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.

    Besides the certification of the applied quality management system according to ISO 9001, in 2008 the first product was externally validated according to AOAC and Microval requirements, thus confirming the comparability with standard microbiological procedures. On the basis of many years experience, in 2013 CONGEN obtained certification for medicinal products in accordance with DIN ISO 13485.

  • DIN EN ISO 9001

  • Certification

    The certification of our quality management system beginning in 2001 in accordance with DIN ISO 9001:2015 serves to maintain our quality standards and the consistent reliability of our kits.

    Certificate ISO 9001 (E) DQS valid until September 12th, 2021

    Certificate ISO 9001 (E) GutZert  valid until September 12th, 2024

  • DIN EN 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)

    Certificate ISO 13485 (E) DEKRA  valid until August 30th, 2024

  • Research & Development

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