Providing our customers with products and services of constantly high quality is one of the cornerstones of DIARECT's philosophy.
Consequently, our quality management system has been certified according to the DIN EN ISO 9001:2000 standard in July 2002 (Reg. Nr. DE-251655QM; routinely recertified for the 2008 - 2011 period by audit in July 2008; follow this link to pdf of certificate or click on the left-side grafic).
In 2006 DIARECT began incorporating techniques of Six Sigma and EFQM into the continuous improvement program of the quality management system. As one step in this process, DIARECT's quality management system has been certified according to the DIN EN ISO 13485:2003 standard in July 2008 (Reg. Nr. DE-251655 MP23; certification is valid for the period 2008 - 2013; follow this link to pdf of certificate or click on the right-side grafic).
SurModics, manufacturer of the immunoassay stabilization product line distributed by DIARECT in Europe and distributor of the DIARECT antigens in North America, maintains a Quality Management System in accordance to the ISO 9001:2000 and ISO 13485:2000 standards. Follow these links to view PDF files of SurModics' ISO 9001:2000 certificate (162 kB) or ISO 13485:2000 certificate (236 kB).
In addition, since September 2002, DIARECT has been listed as a manufacturer of recombinant human antigens for autoimmune testing in the databases of the Food and Drug Administration (FDA).
Follow this link to view DIARECT's FDA registration data (search Registration Database using DIARECT as Establishment Name).
