Training needs in quality systems : a course on standards : ISO 17025:2017

Abstract

Quality assurance is key to reliable laboratory functions and a fundamental step towards accreditation. The laboratories in Malta have been encouraged for high-quality laboratory standard practices and there is room for improvement. This study aims to identify the educational needs of laboratory personnel with regard to quality and to develop, implement, and evaluate a training course with a focus on ISO17025:2017 as a case example. A questionnaire to capture the training needs of laboratory personnel on quality standards was developed, validated by a focus group, and disseminated to laboratory personnel. A course on ISO 17025:2017 was developed, validated, and implemented. The training was evaluated by the participants. The respondents (N=50) of the questionnaire on training needs consisted of laboratory managers, pharmacists, and scientists from pharmaceutical & nutraceutical QC, medical & diagnostic, research & teaching, food & water, plant & veterinary, and forensic laboratories. Courses on ISO 17025:2017 (n=10), instrument use and quality control (n=9), measurement uncertainty (n=5), ISO 9001:2015 (n=3) and Good Laboratory Practices/Good Manufacturing Practice (n=3) were requested by 30 respondents. A two-day interactive training programme on ISO 17025:2017 General requirements for the competence of testing and calibration laboratories awareness course was developed for the laboratory professionals of a forensic science service. The programme of the course consists of learning objectives, outcomes, and description of the content scheduled over 14 hours delivered in a classroom mode. Out of 25 laboratory personnel working in the forensic field, 22 participated in the course delivered by qualified tutors. The course topics covered the individual requirements of the ISO 17025:2017, the basic understanding of quality management systems, and the practical aspect of the quality manager with a specific focus on forensic sciences. The training course was evaluated by 18 participants (N=22). The majority of the respondents strongly agreed that the subject (n=11), content (n=12), tutors’ knowledge (n=14), and logistics (n=12) met their expectations. This research has the potential to have a significant impact in improving the quality systems within laboratory operations by providing an academic platform for sharing the expertise between participants and experts. Addressing training needs on quality management systems through developing courses that are tailor-made for the end-users helps to sustain the quality requirements.