ADLER ISO 13485 Certification ISO 13485:2003 is a new quality management system standard with special emphasis on medical devices. It is based substantially on the earlier ISO 9001 standard. However, it elaborates on the earlier standard by laying greater emphasis on implementation and maintenance of requirements, activities and special arrangements that form a part of the quality management system. One of the important differences of the ISO 13485 standard is that it insists on formal procedures to control processes as compared with the earlier ISO 9001 standard which generally allowed users to choose their own methods of control. Most importantly, the ISO 13485 standard is all about medical devices and related services and adds a great number of compliance requirements which address the issues specific to the medical device industry.