Rinsho byori. The Japanese journal of clinical pathology
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Review
[Quality management system in the medical laboratory--ISO15189 and laboratory accreditation].
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. ⋯ 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.