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Accreditation to ISO 15189 involves the independent assessment of a laboratory to determine competence, impartiality and consistency. It addresses the qualifications and on-going competency of personnel involved in medical laboratory examinations, laboratory equipment, reagents, supplies, pre-analytical and analytical factors, quality assurance considerations, and post-analytical factors. Conduct a thorough evaluation of all factors in the laboratory that affect the production of test data, including : • technical competence of staff; • validity and appropriateness of test methods, including pre- and post- analytical elements such as sample collection and reporting; • sample quality, including patient identification, handling and transport to maintain sample integrity. A review of the history relating to previous patient results and any known clinical diagnoses. Procedures relating to the use of "referral laboratories" such as specia- lised testing centres for specific diseases. Traceability of measurements and calibrations to relevant standards. Suitability, calibration and maintenance of test equipment. Quality assurance of test data. To help you get accreditated, ALLDIAG has put in place various reagent Feel free to contact us to help you through the steps on getting accreditated. ALL.DIAG was founded in 1993 by healthcare professionals with a large experience in the in vitro diagnostic industry. Today ALL.DIAG is one of the leaders among clinical laboratories providing rapid diagnostic and healthcare products based on a philosophy of high quality and innovative products. ALL.DIAG is present over 40 countries and territories worldwide. 67038 Strasbourg Cedex - FRANCE AllLi DIAG

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