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ILNAS-EN ISO 15189:2022 Edition 12/2022
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
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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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 140 : In vitro diagnostic medical devices

Implementation

start of the vote on the project    21/10/2021   date of ratification (dor)    15/11/2022
end of the vote on the project    11/01/2022   date of anouncement (doa)    31/03/2023
start of the vote on the final project    18/08/2022   date of publication (dop)    30/06/2023
end of the vote on the final project    14/10/2022   date of withdrawal (dow)    31/12/2025


Publication Official Journal
of the Grand-Duchy of Luxembourg
22/06/2023
Reference Mémorial A N° 317

Relations

Evolutions
ILNAS-EN ISO 15189:2022/A11:2023

Relations to older standards
ILNAS-EN ISO 22870:2016
ILNAS-EN ISO 15189:2012

Relations to international standards
ISO 15189:2022 
ISO 15189 

International Classification for Standards (ICS codes) :

03.120.10 : Quality management and quality assurance
11.100.01 : Laboratory medicine in general

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