Ann Biol Clin (Paris)
June 2013
Metrology resumes activities which allow the management of results measurement quality. In this paper, we present basic principles of metrology applied to the activities of laboratory medicine. We successively treat general concepts useful for laboratory staff, the interest in the definition of a metrological function and its activities field, the applications in measuring instruments necessary for the exams of medical biology, and the specific documentation control needed.
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June 2013
This article describes the dispositions to apply according to the requirements of the EN ISO 15189 standard for selection, purchasing and management of equipment, reagents and consumables in the medical laboratory. Recommendations are developed for acceptance testing, calibration and metrological traceability, maintenance and repair, adverse incident reporting and records to keep.
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June 2013
Continual improvement of the quality in a medical laboratory is based on the implementation of tools for systematically evaluate the quality management system and its ability to meet the objectives defined. Monitoring through audit and management review, addressing complaints and nonconformities and performing client satisfaction survey are the key for the continual improvement.
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June 2013
The aim of this article is to review the main issues to fulfil for implementing an efficient quality management system. This is a condition of successful for continuous improvement.
View Article and Find Full Text PDFThe guidelines describe the essential parts of the quality management system to fulfil the requirements of the standard EN ISO 15 189. It includes mainly the organisation, the definition of responsibilities, training of personnel, the document control, the quality control, identification and control of nonconformities, corrective actions, preventive actions and evaluation, as audits and the management review.
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