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ILNAS-EN ISO 15189:2012 Edition 11/2012
Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
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ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.


Standard - Active


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


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


start of the vote on the project    06/01/2011   date of ratification (dor)    31/10/2012
end of the vote on the project    06/06/2011   date of anouncement (doa)    28/02/2013
start of the vote on the final project    09/08/2012   date of publication (dop)    31/05/2013
end of the vote on the final project    09/10/2012   date of withdrawal (dow)    30/11/2015

Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference Mémorial A N° 92



Relations to older standards
ILNAS-EN ISO 15189:2007

Relations to international standards
ISO 15189 
ISO 15189:2012 
ISO 15189:2012 

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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