Abstract: Objective To establish a traceability audit mode of blood collection and supply organization, and to improve the level of quality management system audit. Methods Under the centralized quality management audit, increase the traceability audit of blood products, facilities and equipment, key materials and personnel, and review the three links of compliance, adequacy and traceability between actual operations, quality system documentation and regulations. Results Through traceability audits, the risk management and control of each quality element is carried out to ensure the implementation of national laws and regulations, industrial standards and product quality requirements, and reduce potential safety hazards. Conclusion The traceability audit enhances the depth of internal audit of the quality management system, and supplements the content of internal audit of blood supply and blood supply organization.

Key words: Blood, collection, and, supply, organization, Quality, management, system, Audit, Internal, audit, Traceability