TRS 1025 - Annex 13: WHO guideline on the implementation of quality management systems for national regulatory authorities

Overview

The aim of this guideline is to assist NRAs to develop, implement and improve their QMSs, based on principles from International Organization for Standardization (ISO) document ISO 9001 standard requirements (5). It provides recommendations on what NRAs should implement and maintain under each QMS to effectively and efficiently support the execution of NRA functions as mandated by national laws and regulations. The guideline is expected to promote consistency in regulatory practices within and across NRAs, to facilitate harmonization, mutual reliance and recognition mechanisms among Member States.