TRS 1025 - Annex 5: Quality management system requirements for national inspectorates
WHO Technical Report Series, no. 1025
20 April 2020
| Technical document
Overview
This document describes the quality management system (QMS) requirements for the operation of inspection services within national regulatory authorities (NRA) or other state structures (for the purpose of this guidance, the term “NRA” will be used in the text to represent both NRAs and other state structures). It is intended that each inspection service
uses these requirements as the basis for developing and implementing its own QMS. Where the inspectorate operates under the umbrella of the NRA QMS, consideration should be given to the WHO guideline on the implementation of quality management systems for national regulatory authorities (4).
WHO Team
Access to Medicines and Health Products (MHP),
Health Product Policy and Standards (HPS),
Norms and Standards for Pharmaceuticals (NSP),
Technical Standards and Specifications (TSS)
Number of pages
14
Copyright
CC BY-NC-SA 3.0 IGO