ISO 13485:2016 procedures are designed for you to use with your ISO 13485 Quality Management System, as required by the ISO 13485 Standard. Our easy-to-customize procedures relate directly to a section of the standard with the following features: Producers list any required forms. Directly referenced by our ISO 13485 Quality Manual. Valuable in your ISO 13485 training efforts. Meets your need to attain ISO 13485 certification.