Quality Management in Spanish Community Pharmacy: Implementation of ISO 9001.

Abstract

Background: Spanish community pharmacy has been incorporating some methods and approaches in the evaluation and improvement of quality, with the ISO 9001 standard being the most used reference. The experience of a community pharmacy in Spain is presented. The pharmacy implemented a management system based on the ISO 9001 standard in 2020, using the Deming cycle with the aim of enhancing the quality of pharmaceutical care. The results obtained in the processes over the following 2 years are also presented.

Methods: The ISO 9001 standard was reviewed to ensure compliance. The Quality Management System control documentation was updated and included the following documents: quality manual, process map, operational processes and procedures, quality indicators and incident records. The pharmacy has planned and implemented a process of monitoring, measurement, analysis of results and continuous improvement for operational, strategic and support processes during the time period of the study. The main operational processes were associated with a set of indicators which permitted to know the results obtained, analyse deviations and implement improvements. The planning and development of the project encompassed approximately 1 year and involved several key stages: (1) diagnosis and assessment of quality situation, (2) analysis of processes, (3) preparation of documentation, (4) implementation of the Quality Management System, (5) internal audit, (6) monitoring of activities and continuous improvement, (7) follow-up audit by the certifying body, (8) obtaining the ISO 9001:2015 quality certificate.

Results: The planned schedule was adhered and the documents were successfully drafted. In total, eight operational processes, nine support processes and six strategic processes were reviewed and included in the Quality Management System. Twenty indicators were established to monitor and analyse the performance of these processes. During audits, deviations in the system or nonconformances were identified and analysed. In the first year of system implementation, five nonconformances were identified, decreasing to two in the subsequent two periods. In 2020, three improvement actions were implemented with the objective of: (1) implementing a medication reconciliation service, (2) developing a medication dose adjustment service for polymedicated patients, and (3) implementing a service to measure and improve inhalation technique in patients using inhalers.

Conclusions: The implementation of a methodology based on the ISO 9001 standard has facilitated: (1) Integrating process management as a regular working methodology, (2) A focus on the continuous improvement of services, (3) Achieving recognition of the staff efforts and involvement.