Organizations need to shift from compliance to performance-based auditing. In many aspects, internal auditing and quality auditing are being combined to achieve a common goal.

Surgically implanting a device, such as a pacemaker, has saved the lives of countless individuals battling with a compromised heart. Infusion pumps that automatically deliver consistent doses of drugs and eliminate the need for daily injections or pills is another example of how medical devices can drastically improve quality of life and treatment for patients.

ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.

Everyone believes that process is a simple thing to manage and there is nothing more to learn about it. Our work environment inspires us to do what is needed. Our quality management systems document every process. We even complete our audits without any findings. Our corrective actions result in recurring problems. Finally, our management reviews are conducted formally without much improvement in performance. Why?