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News Center - Press Release Archive 2008FOR IMMEDIATE RELEASE For more information contact: Sarah Berry DEX’s Ireland Facility Registers to ISO 13485:2003 Standard Camarillo, CA - December 1, 2008 - DEX®, a leading supply chain solutions provider for high-tech industries, announced that DEX’s European facility located in Dublin, Ireland, achieved International Organization for Standardization (ISO) 13485:2003 status through the National Standards Authority of Ireland (NSAI). ISO 13485: 2003 is an international standard that specifies regulatory requirements for medical device manufacturers. It provides a framework for companies to meet their customer and regulatory requirements. The main goal is to provide a harmonized model for quality management system requirements in the international market since different countries might have different standards. To meet the criteria, and per ISO standards, DEX implemented and maintained a quality management system and met additional requirements for process control, retention of records, accountability, traceability, and customer satisfaction. DEX follows pre-determined, internal ISO procedures and work instructions audited by ISO representatives yearly. “This ISO achievement at our Ireland facility, in addition to our California facility earlier this year, strongly demonstrates our commitment to excellence,” said Sheldon Malchicoff, chairman and CEO of DEX. “We consistently maintain our commitment to quality practices, ensuring that our clients receive superior results, and we continue to be a leading provider of solutions to the medical electronics industry.”About DEX DEX is a registered trademark of Data Exchange Corporation. |
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