Environmental Analysis Organization Management Regulations Article 13
When reviewing the applications and extensions submitted by testing and analysis organizations, the central competent authority shall carry out the following procedures. Permits may be issued only after the approval of reviews, with categories and testing and analysis items applied for specified.Ⅰ. Review and approval of written documents: conduct review and approval of all application documents submitted by the testing and analysis organization.Ⅱ. Performance evaluation: conduct blind sample testing, on-site comparison testing or practical application/technical proficiency examinations for all testing and analysis items for which the testing and analysis organization has applied.Ⅲ. Systems evaluation: conduct on-site checks and evaluations of the quality control systems of each laboratory for which the testing and analysis organization has applied.Ⅳ. Other approval and evaluation matters designated by the central competent authority.The application from testing and analysis organizations for resumption of business; relocation of a laboratory; addition of a laboratory, testing and analysis category or item shall be submitted to the central competent authority. The review procedures shall follow the provisions of the preceding paragraph. However, if the added testing and analysis items belong to the same category, the system evaluation may be exempted.Where a testing and analysis organization applies for an extension of its permit under Paragraph 1 and meets the following requirements, the performance evaluation may be exempted for the testing and analysis item during the review procedures.The application for permit extension is submitted within the period prescribed in Article 16.During the validity period of the permit and up to the date of application, the organization has not been penalized for any violation in conducting the relevant testing and analysis items.The testing and analysis items have passed blind sample testing, on-site comparison testing, or sampling technique evaluation as designated by the central competent authority.
中文原文 環境檢驗測定機構管理辦法第13條
中央主管機關審查檢測機構許可證之申請、展延應辦理下列事項,經審查合格始得核發許可證,並記載其類別及申請檢測項目:
一、書面審核:對檢測機構所提申請文件進行審核。
二、績效評鑑:對檢測機構所申請之檢測項目,進行盲樣測試、實地比測或術科考試。
三、系統評鑑:對檢測機構所申請之個別檢驗室品質管理系統,進行現場實地查核與評鑑。
四、其他經中央主管機關指定之審核或評鑑。
檢測機構申請復業、檢驗室搬遷、增加檢驗室、增加檢測類別或檢測項目者,應向中央主管機關提出,審查程序準用前項規定;屬同一類別增加檢測項目者,得免辦理系統評鑑。
檢測機構依第一項申請許可證展延,符合下列規定者,審查程序得免辦理該檢測項目之績效評鑑:
一、於第十六條規定期限提出許可證展延申請。
二、於許可證有效期限內至申請日前,未曾因執行該檢測項目違規而受有裁罰。
三、檢測項目曾接受中央主管機關指定盲樣測試、實地比測或採樣技術評鑑合格。
一、書面審核:對檢測機構所提申請文件進行審核。
二、績效評鑑:對檢測機構所申請之檢測項目,進行盲樣測試、實地比測或術科考試。
三、系統評鑑:對檢測機構所申請之個別檢驗室品質管理系統,進行現場實地查核與評鑑。
四、其他經中央主管機關指定之審核或評鑑。
檢測機構申請復業、檢驗室搬遷、增加檢驗室、增加檢測類別或檢測項目者,應向中央主管機關提出,審查程序準用前項規定;屬同一類別增加檢測項目者,得免辦理系統評鑑。
檢測機構依第一項申請許可證展延,符合下列規定者,審查程序得免辦理該檢測項目之績效評鑑:
一、於第十六條規定期限提出許可證展延申請。
二、於許可證有效期限內至申請日前,未曾因執行該檢測項目違規而受有裁罰。
三、檢測項目曾接受中央主管機關指定盲樣測試、實地比測或採樣技術評鑑合格。