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Rinsho Byori. 2004 Mar;52(3):274-8.

[Quality management system in the medical laboratory--ISO15189 and laboratory accreditation].

[Article in Japanese]

Author information

  • 1Analysis Center for Medical Science, SRL, Inc., Hachioji 192-0031.


Medical laboratory services are essential to patient care and therefore should meet the needs of all patients and clinical personnel responsible for human health care. Recently, ISO15189, the first quality management ISO system for medical laboratories, has attracted the attention of all medical laboratories. ISO 15189:2003, Medical laboratories--Particular requirements for quality and competence, provides a framework for the design and improvement of process-based quality management systems by medical laboratories. It is based on ISO17025:1999, General requirements for the competence of testing and calibration laboratories, but provides specific requirements for implementation in medical laboratories. This will help medical laboratories to comply with regulatory requirements, to meet the expectations of their clients and, most importantly, to improve and maintain their service to patients. ISO15189 will be an important template for assessing and recognizing the competence of medical laboratories in their technical capacity and the effective quality management of a professional service and its staff--with or without the aim of accreditation.

[PubMed - indexed for MEDLINE]
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