The certification ensures that the plant operates a quality management system under ISO 13485 requirements meeting both regulatory and customer requirements, management of risk, and maintaining effective processes for the safe design, manufacture, and distribution of medical devices.
It also ensures that the plant’s management system is aligned with the US Food and Drug Administration’s Quality System Regulation (QSR) requirements and several other global regulatory requirements.
AVX Tantalum general manager Bob Fairey said all AVX plants produce the highest quality components, operates in a safe and environmentally responsible manner, and improves manufacturing processes, efficiency, and product quality,
"Our ISO 13485 certification is our latest achievement with respect to these efforts, as well as a valuable tool that will help us continue to manufacture safe, trusted, and high-quality tantalum capacitors for use in critical medical devices," Fairey added.
