| 于欣.药品检验机构内审不符合项回顾性分析及讨论[J].中国药事,2020,34(7):786-789 |
| 药品检验机构内审不符合项回顾性分析及讨论 |
| Retrospective Analysis and Discussion on the Nonconformities in the Internal Audit of the Quality Management Systems in the Drug Testing Institutes |
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| DOI：10.16153/j.1002-7777.2020.07.009 |
| 中文关键词: 内审 不符合项 改进 |
| 英文关键词: internal audit nonconformity improvement |
| 基金项目: |
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| 中文摘要: |
| 药品检验机构检验检测(ISO/IEC：17025)质量管理体系内部审核中不符合项的发现与改进，对识别体系薄弱环节，保证体系持续改进有重要的意义。本文通过分析和讨论A药品检验机构在2016-2019 年内部审核中发现的不符合项的类型数据及变化情况，识别出常发生不符合的要素，讨论有针对性的整改措施，以期达到维护和提升质量管理体系的目的。 |
| 英文摘要: |
| To discover and improve the nonconformities in the internal audit of the quality management system (QMS) is of great significance for identifying the weakness and maintaining the continuous improvement of the systems of the drug testing institutes (ISO/IEC: 17025). By analyzing and discussing the types and changes of the nonconformities found during the internal audit in drug testing institute A from 2016 to 2019, the frequently occurred nonconformities have been identified and the relevant corrective actions have been discussed to maintain and upgrade the QMS in institute A. |
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