Electronic Systems Achieves ISO 13485 Certification.SIOUX FALLS Sioux Falls, city (1990 pop. 100,814), seat of Minnehaha co., SE S.Dak., on the Big Sioux River; settled 1856, inc. as a village 1877, as a city 1883. Settlers abandoned the site in 1862 because of Native American raids, but with the establishment (1865) of Fort , S.D. -- Electronic Systems, Inc today announced that the British Standards Institute (body, standard) British Standards Institute - (BSI) The British member of ISO. (BSI BSI - British Standards Institute ) has certified Electronic Systems to the ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485:2003 Medical Device Quality Management Systems (QMS (1) (Minolta-QMS, Inc., Mobile, AL) A manufacturer of laser printers founded in 1977 by Jim Busby. Initially involved with controllers for printing bar codes and labels, it entered the laser printer business in the mid-1980s and set numerous records. ) Standard. According to the Institute, ". . . the BSI Quality Management Systems certificate is objective, accredited accredited recognition by an appropriate authority that the performance of a particular institution has satisfied a prestated set of criteria. accredited herds cattle herds which have achieved a low level of reactors to, e.g. , recognized evidence of your company's commitment to quality and helps you demonstrate this to discriminating customers. ISO 13485:1996, ISO 13488:1966 and increasingly ISO 13485:2003 are becoming widely accepted as the international standards to address medical device regulations around the world." "We've worked with our registrar, BSI, for nearly ten years to assure continued compliance to the ISO 9000 standards so the addition of internal systems to comply with the ISO 13485 has been a straightforward sequence from gap analysis through final implementation," said Jim Subart, Quality Manager. "As our company has grown and expanded more into the medical device area we have sought to improve and add to our QMS expertise by designing and adding the necessary systems to comply with ISO 13485:2003 as well as ISO 9001:2001", said Gary Larson, President. "The Medical Device industry continues to be an integral part of our long term growth plan." Founded in 1980, Electronics Systems, Inc. is headquartered in Sioux Falls, SD and operates three facilities there. The company offers complete contract electronics manufacturing and system-level assembly services, from supply chain management through order fulfillment, to OEM's (original equipment manufacturers) in the industrial, medical, business equipment, consumer product, defense and telecommunications sectors. The company is ISO 9001:2000 Registered and has been certified to the ISO 13485:2003 Registration for medical product manufacturing. Founded in 1901, BSI has issued more than 35,500 registrations in over 90 countries. As the world's first national standards body, and a founding member of the International Organization for Standardization International Organization for Standardization (ISO) Organization for determining standards in most technical and nontechnical fields. Founded in Geneva in 1947, its membership includes more than 100 countries. (ISO), BSI facilitated and published the first commercial standards to address quality management systems, environmental management systems, occupational health and safety management systems, and project management. |
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