The Impact of Implementing ISO/IEC 17025 in the Quality of Sudanese Laboratories’ Services

Abstract

This research presents a study of current situation of Sudanese testing laboratories and aim to emphasize the impact of implementing ISO/IEC 17025:2005 standard in quality of Sudanese laboratories’ services. An evaluation of the management system in a case study laboratory -National Public Health Laboratory (NPHL) – was carried out in some aspects like the quality of the service, the management system, the qualification & participation of the staff and working environment. The ISO/IEC 17025:2005 – General Requirements for the Competence of Testing and Calibration Laboratories is the standard used for laboratory accreditation and have a sound effect in improving the quality of the services provided by international laboratories. The study tried to answer the following questions: Is there is quality management system inside the Sudanese laboratories? Is the laboratories offer service with the required quality? Can ISO/IEC 17025 improve the quality of services provided by Sudanese laboratories? The objectives of this study are: study and identify the clauses of ISO/IEC 17025:2005, examine if implementing ISO/IEC 17025:2005 can provide high quality working environment, and examine if implementing ISO/IEC 17025:2005 can help the lab to provide reliable and high quality results. To achieve the objectives of the study a questionnaire was designed to carry the situational analysis and to answer the research questions. The SPSS 11.0 software is used to analyze the data by using Cronbach's Alpha (α) test, Chi-Square test and Frequency Test. The study found that the service provided by NPHL is low quality, there is no clear management system with known responsibilities in side NPHL, there is defect on the training method inside NPHL and working environment inside NPHL is not suitable and not helps in correct testing results.