摘要
目的建立采供血机构溯源性审核模式,提升质量管理体系审核水平。方法在集中式质量管理体系审核中增加对血液产品、设施设备、关键物料、人员的溯源性审核,审查各环节实际操作、质量体系文件与法律法规三者之间的符合性、充分性与可追溯性。结果通过溯源性审核对各质量要素进行风险管控,确保国家法律法规、行业标准、产品质量要求的贯彻执行,减少安全隐患。结论溯源性审核提升了质量管理体系内部审核的深度,补充了采供血机构内部审核的内容。
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.
作者
王锦
邱艳
崔爽
石丽萍
徐华
WANG Jin;QIU Yan;CUI Shuang(Shaanxi Blood Center,Xi'an 710000)
出处
《临床输血与检验》
CAS
2020年第4期405-407,共3页
Journal of Clinical Transfusion and Laboratory Medicine
关键词
采供血机构
质量管理体系
审核
内审
溯源性
Blood collection and supply organization
Quality management system
Audit
Internal audit
Traceability
