ISO 15189: Difference between revisions

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{{Short description|ISO standard}}
{{nofootnotes|date=January 2016}}
'''''ISO 15189''' Medical laboratories — Particular requirements for quality and competence'' specifies the quality management system requirements particular to medical laboratories. The standard was developed by the [[International Organisation for Standardization]]'s Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of [[ISO/IEC 17025|ISO/IEC 17025:1999]] ''General requirements for the competence of testing and calibration laboratories''. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of health care staff.
'''''ISO 15189 Medical laboratories — Requirements for quality and competence''''' is an international standard that specifies the [[quality management system]] requirements particular to [[Medical laboratory|medical laboratories]]. The standard was developed by the [[International Organisation for Standardization]]'s Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of [[ISO/IEC 17025|ISO/IEC 17025:1999]] ''General requirements for the competence of testing and calibration laboratories''.<ref name="PereiraISO15189_17">{{cite web |url=https://www.westgard.com/iso-15189-2012-requirements-1.htm |title=ISO 15189:2012 Medical laboratories - Requirements for quality and competence |author=Pereira, P. |publisher=Westgard QC |date=February 2017 |access-date=28 November 2017}}</ref> This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff.<ref name="PereiraISO15189_17" /> While the standard is based on ISO/IEC 17025 and [[ISO 9001]], it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.<ref name="lqms">{{cite news |title=Laboratory Quality Management System Handbook |url=https://www.who.int/ihr/publications/lqms_en.pdf |publisher=World Health Organization |date=2011}}</ref>


==History==
The first version was published in 2003, it was revised in 2007 and the third edition of the standard was published in 2012.
The first version of the standard was published in 2003, and it was revised in 2007 to align more closely to ISO/IEC 17025.<ref name="PereiraISO15189_17" /> A third edition of the standard was published in 2012, which revised the layout again and added a section on [[Laboratory information management system|laboratory information management]].<ref name="RejWhats13">{{cite web |url=https://www.aphl.org/mrc/documents/lss_2013sept11_qif-presentation-whats-new-in-iso-15189(2012).pdf |title=What's new in ISO 15189: 2012? |author=Rej, R. |publisher=Association of Public Health Laboratories |date=11 September 2013 |access-date=28 November 2017}}</ref>


Starting in 2010, it took four years for the [[Kenya]] National HIV [[Reference Laboratory]] to gain ISO 15189 accreditation.<ref name="gachuki14">{{cite journal |doi=10.4102/ajlm.v3i2.216|title=Attaining ISO 15189 accreditation through SLMTA: A journey by Kenya's National HIV Reference Laboratory |year=2014 |last1=Gachuki |first1=Thomas |last2=Sewe |first2=Risper |last3=Mwangi |first3=Jane |last4=Turgeon |first4=David |last5=Garcia |first5=Mary |last6=Luman |first6=Elizabeth T. |last7=Umuro |first7=Mamo |journal=African Journal of Laboratory Medicine |volume=3 |issue=2 |page=216 |pmid=26753130 |pmc=4703332 |s2cid=17192412 }}</ref>
While the standard is based on ISO/IEC 17025 and [[ISO 9001]], it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.


In 2015 Plebani ''et al'' pointed out that "despite its growing global recognition by the main scientific organizations in the field of laboratory medicine, in many countries only a small number of laboratories are currently accredited" to ISO 15189.<ref name="plebani15">{{cite journal |doi=10.1515/cclm-2015-0355|title=Once upon a time: A tale of ISO 15189 accreditation |year=2015 |last1=Plebani |first1=Mario |last2=Sciacovelli |first2=Laura |last3=Chiozza |first3=Maria Laura |last4=Panteghini |first4=Mauro |journal=Clinical Chemistry and Laboratory Medicine |volume=53 |issue=8 |pages=1127–1129 |pmid=25992514 |s2cid=207448605 |doi-access=free }}</ref>
Software solutions designed specifically for medical laboratories can aid in achieving ISO 15189 based [[accreditation]]. In particular, document control software can help by improving turnaround time (TAT) for document reviews, increasing efficiency of staff and improving overall quality.


In 2019 the question was asked "How Does ISO 15189 Laboratory Accreditation Support the Delivery of [[Healthcare]] in [[Ethiopia]]?" and answered by a systematic review.<ref name="adane19">{{cite journal |doi=10.4314/ejhs.v29i2.13|title=How Does ISO 15189 Laboratory Accreditation Support the Delivery of Healthcare in Ethiopia? A Systematic Review |year=1970 |last1=Adane |first1=Kasaw |last2=Girma |first2=Mekonnen |last3=Deress |first3=Teshiwal |journal=Ethiopian Journal of Health Sciences |volume=29 |issue=2 |pages=259–264 |pmid=31011274 |pmc=6460445 }}</ref>
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== See also ==
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* [[List of ISO standards]]
* [[Medical technologist]]
* [[Clinical biologist]]
* [[Pathologist]]


In 2021 it became apparent that the [[International Health Regulations]] was a driver for ISO 15189 accreditation when the [[UKHSA]] provided training to [[Ethiopian Public Health Institute|EPHI]] staff.<ref name="tghni">{{cite news |title=ISO 15189 medical laboratory training provided to EPHI staff |url=https://gphihr.tghn.org/news/iso-15189-medical-laboratory-training-provided-ephi-staff/ |agency=International Health Regulations Strengthening Project |publisher=The Global Health Network |date=28 October 2021}}</ref>
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== References ==
* ISO 15189:2012
* ISO 15189:2007
* ISO 15189:2003
* ISO/IEC 17025:1999
* ISO/IEC 17025:2005
* ISO 9001:2000


In 2022 the 4th edition of ISO 15189 was published.
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== External links ==

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==See also==
* [[Quality management system]]
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* [[List of ISO standards]]

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==External links==
*{{Official website|1=http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=56115 |name=Entry in ISO Standards catalogue}}
*{{Official website|1=http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=56115 |name=Entry in ISO Standards catalogue}}
* [Benefits of ISO 15189 Accreditation http://www.punyam.com/iso-15189-certification-consultant.htm]
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{{ISO standards}}


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==References==
{{Reflist|colwidth=30em}}

<!---Place all category tags here-->
[[Category:ISO standards|#15189]]
[[Category:ISO standards|#15189]]
[[Category:International Health Regulations]]
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{{ISO standards}}

Latest revision as of 06:29, 2 August 2023

ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories.[1] This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff.[1] While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.[2]

History[edit]

The first version of the standard was published in 2003, and it was revised in 2007 to align more closely to ISO/IEC 17025.[1] A third edition of the standard was published in 2012, which revised the layout again and added a section on laboratory information management.[3]

Starting in 2010, it took four years for the Kenya National HIV Reference Laboratory to gain ISO 15189 accreditation.[4]

In 2015 Plebani et al pointed out that "despite its growing global recognition by the main scientific organizations in the field of laboratory medicine, in many countries only a small number of laboratories are currently accredited" to ISO 15189.[5]

In 2019 the question was asked "How Does ISO 15189 Laboratory Accreditation Support the Delivery of Healthcare in Ethiopia?" and answered by a systematic review.[6]

In 2021 it became apparent that the International Health Regulations was a driver for ISO 15189 accreditation when the UKHSA provided training to EPHI staff.[7]

In 2022 the 4th edition of ISO 15189 was published.

See also[edit]

External links[edit]

References[edit]

  1. ^ a b c Pereira, P. (February 2017). "ISO 15189:2012 Medical laboratories - Requirements for quality and competence". Westgard QC. Retrieved 28 November 2017.
  2. ^ "Laboratory Quality Management System Handbook" (PDF). World Health Organization. 2011.
  3. ^ Rej, R. (11 September 2013). "What's new in ISO 15189: 2012?" (PDF). Association of Public Health Laboratories. Retrieved 28 November 2017.
  4. ^ Gachuki, Thomas; Sewe, Risper; Mwangi, Jane; Turgeon, David; Garcia, Mary; Luman, Elizabeth T.; Umuro, Mamo (2014). "Attaining ISO 15189 accreditation through SLMTA: A journey by Kenya's National HIV Reference Laboratory". African Journal of Laboratory Medicine. 3 (2): 216. doi:10.4102/ajlm.v3i2.216. PMC 4703332. PMID 26753130. S2CID 17192412.
  5. ^ Plebani, Mario; Sciacovelli, Laura; Chiozza, Maria Laura; Panteghini, Mauro (2015). "Once upon a time: A tale of ISO 15189 accreditation". Clinical Chemistry and Laboratory Medicine. 53 (8): 1127–1129. doi:10.1515/cclm-2015-0355. PMID 25992514. S2CID 207448605.
  6. ^ Adane, Kasaw; Girma, Mekonnen; Deress, Teshiwal (1970). "How Does ISO 15189 Laboratory Accreditation Support the Delivery of Healthcare in Ethiopia? A Systematic Review". Ethiopian Journal of Health Sciences. 29 (2): 259–264. doi:10.4314/ejhs.v29i2.13. PMC 6460445. PMID 31011274.
  7. ^ "ISO 15189 medical laboratory training provided to EPHI staff". The Global Health Network. International Health Regulations Strengthening Project. 28 October 2021.
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