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Accreditation For a Better Medical Laboratory Quality: ISO 15189:2012
EP30190
Poster Title: Accreditation For a Better Medical Laboratory Quality: ISO 15189:2012
Submitted on 28 May 2019
Author(s): Lee Siew Fun, Tay Yi Wen, Muhammad Hafizan Mustari, Wong Sweet Mun, Nur'Awatif Ishak
Affiliations: Department of Biomedical Science, Faculty of Medicine, University of Malaya
This poster was presented at In the course of "Laboratory Management And Quality Control" at Department of Biomedical Science
Poster Views: 253
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Poster Information
Abstract: ISO 15189:2012 based upon ISO/IEC 17025 and ISO 9001, specifies requirements for quality and competence in medical laboratories. ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. The 15189 standard is focused on the medical laboratory, and its goal is the customers’ satisfaction. For this purpose, the 15189 standards are based not only on a management system but also a set of medical laboratory technical specifications. ISO ‭Technical Committee ‭(TC) 212 ‬has developed ISO 15189‭ ‬‬in 2013 and revised it in 2017. ISO 15189:2012 is now under review and will be ISO/AWI 15189.Summary: -References: Schneider, F., Maurer, C.,& Friedberg, R. C. (2017). International Organization for Standardization (ISO) 15189. Annals of laboratory medicine, 37(5), 365-370.

International Organization for Standardization (2012). ISO 15189 Medical laboratories

Requirements for quality and competence. 3rd ed. Geneva: The Organization

Pereira P., (2017). ISO 15189:2012 Medical laboratories Requirements for quality and competence. Retrieved from https://www.westgard.com/iso 15189 2012 requirements 1.htm.
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