First Inductor Manufacturer to Achieve ISO 13485:2003 CertificationAugust 16, 2006
Gowanda Electronics makes commitment to global medical market.
Gowanda, NY [company release] - Gowanda Electronics, a manufacturer of high performance electronic inductor components, is now registered as conforming to International Organization for Standardization (ISO) 13485:2003 quality management standard by NSF International Strategic Registrations, Ltd. (NSF-ISR).
ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. This ISO certification is applicable to organizations that are involved in the manufacture of medical devices, and to companies like Gowanda Electronics that manufacture components for such devices. According to Gowanda, it is the first inductor manufacturer to attain ISO 13485.
Most of the companies that have achieved ISO 13485 certification are manufacturers of the medical devices themselves. Gowanda Electronics, as a sub-component manufacturer, is in the secondary tier of companies to be impacted by this relatively new ISO certification. Nevertheless, Gowanda pursued the ISO 13485 certification well in advance of other component manufacturers.
David Schaack, President of Gowanda Electronics, said, "We've been supplying components, mostly on a custom basis, to medical device manufacturers for several years. By making the business decision to achieve our ISO 13485 certification now, we are demonstrating our commitment to the global medical device marketplace and leading the way in addressing requirements which will become essential to doing business in the medical community in the months and years ahead."
Ken Hicks, Director of Quality at Gowanda Electronics, added, "By taking action now to address the future needs of our customers, this ISO certification will not only strengthen our existing relationships with medical customers, but also establish us as the supplier of choice in the global medical market for both custom and standard inductor components."
In addition to typical ISO documentation control and record-keeping requirements, ISO 13485 also includes risk management elements and greater emphasis on root cause analysis, with long term reliability as the overall goal.
The ISO 13485:2003 certification complements Gowanda's already-established ISO 9001:2000 certification which was attained in 2002.
Gowanda Electronics is a privately held company that designs, manufactures and supplies precision electronic components for both signal and power applications. Components include inductors, chokes, toroids, and other surface mount devices that are used in a wide variety of electronic applications. Gowanda's products are used primarily by OEM companies interested in high performance electronic component solutions for the equipment and devices they manufacture. Applications include use in test & measurement equipment, medical & diagnostic equipment/devices, industrial automation & control equipment, and instrumentation. Such products are used in a broad range of industries, including process and assembly industries, aviation, telecommunications, health care, data processing, security and education. Gowanda's customers include Fortune 500 companies and other significant players in these global markets.
NSF-ISR Strategic Registrations, Ltd: NSF-ISR is a wholly-owned subsidiary of NSF International. NSF International, an independent, not-for-profit organization, is the leading global provider of public health and safety risk management solutions. As a member of ISO/TC-207, a subcommittee of ISO, NSF-ISR helped develop ISO 14001. NSF-ISR is accredited as an ISO 13485, ISO 9001, ISO 14001, RC14001, QS-9000, TE Supplement, AS9100, AS9120, AS9003, and TL-9000 Registrar under the joint program operated by ANSI/ANAB. NSF-ISR has also achieved recognition from the IATF to issue ISO/TS 16949 certificates. Serving companies in 80 countries, NSF was founded in 1944 and is headquartered in Ann Arbor, MI USA.
Most Read Articles