The thesis describes the problems and requirements that must be met by the contractor (external company, VALFOR, Meritve in kvaliteto, d.o.o.) for the performance of qualifications and calibrations in the pharmaceutical industry. An external contractor is qualified when it has established a quality system and appropriate procedures in accordance with the requirements of the SIST EN ISO/IEC 17025:2017 standard.
Before the established quality system, the laboratory operated according to good engineering practice, customer instructions and prior knowledge of qualification activities, tests and calibrations. The purpose of the diploma thesis is to improve the laboratory's operating system and ensure that the laboratory will operate in accordance with the ISO/IEC17025:2017 standard.
The first part of the thesis presents the SIST EN ISO/IEC 17025:2017 standard and its content (scope of application, connections with standards, terms and definitions, general requirements, etc.), as well as the method of performing calibrations and qualifications.
The second part presents the practical part of the internal audit, defining the documentation and implementing the requirements according to the SIST EN ISO/IEC 17025:2017 standard. When conducting an internal audit, I compared the compatibility of the implementation of laboratory activities and the company's regulations with the ISO/IEC 17025:2017 standard. During the internal audit of the company VALFOR d.o.o., I found inconsistencies and deficiencies. The identified non-conformities were presented to the management and other employees of the company VALFOR d.o.o.. The management eliminated the deficiencies and thus improved its quality system.
The goal of the internal audit is to arrange the laboratory's operation system so that it will work in accordance with the ISO/IEC 17025:2017 standard and, as a result, to raise the quality of the laboratory's operation.
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