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. 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. 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.
The first version of the standard was published in 2003, and it was revised in 2007 to align more closely to ISO/IEC 17025. A third edition of the standard was published in 2012, which revised the layout again and added a section on laboratory information management.
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.
- Pereira, P. (February 2017). "ISO 15189:2012 Medical laboratories - Requirements for quality and competence". Westgard QC. Retrieved 28 November 2017.
- "Laboratory Quality Management System Handbook" (PDF). World Health Organization. 2011.
- Rej, R. (11 September 2013). "What's new in ISO 15189: 2012?" (PDF). Association of Public Health Laboratories. Retrieved 28 November 2017.
- 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.
- 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.
- 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.
- "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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