Gap analysis in implementation of ISO/IEC 17025:2017 accreditation Programme in selected microbiological laboratory

Abstract

ISO/IEC Guide 17025 is a universal guideline that comprises benchmarks for product testing service laboratories. This instruction will assure the testing laboratory to carry out testing services consistently and reliably. Implementation and improvement of the quality management system is an objective of many companies. Having a quality management system is part of strategic business development. A company with good quality practices simply increases faith and interest from existing customers and also from potential customers. Quality is a comprehensive topic, and it indeed cannot be covered thoroughly within this project, therefore focused on three significant angles that could help the process of implementing quality systems become easier. Those are the requirements of ISO/IEC 17025:2017 standard, the construction of a quality manual, and also the company’s readiness for accreditation. The main objectives of this study are to identify and analyze the gaps and also implement the ISO/IEC 17025:2017 quality management system in conformance with the standard. The key data was collected through questionnaires, interviews, observations and study of internal documents. The secondary data was collected from reliable sources of information, including guidebooks and standards linked to the study. As well as this study use gap analysis techniques compare to the existing situations with the expected conditions. It gives a quantitative approach to the research. According to the outcomes, the company was mostly compliant with the standard, and there was a need for slight modifications or updates in the system to be fully conformed.