Navigating Training Needs: A Study of Medical Devices Industry Laboratories

Abstract

Imparting effective training for laboratory personnel in the medical device industry is crucial for ensuring operational excellence and reducing quality-related incidents. This article, therefore, explores the relationship between the adequacy of training for laboratory personnel and the frequency of quality-related incidents affecting operational excellence. The goal is to identify gaps in existing training programs and propose solutions to enhance them. A mixed-methods approach was employed, combining quantitative survey data with qualitative interviews to assess current training practices. The results indicate that, although training is generally perceived as effective, recurring incidents-such as documentation errors and testing inaccuracies reveal gaps in the depth of the training. This research highlights the need for tailored training solutions that address technical and soft skills, fostering continuous improvement and minimizing costly quality-related errors. Future work will focus on refining training programs and assessing their effectiveness in reducing incidents and improving overall operational performance. Key Terms - ISO 17025, Laboratory Personnel, Medical Device Industry Quality Assurance, Training Program.