Regulations Governing the Surveillance of Machinery, Equipment and Tools Article 5
The type certification body shall have an annual implementation plan based on the risk level of the products it certifies.The implementation plan mentioned in the preceding paragraph shall cover the factory's production processes of type-certified products, checks of production and distribution records and sampling inspection.The risk level of products mentioned in the first paragraph may be determined by factors such as the violation records of the manufacturer or type-certified products, occurrences of incidents, noncompliance records of purchased or sampled products, quality assurance of factories, or place of origin.
中文原文 機械設備器具監督管理辦法第5條
型式驗證機構每年度應依據發證產品之風險等級,訂定執行計畫。
前項執行計畫,包括型式驗證合格產品之工廠製程與產銷紀錄之查核及取樣檢驗。
第一項之產品風險等級,得依據廠商或其型式驗證合格產品之違規紀錄、事故發生率、購樣或取樣檢驗不合格紀錄、工廠品保模式或產地等風險因素區分之。
前項執行計畫,包括型式驗證合格產品之工廠製程與產銷紀錄之查核及取樣檢驗。
第一項之產品風險等級,得依據廠商或其型式驗證合格產品之違規紀錄、事故發生率、購樣或取樣檢驗不合格紀錄、工廠品保模式或產地等風險因素區分之。