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SwRI’s Bioengineering Department receives ISO 9001 certification

Standards ensure quality for the healthcare industry

San Antonio -- December 16, 1998 -- Southwest Research Institute® (SwRI®) Bioengineering Department has been certified as meeting ISO 9001 standards. The certification, issued by the notified body Det Norske Veritas, headquartered in Hovik, Norway, covers “engineering services for the design, development, testing, and servicing of devices for the healthcare industry.”

ISO 9001, initiated in the late 1980s by the International Organization for Standardization, is a set of international standards used to certify a quality system for the development of products, starting with the initial design through production and servicing. The department was also certified under EN 46001, the European Community standards that are specific to medical devices.

To achieve certification, the department had to set up a quality system within the guidelines of ISO, develop procedures for doing business in accordance with those guidelines, and demonstrate that it followed those guidelines over a period of time and for a number of different projects.

“Twenty elements comprise the ISO 9001 standard, and our department had to develop procedures to comply with each of them,” said Dr. Dean Winter, director of the Bioengineering Department. “We also established a quality council that meets monthly to discuss quality issues, such as procedural changes that might be needed or client concerns.”

“ISO certification is widely accepted by the medical device companies with whom we do business,” said Susan Zogbi, a research engineer in charge of the department’s quality assurance program. “Our certification demonstrates to our clients our commitment to quality standards.”

SwRI has performed bioengineering research and development for more than 35 years. Working primarily for medical device companies, the Bioengineering Department specializes in the development of sophisticated diagnostic and therapeutic systems, from non-invasive blood pressure monitors to accessories for heart pacemakers.

For more information about the department's ISO status, contact Deborah J. Deffenbaugh, Communications Department, Southwest Research Institute, P.O. Drawer 28510, San Antonio, Texas 78228-0510, Phone (210) 522-2046, Fax (210) 522-3547.

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