Medical laboratories accredited to ISO 15189:2012 (a sector-specific technical competence and management system standard) are recognized as meeting the management system principles of ISO 9001:2008.
The move was announced in a joint communiqué by ISO (the International Organization for Standardization), ILAC (the International Laboratory Accreditation Cooperation) and the IAF (the International Accreditation Forum) in September 2009 and updated in January 2015 as a result of the revision of ISO15189 in 2012.
The ISO-IAF-ILAC communiqué was issued to address the misconception in the market that medical laboratories accredited to ISO 15189:2012 do not operate a recognized management system.
Until now, accredited medical laboratories were often requested by their customers to undertake the additional step of obtaining certification to ISO 9001:2008 to demonstrate that they are in full control of their processes.
Medical laboratories accredited to ISO 15189 have demonstrated that they also meet the management systems principles of ISO 9001:2008. Accredited medical laboratories that are included in the scope of a larger organization’s certification to ISO 9001 should only need to be assessed according to ISO 15189, and these results will be accepted as meeting the principles of the management system requirements (ISO 9001:2008).
This recognition will improve the efficiency of audits and enable medical laboratories to better meet their customers’ needs.