Information on implementation of the new standard МКС EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence

Information on implementation of the new standard МКС EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence

 

In December 2012, ISO published the new standard ISO 15189:2012 " Medical laboratories - Requirements for quality and competence " , which replaces the standard (МКС ISO 15189:2010) "Medical laboratories - Particular requirements for quality and competence".

 

The transition period of standard ends on 1 March 2016.

 

According to the Procedure PR 04-01 "Modification of the Requirements for Accreditation" IARM prepare an action plan for implementation of the changes to the requirements for accreditation under the new standard.

 

Under the plan, IARM will start performing assessments according to the new standard MKS EN ISO 15189:2013, by the client’s request from 1st of March 2014 and from 1st of January 2015 all assessments will be conducted in accordance with the new standard.
 

PUBLIC ANNOUNCEMENT