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ONORM EN ISO 15189:2023

Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in the development of their management systems and the assessment of their competence. Furthermore, it is applicable to confirm or recognize the competence of medical laboratories by customers of the laboratory, supervisory authorities and accreditation points. This document can also be applied to the patient -related immediately diagnosis (POCT).

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