国家级卫生检验检测机构资质认定现场评审不符合项分析-《中国卫生质量管理》

文章信息/Info

Title:: Non-Conformance Terms in Field Assessment of China Metrology Accreditation of Sanitation Institution

Author(s):: LIU Yan; ZHAO Chihong; Chinese Center for Disease Control and Prevention

Keywords:: Sanitation Evaluation Group; Sanitation Inspection and Testing Institution; Qualification Certification; Field Assessment; Non-Conformance Terms; Quality Control

摘要:: 目的分析国家级卫生检验检测机构资质认定现场评审中出现的不符合项，提出整改建议。方法统计2016年-2018年卫生行业评审组资质认定现场评审中发现的不符合项，根据相关准则要求进行归类分析。结果现场评审中发现69个不符合项，涉及23个条款。设备检定、校准和期间核查，方法确认、方法验证与偏离，文件控制、无效和作废，供应商，记录，建立和保持质量控制程序，为主要不符合项。结论卫生检验检测机构应重视资质认定现场评审工作，积极分析不符合项产生原因，通过文件控制、人员培训、纠正和关闭不符合项等落实整改，从而确保实验室质量管理体系有效运行和持续改进。

Abstract:: ObjectiveTo analysis the non-conformance terms in field assessment of China metrology accreditation of sanitation institution and put forward the improvement measures. MethodsThe non-conformance terms in field assessment of China metrology accreditation of sanitation institution from 2016 to 2018 were analyzed according to relative rules. ResultsThere were totally 69 non-conformities which were distributed in 23 elements with the major terms of equipment verification, calibration and period inspect,method confirm, method verification and deviate,document control, invalid and obsolete,supplier,records,establishment and maintaining quality control procedure.Conclusion The metrology accreditation of sanitation institution should pay attention to the field assessment of qualification accreditation to ensure the effective operation and continuous improvement of the laboratory quality management system by analyzing the causes for non-conformance terms and putting forward the improvement measures ofdocument control, personnel training, correction and closure of non-conformance terms.