DYCONEX, a leading manufacturer of high-end medical PCBs, is proud to announce that it has been awarded ISO 13485:2003 certification. The ISO 13485 standard complements DYCONEX’s existing ISO 9001 Quality Management System, that the company has maintained for many years and documents DYCONEX’s capabilities as a supplier of high quality and reliability components to its customers in the medical market.
In order to receive this certification, companies must demonstrate their ability to consistently fulfill customer and regulatory requirements emphasising in particular:
Process introduction, verification and validation
Process change management
Documentation and traceability
Achieving the ISO 13485 Quality Management System certificate represents a major milestone in DYCONEX’s continued strive for superior performance and demonstrates DYCONEX’s commitment to the medical industry.
Our organisation was audited by Bureau Veritas Certification, a global certification leader that is recognised by more than 50 national and international accreditation bodies.