Congratulations to our Covance Central Laboratory Services SA, in Geneva Switzerland for being the first of our laboratories to receive their ISO 15189 accreditation. The accreditation is based on the International Organization for Standardization (ISO) 15189 Standard for laboratories’ technical competence, management, and continual improvement. It focuses on improved patient safety and risk reduction, outlining standards for quality, and competence particular to medical laboratories.
CAP 15189 is voluntary, non-regulatory accreditation program to the ISO 15189 Standard as published by ISO. The program does not replace the CAP’s Clinical Laboratory Improvement Amendments (CLIA)-based Laboratory Accreditation Program, but complements CAP accreditation and other quality systems. The program optimizes processes to improve patient care and strengthens quality standards while managing to reduce institutional errors and risks.
Covance began its journey to move beyond US-centric regulatory standards and to embrace the new, more stringent global ISO standards back in 2010 via a systematic process of enhancing our Quality Management System (QMS). We chose our central laboratory in Geneva to be the first of our labs to go through the ISO 15189 accreditation process. In October 2013, our Geneva laboratory was assessed for ISO 15189 compliance, and received accreditation shortly afterward.
We were delighted to receive the following feedback from the CAP ISO 15189 assessment team during our Geneva Accreditation audit:
“Overall, Covance Laboratory Geneva has a robust quality management system. The processes in place and the consistency in messaging between upper management and staff show evidence of the dedication and commitment to live the Covance mission of helping clients bring miracles of medicine to market sooner, and vision whose hallmarks are great people, high-quality data, and a proven track record of integrating and streamlining development processes.”
Covance is committed to delivering the highest possible data quality. We believe living up to the ISO 15189 standards will aid us in this journey of continuous improvement. The journey continues… Our laboratory in Singapore received its accreditation audit in June 2014 and is waiting to receive confirmation of accreditation.