/CNW/ - Norgen Biotek Corp., an innovative Canadian biotechnology company focusing principally on advancing powerful innovations for nucleic acid and protein preservation and purification from all type of specimens for research and molecular diagnostic applications, today announced successful accreditation to ISO 15189:2007 by the Standards Council of Canada (SCC). This ISO accreditation emphasizes our commitment to quality in our laboratory and R&D services. Norgen's scope of accreditation for ISO 15189 will allow the company to provide high quality, competent molecular diagnostic testing for research purposes and clinical trials. Moreover, this ISO certification will be a great benefit to Norgen in obtaining regulatory approval for our various in vitro molecular diagnostic kits which are currently marketed for research use.
"Currently, we have over a 100 in vitro MDx kits for the detections of all type of pathogens for research use."
This new ISO 15189:2007 accreditation will complement Norgen's current quality certifications to ISO 9001:2008 as well as ISO 13485:2003. ISO 9001:2008 certification indicates our continuing commitment to our quality management system, while certification to ISO 13485 is a requirement for the manufacturing of commercial medical devices including in vitro diagnostic kits. Certification to all three of these ISO standards strengthens Norgen's commitment to uphold the highest quality in manufacturing our best-in-class products for sample preparation as well as our commitment to providing highly competent R&D and diagnostic testing services.
"Currently, we have over a 100 in vitro MDx kits for the detections of all type of pathogens for research use. This latest ISO certification (15189:2007) is critical for taking all of these kits through the regulatory approval process. Also, this certification is a testimony to the high quality products and services that we provide at Norgen Biotek" said Dr. Yousef Haj-Ahmad, President & CEO of Norgen Biotek.
Copyright © 2020 Norgen Biotek Corp.