. ISO15189 is pretty big in Europe, however it is barely known in the US. I am writing my doctoral dissertation on ISO9000 systems implementation in the clinical laboratory, and it has created a little bit of a stir...
AL K. DORIS MBA,MT(ASCP)SC
 
Y

yfk99

#7
Need help to developt a bioequvalency testing lab

I'm Yusuf from the Faculty of Pharmacy, University of Surabaya, Indonesia
Our 'FDA' here give us a job to build a new laboratory..the drugs bioequivalency testing laboratory..and they want us using the ISO17025 and 15189..
Anyone can help us..??

Thanks for the everything!
Our regards.
 
Last edited by a moderator:
S

SilverHawk

#8
Do you think KAN can accredited Lab. to ISO 15189 or not? I am sure that KAN can accrediate ISO 17025 but not too sure about this new scope.

If you want your Lab. to be accrediated, are you going to KAN or another other Accreditation Bodies and who can offer this accreditation????
 
K

Karen Matthews

#10
akdoris said:
Thank you Marc,
These two PDF files accompany the book "A Practical Guide to Accreditation in Laboratory Medicine" which I reviewd last October, and my review was published in the british journal "The Biochemist" last December. ISO15189 is pretty big in Europe, however it is barely known in the US. I am writing my doctoral dissertation on ISO9000 systems implementation in the clinical laboratory, and it has created a little bit of a stir...
AL K. DORIS MBA,MT(ASCP)SC
I am in laboratory in Canada looking for information on obtaining ISO 15189 compliance, can you supply any information or contacts?
 
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