Regulations Governing Accreditation and Outsourced Accreditation Management of Food Testing Institutions Article 4
Testing institutions applying for accreditation shall submit an application form, togetherwith the following supporting documents and information to the central competent authority:1. the certificates manifesting the compliance with the requirements stipulated in the preceding article;2. documents certifying the testing capability;3. documents prepared in accordance with the Basic Guidelines Governing the Quality System of Testing Institutions and Laboratories as provided by the central competent authority:(1) Quality Manual;(2) Standard operating procedures for methods of testing, including the measures for quality control of testing results;(3) Assessment report of uncertainty of measurements in case of an application filed for quantitative test item;(4) Amethod validation assessment report if the central competent authority does not prescribe a testing method foratest item under accreditation application pursuant to Article 38 of the Act;(5) The template of test report of the accredited test items and the signature format of the report signatory in Chinese.4. Laboratory location map and the configuration diagram of the test facilities.
中文原文 食品檢驗機構認證及委託認證管理辦法第4條
檢驗機構應填具申請書,並檢具下列文件、資料,向中央主管機關申請認證:
一、符合前條所定條件之證明。
二、檢驗能力之證明。
三、依中央主管機關公告之檢驗機構實驗室品質系統基本規範編製之下列文件:
(一)品質手冊。
(二)檢驗方法標準作業程序,其內容包括檢驗結果品質管制之措施。
(三)申請定量檢驗項目者,應提供其量測不確定度之評估報告。
(四)申請認證之檢驗項目,中央主管機關未依本法第三十八條訂定檢驗方法者,其方法確效試驗評估報告。
(五)認證檢驗項目之檢驗報告出具格式、報告簽署人中文正楷簽名。
四、實驗室位置簡圖及檢驗設施配置圖。
一、符合前條所定條件之證明。
二、檢驗能力之證明。
三、依中央主管機關公告之檢驗機構實驗室品質系統基本規範編製之下列文件:
(一)品質手冊。
(二)檢驗方法標準作業程序,其內容包括檢驗結果品質管制之措施。
(三)申請定量檢驗項目者,應提供其量測不確定度之評估報告。
(四)申請認證之檢驗項目,中央主管機關未依本法第三十八條訂定檢驗方法者,其方法確效試驗評估報告。
(五)認證檢驗項目之檢驗報告出具格式、報告簽署人中文正楷簽名。
四、實驗室位置簡圖及檢驗設施配置圖。