[ISO 9001: 2015 certification of the clinical trial unit of a university hospital center].

Abstract

Objectives: The field of clinical research is continuously developing in healthcare institutions in France. However, this development should not come at the expense of the quality of studies or the safety of patients involved in research projects. Describe the certification process of the pharmaceutical clinical trials unit of Lariboisière hospital-Fernand Widal's (unité pharmaceutique des essais cliniques de l'hôpital Lariboisière-Fernand Widal UPEC) quality management system according to the ISO 9001: 2015 standard for the continuous improvement of quality.

Methods: This certification project, initiated by the medical-university department to which UPEC belongs, was led by a quality assurance officer, supported by a quality consultant, and carried out by the members of the UPEC team. An initial audit provided a status report, and a planning schedule structured the entire process by setting deadlines.

Results: Obtained in September 2023, the certification for the pharmaceutical management of investigational products in our sector was achieved by identifying internal and external issues, interested parties, and the risks and opportunities related to UPEC's activities. Additionally, the development of relevant monitoring indicators allows for the evaluation of the quality systems management's (QMS) effectiveness. Finally, the prioritization of actions based on the conclusions of the initial audit report enabled effective progress, resulting in a QMS compliant with the ISO 9001: 2015 standard within 21 months.

Conclusions: Thus, obtaining the certification represents a tremendous experience, the culmination of the substantial work provided by the entire team, and an external recognition that is beneficial for the development of the activity through future partnerships.