In order to sustain our vision and mission and to guarantee the best products and services to our customers and stakeholders; the EDQM implements a Quality Management System based on the following International Standards:
- ISO 9001:2015 "Quality management systems - Requirements"
The certification of compliance with ISO 9001:2015 recognises that the policies, practices and procedures of the organisation ensure consistent quality in the services and products provided to customers and stakeholders.
The EDQM is certified as meeting the requirements of ISO 9001:2015 for the following activities:
- Evaluation of applications for certificates of suitability to the monographs of the European Pharmacopoeia (Ph. Eur.) and management of the inspection programme of manufacturing sites and associated brokers;
- Planning, implementation and coordination of post-marketing surveillance studies for medicinal products and management of related databases;
- Coordination of the elaboration and issuing of guidelines related to the OCABR procedure for the release of batches of human biological medicinal products (blood and vaccine);
- Management of the elaboration, revision, correction and suppression of Ph. Eur. texts, their publication in printed and electronic format, as well as their distribution;
- Conduct of laboratory studies; and
- Establishment, manufacturing, storage, provision and monitoring of European Pharmacopoeia reference standards.
The EDQM received the ISO 9001 certification from the French certification body AFAQ/Afnor certification.
- ISO/IEC 17025:2005 "General requirements for the competence of testing and calibration laboratories"
This accreditation certificate demonstrates that the EDQM laboratory operates a quality system, is technically competent (please refer to the Annex to the accreditation certificate (in French only) for the complete list of accredited techniques), and is able to generate technically valid results.
It covers all aspects of laboratory management, including the sample preparation, the analytical testing competence, the documentation control, the accommodation and environmental conditions, equipment, traceability and reporting.
The EDQM laboratory received the official ISO/IEC 17025:2005 accreditation from the Belgian accreditation body BELAC.
The ISO/IEC 17025 audit attestation has been granted to the EDQM laboratory from the General European OMCL Network. Mutual Joint Audits of OMCLs are carried out by experts, from the Network, trained in Quality Management. These check that the laboratory quality management systems complies with the requirements laid down in ISO/IEC 17025, in the General European OMCL Network Quality Management Guidelines and in the European Pharmacopoeia.
- ISO 17034:2016 "General requirements for the competence of reference materials producers"
- ISO/IEC 17043:2010 "Conformity assessment - General requirements for proficiency testing"