[ISO 9001: 2015 certification of all research activities of a university hospital center]

Abstract

Introduction: In France, the number of hospitals involved in clinical research and committed to a quality approach is increasing. The objective of such approaches is to ensure the safety of patients involved in research projects by improving quality.

Objective: The University Hospital of Amiens has chosen to certify all its clinical research activities in the same scope according to the ISO 9001: 2015 standard.

Methods: Action planning has been established and a head of quality management has been appointed to oversee this process.

Results: The activities in the five departments of our university hospital jointly certified in December 2019, are: activities related to internal and external sponsors, as well as methodology and monitoring of clinical research projects conducted in the Clinical Research and Innovation Department (CRID); help with clinical research investigations in the Clinical Research Center (CRC); management of the pathway of therapeutic units used in clinical research (excluding the manufacture of drugs) in the Clinical Trials Unit (CTU) of the Hospital Pharmacy; the conservation and provision of biological resources (tissues and fluids) for cancer research in the Tumor bank of Picardy; the collection, reception, preparation, quality control, conservation and provision of biological resources for research purposes. These activities fall within the framework of legal and regulatory activities and the provision of secure storage in the Biological Resources Center already ISO 9001 certified since 2004 and NF S96-900: 2011 certified since 2009.

Conclusions: The choice of a common quality approach has brought together more than 70 persons from 5 departments involved in clinical research projects within a single certificate with the aim of continuous improvement.

Keywords: Certification; Clinical research; Management par la qualité; Quality management; Recherche clinique.