On January 14th, the company received official certificates for ISO 13485 : 2003 and ISO 9001 : 2008, with an expanded scope from the previous certification announced in 2015. The registration numbers, no. 10013216 MP23 and no. 10013216 QM08 respectively, remain unchanged from the previous certifications.
Whereas the previous certifications were granted to DNA Logix Inc., a wholly-owned subsidiary of Co-Diagnostics, Inc., the updated registrations apply to the company as a whole. They certify that we maintain a Quality Management System at the laboratory location, and meet ISO standards for the design and manufacture of medical device products for the handling, stabilization, separation, purification, amplification, and detection of nucleic acids. Previously the certifications applied only to products related to tuberculosis.
The International Organization of Standards, or ISO, is a non-government entity comprised of academic and industry professionals which certifies that companies are compliant with industry-standard best practices in their production and operations.
We are pleased to receive ISO certification with a scope that encompasses all of the developments of our first-rate research team. As more products become available for validation and export, ISO certification is a necessity, not a luxury. It will facilitate expansion of our increasingly diverse product line to meet the demands of the diagnostics market both home and abroad and represents a tremendous step forward for Co-Diagnostics.