ASPECTS OF QMS IN RADIATION PROCESSING FACILITIES

摘要

—Industrial-scale radiation processing is a highly regulated industry due to the fact that most customers activate on the medical and pharmaceutical market. It is widely used mainly for sterilization and bioburden reduction in the medical and pharmaceutical industry, food industry, treatment of plastic materials and even in cultural heritage preservation. Considering its broad applicability insensitive and demanding domains, most clients require an accredited Quality Management System (QMS). The aim of this study is to present one approach of how some particular aspects of QMS impact the effectiveness of service realization. Due to the fact that there are numerous factors that influence the effectiveness of service process, the objective is to analyze few important criteria like traceability, maintenance and control of nonconform products and how it influence the desired results. The expected results show the necessity and utility of such an assessment in order to achieve improved results and implicitly, the increase in customer satisfaction.