检测实验室同时运行多种质量体系的风险与应对措施
Risk and Countermeasures of Testing Laboratory Running Multiple Quality Systems Simultaneously
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摘要: 首先通过比较良好实验室规范（GLP）和ISO/IEC 17025：检测和校准实验室能力通用要求的体系条款、管理方式和技术能力，得出不同质量体系的关系和联系。然后通过实验室内部管理和外部评审中出现的偏离和不符合项，识别出关键环节的潜在风险。进一步通过质量管理体系建设过程中不同技术要素和管理要素对检测效果的影响，评估实验室应该如何处理不同质量体系之间的关系。最后，希望通过不同角度的比较分析，能够为实验室建设和管理多种质量管理体系提供有益的参考。Abstract: This article first compares the system clauses, management and technical requirements between Good Laboratory Practices (GLP) and ISO/IEC 17025:General Requirements for the Competence of Testing and Calibration Laboratory, from which we can derive the relationship and connection of different quality systems. Then, by analyzing the deviations and non-conformities during laboratory's internal management and external review, the risks in the key stages can be comprehensively identified. Furthermore, by analyzing the influences of different technical and management elements on the testing results in construction of quality management systems, we discuss how the laboratory should handle the relationship between different systems. Finally, it is expected that the comparative analysis from different aspects can provide useful reference for the laboratory management and construction of multiple quality systems.
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Key words:
- CNAS /
- CMA /
- GLP /
- quality system /
- risk management
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