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Airtronics Metal Products
Airtronics Metal Products Earns ISO 13485 Certification
SAN JOSE, Calif.--Airtronics Metal Products, a sheet metal design, engineering, and precision manufacturing company, recently announced that it has received ISO 13485:2003 certification from TÜV SÜD, an international quality management systems certification body. Airtronics called the ISO 13485:2003 certification "a major milestone" in its 50-year history, saying that it validates "the company's high quality standards and its commitment to expanding into the medical device industry." The company also reported that it has upgraded to ISO 9001:2008 certification.
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 the 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, in a statement announcing the certification. "ISO 13485 verifies our ability to produce high-precision medical components and complex assemblies that consistently meet customer needs and regulatory requirements."
Airtronics Metal Products (www.airtronics.com) is a precision sheet metal products company that provides standard and custom engineering, design, production, and value-added manufacturing services for the semiconductor, medical, networking, food processing, architectural, and consumer electronics industries, among others. Founded in 1960, the company operates in a facility located in San Jose’s Enterprise Zone, where it uses "the latest in CAD design, production equipment, and ERP systems."
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