Quality

  • Adherence to the highest quality standards

  • Since the beginning, the work of CONGEN Biotechnologie GmbH has adhered to the highest quality standards, focussing on constantly improving service quality as well as expanding our service and product range.

    As well as certification of the quality management system according to ISO 9001 we use, the competence of the service laboratory has been certified by accreditation by DAkkS (formerly DAP) in accordance with  DIN ISO 17025. In 2008, the first product was externally validated in accordance with AOAC and Microval requirements and comparability with microbiological standard procedures was thus confirmed. On the basis of many years experience, in 2013 CONGEN obtained certification for medicinal products in accordance with DIN ISO 13485.

  • Dakks-Akkreditierung

  • Accreditation

    Our analysis laboratory is accredited by DAkkS in accordance with DIN EN ISO/IEC 17025. The Servicelab has exclusively used validated detection methods since 2003. Regular participation in suitability tests (e.g. FEPAS, ISTA, GIPSA) ensures the constant precision and efficiency of our analysis services.

    Accreditation certificate DIN 17025

  • ISO 13485

  • Medicinal products

    In 2013, certification in accordance with DIN ISO 13485 confirmed that CONGEN also satisfies the quality requirements for medicinal product manufacturers and is thus entitled to provide products with the globally recognised CE label.

    Certificate ISO 13485 (E)

  • Research & Development

    CONGEN receives the official seal “Innovative through Research” by the German Stifterverband