An overview of ISO 15189 accreditation, and the impact on and the efforts exerted toward its maintenance after accreditation
Journal Title: Journal of Analytical Bio-Science - Year 2011, Vol 34, Issue 4
Abstract
The quality and safety of medical care is an important issue in today's world, where the clinical laboratory must specifically demonstrate its quality and capability to both clinicians and patients. To do so, their evaluation and accreditation with ISO 15189 according to a third-party organization is necessary. The reviews for accreditation with ISO 15189 by the Japan Accreditation Board for Conformity Assessment (JAB), which became one of the Public Interest Incorporated Associations in July of 2010, were inaugurated in 2004. Fifty-nine Japanese institutions obtained ISO 15189 accreditation by July of 2011. The number of institutions with ISO 15189 accreditation is gradually increasing. Last autumn, four years after the first ISO 15189 accreditation in January 2007, we, the Department of Clinical Laboratory of the University of Tokyo Hospital, renewed our accreditation. Here, we provide an overview of ISO 15189 accreditation and its impact as well as our efforts for its maintenance following accreditation.
Authors and Affiliations
Shigeo Okubo, Hiromitsu Yokota, Hitoshi Ikeda, Yutaka Yatomi
Keywords
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