ISO, ILAC, IAF Streamline Quality Mgmt. Requirements for Medical Labs
November 5, 2009 // Published as a news service by IHS
In a joint communiqué by the International Organization for Standardization (ISO), the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF), medical laboratories accredited to ISO 15189:2007 are now recognized as meeting the management system principles of ISO 9001:2008.
The move was announced in September 2009 and was issued to address the misconception in the market that medical laboratories accredited to ISO 15189:2007 do not operate a recognized management system.
ISO 15189 is a sector-specific technical competence and management system standard.
Until now, accredited medical laboratories were often requested by their customers to take the additional step of certification to ISO 9001:2008 to demonstrate that they are in full control of their processes.
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, with the results accepted as meeting the principles of the management system requirements (ISO 9001:2008).
This recognition, according to ISO, will reduce redundant, costly and time-consuming audits.
Source: International Organization for Standardization (ISO).