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ISO 15189: An Essential Standard for Medical Laboratories

The healthcare industry operates under rigorous standards to ensure the accuracy, reliability, and timeliness of medical diagnoses and treatment. Among these, ISO 15189 has emerged as a cornerstone in the domain of medical laboratories. This international standard specifies the quality and competence requirements particular to medical laboratories, playing a pivotal role in ensuring consistent and reliable patient care. Understanding ISO 15189 ISO 15189, titled "Medical laboratories — Requirements for quality and competence," was first published by the International Organization for Standardization (ISO) in 2003. This standard is specifically tailored to medical laboratories, drawing from the general requirements of ISO/IEC 17025 (testing and calibration laboratories) and ISO 9001 (quality management systems). It serves as a framework for laboratories to develop robust management systems, ensure technical competence, and consistently generate valid results. The standard cov...