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SRPS EN ISO 15189:2023
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
Buying
Published
Scope
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.
Related directives
Directives related to this standard.
765/2008
REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
Life cycle
PREVIOUSLY
WITHDRAWN
SRPS EN ISO 15189:2014
WITHDRAWN
SRPS EN ISO 22870:2017
WITHDRAWN
SRPS EN ISO 22870:2017
NOW
PUBLISHED
SRPS EN ISO 15189:2023
60.60
Standard published
Feb 28, 2023