ISO 15189:2012 is an international standard that specifies requirements for the competence and quality management of medical laboratories. It outlines criteria for the development, implementation, and maintenance of a quality management system tailored to the specific needs of medical testing laboratories. The standard covers various aspects of laboratory operations, including personnel competence, equipment calibration, testing procedures, quality control, and result reporting. ISO 15189:2012 emphasizes the importance of accuracy, reliability, and traceability in laboratory testing processes to ensure the provision of reliable and timely diagnostic information.
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ISO certification is a globally acknowledged framework used to evaluate the management systems of companies on an international scale.
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