College Park Industries has been awarded the ISO 13485:2003 certification from BSI America. To qualify for this certification, the International Organization for Standards (ISO) requires that an organization demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
To be certified, College Park implemented a comprehensive quality management system that addresses all areas of operation. The ISO certification ensures on-going compliance to high standards of performance because, once certified, College Park will be externally audited annually by BSI America for conscientious execution of the standards. “As one of the first O&P Manufacturer to be awarded this certification, it reinforces our commitment to providing the best possible products to the end-user.” said Kimberly Light, Director of Product Development. “Part of the ISO 13485 requirement is to continuously solicit and record the feedback of customers. As we move towards more complex engineered electronic devices, compliance with our ISO certification will guarantee that processes and procedures will be developed correctly and to the highest possible standards.”