強化食品藥物化粧品實驗室認證與管理

為擴大民間實驗室檢驗量能，依99年制定「加速擴大實驗室認證行動方案」，100年持續推動食品與中藥邊境查驗、中藥相關限量標準及施政委託檢驗品項之認證，快速提昇檢驗之量能。認證之實驗室由原來98年之30家353品項，增加至100年底的81家729品項，認證家數及品項數均呈倍數增加，分別為食品55家、西藥9家、中藥14家、化粧品11家、醫療器材6家。100年增加辦理能力試驗次數至22次，較99年增加近1倍，並執行79家認證實驗室監督查核。亦新增「不定期」突擊查核機制，加強出具虛假不實檢驗報告與實驗室認證標章等查核，並針對出具捏造虛假不實檢驗報告、能力試驗不通過等廢止認證證書淘汰機制，以進一步落實強化監督管理認證實驗室。執行「不定期查核計畫」已完成34家塑化劑檢驗實驗室之查核，以及7家認證實驗室不定期查核。同時推動「實驗室認證標章」，教育民眾「認證」的意義，以及如何選擇適當實驗室進行委託檢驗。100年辦理「民眾如何選擇適當實驗室」記者會，記者會於相關媒體露出計16則。

關鍵字

檢驗量能；認證；實驗室認證標章

並列摘要

To promote the testing capacity and efficiency of private laboratories, we performed the port-of-entry inspection of imported food and traditional Chinese medicine, the standard quantity limit of traditional Chinese medicine, and the administrated of requested examination continuously in 2011, based on implemented simplified accreditation procedure laid down in 2010. The number of accredited laboratories increased from 30 in 2009 to 81 in 2011. The number of accredited items also increased from 353 in 2009 to 729 in 2011. They both are two-fold higher in 2011 than those in 2009.In order to monitor double-figure laboratories, 22 proficiency tests and 79 conducting supervision assessments were held for private accredited laboratories in 2011. In addition, the non-periodical assessment was added to the plan of the conducting supervision assessment, focusing on the false examination report and ”The FDA logo of laboratory accreditation”. If the accredited laboratories fail to provide real examination reports or perform proficiency tests, the government would trigger the revocation of accreditation. These procedures could help the government monitor the accredited laboratories more thoroughly.We had established the application guidelines of ”The FDA laboratory accreditation logo” and promoted products tested by accredited laboratories. The public were also educated how to select a qualified laboratory for their requested examination.

並列關鍵字

testing capacity and efficiency ； accreditation laboratories ； the FDA logo of laboratory accreditation

國際替代計量

強化食品藥物化粧品實驗室認證與管理

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