Quality Management System

Our commitment to a high standard of quality both in our operational environment and in our manufacturing procedures is largely attributable to the high quality and sensitivity of the in vitro diagnostic reagents.

As a result, we are not only committed to complying with the guidelines for the relevant quality management systems GMP and EN ISO, but have also introduced these guidelines as a certified QM system within the company.

CE-Immundiagnostika as a successor organisation has been EN ISO 9001 certified since 1996 for production, distribution, and product development, and since 2003 has been audited for EN ISO 13485 according to the In Vitro Diagnostic Directive EC 98/79 of the European Parliament and the Council.

All manufacturing processes fully comply with the requirements of GMP.

The operational QM system ensures that the internal operational procedures take into consideration both customer expectations and legal provisions.

In accordance with our manufacturing licence pursuant to EN ISO 13485 we fulfil all technical and staffing requirements for a manufacturing operation qualified to meet your needs.