Sanmina-SCI Earns Quality Certifications for 7 Medical Device Manufacturing Facilities
Sanmina-SCI Corp. (San Jose, CA), an electronics contract manufacturer, announced that seven of its medical device manufacturing facilities have been certified for ISO 13485 or 13488 as well as for Canadian Medical Devices Conformity Assessment System (CMDCAS) by TUV Rheinland of North America Inc. (Newtown, CT), a compliance engineering and independent testing services provider. The TUV quality sanctions augment earlier facility registrations for all seven facilities by the United States Food and Drug Administration (USFDA).
According to John Hendrick, executive vice president of Sanmina-SCI's Medical Systems Division, ISO 13488 certifications have been granted to facilities located in Alabama, China, Ireland, Singapore and Sweden while ISO 13485 certifications have been granted to facilities in California and Israel. The Israel facility was granted ISO 13485 certification by the Standards Institute of Israel, which plans to transition its certification to TUV Rheinland later this year.
Hendrick said, "By the end of the third quarter 2004, we expect to earn two more TUV certifications—one for an additional facility in Alabama and another for a facility in Mexico—which will expand TUV quality certifications to nine Sanmina-SCI medical facilities worldwide."
According to TUV Rheinland, the ISO 13485/13488 quality standards are specific to medical device quality systems and supplement the more generic ISO 9001 and 9002 standards that apply to many industries. The company also notes that the European Union (EU) has issued a number of directives that set forth compliance criteria for medical devices destined for the European market. These directives apply to a number of medical products, including active implantable medical and in vitro diagnostics devices. With its recent certifications, Sanmina-SCI is positioned to comply with EU directives, since a significant portion of demonstrating EU compliance depends on the prior establishment and independent assessment of quality systems.
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