Quality assurance in occupational and environmental laboratory medicine.
In a medical laboratory service, quality assurance (QA) concerns all those actions necessary to provide confidence that the results of laboratory tests will satisfy defined standards for quality. Taking into account the type of testing concerned and the techniques involved, quality assurance will encompass all steps taken to ensure that laboratory results are reliable. It covers the use of scientifically and technically sound practices for laboratory investigations, including selection, collection, transport, identification, storage, preparation and manipulation of specimens and recording, reporting and interpretation of the results. QA refers also to other activities designed to improve the reliability of investigations such as staff training and management, evaluation of the adequacy of the laboratory environment, maintenance and calibration of instruments and the use of technically validated and properly documented methods. All these activities should be described in a quality manual. This document is a prerequisite to obtain certification of the quality system or laboratory accreditation, according to the International Standard ISO 29000 series or the European Standard EN 45001, respectively.
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Laboratorio di Biochimica Clinica, Istituto Superiore di Sanità, Rome, Italy.
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D000068:Accreditation; D002568:Certification; D019550:Environmental Medicine / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D009787:Occupational Medicine / Q000592:standards*; D011786:Quality Control