TEMPE, AZ-Avnet Technology Solutions, a division of Avnet Inc., announces it has earned ISO 13485: 2003 Certification for Medical Devices. ISO 13485 is the internationally recognized standard to ensure quality procedures are followed in the design and manufacture of medical devices.
Registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Food and Drug Administration's Current Good Manufacturing Practices (CGMP), maintenance of documentation and traceability of products.
Created by the International Organization for Standardization, ISO 13485: 2003 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, systems approach to management, continual improvement, fact-based decision making and mutually beneficial supplier relationships. When fully adopted, these principles have been proven to enhance organizational performance.
Certification is good for three years and covers Avnet's operations in the United States, including U.S.-based support for international companies.