A key to MedDRA’s success is a robust maintenance process. To support the MedDRA change request process, the MSSO has implemented a quality management system that includes several different audits: Reilly
The MSSO change request process is ISO 9001:2008 certified. The MSSO maintains this certification with annual independent audits conducted by BSi™. The ISO 9001:2008 standard is an internationally recognised quality management system standard developed by the International Organization for Standardization (ISO)
The MSSO conducts internal procedural and clinical audits on change requests and responses sent to users
Each MedDRA release is audited by an external physician that reviews a random sample of change requests processed by the MSSO with that release
The MedDRA Management Board periodically conducts external system and clinical audits of the MSSO
The results of all audits are provided to the MedDRA Management Board and are reviewed by the MSSO for possible process improvements.