CLINICAL SOFTWARE QUALITY POLICY

Reaching a higher standard

No instrument, reagent, soſtware or system carries our name unless it meets our exceptional standards. We proudly put quality before everything else, and always will.

Download our Quality Policy

Quality is our utmost priority.

Our Quality System has been certified in accordance with ISO 9001 since 2002. In 2016, we obtained a second certification according to the ISO 13485, specific for a medical device sector, to ensure the safety of our products.

ISO Certificates

ISO certificates are issued by the International Organization for Standardization (ISO) and their purpose is to ensure the safety, reliability and quality of products and services.

ISO 9001

Ensures that the organization provides products and services that consistently meet customer and regulatory requirements, and that the organization consistently aims to enhance customer satisfaction.

Download our ISO 9001:2015 certificate

ISO 9001

ISO 13485

Ensures that the organization provides medical devices and related services that consistently meet customer and regulatory requirements. All Werfen manufacturing sites are certified with this standard.

Download our ISO 13485:2016 certificate

ISO 13485