What is ISO 13485?

The International Organization of Standards, (ISO) is a worldwide organization that develops many different kinds of standards. One of these standards, ISO 9001, defines the requirements of a Quality Management System Standard.

ISO 13485 is a version of the standard developed for the Medical Device Industry. It contains most of the requirements of ISO 9001 plus several additional requirements specifically for the Medical Device. It also eliminates sections of ISO 9001.

ISO 9001 All in One Package