At EPAC, we always try to meet the highest standards in the industry. Therefore, we are always trying to improve ourselves. So we are very pleased to announce that after an external audit, we are once again certified for ISO-9001 and ISO-13485.
EPAC has already been ISO-9001 and IPC-610 certified since 2019. ISO-13485 was issued to us for the first time last year and is an important addition to it. ISO-13485 has 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. EPAC thus complies with all legal and customer requirements involved in the manufacture of medical devices.
These certifications are internationally recognized as the standard for quality management systems in the (medical) industry.