Claritas is the eighth clinical laboratory in the United States to be awarded ISO 15189 accreditation, the accreditation for quality and competence in medical laboratories

January 07, 2016

BOSTON, Massachusetts | January 7, 2016 – Claritas Genomics, Inc., is pleased to announce that they have been granted ISO 15189 accreditation (Certificate 3712.01) by the American Association for Laboratory Accreditation (A2LA), after a thorough assessment and review of its quality management system and competence to perform over 100 molecular diagnostic tests on the Claritas menu. 

Claritas decided to pursue ISO certification shortly after spinning out of Boston Children’s Hospital in February 2013.  “We felt the complex nature of molecular diagnostics warranted the rigor of a total quality management system in addition to traditional clinical laboratory certifications” says Mary Ellen Cortizas, COO of Claritas Genomics.  “The ISO process requires quality management systems for not only the testing processes but for all the underlying programs in a laboratory that support clinical testing.”  In addition, while other programs accredit the organization, ISO 15189 accredits at the individual test level.  Test level review insures that all new tests are reviewed prior to being added to the accreditation.

The two year process involved staff from all parts of the organization, and included implementation of a new document control system and integration of over five hundred standards.  “Everyone at Claritas was motivated to achieve ISO accreditation, and is  proud to  have completed this in a fairly short time frame,” says Cortizas.

A2LA is the largest U.S.-based, multi-discipline accreditation body with over 35 years of experience providing internationally recognized accreditation services and quality training.  A2LA’s world-class accreditation services encompass testing and calibration laboratories, medical testing laboratories, inspection bodies, proficiency testing providers, reference material producers and product certification bodies.  Organizations are accredited to international standards and field-specific requirements developed with government and industry collaboration.  A2LA also offers a wide variety of both public and private on-site training programs to complement the various accreditation programs.  

About Claritas Genomics
Claritas Genomics serves children affected with complex genetic disorders by providing timely and accurate results, resolving families’ long search for answers. By combining clinical expertise of the world’s best pediatric specialists with innovative platform solutions, Claritas is working to improve patient care and enable new discoveries.

For more information about Claritas Genomics, visit

Betsy Stevenson
Director of Corporate Communications
[email protected]
Tel: (860) 984-1424