Quality, safety and sustainability at KARL STORZ
KARL STORZ focuses on the highest quality and safety as well as a sustainable environment.
Our certified Quality Management System complies with the standards DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016 as well as international guidelines such as the EC Directive 93/42/EEC, the Canadian Medical Device Regulation, the Japanese Pharmaceutical Affairs Law and the QSR of the American FDA.
Energy Management System
It is of great importance for KARL STORZ to use energy more efficiently and to comply with energy-related legal requirements. Therefore, an Energy Management System according to ISO 50001:2018 has been implemented covering all German sites at KARL STORZ. We are focussed on continuous improvement of the energy-related performance and an increasing energy efficiency in order to shape a sustainable future.
Product safety
The safety of our instruments and devices is our top priority. We only use tried and tested components and work closely with accredited test centers to carry out detailed tests and product certifications. Our manufacturing and testing processes are efficient and continuously monitored.
Individual safety tests
Each product undergoes rigorous safety tests with automated testing systems at the end of production. The results are documented individually so that each product leaves its own unique fingerprint.
Certificates
- EN ISO 13485:2016 Medical Devices – Quality Management System (PDF | 0.4 MB)
- ISO 13485:2016 – MDSAP Certificate (PDF | 0.7 MB)
- ISO 9001:2015 – Quality Management System (PDF | 0.1 MB)