/CNW/ - Norgen Biotek Corp., an innovative Canadian biotechnology company focusing principally on advancing powerful innovations for nucleic acid and protein purification, today announced successful certification to ISO 13485:2003 and ISO 9001:2008. ISO 13485 and ISO 9001 are world-recognized quality management system standards, with ISO 13485 specifically pertaining to the requirements for a comprehensive management system for the design and manufacture of medical devices. Certification to these ISO standards strengthens Norgen’s commitment to uphold the highest quality in manufacturing our best-in-class kits for sample preparation, as well as our commitment to continual improvement in our overall performance. The quality system was audited by BSI Management Systems Inc, one of the foremost auditing bodies in the world.
This move to certification comes as Norgen looks to leverage their first-in-class kits and sample preparation expertise to produce diagnostic kits. In particular, Norgen is in the process of transitioning a number of their leading products into nucleic-acid based diagnostic kits. Reliable and simple procedures for isolating DNA or RNA are critical to the sensitivity and specificity of nucleic-acid based diagnostic kits, and Norgen’s technology is well positioned to set new standards in the area of diagnostics. Certification to ISO 13485 is a requirement for the manufacturing of commercial medical devices including in-vitro diagnostic kits, thus achieving ISO 13485 certification will greatly facilitate this transition for Norgen.
“...with the ISO certification we can transition our first in class kits into diagnostics. The sensitivity and specificity of the diagnostic kit is highly dependent on sample preparation, therefore we are in an excellent position to make this successful transition”
“We are dedicated to providing our customers with first class sample preparation kits for RNA, microRNA, DNA and protein purification, clean-up and concentration and to provide dedicated and expert support services to our customers and partners worldwide” said Dr. Yousef Haj-Ahmad, President & CEO. “And now with the ISO certification we can transition our first in class kits into diagnostics. The sensitivity and specificity of the diagnostic kit is highly dependent on sample preparation, therefore we are in an excellent position to make this successful transition” said Dr. Yousef Haj-Ahmad, President & CEO of Norgen Biotek.