Medical laboratories accredited to ISO 15189:2007 (a sector-specific technical competence and management system Standard) are recognised as meeting the management system principles of ISO 9001:2008 Quality management systems – Requirements.
The move to streamline quality management requirements for medical laboratories was announced in a joint communiqué by International Organization for Standardization (ISO), International Laboratory Accreditation Cooperation (ILAC), and International Accreditation Forum (IAF) 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 recognised 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.
Under the new procedures, medical laboratories accredited to ISO 15189 will now be recognised as meeting the management system principles of ISO 9001:2008. Accredited medical laboratories that are part of a larger organisation 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.