目的：本科微生物檢驗室已通過CAP-LAP及ISO 15189醫學檢驗室認證。本研究是依據ISO 15189認證規範，檢驗室導入品質管理系統運作5年之成效評估。材料與方法：評估期間為2015~2019年。依據ISO 15198的規範：(1)建立品質管理系統，(2)訂定年度工作計畫，(3)訂定適當指標，包括：6項質性指標及14項量性指標，(4)制定各項指標的閾值，(5)每個月定期檢討與持續改善。以Microsoft Excel (2016版)，計算各項指標之百分比。結果：(1)檢驗前指標，包括：總檢體年平均量為137705件。檢體退件率年平均為0.03%。人員教育訓練每年10~12場及操作訓練3~5次，都符合品質要求。人員能力評估每年2~4次，都合格並授權。文件審查與修改每年達100%。儀器維修件數年平均7次，儀器保養率每年達100% 。 (2) 檢驗中指標， 包括： 品管失敗率年平均<5%。各項能力試驗（proficiency test；PT）合格率達100%。(3)檢驗後指標，包括：檢驗室發出錯誤報告年平均3件。時效總達成率為90.6%。委外報告時效達成率每年達100%。嗜氧培養陽性報告在5天內達成率為91.9%、嗜氧培養陰性報告在3天內達成率為91.5%、厭氧培養陰性報告在4天內達成率為91.4%、厭氧培養陽性報告在10天內達成率為96.5%、染色報告時效為98.0%、一般培養與厭氧培養的陽性率分別為34.8%與19.3%、血液培養陽性率與污染率及偽陽性率分別為11.1%與2.5%及0.2%。上述檢驗後的各項指標都符合檢驗室的閾值。每年的管理審查會議輸出事項計6~7項，完成改善項目計3~4項(改50%)，未完成改善列入持續追蹤。結論：檢驗室通過ISO 15189實驗室認證後，導入品質管理系統，監控檢驗前、中、後的質性指標及量性指標的結果，均符合檢驗室的設定閾值。每年至少一次的內部稽核及年度的管理審查。5年總評估的結果證實：在品質管理系統的定期檢討及持續改善，提供臨床具有醫療價值的數據，可提升醫療品質及病人安全。

Purpose: Our microbiological laboratory has passed the CAP-LAP and ISO 15189 certification for medical laboratory. The purpose of this study is to evaluate the effectiveness of the application ISO 15189 to a microbiological laboratory in a medical center for five years. Materials and methods: The evaluation period was from 2015 to 2019. According to ISO 15198 specifications: (1) establish a quality management system, (2) establish an annual work plan, (3) establish appropriate indicators, including: 6 qualitative indicators and 14 quantitative indicators, (4) formulate the thresholds of various indicators, and (5) review regularly and improve continuously every month. We use Microsoft Excel (2016 version) to calculate the percentage of each indicator. Results: (1) Pre-analytical indicators, including: the average annual specimens were 137,705. The average annual rejection rate of specimens was 0.03%. Staff were educated and trained by 10~12 times per year and received operation training by 3~5 times per year, all above meeting the quality requirements. The personnel ability assessment was performed by 2 to 4 times in a year, and they were all qualified and authorized. The annual review and revision for document reached 100%. The average number of equipment repair was 7 times per year, and the equipment maintenance rate reached 100% every year. (2) Analytical indicators, including: the annual average failure rate of quality control <5%. The pass rate of each proficiency test (PT) reached 100%. (3) Post-analytical indicators, including: an average of 3 error reports by the laboratory every year. The total completion rate within our threshold was 90.6%. The completion rate within our threshold for outsourcing inspection reached 100% every year. The completion rate within 5 days for positive report of anaerobic culture reached 91.9%. The completion rate within 3 days for negative report of anaerobic culture reached 91.5%. The completion rate within 4 days for negative report of anaerobic culture reached 91.4%. The completion rate within 10 days for positive report of anaerobic culture was 96.5%. The completion rate for staining report was 98.0%. The positive rates for general culture and anaerobic culture were 34.8% and 19.3%. The positive rate, contamination rate, and false positive rate for blood culture were 11.1%, 2.5% and 0.2%, respectively. All the post-analytical indicators meet the threshold of our laboratory. The annual management review meeting outputted 6 ~ 7 items, and completed 3 ~ 4 items which needed to be improved (50% improvement). Unfinished items which needed to be improved were included in continuous tracking. Conclusion: After the laboratory passed the ISO 15189 certification, the quality management system was applied to monitor the results of qualitative and quantitative indicators whenever pre-analytical, analytical, post-analytical, and all meet the threshold of the laboratory. At least one annual internal audit and annual management review were performed. The results of the five-year general evaluation confirmed that: regular review and continuous improvement in the quality management system, not only provided clinically valuable medical data, but also improved medical quality and patient safety.