9/3/2004 - Pinnacle Data Systems, Inc. (PDSi) (AMEX: PNS) announced that it has received ISO 13485 registration for its company-wide quality management systems. NSF International Strategic Registrations, Ltd. granted the registration.
“This registration is one aspect of PDSi’s overall program for supporting the United States FDA’s 21CFR820 quality requirements, a rigorous quality program required for participation in the medical device manufacturing industry,” said Christopher L. Winslow, President and COO. “By meeting these requirements, PDSi can better support its clients in this important market segment by expanding its product lifecycle service offerings to include those critical elements for which ISO 13485 registration and 21CFR820 support are essential. Several new and current customers have already begun moving active programs to PDSi as a result of this accomplishment.”
The ISO 13485 series, developed by the Geneva-based International Organization for Standardization, sets forth guidelines and requirements for quality system design for the medical device industry. This standard is intended for use by organizations involved in the design, production, installation, and servicing of medical devices as well as in the design, development and provision of related services. Other criteria for earning registration status include good management practices, thorough quality planning, effective communications and prevention of errors.
"Our quality management systems affect every aspect of our operations, ensuring that we meet our clients' quality goals, the medical industry’s quality goals and that we provide a consistently high level of service," said John Bair, Chairman and CEO. "Our achievement of ISO registration recognizes the caliber of our personnel, strength of our training programs and procedural integrity of our entire quality management process. It also demonstrates the commitment and dedication our company has to ensuring that our quality policies are clear, streamlined, thoroughly documented, communicated and audited."
PDSi is a leading provider of computer hardware design, engineering, manufacturing, integration and global service and support solutions for original equipment manufacturers (OEMs) in the telecommunications, aerospace, digital-imaging, medical diagnostic, process-control, computer, computer peripheral, and data storage industries. Specializing in powerful, reliable and scalable hardware platforms, PDSi offers a full range of services to increase product speed to market and to provide service and support to units in the field through comprehensive product lifecycle management programs encompassing depot repair, advanced exchange, contact center support and end-of-life control. For more information, visit the PDSi web site at www.pinnacle.com.
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