The recommended practice identifies best practices for establishing a quality management system for datasets used for artificial intelligence medical device. The recommended practice covers a full cycle of dataset management, including items such as but not limited to data collection, transfer, utilization, storage, maintenance and update. The recommended practice recommends a list of critical factors that impact the quality of datasets, such as but not limited to data sources, data quality, annotation, privacy protection, personnel qualification/training/evaluation, tools, equipment, environment, process control and documentation.