In our study, a food safety management system was developed for a chaga mushroom biotechnology product manufacturer, with the purpose of meeting the quality demands of customers and enhancing the manufacturer's reputation. The study focused on identifying the potentially significant hazards present at each stage of the production process for chaga mushroom capsule products, and on ensuring that the biotechnology company in question has fully implemented ISO22000:2018 and the HACCP methodology. The results indicate that, in the 1 year following the implementation of ISO 22000:2018, there was a statistically significant drop (P <0.05) in the coliforms level of the tested biotechnology product samples that started in the ninth month following implementation. The rapid screening of mycotoxin, heavy metal, and pesticide residue levels also increased monitoring intensity and strengthened the periodic rotation plan, enabling control over potential problems relating to raw materials and ensuring product quality. This finding reveals the importance and necessity of rapid screening for small- and medium-sized food industry enterprises. Furthermore, 1 year after the system's implementation, the defect rate for chaga products was also observed to have declined, and the number of process flow anomalies requiring correction was also found to have decreased significantly (P <0.05), indicating that safety and quality levels were improving and stabilizing. If implemented over a longer period of time, the food safety management system's benefits would stand out even more, and significant improvements would be observed for more monitored items. PRACTICAL APPLICATION: Few studies have touched on food safety management systems (FSMSs) developed for capsule health food products. The enterprise examined in this study had actively worked to improve its quality system and meet its customers' needs through the implementation of the FSMSs.