Quality Management in Spanish Community Pharmacy: Implementation of ISO 9001

  • 0Program of Biomedicine, Translational Research and New Health Technologies, School of Medicine, University of Malaga, Malaga, Spain.

|

|

Summary

This summary is machine-generated.

Implementing ISO 9001 in Spanish community pharmacies enhances pharmaceutical care quality. This quality management system integration led to fewer nonconformances and improved services.

Area Of Science

  • Pharmacy Practice
  • Quality Management Systems
  • Healthcare Administration

Background

  • Spanish community pharmacies are adopting quality improvement methods, with ISO 9001 being a key standard.
  • A specific pharmacy implemented an ISO 9001-based management system in 2020 to improve pharmaceutical care.
  • The study presents the results of this implementation over two years.

Purpose Of The Study

  • To implement and evaluate a Quality Management System (QMS) based on the ISO 9001 standard in a Spanish community pharmacy.
  • To enhance the quality of pharmaceutical care through systematic process management and continuous improvement.
  • To assess the impact of the ISO 9001 implementation on operational processes and service quality.

Main Methods

  • Reviewed ISO 9001 standards and updated QMS documentation, including quality manuals and process procedures.
  • Implemented a continuous improvement cycle (Deming cycle) for operational, strategic, and support processes.
  • Established 20 quality indicators to monitor performance, analyze deviations, and drive improvements over a two-year period.

Main Results

  • Successfully integrated eight operational, nine support, and six strategic processes into the QMS.
  • Reduced nonconformances from five in the first year to two in subsequent periods.
  • Launched three new services: medication reconciliation, dose adjustment for polymedicated patients, and improved inhaler technique education.

Conclusions

  • ISO 9001 implementation integrated process management into daily operations.
  • The QMS fostered a culture of continuous service improvement.
  • The initiative resulted in staff recognition and increased involvement in quality initiatives.

Related Concept Videos

Quality Control 01:05

151

Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...

Quality Assurance 01:19

115

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...

Nursing Clinical Information System 01:27

756

Nursing Clinical Information System (NCIS)
A Nursing Clinical Information System (NCIS) is a specialized type of healthcare information system tailored to meet the unique needs of nursing practice. It incorporates the principles of nursing informatics to streamline information management and improve the quality of care delivery.
Critical attributes of NCIS include:

Efficient Information Management: NCIS is designed to manage patient information efficiently, making it easily accessible to...

Pharmacovigilance 01:19

774

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

Factors Influencing Drug Absorption: Pharmaceutical Parameters 01:28

121

Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...

Health Information Technology and Healthcare Information System 01:30

802

Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:

Documentation and Monitoring of Patient Care: HIT systems facilitate the efficient recording and tracking of patient data, aiding healthcare providers in monitoring patients' health status and making informed decisions.
Managerial and Organizational Functions: Beyond patient care, HIT is...