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Our Quality Policy

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The CIC-P carries out and ensures the development of a Quality Management System (QMS) based on the NF EN ISO 9001: 2015 certification.

In order to better meet the needs of its partners and to continuously improve stakeholder satisfaction, the CIC-P has begun a certification process regarding the ISO 9001:2015 certification.

The following Quality Policy implemented by the CIC-P is oriented according to the principal departments:

  • Ensuring the security of the patients and volunteers participating in the clinical studies

  • Contributing to create services even more performant to meet the needs of its “users” with the quality level required by the research activity

  • Ensuring the constant progress of its collaborators in order to maintain skills, both from a scientific and regulatory point of view

  • Guaranteeing the respect of ethical principles and of the regulations in force during every step of the research

Those Departments are divided into operational objectives involving concrete actions by process and for each of the organization’s activity within the scope of the Standard

The quality policy implemented is at the intersection of the quality systems set up by:

  • The University Hospital of Bordeaux, for the hospital activities and the management of the risks associated with them (Quality Risk Management — QRM) and the Department of Clinical Research and Innovation, for the elements specific to the clinical research 

  • The National Institute of Health and Medical Research (Inserm), because of its integration to the CIC’s National Network and its involvement in the “QUALI-CIC”  (Quality in the CICs) group

  • The University of Bordeaux and the ADERA regarding the carrying out of pharmacoepidemiological studies and STAFF management of the BPE platform

  • The Bergonié Institute, which collaborates with the CIC-P’s research activities as part of its oncology department

The Quality Policy integrates the current French, EUropean and International regulatory and legislative reference documents, as well as the standard professions applicable to clinical research.

For more information on the Quality System, you can contact us:  qualite.cicp@chu-bordeaux.fr

Download the process map

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