Regulations Governing the Surveillance of Machinery, Equipment and Tools Article 6
To monitor type-certified products, the type certification body shall assign professionals to perform the following tasks at the production premises or warehouses of the products, whereas surveillance of production processes shall only be carried out at the production premises:1. Surveillance on products: including sampling inspection and checking of the production and distribution records.2. Surveillance on production processes: including the management of raw materials and components, inspection and testing of semi-finished and final products, verification of consistency in safety specifications of products at the production premises with type-certified products.The type certification body shall make product surveillance records of the surveillance mentioned in the preceding paragraph and maintain them properly.
中文原文 機械設備器具監督管理辦法第6條
型式驗證機構監督驗證合格產品,應依產品類別,指派適當專業人員於產品之生產廠場或倉儲場所執行下列事項。
但製程監督之執行地點,以生產廠場為限:
一、產品實體監督:包括取樣檢驗及查核產品之產銷資料。
二、製程監督:包括對生產廠場有關原物料、零組件之管理,及半成品、成品之檢測,檢視生產廠場之產製品與原型式驗證合格品,應持續維持安全規格之一致性。
前項監督,型式驗證機構應製作產品監督紀錄,並妥存備查。
但製程監督之執行地點,以生產廠場為限:
一、產品實體監督:包括取樣檢驗及查核產品之產銷資料。
二、製程監督:包括對生產廠場有關原物料、零組件之管理,及半成品、成品之檢測,檢視生產廠場之產製品與原型式驗證合格品,應持續維持安全規格之一致性。
前項監督,型式驗證機構應製作產品監督紀錄,並妥存備查。