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ISO 15189 - Medical Laboratories Accreditation: Particular Requirements for Quality and Competence |
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Tuesday, 13 October 2009 17:51 |
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The duties of medical laboratories consist essentially of analyzing biological samples for purposes of screening, diagnosis, follow-up, and the treatment and prevention of disease. The laboratory's aim is not only to provide accurate results but also to do so within a reasonable turn around time, with traceability of all laboratory procedures, a respect for ethics and to assure the safety of patients and staff alike.
A quality management system for laboratories sets standards for the requisition of the analysis, patient identification and preparation, collection, transportation, storage, processing and examination of patient samples, in addition to setting standards for validation and interpretation of patient test results. In order to obtain recognition for service and output quality, medical laboratories seek to demonstrate compliance with international standards.
International standard ISO 15189 is closely related to ISO 17025 but is designed specifically for accreditation of medical laboratories, using language adapted to a medical testing environment and with an emphasis on providing quality service to patients and health care providers. ISO 15189 emphasizes the quality of contributions to patient care, as well as of laboratory and management procedures.
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Accreditation 
