Practical tool for laboratory certification according to ISO 9001:2015

Abstract

Introduction: The objective is to conduct a self-assessment of the constraints and challenges related to the laboratory's strategy for certification according to the ISO 9001:2015 standard.

MATERIALS AND METHODS: This descriptive study was conducted within the biochemistry laboratory of the Main Military Training Hospital of Tunis (MMTH) during 2024. To design quality management systems (QMS), it is important to begin by mapping the biochemistry laboratory's processes. Subsequently, to study the context, a PESTEL analysis was performed to understand the biochemistry laboratory's macro-environment, followed by a SWOT analysis. The various chapters of the standard were presented in the form of a grid to measure compliance rates between actual practices and the standard's requirements.

Results and Discussion: In our study, the main challenges were represented by the laboratory management's commitment to implementing a certification project and subsequently another accreditation project according to the 15189 standard, version 2022, with rigorous control of economic and environmental constraints. Furthermore, the SWOT analysis highlighted the laboratory's strengths, namely the availability of adequate and necessary resources (personnel, financial, infrastructure, etc.). Across the seven chapters of the ISO 9001:2015 standard and depending on the grid, the compliance rate was between 81% and 89%.

Conclusion: Updating and monitoring the measures undertaken must be part of an ongoing process to achieve satisfactory results.