Comparative Studies on Medical Laboratory Safety Requirements: ISO 15190:2003 and ISO 15190:2020

Abstract

       The Bureau of Laboratory Quality Standards (BLQS) has a medical laboratory accreditation program based on ISO 15189:2012 and adopted ISO 15190:2003 as its requirements for safety accreditation. ISO 15190:2020 has been announced to replace the original edition. Therefore, in order to provide the information for medical laboratories to use as guidelines for the efficient and effective application of the safety standards, this study was conducted to compare the differences in the requirements between the two standards. The study found that the new standard has two new requirements: employee impairment and equipment safety. Ten requirements have been significantly revised, namely, designing for safety, safety management program, hazard identification and risk assessment, emergency preparedness and response, fire safety, Laboratory ergonomics, Safe personnel work practices, waste disposal, housekeeping practices, and incidents, injury, accidents and occupational illnesses. It has been found that the quality documents classified in the new standard are policy, program, planning, manual and procedures, with 10, 12, 12, 2 and 23 topics, respectively; and one requirement, risk group classification, was deleted. Thus, medical laboratories can adapt their safety systems to comply with the new requirements, utilizing the data presented in this study together with the suggestions as well as the assessment forms in which the requirements have been translated into the Thai language by BLQS. The ISO 15189 quality management system can also be simultaneously used by the laboratories since its processes involve several concordant requirements. This will combine the management of the quality system into a single system and increase its efficacy and efficiency. As a result, the operators and related personnel can work safely in the laboratory. It will also support better understanding of the assessors and the accreditation committees and facilitate the smooth and successful development of the safety systems within the specified period.