Norgen Biotek Corp. Achieves ISO 13485:2003 and ISO 9001:2008 Certification
Norgen Biotek Corp. 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. The quality system was audited by BSI Management Systems Inc, one of the foremost auditing bodies in the world.
“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.
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