ISO15189:2007 2nd edition - Main Changes

Date: 15 October 2007 

ISO15189:2007 2nd edition was published in April 2007.  The standard is only available from ILI, 42-44 Northumberland Road, Dublin 4, Web:  www.standards.ie

The standard was revised to align it with ISO17025:2005 2nd Edition. The main changes are as follows:-

  • Clause 4.1.6 “Laboratory management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the quality management system” has been added.  (This clause is in ISO 17025:2005.)
  • Annex A cross-reference table has been updated to align it with ISO17025:2005.

There will be a 2 year transition period to ISO 15189:2007 from date of publication (15th April 2007).

INAB does not envisage laboratories having any difficulties implementing the minor change (implementation of Clause4.1.6) into their management systems. 

In order to ensure that all laboratories have been verified as complying with ISO 15189 2nd edition by April 2009, INAB will commence assessing laboratories to the new standard from January 2008.

INAB looks forward to working with you to ensure a smooth transition to ISO 15189:2007 2nd Edition.

If you have any queries please contact me..