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EVS-EN ISO 15189:2012

Medical laboratories - Requirements for quality and competence (ISO 15189:2012)

General information
Withdrawn from 30.12.2022
Base Documents
ISO 15189:2012 + EVS-EN ISO 15189:2012/AC:2013; EN ISO 15189:2012

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 1221/2009 and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 765/2008 and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 768/2008 and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

The transition period to the new standard EVS-EN ISO 15189:2022 is 3 years and ends on 29.12.2025.

Standard history

Status
Date
Type
Name
30.12.2022
Main
09.09.2013
Corrigendum
05.12.2012
Main
Main
EVS-EN ISO 15189:2008
This International Standard specifies requirements for quality and competence in medical laboratories.
This International Standard 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.
NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
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