Implementing quality management systems in national regulatory authorities: Examples and practices

Overview

This document has been developed to assist NRAs with the practical implementation of the WHO guideline within their respective contexts. The document includes a combination of practices and real examples from QMSs that have been implemented in different NRAs and that are in line with the guideline’s recommendations. These examples may assist other NRAs to understand the guideline further and to gain insight on the application of the recommendations within the specific context of an NRA. This version provides examples that have been voluntarily provided by NRAs in the spirit of sharing their experience with other regulators.