Regulations Governing Accreditation and Outsourced Accreditation Management of Cosmetic Testing Institutions Article 13

A testing institution shall perform testing based on the quality manual as specified in Item (1) in Subparagraph 3 of Article 4 and the standard operating procedures for methods of testing as specified in Item (2) and shall comply with the following provisions:1. Sign a written contract of test entrustment with the client when entrusted with a test, indicating the entrusted test items, test methods, test scope, status of accreditation of the entrusted test items, and other matters. For any changes to the entrustment, the content of and the reasons for the changes shall be stated in the contract of test entrustment and verified and recorded by both parties.2. Accurately record the detailed informationof the client and the use purpose of the test report.3. Accurately record the condition of sample(s) received, including the name,batch number, manufacturing date or expiry date, source, packaging, and quantity of the sample(s). No space or column shall be left blank; moreover, photographs of the sample(s) submitted for testing shall be kept on file.4. The test report shall indicate the sample information, test item, testing method, test scope, and test results. All information shall be true and accurate.5. Make clear statements or remarks where the report also contains results beyond the scope of accreditation (including test item, testing method, and test scope)6. Non-accredited testing methods shall not be used for performing tests on accredited test items; however, this limitation shall not apply where such is requested in a specifically signed contract with the client or in a written request of the client, and such is specified in the test report.7. The test report shall clearly note the following:"The test report merely reflects the test results of the consigned matters of the client and is not a certification of the legitimacy of the related products."8. The test report and records of quality control information and raw data shall be kept on file together for at least 3 years.9. Test reports shall be designed to thwart forgery.10. The entrusted matter shall not be sub-entrusted to another person without the consent of the client; in the case where consent is granted to sub-entrust the matter to another person, the other person shall be one that possesses the ability to perform the entrusted test items, and the test report shall include the serial number of the test report issued by the sub-entrusted organization or other traceable information.11. Products of different names, raw material sources, or samples in minimum individual packages shall be tested separately and covered in separated test reports, with no mixture.12. The results of all the entrusted test items of the same sample listed in the test entrustment contract shall be stated in the same test report.13. For tests performed on accredited test items, the results shall be stated in a test report in the form recognized by the central competent authority.
中文原文 化粧品檢驗機構認證及委託認證管理辦法第13條
檢驗機構應依第四條第三款第一目品質手冊及第二目檢驗方法標準作業程序執行檢驗,並應遵行下列規定:
一、接受委託檢驗時,與委託者訂定書面檢驗委託契約,載明委託檢驗項目、檢驗方法、檢驗範圍、委託檢驗項目之認證狀況及其他事項。
委託事項有變更者,於檢驗委託契約載明變更內容及理由,並經雙方當事人確認及記錄。
二、詳實記錄委託者資料、檢驗報告用途。
三、詳實記錄樣品之收樣狀態,包括產品名稱、批號、製造或有效日期、來源、包裝及數量之樣品資訊,不得空白,並就送驗樣品照相留存。
四、檢驗報告註明樣品資訊、檢驗項目、檢驗方法、檢驗範圍及檢驗結果,不得有虛偽不實之情事。
五、同一份檢驗報告有非認證範圍,包括檢驗項目、檢驗方法及檢驗範圍者,明確載明或註記。
六、不得以非認證之檢驗方法執行認證檢驗項目之檢驗。
但檢驗委託契約另有約定或委託者以書面要求,且於檢驗報告中確實敘明者,不在此限。
七、檢驗報告註明:「檢驗報告僅就委託者之委託事項提供檢驗結果,不對產品合法性作判斷」。
八、檢驗報告與品質管制資料、原始數據及其他相關紀錄,併案保存至少三年。
九、檢驗報告有防偽設計。
十、非經委託者同意,不得將受託事項轉由他人辦理;其經同意轉由他人辦理者,該他人應具執行轉委託項目之能力,且於檢驗報告中載明轉委託承接機構出具之檢驗報告編號或其他可供追溯之資料。
十一、不同產品品名、原料來源或最小獨立包裝之樣品,分別執行檢驗並出具報告,不得混測。
十二、同一樣品於一份檢驗委託契約上載明之所有委託檢驗項目,其檢驗結果以同一份檢驗報告出具。
十三、執行認證檢驗項目之檢驗,以中央主管機關認證之檢驗報告格式出具檢驗結果。

English translation for reference only; the Chinese text prevails. Not legal advice.