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ISO 15189

ISO 15189 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the quality management system of medical laboratories.

What is ISO 15189?

ISO 15189 is an international standard that outlines the requirements for medical laboratories to demonstrate competence in their operations. It specifically focuses on the quality management system within medical laboratories and covers aspect such as personal competency, testing procedures, equipment calibration, and result reporting. 

Why is ISO 15189 important?

ISO 15189 is important as it helps ensure the accuracy, reliability and overall quality of the medical laboratory testing, which is crucial for patient care and safety. By complying with ISO 15189, medical laboratories aim to establish and maintain a high level of quality in their operations. It helps ensure that laboratory testing is consistent, reliable, and meets the needs of patients and healthcare professionals. Compliance with this standard demonstrates a commitment to patient safety, quality healthcare, and continuous improvement in laboratory practices.

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