It was an important project for Xpedite Diagnostics to set up and let audit our operations by an external certification organization. The last months were intense and stressful, but we managed to establish a Quality Management System that is compliant with the ISO 9001:2015 standard. In late April, Xpedite Diagnostics passed the initial audit for independent certification of the QMS according to ISO 9001:2015. The certificate was issues in early May. Our certifier QA Technic is recognized by the renowned German Accreditation Body DAkkS.
Xpedite Diagnostics is committed to providing high-quality products and services. The ISO 9001 certification was the first important milestone in our endeavour. Beyond that, our QMS is also enabling compliance to ISO 13485 and IVDD 98/79/EC. External certification according to these schemes will follow in the near future.