The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 7 and 8 December 2020 by the official French standardisation body Association française de normalisation (AFNOR), via AFNOR Certification (AFAQ).
The ISO 9001 certification covers the following activities:
- evaluation of applications for Certificates of suitability to the monographs of the European Pharmacopoeia and management of the inspection programme of manufacturing sites and associated brokers;
- planning, implementation and co-ordination of post-marketing surveillance studies for medicinal products and management of related databases;
- co-ordination of the elaboration and issuance of guidelines related to the Official Control Authority Batch Release (OCABR) procedure for the release of batches of human immunological medicinal products (blood and vaccines);
- management of the elaboration, revision, correction and suppression of European Pharmacopoeia texts, their publication in print and electronic format, as well as their distribution;
- performance of laboratory studies;
- establishment, manufacturing, storage, provision and monitoring of European Pharmacopoeia reference standards.
The certification of compliance with ISO 9001:2015 recognises that the EDQM’s policies, practices and procedures ensure consistent quality in the services and products we provide to our customers and stakeholders. They can therefore be confident that the EDQM is dedicated to maintaining the highest levels of efficiency and responsiveness in achieving its mission.