Medical products must meet high standards in terms of reliability and safety. This includes also surface treatments of medical equipment – no matter of how small the refined part is.
BWB-Ampho SA ensures these quality requirements by a continuous circle of prove and improve: The certification pays extra attention to management responsibility, process screening and active risk management.
«Implementing the medical requirements in the existing ISO landscape was a challenge. All parties are very satisfied to have succeeded at their first attempt» states Urs Scheuber, head of quality management BWB group.
BWB-Ampho employees have been working intensively to adopt internal processes and in order to establish the required quality management system.
Serge Wainsenker, director of BWB-Ampho SA adds: «Now, we are ready to meet medical technology markets».
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.Certificate ISO 13485