ISO Compliance

This logo represents a registration or certification mark signifying the MedDRA MSSO’s compliance with the ISO 9001:2008 standard for Quality Management Systems by BSi™.  The ISO 9001:2008 standard is an internationally recognized quality management system standard developed by the International Organization for Standardization (ISO). 

To be certified to the standard, enterprises must implement a Quality Management System (QMS) encompassing the activities of the enterprise for controlled product planning, ensuring staff training on their roles and responsibilities in the QMS, the controlled development of products, controlled purchasing of materials and services, and the controlled delivery of the products and services.

Certification to the ISO standard reinforces to MedDRA users through an independent third-party, that the MSSO operates a QMS that delivers a high quality product.

BSi™ is a trademark of BSI Management Systems America, Inc.