Services | Quality Assurance

Based on our commitment to provide best-in-class solutions for Clinical Genotyping we have implemented a comprehensive Quality Management System for our operations guided by standardized, well defined processes. Our quality is proven externally according to the following standards:

• DIN EN ISO 9001:2000: initial certification already in June 2001, re-certification in December 2003 and regular monitoring audits every year. The current certificate was issued by DEKRA-ITS Certification Services and is valid until December 2008.
  
  

• Proficiency Testing (PT) for pharmacogenetic tests. Epidauros successfully participates in semiannual PT for pharmacogenetic diagnostics provided by the Reference Institute for Bioanalytics (DGKL-RfB) of the Joint German Society for Clinical Chemistry and Laboratory Medicine (DGKL) since October 2003. The actual certificate is issued by the DGKL-RfB and valid for one year.Remarkably, we fully complied without failure in all rounds.

   

Epidauros already works in accordance with the standards of the OECD’s strict GLP principles and those of the German Chemicals Act.

• Coming soon: Principles of Good Laboratory Practice (GLP) certification according to the OECD guidelines and to the corresponding GLP guidelines in the German law, the German Chemicals Act. The inclusion of Epidauros in the monitoring program of the Bavarian authority has been initiated.

Many customer audits have also proven our high quality procedures and services.