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Adding Quality to Values, ISO 15189:2012
Poster Title: Adding Quality to Values, ISO 15189:2012
Submitted on 26 May 2019
Author(s): Saundarya Kunaratnam,Turgaa Shini Devaraj,Chin Chin Liew, Suh Kuan Fong, Nor Hasyimah Emran, Anis Joelaira
Affiliations: Department of Biomedical Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
This poster was presented at Department of Biomedical Science, Faculty of Medicine
Poster Views: 455
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Poster Information
Abstract: ISO 15189:2012, also known as Medical laboratories - Requirements for quality and competence was developed to bring globally consistent standards to the quality management system requirements for medical laboratories. By 2015, medical laboratories in over 60 countries had adopted this standard in order to improve their health care quality. The management of laboratory is responsible for the competence and quality of laboratory services. Besides, this standard also emphasized on customer's satisfaction by meeting their requirements. The first publication of this standard was in 2003. Then, it was revised and republished in 2007 and 2012. ISO 15189:2012 is divided into two components which are management requirements (Part 4) and technical requirements (Part 5). Subsequent from the second revision, this standard is presented in a more understandable and approachable way with new clauses and subclauses included. With some additional details on requirements, this comprehensive document is now ordered in a more logical structure that corresponds to the realistic structure of modern medical laboratory. In short, accreditation with this standard promotes your laboratory systems that are as failure resistant as possible and more compliance to International Standards.

Summary: ISO 15189:2012 is an internationally accepted accreditation standard for quality management specific to medical laboratories. References: Noble, M. A. (2013). Everything you want to know about ISO 15189: 2012. Retrieved from
Rej, R. (2013). What’s new in IS0 15189:2012? [APHL QI Forum]. Retrieved from
Schneider, F., Maurer, C., & Friedberg, R. C. (2017). International Organization for Standardization (ISO) 15189. Annals of laboratory medicine, 37(5), 365-370.

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