Mologic certification to ISO 9001 and ISO 13485 recommended, September 2015.
Following the audit by an independent certification body (URS Ltd) on 8-10 September, we are extremely pleased to announce that Mologic has been recommended for certification to ISO 9001 and ISO 13485. Meeting these standards demonstrates Mologic’s commitment to ensuring efficient business processes are in place. This means that we meet our customers’ requirements as well as continuously striving for improvement.
ISO 9001 is the generic quality management system (QMS) standard for businesses. ISO 13485 is recognised internationally as the gold standard, ensuring rigorous quality systems are in place for the development and manufacturing of medical devices.
“We have always been dedicated to creativity and scientific rigour in meeting our customers’ requirements. This recommendation provides additional assurance that we meet the highest professional standards for medical device design, development and manufacture.” Mark Davis, Mologic CEO.
More details to follow shortly.
Mologic is a leading developer of lateral flow and rapid diagnostic technologies, products and services. We work with companies, researchers and clinicians to help them deliver fast, reliable and accurate diagnosis at the point-of-care.
Our Co-founder and Chief Scientific Officer, Paul Davis, was the originator of the Clearblue pregnancy test. Launched in 1988, it was the world’s first commercial application of lateral flow technology. The creativity, insight and knowledge that led to that ground-breaking invention has guided Mologic since our formation in 2003.