| 于欣.关于综合性药品检验机构质量管理体系内部审核的探究[J].中国药事,2020,34(3):311-314 |
| 关于综合性药品检验机构质量管理体系内部审核的探究 |
| Exploration of the Internal Audit of Quality Management System in Comprehensive Drug Testing Institutes |
| 投稿时间：2019-10-15 |
| DOI：10.16153/j.1002-7777.2020.03.010 |
| 中文关键词: 综合检验机构 质量管理体系 内部审核 药品检验 |
| 英文关键词: comprehensive drug testing institutes quality management system internal audit drug testing |
| 基金项目: |
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| 摘要点击次数: 912 |
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| 中文摘要: |
| 目的： 探究如何科学有效地在规模大、内设实验室多、专业领域范围广的综合性药品检验机构开展内部审核。方法： 从内部审核的策划、实施、后续纠正措施及关闭、内部审核记录与报告等过程进行分析，探讨每个环节实施过程的有效性。结果与结论： 内部审核是药品检验机构质量管理体系中的重要组成部分，也是实验室自身核查的良好契机。药品检验机构本身应充分认识到内审的重要意义，通过这一手段对实验室的管理体系存在的问题进行梳理。。 |
| 英文摘要: |
| Objective: To explore how to effectively conduct internal audit in comprehensive drug testing institutes with wide coverage and a number of laboratories. Methods: To discuss the effectiveness of the implementation of internal audit by analyzing the aspects, such as internal audit planning and implementing, correction and closing of the findings, internal audit documentation and reporting. Results and Conclusion: Internal audit is an essential component of quality management system in drug testing institutes, and is also an opportunity for self-verification of labs. All the institutes should realize the importance of internal audit, through which the potential problems could be found out. |
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