Quality management and regulatory affairs
As a supplier to the clinical diagnostic market, SIRS-Lab places the highest priority on production standards.
ISO 9001
In November 2004, SIRS-Lab received the ISO 9001:2000 certificate for the "development, production and sale of diagnostic analytic systems." The ISO 9001 certificate was renewed in 2008.
IVD Quality Management EN ISO 13485
In 2008 SIRS-Lab received the IVD Quality Management EN ISO 13485 for diagnostic products. This in vitro diagnostics certification is an official approval for the production of medical devices according to European clinical diagnostic regulations.