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ILNAS-EN ISO 15189:2012
Edition
11/2012
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
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Abstract
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.
Status
| Standard - Superseded |
Origin
| Technical Committee : |
| CEN/TC 140 : In vitro diagnostic medical devices |
Directives
Implementation
| 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 |
05/06/2013 |
| Reference | Mémorial A N° 92 |
Relations
| Evolutions |
| ILNAS-EN ISO 15189:2022 |
| 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 |
