ISO 15189 CommuniquéNotices
Medical laboratories accredited to ISO 15189:2007 (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.
The ISO-IAF-ILAC communiqué was issued to address the misconception in the market that medical laboratories accredited to ISO 15189:2007 do not operate a recognized management system.
Until now, accredited medical laboratories were often requested by their customers to undertake the additional step of certification to ISO 9001:2008 to demonstrate that they are in full control of their processes.
Based on the new procedures, medical laboratories accredited to ISO 15189 will now be recognized as meeting the management systems principles of ISO 9001:2008. Accredited medical laboratories that are part of a larger organization certified to ISO 9001 should only need to be assessed once according to ISO 15189, and these results accepted as meeting the principles of the management system requirements (ISO 9001:2008).
This recognition will reduce redundant, costly and time-consuming audits and, at the same time, enable medical laboratories to better meet their customers’ needs.