R-Biopharm’s commitment to reliably high quality
As an internationally recognized top provider, R-Biopharm develops excellent technologies, products and solutions. For food and feed analysis we do this based on the requirements of ISO 9001:2015, for clinical diagnostics and nutrition care based on the requirements of DIN EN ISO 13485:2016, MDSAP and the corresponding EU regulations for in vitro diagnostics.
Introducing a quality management system and continuously developing and improving it is a conscious strategic decision by R-Biopharm. We want it to meet the requirements and needs of the various stakeholders we work with and develop our products and solutions for. We do not see the QM system as a sales argument, it rather represents the basis of our daily work. An effective QM system not only increases quality, it can also optimize processes with regard to time and costs.
R-Biopharm AG was first certified according to the general quality management standard ISO 9001 in 1996. Certification according to the DIN EN ISO 13485 standard for medical products followed in 2003. Certification according to MDSAP took place in 2018. In addition, R-Biopharm was one of the first companies to undergo the comprehensive audit for the new IVDR certification with its quality management system in fall 2021. In summer 2022, R-Biopharm received the corresponding certificate in accordance with the new EU regulation for in vitro diagnostics.
- IVDR Certificate
- Certificate ISO 9001 (EN)
- Certificate ISO 13485 (EN)
- Certificate MDSAP (EN)
- R-Biopharm Italia Srl: Certificate ISO 9001:2015 (IT)
- R-Biopharm Inc.: Certificate ISO 9001:2015 (EN)
- R-Biopharm Rhone Ltd: Certificate ISO 9001:2015 (UK)
- R-Biopharm Nederland B.V.: Certificate ISO 9001:2015 (EN)
- R-Biopharm Nederland B.V.: Certificate ISO 9001:2015 (NL)