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:
Quality management systems - Requirements;
The certification of compliance with ISO 9001:2008 recognises that the policies, practices and procedures of the organisation ensure consistent quality in the services and products provided to customers and stakeholders.
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 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.
ISO Guide 34:2009
General requirements for the competence of reference materials producers.
Conformity assessment - General requirements for proficiency testing.
The EDQM protects public health with quality standards for safe medicines and their safe use (see EDQM Vision, Mission & Values). Whenever possible, the use of substances of high concern is avoided in these quality standards; most notably in the European Pharmacopoeia monographs.
In its roles as a downstream user of materials and as a supplier of Reference Standards, the EDQM applies rules for chemical or biological hazards; in particular Regulations (EC) No 1907/2006, (EC) No 1272/2008 and Directive 2000/54/EC. This includes hazard classification and the supply of safety data sheets (SDS). Under no circumstances should the EDQM SDS be used to determine any characteristics of the products described, except for the purposes intended by these rules.
The EDQM successfully maintains its ISO 9001 certificate.
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