QM System

EN ISO 9001:2015 certificate CANDOR Bioscience
EN ISO 13485:2021 certificate CANDOR Bioscience

We work according to EN ISO 9001:2015 and EN ISO 13485:2016.
Our quality standards comprise:

  • standardised records and documentation
  • standard operation procedures (SOPs) for all relevant work steps
  • inspection equipment monitoring
  • tracing of all incoming materials 
  • testing laboratory for handling of human specimens

Assay Defender® - Total HAMA and interference blocker

Assay Defender®  is a ready-to use assay diluent for reduction of interference caused by HAMA (human anti-mouse antibodies), rheumatoid factors, nonspecific binding, cross-reactivities and matrix effects.
Assay Defender® is particularly suitable for human or animal specimens…

Certification EN ISO 13485

Additionally to the EN ISO 9001 certification, CANDOR is now also certified according to EN ISO 13485.