Implementation of quality management system in healthcare institution for the production of radiopharmaceuticals and nuclear medicine practice

Cocevska, Maja (2024) Implementation of quality management system in healthcare institution for the production of radiopharmaceuticals and nuclear medicine practice. In: 11th Balkan Congress of Nuclear Medicine, 30 May - 02 Jun 2024, Skopje, North Macedonia. (Unpublished)

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Abstract

Quality management system has become an important issue for healthcare institution over the last decades. The adoption of a quality management system (QMS) is a strategic decision for all organizations especially for our healthcare institution due to the multidisciplinary activities in production of radiopharmaceuticals and nuclear medicine practice. Specifically, the quality management system includes international standards of Quality management systems - Requirements (ISO 9001:2015), the principle of the pharmaceutical quality system - Good Manufacturing Practice (GMP) requirements and comprehensive program QUANUM (Quality Management Audits in Nuclear Medicine) developed by International Atomic Energy Agency (IAEA). All are interlinked with each other as they all focus on ensuring product quality, safety, and nuclear medicine efficiency in different ways.
Our goal was to find an appropriate approach and to integrate all of these parts in interrelated processes that function as a coherent QMS system. We used process-oriented approach as a management strategy which incorporates the plan-do-check-act cycle and risk-based thinking in production of radioisotopes and radiopharmaceuticals department, nuclear medicine department, general and radiation safety and administrative sector. The quality management implementation comprised training, methodological assistance, continuous communication with external organization - Macedonian organization for certification and assessment, continuous communication between quality manager and the staff, and analysis of the written documents produced by all the departments.
In healthcare institution for the production of radiopharmaceuticals and nuclear medicine practice quality management can be greatly improved through the right quality management strategy. Successful implementation and continual improvement of process performance and product quality requires active participation of all parties involved in the processes, management review and leadership.

Item Type:	Conference or Workshop Item (Speech)
Subjects:	Medical and Health Sciences > Other medical sciences
Divisions:	Faculty of Medical Science
Depositing User:	Maja Cocevska
Date Deposited:	18 Jun 2024 11:33
Last Modified:	18 Jun 2024 11:33
URI:	https://eprints.ugd.edu.mk/id/eprint/34284

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