The possibility of applying the technical requirements clause according to the specification (ISO 15189: 2012) in the Sama Al-Wathiq National Laboratory / a case study

Abstract

The research aims to identify the level of application of technical requirements in accordance with ISO15189:2012 and to determine the size of the gap between the actual reality of the application of the fifth clause of the requirements. Quantitative and qualitative methods were adopted in data collection and analysis. Where quantitative methods were used such as the weighted arithmetic mean, percentage measurement and measuring the size of the gap, while the qualitative methods included visits, personal observation, access to documents, records, and interviews. laboratory equipment, pre-examination processes, examination procedures, quality assurance of examination results, post-test procedures, laboratory information management) which fall under the fifth item to assess the application of technical requirements in order to diagnose the extent of the application of the fifth item of the standard, in addition to identifying the sections that have been found In their application of those clauses the requirements of the specification, in addition to identifying the sections that have succeeded in implementing those clauses. The extent of application of the axes was diagnosed, and which axes were most and least applied. The research reached a set of important results about the reality of the application of administrative requirements. There was a gap in the level of actual application of the fifth item of the specification in the researched laboratory. The research reached the most prominent conclusions that the laboratory management possesses documented procedures related to a job description, the appropriate qualification, duties and tasks required for each job, and There are also records for each employee that include qualifications and certificates, courses, sick leaves, employee movements between units, and in light of the conclusions, the research reached the most prominent recommendations, the most important of which is the adoption of the evaluation results that were produced by the checklists in accordance with the requirements of the specification (ISO15189:2012) in order to stand on the actual reality of management systems List in every laboratory