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CENTOGENE Earns Accreditation to ISO 15189:2012 from CAP

The College of American Pathologists (CAP), a Center for Medicare and Medicaid Services (CMS)-approved accreditation authority, has awarded CENTOGENE AG accreditation to the ISO15189standardunder the CAP 15189SM Accreditation Program.

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 15189SMcomplements CAP accreditation and other quality systems. The program optimizes processes to improve patient care, strengthens quality standards while reducing institutional errors and risks, and controls costs. CAP 15189SM is an educational program that offers a highly disciplined approach to implementing and sustaining change.

“The ISO15189 Standard provides a comprehensive quality management framework that allows laboratories not only to 'study for the exam' but also to 'learn for life',” said Frank Schneider, MD, FCAP, and Chair of the CAP 15189 Committee. “Laboratories working towards its implementation have chosen a path of continual improvement. They embrace their problems and seek intelligent solutions, thereby enhancing patient care as well as customer and staff satisfaction.”

“Our Quality Management System integrates into every aspect of our operations, spanning from data integrity and privacy, patient safety, responsibility to scientific research and innovations. We follow the strictest quality criteria in an effort to meet our customer’s requirements in clinical diagnostics, clinical trial services and research and development,” said Dr. Arndt Rolfs, founder and CEO of CENTOGENE.

For additional information on the CAP 15189SM Program, e-mail


CENTOGENE unlocks the power of genetic insights to improve the quality of life of patients with rare genetic diseases. We achieve this through knowledge created by our worldwide diagnostic testing services incorporating global diversity, the world’s leading proprietary human genetic interpretation database- CentoMD® and by providing solutions for pharmaceutical companies developing life-changing therapies.

As one of the largest genetic testing companies worldwide, CENTOGENE is dedicated to translating the science of genetic information into solutions- bringing hope to patients with rare diseases and their families.;

About the College of American Pathologists

As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, READ THE CAP ANNUAL REPORT at CAP.ORG.

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Last Updated: 08-Nov-2018