02.19.15
OnCore Manufacturing LLC, a supplier of electronic manufacturing services, has been certified to ISO 13485:2012 quality management system standards for medical devices, for its manufacturing facility in Suzhou, China. The Suzhou site also has been certified by IPC (the association for electronics—printed circuit board—manufacturers) to J-STD-001/IPC-A-610 Qualified Manufacturers List for electronics assembly.
ISO 13485 outlines a comprehensive quality management system for the design and manufacture of medical devices. Achievement of the IPC QML requires passing an intensive audit process to IPC J-STD-001 standard that describes materials, methods and verification criteria for producing high-quality soldered interconnections, and IPC-A-610, Acceptability of Electronic Assemblies. OnCore Suzhou is one of only two manufactures in China to achieve the QML certification, according to the company.
“The recent certification brings all eight of OnCore Manufacturing sites to ISO 13485 compliance,” said David Busch, OnCore’s vice president, medical. “It demonstrates OnCore’s commitment to expanding our service offering for medical manufacturing with consistent processes at any of the OnCore sites worldwide.”
“Completing these new milestones at our recently expanded Suzhou, China, location demonstrates OnCore’s industry quality leadership and also creates alignment of our strategy with our customers seeking China medical product manufacturing,” says David Brakenwagen, OnCore Manufacturing’s senior vice president of sales and marketing.
OnCore Manufacturing serves the aerospace and defense, industrial, and medical industries. In addition to its manufacturing facility in China, the company also has sites in Springfield and Wilmington, Mass.; Longmont, Colo.; San Marcos and Fremont, Calif.; and Tijuana, Mexico. OnCore is based in Fremont, Calif.
ISO 13485 outlines a comprehensive quality management system for the design and manufacture of medical devices. Achievement of the IPC QML requires passing an intensive audit process to IPC J-STD-001 standard that describes materials, methods and verification criteria for producing high-quality soldered interconnections, and IPC-A-610, Acceptability of Electronic Assemblies. OnCore Suzhou is one of only two manufactures in China to achieve the QML certification, according to the company.
“The recent certification brings all eight of OnCore Manufacturing sites to ISO 13485 compliance,” said David Busch, OnCore’s vice president, medical. “It demonstrates OnCore’s commitment to expanding our service offering for medical manufacturing with consistent processes at any of the OnCore sites worldwide.”
“Completing these new milestones at our recently expanded Suzhou, China, location demonstrates OnCore’s industry quality leadership and also creates alignment of our strategy with our customers seeking China medical product manufacturing,” says David Brakenwagen, OnCore Manufacturing’s senior vice president of sales and marketing.
OnCore Manufacturing serves the aerospace and defense, industrial, and medical industries. In addition to its manufacturing facility in China, the company also has sites in Springfield and Wilmington, Mass.; Longmont, Colo.; San Marcos and Fremont, Calif.; and Tijuana, Mexico. OnCore is based in Fremont, Calif.