Abstract
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Highlights
The International Organization for Standardization’s (ISO) 15189 is the gold standard quality criteria for medical laboratories[1] and accreditation is the recognition of a quality system in full compliance with this standard
Launched by the World Health Organization’s Regional Office for Africa (WHO AFRO) and partners, the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) and Strengthening Laboratory Management Toward Accreditation (SLMTA) programmes have emerged in recent years in Africa to support laboratories in the implementation of quality processes.[2,3,4,5]
At the end of 2012, ISO published the third edition of ISO 15189,6 which replaces the 2007 version.[7]
Summary
The International Organization for Standardization’s (ISO) 15189 is the gold standard quality criteria for medical laboratories[1] and accreditation is the recognition of a quality system in full compliance with this standard. Aware of the current challenges in the fields of public health and biomedical research, African medical laboratories may need to develop Quality Management Systems (QMS) compliant with the requirements of ISO 15189. As with any other quality system, ISO standards evolve and are revised periodically. At the end of 2012, ISO published the third edition of ISO 15189,6 which replaces the 2007 version.[7] The goal of this article is to highlight the major changes between the two versions of this standard, as well as the modifications these changes will require in quality systems already in place in laboratories, especially in African laboratories
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