การวิเคราะห์ข้อกำหนดมาตรฐานระหว่าง มอก. 2677-2558 และ ISO 15190:2020 เพื่อแสดงจุดแข็ง จุดอ่อน โอกาส และอุปสรรคของแต่ละมาตรฐาน เพื่อเป็นแนวทางสำหรับห้องปฏิบัติการที่ต้องการเปลี่ยนผ่านจากมาตรฐานไทย สู่มาตรฐานสากล

บทคัดย่อ

Laboratory standard plays a crucial role in the operations of medical laboratories, ensuring reliable and accurate diagnostic and testing services. Key standards in this field include the Thai standard TIS 2677–2558 and the international standard ISO 15190:2020. This article aims to analyze and compare the requirements of these two standards, providing insights to support an effective transition, enhance laboratory safety, and align operations with international standards. The study employed document analysis to compare the provisions of TIS 2677–2558 and ISO 15190:2020, focusing on grouping similar requirements and identifying new additions in the international standard. SWOT analysis was also utilized to assess strengths, weaknesses, opportunities, and threats associated with the transition, offering valuable insights for improving laboratory operations. The findings revealed similarities in quality management, such as quality control and verification of test results, across both standards. However, ISO 15190:2020 introduces significant new requirements, including biosafety, radiation risk management, ergonomics, and comprehensive risk management, which enhance workplace safety and global credibility. Despite these advantages, challenges such as costs, personnel adaptation, and resistance to change remain barriers to a successful transition. Laboratories capable of overcoming these challenges will be better positioned to elevate their operations to meet international standards. To ensure an effective transition, laboratories should systematically plan the adaptation process, emphasizing staff training to understand the new standards and their critical safety requirements. Management should play a pivotal role in providing resources and fostering a supportive work environment. Additionally, processes should be refined to align with the new requirements, leveraging appropriate technologies. Continuous monitoring and evaluation are essential to ensure compliance with the requirements and promote sustainability within the system.