Sunburst Electronics Achieves New Quality Goals for Medical Device Manufacturing and Design—ISO 13485 Certification and ISO 9001 Upgrade
ERIE, Pa. (February 18, 2009) – Sunburst Electronics, a contract manufacturer of electronic controls in Erie, Pa., has successfully completed key quality objectives, which further equip the company to service the medical device manufacturing sector. In early February 2009, Sunburst officially achieved ISO 13485 certification (a quality management standard for medical device manufacturing developed by the International Organization for Standardization) and through that process also upgraded its ISO 9001 quality system to the 2008 standard.
“Sunburst is very proud of our new certification and quality upgrades, and we are excited to be extending our market reach to the medical device industry as a result,” said Steve Stamper, Vice President of Operations at Sunburst. “ISO 13485 certification is not commonly found amongst mid-tier electronic contract manufacturers because of the financial, manpower and time investments involved.”
Frank Anderson, Quality Manager at Sunburst Electronics, added, “Stemming from this certification, Sunburst Electronics has integrated a number of additional quality standards that further compliment our overall quality system, such as risk management, regulatory requirements, and process management for medical device design and manufacturing.”
Sunburst received its ISO 13485 certification and 9001 update via the auditing efforts of QMI - SAI Global, North America’s leading management systems registrar. QMI - SAI Global certificates are recognized and accepted worldwide; and the organization is accredited by a number of organizations including but not limited to the American National Standards Institute, the Registrar Accreditation Board of the USA, and the Standards Council of Canada.
About Sunburst Electronics:
Sunburst Electronics specializes in developing electronic assemblies (printed circuit boards, chassis assembly, cables and harnesses) for medical devices/equipment, aerospace/aeronautics, military applications, process controls and instrumentation, industrial equipment, measurement systems and transportation.
Sunburst is a J-STD-001 facility adhering to stringent standards spanning defect and process control, inspection methodology and process verification inspection, and is well equipped to serve the military and other high-reliability electronics markets (aerospace, medical equipment and telecommunications).
The company houses its operations in a 31,000-square-foot, state-of-the-art facility based in Erie, Pa., and maintains a separately staffed, 4,000-square-foot repair center specializing in end-of-life product management.
Founded in 1975 and ISO 9001:2008 certified, Sunburst is a wholly-owned subsidiary of Bliley Technologies, Inc. Bliley (www.bliley.com) is a manufacturer of quartz crystals and crystal oscillators used in the telecommunications, military and space industries.
For more information, visit www.sunburstelectronics.com, or call or write Sunburst Electronics at 420 East Bayfront Parkway, Erie, Pa., 16507-1456. Phone: (814) 461-9120.
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