Implementing ISO 9001 Standards in Pharmacy Quality Management Systems: A Case Study Approach

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DOI: https://doi.org/10.63345/ijrmp.v14.i9.1

Prof (Dr) Ajay Shriram Kushwaha

Sharda University

Knowledge Park III, Greater Noida, U.P. 201310, India

kushwaha.ajay22@gmail.com

Abstract

Pharmacy services have evolved from product-centric dispensing to patient-centered pharmaceutical care, demanding robust quality management systems (QMS) that ensure consistency, traceability, and continuous improvement. ISO 9001:2015 provides a globally recognized framework for establishing, implementing, maintaining, and continually improving a QMS. This manuscript presents a comprehensive case study of ISO 9001 implementation in a multi-site hospital pharmacy network (HPN) and a medium-scale community pharmacy chain (CPC) in India. Employing mixed methods—document analysis, stakeholder interviews, process mapping, and clinical quality indicator tracking—the study investigates (a) baseline gaps against ISO 9001 clauses, (b) the implementation roadmap (context analysis, risk-based thinking, process approach, leadership engagement, and performance evaluation), and (c) the impact on key performance metrics such as medication error rate, turnaround time (TAT) for dispensing, adverse drug event (ADE) reporting, patient satisfaction, and staff competency indices. Results demonstrate a statistically significant reduction (p < 0.05) in dispensing errors (32% decrease), improved corrective and preventive action (CAPA) closure times (from 45 to 18 days), enhanced documentation compliance (from 54% to 92%), and higher patient satisfaction scores (from 3.6 to 4.4 on a 5-point Likert scale) within 12 months post-certification. The case highlights critical success factors: top management commitment, cross-functional quality teams, digital document control, and an integrated clinical governance interface. Challenges included staff resistance, documentation overload, and aligning ISO requirements with regulatory (e.g., Schedule M, NABH, and Pharmacy Practice Regulations) and clinical audit frameworks. The manuscript concludes with a practical toolkit for pharmacies seeking ISO 9001 certification—checklists, KPIs, risk registers, and training blueprints—while outlining the scope for integrating ISO 15189 and ISO 31000 for broader clinical risk management. Limitations include single-country context, limited longitudinal follow-up (18 months), and the absence of randomized control comparisons.

Keywords

ISO 9001:2015; pharmacy quality management system; medication safety; case study; continuous improvement; CAPA; risk-based thinking; hospital pharmacy; community pharmacy; clinical governance

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