Quality Management

FUJIFILM Wako Chemicals Europe GmbH is known for its high quality chemicals and reagents. To maintain and even enhance the high quality level of our products, we have implemented an integrated quality management system based on the international quality standard DIN EN ISO 9001:2015 which is supplemented by the additional requirements of medical devices defined in DIN EN ISO 13485:2016.

Furthermore, we fully comply with the specifications of the EU directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVD regulation) and the German Medical Devices Safety Regulation (Medizinprodukte-Sicherheitsplanverordnung).

We are committed to quality and safety and strive to provide our customers with reliable products and technical service which meet their needs and requirements.

Therefore, our quality management system is regularly assessed by an independent certification company. Our quality police requires us to continously develop and improve our processes to be able to react quickly to new requirements and regulations and to provide customers with state-of-the-art solutions.

In order to further enhance our environmental protection efforts and to focus even more on a sustainable business, we plan to implement the international quality standard DIN EN ISO 14001 : 2015 in 2017. So far, only our mother company FUJIFILM Wako Pure Chemical Corporation is certified according to this standard.