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  • Title: [Effects of the ISO15189 accreditation on clinical laboratory].
    Author: Shitara M, Umezu S, Katsuno H.
    Journal: Rinsho Byori; 2009 Jun; 57(6):521-6. PubMed ID: 19621783.
    Abstract:
    The WTO/TBT (World Trade Organization/Technical Barriers to Trade) was made in 1995, which made it obligatory to use international standards as a basis for establishing technical standards. As a result, in order to secure technical superiority, efforts to reflect one's own country's technical superiority in the international standards by the ISO/IEC(International Organization for Standardization/International Electrotechnical Commission) are needed, as well as establishment of a system that enables prompt response to standardization through opinion exchange and information collection by active attendance in conferences on standardization. Also in clinical testing, ISO15189 standard "Medical Laboratory-Particular Requirements for Quality and Competence" was issued in February 2003, and an environment for international standardization of clinical laboratory was established. Meeting Chapter 4: management requirement and Chapter 5: technical requirement, the requirements of this standard, being evaluated by a third party, and getting accredited results in an enhancement of credibility of clinical testing service both in Japan and abroad, and increased possibility of realizing mutual comparison of test results. Therefore, as someone in charge of clinical testing, I recognized the necessity to establish a testing environment that responds to standardization, and applied for pilot examination by the Japan Accreditation Board for Conformity Assessment (JAB) and acquired ISO15189 certification on December 1, 2005. Three years have passed since the accreditation. Aiming to evaluate the effects of the accreditation, I focused on the incidents and accidents of our department of clinical laboratory, and analyzed the changes in their number and content in the past five years for a comparison of before and after the accreditation. I herein report the results of the analysis.
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