Quality

Our focus is on providing high quality samples that are essential for research. This is why we are certified according to DIN EN ISO 9001: 2015. All of our services are oriented towards the requirements of GCP / GCLP, GDP and GLP.

Our motivation is to offer the best possible service when it comes to flexibly and reliably implementing customer specifications. We follow the principle of continuous improvement - all processes are permanently being monitored and optimized. Our quality management system is regularly checked and confirmed by internal and external audits.

Nevertheless, we can still look back on more than three decades of active business operations in the diagnostic and life science industry and incorporate this expertise and the know-how gained into all our projects.

All of our projects comply with the requirements of the ethics committee of the RP Bavaria,
while all our actions are also subject to the following regulatory requirements:

  • GCP / GCLP, GDP, GLP
  • L2 and L3** laboratory compliant with DIN 58956-3
  • Clinical testing of medical devices according to DIN EN ISO 14155
  • Clinical & Laboratory Standards Institute Guidelines (CLSI)
  • International Council for Harmonisation Guidelines (ICH)
  • Directive on in vitro diagnostic medical devices (98/79/EC)
  • IVDR Regulation ((EU) 2017/746)
  • Guideline on hemotherapy of the German Medical Association

 

Current milestones of our quality management

  • Start of the accreditation process according to EN ISO/IEC 17025: 2018
  • Monitoring audit according to DIN EN ISO 9001: 2015 by the Notified Body mdc
  • Customer audit by Abbott USA
  • Customer audit by Fujirebio Diagnostics, Inc.
  • Monitoring audit according to DIN EN ISO 9001: 2015 by the Notified Body mdc, part 2
  • Customer audit by Abbott (UK)
  • Customer audit by Roche (Switzerland) on the subject of SHE (Safety, Health, Environmental)
  • Customer audit by ESfEQA GmbH in the area of ​​“Monitoring of cooling equipment”
  • Monitoring audit according to DIN EN ISO 9001: 2015 by the Notified Body mdc, part 1 (divided in two due to the covid pandemic)
  • A multi-day audit by a delegation from the Chinese Supreme Customs Authority with the result: Biomex GmbH receives an export permit for plasma products to China.
  • Customer audit by Bio-Rad Laboratories GmbHR for qualification as a supplier
  • Customer audit by Roche Diagnostics GmbH in the area of “​Plasma for controls/clinical studies”
  • Customer audit by ESfEQA GmbH in the area of ​​“Production of round robin test samples”
  • Monitoring audit according to DIN EN ISO 9001: 2015 by the Notified Body mdc
  • Monitoring audit according to DIN EN ISO 13485:2012 by the Notified Body mdc
  • Surveillance audit according to EU Directive 98/79/EC by the Notified Body mdc
  • Customer audit by Roche Diagnostics GmbH in the area of “​Plasma for controls/clinical studies”
  • Customer audit by ESfEQA GmbH in the area of ​​“Production of round robin test samples”
  • Recertification audit according to ISO 9001: 2008 by the Notified Body mdc for Biomex GmbH with the plasma centers in Heidelberg and Munich
  • Monitoring audit according to ISO 13485: 2012 by the Notified Body mdc for Biomex GmbH in the field of in vitro diagnostics
  • Customer audit by Abbott USA
  • WCA audit (Workplace Condition Assessment) by Intertec Certification GmbH commissioned by our customer Abbott USA
  • Customer audit by ESfEQA GmbH in the area of ​​“Cooling equipment”
  • Customer audit by ESfEQA GmbH in the area of ​​“Production of round robin test samples”
  • Monitoring audit according to ISO 9001: 2008 by the Notified Body mdc for Biomex GmbH with the Munich plasma center
  • Monitoring audit according to ISO 13485: 2012 by the Notified Body mdc for Biomex GmbH in the field of in vitro diagnostics
  • Customer audit by ESfEQA GmbH