“Are you addicted?” This is the title of Oswald Sonntag’s report on independent quality controls and their significance in the magazine Trillium Diagnostik TD4/2019, starting on page 156. ISO 15189 indicates independent quality controls. The IVDR now also sets new standards for independent control material. Up to now, only the interlaboratory test in Germany [...]
Following validation and verification, the quality standard of control results in laboratories is now also declining. This is stated in the essay “Diluting Quality Standards: Validation, Verification and now “Confirmation” by James O. Westgard and Sten A. Westgard from September 2020. The changes made by the College of American Pathologists (CAP) to its 2020 [...]
We proudly present our new ISO 13485 certificate. After successful audit by the British Standards Institution (bsi.) our ISO 13485:2016 & EN ISO13485:2016 certificate was successfully renewed. The certificate further certifies our ISO compliant actions in the manufacturing and distribution of in-vitro diagnostics (IVD). In line with the bsi. motto, we also try to [...]
