prBAS EN ISO 15189:2023
Medical laboratories - Requirements for quality and competence
General information
Status:Project
Number of pages:75
Adoption method:Prijevod
Language:engleski
Edition:5.
Realization date:04.05.2023
Forseen date for next stage code:30.06.2023
Technical committee:BAS/TC 25, Healthcare
Directives:
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
ICS:
03.120.10, Quality management and quality assurance
11.100.01, Laboratory medicine in general
11.100.01, Laboratory medicine in general
Abstract
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.
Lifecycle
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Original document and degree of correspondence
EN ISO 15189:2022, identical
ISO 15189:2022, identical
Relation to BAS standards
Work material
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