ERIE, PA-Sunburst Electronics, a contract manufacturer of electronic controls, has achieved ISO 13485 certification, a quality management standard for medical device manufacturing developed by the International Organization for Standardization (ISO) 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,” says 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.”
“Stemming from this certification, Sunburst Electronics has integrated a number of additional quality standards that further complement our overall quality system, such as risk management, regulatory requirements, and process management for medical device design and manufacturing,” says Frank Anderson, quality manager at Sunburst Electronics
Sunburst received its ISO 13485 certification and 9001 update via the auditing efforts of QMI - SAI Global. 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.
For more information, visit www.sunburstelectronics.com or call (814) 461-9120.
Sunburst Electronics Achieves ISO 13485 Certification
February 23, 2009