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Université de Bordeaux

Assessment of the QMS and audit results

Dernière mise à jour :

The Quality Management Systems assessment involves:

  • The establishment of an annual quality program with the definition of quality indicators and objectives

  • Implementing internal assessment to ensure the on-site operations comply with the quality system

  • The monitoring and measuring process performance through targeted indicators and the carrying out of process reports

  • The assessment of risks and opportunity

  • Internal process audits

  • The monitoring of study quality, promoter audits and inspections by the authorities

  • The Carrying out of satisfaction surveys of partners, patients, and investigator

  • The assessment of the performance of service providers

  • The management and resolution of identified non-conformities, by implementing corrective and/or preventive actions

  • The conducting of an annual QMS Management Journal in the presence of the medical coordinator and its process managers

Assessment of audits and inspections 2017-2024

Audits and inspections carried out:

  • S2 follow-up certification audit by AFNOR in March 2024
  • Internet audit carried out by the CHU de Bordeaux quality unit in November 2023
  • Authorization for our pulmonology platform at the Haut-Lévêque hospital to operate as a research site in June 2023

  • Follow-up certification audit by “Association Française de Normalisation” (AFNOR, English: French Standardization Association) in March 2023

  • Certification renewal audit by AFNOR in March 2022

  • ISO 9001:2015 audit of the QMS by the “Réseau Inserm Qualité ” (RIQ, English: Inserm Quality Network) in December 2023

  • Certification audit by AFNOR in March 2019

  • Internal white audit by a service provider in December 2018 (SOCOTEC)

  • Internal annual assessment of the IDE and CRA in Pellegrin and Haut-Lévêque

  • Obtaining research site authorization for our platform dedicated to neuropsychopharmacology at the Pellegrin hospital in February 2021

  • Obtaining research site authorization for our platform dedicated to pulmonology at the Haut-Lévêque hospital in June 2020

  • External audits carried out by pharmaceutical laboratories*ISO 9001:2015 audit of the QMS by the ISO 9001:2015 audit of the QMS by the RIQ in June 2017

Results 

No major remark about the organization or operation of the CIC-P during the industrial audits.

ISO 9001:2015 certification by AFNOR in 2022, 2023 and 2024 without non-conformities