ISO 15189:2003 - Standard for Medical Laboratories

A

akdoris

#1
#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???
 
Download Free White Paper
Elsmar Forum Sponsor
S

SilverHawk

#2
#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
#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
#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
#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
#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
#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
#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
Click to expand...
I am in laboratory in Canada looking for information on obtaining ISO 15189 compliance, can you supply any information or contacts?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
E Searching for ISO 15161:2001, 15189:2003, 90003:2004... Other ISO and International Standards and European Regulations 9
E What does referral laboratory determined in ISO 15189-2003 really equal to? Other ISO and International Standards and European Regulations 4
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
P Where to find conformance statistics for ISO 15189 Other Medical Device Regulations World-Wide 1
K List of procedures and forms or records required by ISO 15189:2012 Document Control Systems, Procedures, Forms and Templates 2
S ISO 15189 - When commercial QC Material is not available Hospitals, Clinics & other Health Care Providers 4
S ISO 15189 Procedures, Manuals & Forms wanted Document Control Systems, Procedures, Forms and Templates 2
B ISO 15189:2012 Misc. Quality Assurance and Business Systems Related Topics 2
R What an ISO 15189 Implementation Plan looks like Quality Manager and Management Related Issues 1
K ISO 15189, QA & how to calibration for Balance, refrigerator and centrifuge? Qualification and Validation (including 21 CFR Part 11) 5
S ISO 15189 Hospital Laboratory Accreditation - Forms and Templates needed Document Control Systems, Procedures, Forms and Templates 1
A ISO 15189 - International Standard for Medical/Clinical Labs Other ISO and International Standards and European Regulations 1
R ISO 17025 vs. ISO 15189 - Differences ISO 17025 related Discussions 4
Hershal Anyone have experience with ISO/IEC 15189 for medical laboratories? US Food and Drug Administration (FDA) 12
L ISO 9001, 14001, 45001 Audit Questions for a Security & Corporate Affairs Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
Moncia Full system pre certification audit ISO 50001 Other ISO and International Standards and European Regulations 8
C Test Method Validation - ISO Standards Qualification and Validation (including 21 CFR Part 11) 1
M ISO 13485 Supplier Question ISO 13485:2016 - Medical Device Quality Management Systems 12
giavannatabbs ISO 9001:2015 Control of Records - QMS Communications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
O ISO 14971 on Hazards during service/installation ISO 14971 - Medical Device Risk Management 2
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
M ISO 13485:2016 Identification & Traceability ISO 13485:2016 - Medical Device Quality Management Systems 4
K Clause 7.5.2 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Informational Being developed ISO 30201 Human Resource Management System — Requirements Other ISO and International Standards and European Regulations 6
Sidney Vianna Informational ISO 30415:2021 Human resource management — Diversity and inclusion Other ISO and International Standards and European Regulations 2
H ISO 9001:2015 - 8.5.1 - Routers not being signed Manufacturing and Related Processes 5
Q Documented information ISO 9001:14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Is there a mandatory requirement to notify customers of the complaint resolution in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J ISO 9001:2015 Document Revison History ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q Risk Management ISO 14971 - Probability of Occurrence ISO 14971 - Medical Device Risk Management 8
Z Risk Management SOP ISO 14971 ISO 14971 - Medical Device Risk Management 1
C Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137) Qualification and Validation (including 21 CFR Part 11) 1
J ISO 13485 and new warehousing ISO 13485:2016 - Medical Device Quality Management Systems 2
Richard Regalado Informational ISO/IEC 27001:2022 has been published IEC 27001 - Information Security Management Systems (ISMS) 0
A Applying for ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 8
Q KPI rules for ISO 9001 first certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Ed Panek Auditor Feedback ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
K Help with ISO 14971: Benefit-Risk Analysis ISO 14971 - Medical Device Risk Management 3
A ISO 80601-2-30 - the rated range of cuff pressure in the IFU Other Medical Device Related Standards 0
V ISO 17025 Accreditation Consulting Needed ISO 17025 related Discussions 1
S ISO 13485 certification training Training - Internal, External, Online and Distance Learning 1
B New to ISO 14971. Comparing to MIL-STD-882 ISO 14971 - Medical Device Risk Management 7
Sidney Vianna Informational ISO Net Zero Guidelines - Free Download Sustainability, Green Initiatives and Ecology 4
Sidney Vianna Tesla Lacks Major Automotive Quality Certifications such as IATF 16949 and ISO 9001 IATF 16949 - Automotive Quality Systems Standard 15
D Is Good Laboratory Practice (GLP) Required in ISO 17025? ISO 17025 related Discussions 4
Ed Panek ISO 13485 Reporting Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
Cats Clause ISO 9001 - verification of Tape Measures and Steel rules ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
W Looking for IATF 16949 (and ISO 17025) QMS software Suggestions Quality Tools, Improvement and Analysis 8
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2

Similar threads

Top Bottom