ON Semiconductor Awarded ISO 13485 Certification for its Advanced Packaging Facility
2013/09/11ON Semiconductor
企业/市场走向
PHOENIX, Ariz. – July 17, 2013 – ON Semiconductor (Nasdaq: 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,” commented 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.”
About ON Semiconductor
ON Semiconductor (Nasdaq: ONNN) is driving innovation in energy
efficient electronics, empowering design engineers to reduce global
energy use. The company offers a comprehensive portfolio of energy
efficient power and signal management, logic, discrete and custom
solutions to help customers solve their unique design challenges in automotive,
communications, computing, consumer, industrial, LED lighting, medical,
military/aerospace and power supply applications. ON Semiconductor
operates a responsive, reliable, world-class supply chain and quality
program, and a network of manufacturing facilities, sales offices and
design centers in key markets throughout North America, Europe, and the
Asia Pacific regions. For more information, visit http://www.onsemi.com.
企业HP：
http://www.onsemi.jp/
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