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ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
ISO 15189:2012 outlines requirements for service agreements, as well as all parts of the examination processes. Results of examinations need to be reported accurately and clearly, and the release of these results and those procedures are also specified in this standard.
ISO 15189:2012 all types of medical laboratories, including those that provide diagnostic, therapeutic, and public health services..
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We will do a FREE GAP analysis of your organization with respect to Standard and give you a quote.