March, 2009 ISO Certification Press Release

Our ISO Certificate

As genomic technologies evolve to enable access to affordable, clinically relevant data, regulatory requirements will become a critical element of supply relationships. Enzymatics has anticipated the need for documented regulatory compliance by investing in an ISO 13485:2003 and 9001:2000 certified manufacturing infrastructure that meets certifying body and Global Harmonization Task Force requirements for the production of reagents for use in In Vitro diagnostic tests.

ISO 13485:2003 is a globally recognized standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet applicable customer and regulatory requirements. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. The ISO 9001:2000 standard shares significant overlap with 13485:2003 while including a focus on continuous improvement and customer satisfaction.  Enzymatics Quality Management System encompasses the design, development, production, contract manufacture and distribution of molecular biology enzymes.