Transitioning to ISO 13485:2003 Overview
This one-day course is aimed at medical-device manufacturers who are transitioning their ISO 13485:1996 quality management system to the 2003 revision.
ISO 13485:2003 joins medical-device regulatory issues (ISO 13485:1996) with specific segments of ISO 9001:2000. The worldwide medical-device community developed ISO 13485:2003 in an effort to standardize quality management systems across the supply base. Medical-device suppliers will discover that this new standard gives top management greater responsibility for the quality management system and adds some new regulatory industry guidelines.
This course is designed to review the basic requirements of ISO 13485:2003, the transition issues for existing users of the 1996 standard and the process approach to management. Participants will also gain an understanding of the importance of quality objectives, the relationship of processes to procedures and the major changes to internal auditing. (One-day course)
