At EPAC, we always try to meet the highest standards in the industry. This is why we are always trying to improve ourselves. We are delighted to announce that an internal audit is taking place this week, which brings us one step closer to obtaining an ISO-13485 certificate soon.
This is not the first standard we have been certified for. In 2019, we already achieved ISO-9001 and IPC-610 certification. ISO-13485 is an essential addition to these and sets additional requirements in the areas of risk analysis, sterile production and traceability. This certification shows that we meet the legal requirements for the production of medical devices and their components. When EPAC is certified according to the ISO-13485 standard, EPAC meets all legal and customer requirements involved in producing medical devices.
The ISO-13485 certification is internationally recognized as the standard for quality management systems in the medical industry. The final step in achieving this certification is an external audit scheduled for early April. Follow us to stay informed about all new developments regarding the achievement of this quality mark.