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ISO 15189 - Medical Laboratories

The ISO 15189 standard is used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

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ISO 15189 - Medical Laboratories

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  1. ISO 15189:2012MEDICAL LABORATORIES

  2. The ISO 15189 standarddocument is focused on the medical laboratory, and its goals can be interpreted as the satisfaction of interested parties . Stakeholders cannot be understood as customers only, such as patients, but inclusive of any internal or external involvement with the medical laboratory, including, but not only, professionals, suppliers and accreditation agencies. The difference between ISO 9001 and ISO 15189 approach that is immediately recognized is the presence of medical-technical laboratory requirements in ISO 15189. The framework provides a quality management system close to the ISO 9001:2008 management requirements added by specifications for technical competence that are particular to medical laboratories.

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