Gowanda Electronics Achieves ISO 13485:2003 Certification

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Manufacturer of High Performance Electronic Components Makes Commitment to Global Medical Market

Gowanda Electronics, a manufacturer of high performance electronic inductor components, announces that it is now registered as conforming to International Organization for Standardization (ISO) 13485:2003 quality management standard by NSF International Strategic Registrations, Ltd. (NSF-ISR). The audit was completed by NSF-ISR in the second quarter of 2006.

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. Gowanda is the first inductor manufacturer to attain ISO 13485, establishing Gowanda Electronics as a leader in this field.

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.

Note: 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.

 

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