Jan 17 2010
Airtronics Metal Products, a sheet metal design, engineering and precision manufacturing company, has received ISO 13485:2003 certification from TÜV SÜD, an international quality management systems certification body.
ISO 13485:2003 is an internationally recognized Medical Device Quality Management System (QMS) standard developed by the International Standardization Organization (ISO). To become ISO 13485 certified, companies must implement and maintain a medical device QMS that has tight change control and full traceability, and that ensures steps have been taken to identify, manage, and minimize risks involved in the design, manufacture and distribution of medical devices.
"This certification represents the dedication and teamwork of everyone in the company to continually monitor quality and consistently follow well-organized processes," said Jeff Burke, Airtronics president and CEO. "ISO 13485 verifies our ability to produce high-precision medical components and complex assemblies that consistently meet customer needs and regulatory requirements.
"We are particularly pleased to have been given this accolade at our first attempt," he added.