[Five years of ISO 9001 certification in pharmacotoxicology: Experience feedback and implementation modalities in vigilance structures].

OBJECTIVE

To describe the implementation, certification and five-year experience of an ISO9001:2015-compliant quality management system (QMS) within a university hospital Department of Pharmacotoxicology encompassing pharmacovigilance, addictovigilance, toxicovigilance and telephone-based emergency response activities, and to analyse the benefits and limitations of this approach.

METHODS

The QMS was deployed from 2018 using a structured approach integrating context and stakeholder analysis, process mapping, documentation system formalisation, non-conformity management, internal and external audits, process and management reviews, and monitoring of quality indicators.

RESULTS

Initial ISO9001:2015 certification was obtained in January 2021, followed by two surveillance audits and recertification in February 2024. Over five years, 111 non-conformities were reported by 23 staff members, generating 214 improvement actions, of which 156 (73%) were completed. QMS implementation was accompanied by the deployment of structuring tools, including a dedicated operational software solution, and enabled continuity of activity during a major health crisis. Satisfaction surveys showed high levels of satisfaction among service users (clarity of information: 99.2%; quality of medical advice: 97.6%; response times: 95.1%) and regulatory authorities. No major risks were identified during audits.

CONCLUSION

Implementing an ISO9001:2015-based QMS in a Pharmacotoxicology ward is both feasible and beneficial. It supports a robust and agile organisational framework, strengthens regulatory compliance, traceability and constitutes a key driver for institutional dialogue. This experience provides a transferable model for other vigilance structures.