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CERTIFICATION OF A PHARMACY ADVANCED THERAPIES UNIT ACCORDING TO ISO 9001:2015 STANDARDS

European Statement

Selection, Procurement and Distribution

Author(s)

H. RIBES-ARTERO, MJ RUIZ-CALDES, E. MONTEAGUDO-SANTOLAYA, J. GARCIA-PELLICER, J.L. POVEDA-ANDRES

Why was it done?

We have implemented a quality management system (QMS) in the Pharmacy Advanced Therapies Unit for the management of advanced therapy medicinal products (acquisition, receipt, storage and dispensation) in accordance with ISO 9001:2015 standards.

What was done?

In the healthcare field, improving the quality of care is a fundamental objective. This involves a continuous and self-critical process of evaluation to identify problems and opportunities for improvement in care. The Spanish National Health System’s Quality Plan includes strategies such as external and periodic evaluation of the quality and safety of healthcare centres and services through audits, with the aim of achieving clinical excellence and improving patient safety and care. The rise of advanced therapies led to a change in the processes of acquisition, storage, and dispensing of medications, as these are cryopreserved therapies that require specific facilities. In our hospital, the Pharmacy Service was designated to carry out these processes.

How was it done?

The project was developed over 12 months in three phases: phase 1 (analysis of the current situation, establishment of a pharmacist working group and training of pharmacists), phase 2 (design documentation, and implementation of the QMS and certification), and phase 3 (analysis of the indicators after the implementation of the QMS, continuous evaluation of them and application of corrective measures).

What has been achieved?

To develop the QMS, we had to create 1 management manual, 8 work protocols, 25 records, 2 work instructions and 2 annexed documents. Once created, we obtained the ISO 9001:2015 certification for our QMS through an external auditing company. As quality indicators (after the certification) we have obtained favourable outcomes in 2 external audits from the pharmaceutical industry and recorded a total of 4 minor non-conformities. Regarding activity indicators, we have dispensed 18 therapies and 4 new work protocols have been created.

What next?

The pharmacist must be the healthcare professional responsible for managing advanced therapies, and implementing, certifying and recertifying a QMS in accordance with ISO 9001:2015 standards is a guarantee of the quality of our healthcare work at the hospital, recognized by other healthcare professionals, patients and the pharmaceutical industry.

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