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Joint IAF-ILAC-ISO Communiqué on the Management system requirements of ISO 15189 - Medical laboratories - Particular requirements for quality and competence

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08 November 2021

Joint IAF-ILAC-ISO Communiqué on the

Management system requirements of ISO 15189 - Medical laboratories - Particular requirements for quality and competence

A medical laboratory's fulfilment of the requirements of ISO 15189

means the laboratory meets both the technical competence requirements and the management system requirements necessary for it to consistently deliver technically valid test results. The management system requirements in

ISO 15189 are written in language relevant to a medical laboratory’s operations.

Medical laboratories that implement ISO 15189 operate generally in accordance with the principles of ISO 9001.

_______________________ ______________________

IAF Chair Emanuele Riva

______________________

ILAC Chair

Etty Feller ISO Secretary General

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