Regulations Governing Registration of Product Certification Article 3

The conformity assessment procedures for registration of product certification shall be any of the following modules or their combinations:1.Internal Control Module - Module I: The applicant shall submit technical documents as well as ensure and declare that its production premises are registered under their consent, and are the actual factories manufacturing the registered commodities which comply with the specified standards or relevant technical regulations.2.Type Test Module - Module II: The applicant or the production premises shall submit technical documents together with the type samples and obtain a type-test report indicating that the types are in compliance with specified standards or relevant technical regulations from the following organizations: The Bureau of Standards, Metrology and Inspection (the BSMI) or its branches with jurisdiction over the particular applicant (all being referred to as the inspection authority hereinafter), or Designated testing laboratories recognized by the BSMI.3.Declaration of Conformity to Type Module - Module III: The applicant shall declare and ensure that its production premises are registered under their consent, and are the actual factories manufacturing the registered commodities which comply with those types in Module II.4.Full Quality Management System Module - Module IV: The production premises shall obtain a registration certificate regarding the quality management system that encompasses design, development, production, and manufacturing from the certification bodies recognized by the BSMI, in accordance with the CNS 12681 (ISO 9001).5.Production Quality Management Module - Module V: The production premises shall obtain a registration certificate regarding the quality management system that encompasses production and manufacturing from the certification bodies recognized by the BSMI, in accordance with the CNS 12681 (ISO 9001).6.Product Quality Management Module - Module VI: The production premises shall obtain a registration certificate regarding the quality management system that encompasses the final inspection and testing of the products from the certification bodies recognized by the BSMI, in accordance with the CNS 12681 (ISO 9001).7.Factory Inspection Module - Module VII: The production premises shall obtain a factory inspection report issued by the BSMI or certification bodies recognized by the BSMI.The applicant of the Subparagraph 4-7 of the preceding Paragraph shall also comply with the requirements of Declaration of Conformity to Type Module of the Subparagraph 3 of the preceding Paragraph.
中文原文 商品驗證登錄辦法第3條
驗證登錄符合性評鑑程序之模式如下:
一、自行管制模式(模式一):申請人應依規定提出技術文件,並應確保及聲明其生產廠場確實為生產登錄商品之工廠,並經生產廠場同意登錄,且生產廠場所製造之產品符合檢驗標準。
二、型式試驗模式(模式二):申請人或其生產廠場應提出其產品之代表樣品及相關技術文件,向標準檢驗局或其所屬分局(以下簡稱檢驗機關)或標準檢驗局認可之指定試驗室取得符合檢驗標準之型式試驗報告。
三、符合型式聲明模式(模式三):申請人應確保及聲明其生產廠場確實為生產登錄商品之工廠,並經生產廠場同意登錄,且生產廠場所製造之產品與模式二之原型式一致。
四、完全品質管理制度模式(模式四):生產廠場應取得標準檢驗局認可驗證機構依CNS12681(ISO9001)評鑑核可具有設計、開發、生產及製造功能之品質管理系統登錄證書。
五、製程品質管理制度模式(模式五):生產廠場應取得標準檢驗局認可驗證機構依CNS12681(ISO9001)評鑑核可具有生產及製造功能之品質管理系統登錄證書。
六、產品品質管理制度模式(模式六):生產廠場應取得標準檢驗局認可驗證機構依CNS12681(ISO9001)評鑑核可具有最終檢驗及測試功能之品質管理系統登錄證書。
七、工廠檢查模式(模式七):生產廠場應取得標準檢驗局或其認可機構核發符合規定之工廠檢查報告。
前項第四款至第七款之申請人並應符合前項第三款符合型式聲明模式。

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