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Medical laboratories — Requirements for quality and competence

ISO 15189:2022

Medical laboratories — Requirements for quality and competence

This document specifies requirements for quality and competence in medical laboratories.

This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document is also applicable to point-of-care testing (POCT).

NOTE: International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

This document is available in electronic format only.

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Date of Publication: November 1, 2012

Order Code PDF: ISO15189E

Order Code Print: ISO15189

Edition: Third

Pages: 53

ISO 15189:2022 Additional Details

Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.

ISO 15189:2022 Abstract

ISO 15189:2012: Medical laboratories — Requirements for quality and competence This International Standard specifies requirements for quality management of a medical laboratory. Organization: ISO