ON Semiconductor (ONNN), driving innovation in energy efficiency, has announced that its Burlington, Canada advanced packaging facility has received ISO 13485:2003 certification, the international quality management system standard for the design and manufacture of medical devices. The 95,000-square-foot purpose-built plant, which employs 135 people, specializes in the design and manufacturing of highly miniaturized System-in-Package (SiP) custom assemblies for use in implantable and body-worn medical devices.
“Miniaturization is a key trend in medical devices; by integrating multiple die and discrete components manufactured with diverse technologies in a stacked architecture, significant space savings and improved system performance is achieved,” said Robert Tong, vice president of ON Semiconductor's Medical Division. “Manufacturers designing applications such as hearing aids, continuous blood glucose monitors and implantable defibrillators are constantly challenged to find new ways to further reduce the size of their devices, driving demand for innovative packaging approaches.”
ISO 13485 focuses on risk management and design control during product development; specific requirements for inspection and traceability for implantable devices; and for verification of the effectiveness of corrective and preventative actions. During the certification auditing process, ON Semiconductor had zero “non-conformances” and zero “areas of concern” throughout the design, development, production, sales and service areas of the Burlington facility's operations.
The ISO 13485 certification complements ON Semiconductor's existing quality certifications that include ISO/TS 16949, ISO 9001, AS 9100, ISO 14001, MIL-PRF-38535, QML, C-TPAT and STACK.
“This certification validates our company's quality management system, commitment to the medical market and processes for the design and manufacture of highly miniaturized System-in-Packages (SiPs) demanded by the medical industry,” said Keenan Evans, senior vice president of Quality at ON Semiconductor. “This milestone affirms our commitment to satisfy prevailing quality requirements and compliance to applicable regulations and gives additional confidence to customers who know they have partnered with an organization that is certified in delivering high-quality advanced packaging solutions through a well-defined quality system.”