Since the implementation of the State administration for market supervision and administration's Measures for the Administration of the Qualification of Inspection and Testing Institutions (Order No. 163) amendment and Measures for the Supervision and Administration of Inspection and Testing Institutions (Order No. 39) in 2021, regulatory authorities at all levels have significantly intensified their efforts in conducting random inspections and targeted rectification campaigns. Cases of inspection and testing agencies being stripped of their qualifications, suspended, fined, or publicly reprimanded have frequently appeared in the media, attracting significant attention from the industry. As inspection and testing agencies, it is imperative to enhance their quality compliance management capabilities, thoroughly study and understand various regulatory policies and cases, and strengthen internal quality compliance management to mitigate the risk of administrative penalties, thereby boosting the confidence of all sectors of society in the industry. This article first introduces the necessity and urgency of introducing a quality risk management mechanism in laboratories. It then describes various sources of risk. Finally, it elaborates on the planning, implementation, performance evaluation, and improvement of the quality compliance risk management mechanism in laboratories, aiming to help readers initially grasp and understand the basic approach to implementing quality compliance risk management in laboratories.

quality compliance  /  risk management  /  laboratory  /  quality management system  /  continuous improvement