3.1 General Requirements 一般規定
3.1.1 This Chapter specifies general principles and procedures for type approval of products in confirming the manufacturer’s ability to produce consistent products in compliance with CR Rules.
本章具體說明產品型式認可之一般原則及流程，以確保製造廠生產符合 CR 規範之一致性產品的能力。
3.1.2 Upon application by the manufacturer, the products not required by CR Rules may be approved according to the standards/technical requirements agreed between the Society and the manufacturer.
製造廠申請認可之產品並非 CR 規範所規定，產品可依照本中心與製造廠所同意之標準/技術要求進行認可。
3.1.3 The type approval of products consists of the following processes:
產品型式認可由以下程序組成：
(a) Design assessment, including:
設計評估，包含：
(i) drawing examination; and 圖面審查；及
(ii) type test and/or check.
型式試驗或檢查。
(b) Manufacturing assessment.
製造評估
3.1.4 The manufacturing assessment consists of the following processes:
製造評估包含下列流程：
(a) Audit of the quality management system: the quality assurance and control system of the manufacturing facilities is to be assessed to evaluate and verify their capabilities to meet the specifi ed level of product quality and CR Rules consistently. The manufacturer’s quality assurance and control system is to be a quality management system certified by a State-approved certification body, at least complying with ISO 9001 or equivalent quality management standards, and having an additional CR-approved procedure, if necessary, for ensuring that surveys and tests will be in accordance with CR Rules and guidelines and conventions.
品質管理系統稽核：應評估製造廠之品保及品管系統，以衡量及驗證廠家之產品品質達到指定水準 且一致符合 CR 規範的能力。製造廠之品保及品管系統須由國家認可之認證機構認證，至少需符合 ISO 9001 或同等之品質管理標準，且若必要時，需具有 CR 額外認可程序，確保檢驗及測試符合 CR 規範、準則及公約規定。
(b) Audit of the manufacturing process: The specific manufacturing process of the manufacturer is to be assessed to confirm and verify that production technologies and surveys are specified for the purpose of reaching the quality control level required by the manufacturer and complying with CR Rules.
製造流程審核：需評估製造廠之特定製造流程以確認及驗證指定之生產技術及生產檢驗達到製造廠 要求之品質控制水準，且符合 CR 規範。
3.2 Design Assessment 設計評估
3.2 Design Assessment 設計評估
3.2.1 The following drawings and technical documents, but not limited to, are to be submitted for examination:
應提交下述圖面及技術文件以茲檢閱，但不僅限於此：
(a) Detailed structural drawings;
詳細之結構圖
(b) Documents stating specifications;
規格說明文件
(c) Performance information;
性能資訊
(d) Applicable standards; and 適用標準；及
(e) Other necessary engineering calculation and analysis reports.
其他必須之工程計算及分析報告
3.2.2 The type test is to be in accordance with 4.4. However, the Society may waive the test if the product already owns a certificate issued by other classification society acceptable to the Society.
型式試驗需依 4.4 規定辦理。然而，若該產品已具有其他由本中心可接受之船級協會簽發之證書，則本中心得 不執行該型式檢測。
3.3 Assessment of Manufacturing 製造評估
3.3.1 Audit and/or assessment of the quality management system 品質管理系統之稽核與評估
(a) The specialized quality system for marine products established by the manufacturer is to be audited, verifying that the system is appropriate for the products to be approved and that the implemented system is capable of ensuring compliance of such products with CR Rules, guidelines and/or other acceptable standards. If the manufacturer has a quality management system certified by a State-approved certification body and at least complying with ISO 9001 or equivalent quality management standards, the system is to be assessed by the Society for verifying compliance with CR requirements for specialized quality management systems for marine products.
由製造廠為海事產品建構之特定品質系統須經審核，以驗證該系統適用於認可之產品，且該系統之 執行確實能確保該產品符合 CR 規範、準則或其他可接受之標準。若該生產者之品質管理系統具有 經國家認可之認證機構認證，且至少符合 ISO 9001 或同等之品質管理標準，該系統須經本中心評估，
以確保海事產品之特定品質管理系統符合 CR 之要求。
(b) The manufacturer is in particular to appropriately and sufficiently demonstrate the following aspects so as to confirm the capability of the equipment used in production, inspection and test and the ability of the personnel having influence on product quality to meet the specified level of product quality consistently:
製造廠需特別適切及充分展示說明以下各方面，以確認用於生產、檢驗及測試設備的性能，以及員 工產品品質一致性上具有充分影響使其達到指定水準之能力：
(i) capability and test conditions of survey, test and measurement equipment;
檢驗、測試及量測設備之性能及狀況檢測；
3.4 Issue and Validity of Product Type Approval Certificate 產品型式認可證書之簽發與效力
(ii) survey and test personnel;
檢驗與測試人員；
(iii) technologies and operators of essential processes;
必要流程之技術及操作；
(iv) duties and qualifications of personnel performing quality survey and control;
執行品質檢驗與管制之員工的職責及資格；
(v) documented purchase control procedure (if applicable), preparation and maintenance of lists of suppliers of raw materials, main components and parts, submission to the Society for information;
and
採購控制流程之紀錄(若適用)，原物料、主要組件及零件之供應商清單的準備及維護，相關資 料需遞交本中心以茲參考；
(vi) quality control methods, including control of subcontractors (if applicable).
品質控制方法，包含下包商控制(若適用)。
(c) The manufacturer is to maintain a quality manual in accordance with quality standards. If the quality system certified by an appropriate certification body is found upon assessment to comply with CR requirements for specialized quality systems, the quality manual approved by such body is to be submitted to the Society for information.
製造廠需依品質標準維持品質手冊，若品質系統由適當之認證機構認證，特定品質系統經評估符合 CR 之規定，受該機講認證之品質手冊須遞交本中心以茲參考。
3.3.2 Audit of the manufacturing process 製造流程稽核
(a) A quality control plan for the products within the approval scope is to be established by the manufacturer and submitted to the Society for approval. This quality control plan is to describe the quality assurance and control methods used in the manufacturing process according to the technical requirements or standards of the products, reflecting in particular the survey and test requirements of CR Rules, guidelines and/or manufacturer to the Surveyor for verifying that they are manufactured according to the design documents.
於認可範圍內之海事產品的樣本或代表元件需由製造廠提供給驗船師，以驗證其根據設計文件所製 造。
3.4 Issue and Validity of Product Type Approval Certificate 產品型式認可證書之簽發與效力
3.4.1 The Society will issue a Product Type Approval Certificate valid for not more than 5 years to a manufacturer for whom the design assessment and the assessment of manufacturing have been completed according to 3.2 and 3.3 respectively.
對於設計評估與製造評估均依 3.2 及 3.3 規定完成者，本中心將會對製造廠簽發有效期限不超過 5 年之產品型 式認可證書。
3.4.2 The products having a Product Type Approval Certificate and their manufacturers will be entered into CR Lists of Approved Marine Products.
具有產品型式認可證書之產品及其製造廠將會列入 CR 認可海事產品清單。
3.5 Intermediate Audit 中期稽核
3.5 Intermediate Audit 中期稽核
3.5.1 The intermediate audit is to be carried out within 3 months before or after the second anniversary date or within 3 months before or after the third anniversary date of the certificate. The intermediate audit will include, but not limited to, confirmation of operation of the manufacturer’s quality system, compliance of production technologies with the technical documents accepted at the time of type approval, purchase control of raw materials, components and parts, use of survey marks and approved product logos, languages required to be used in nameplates and operation instructions, product quality feedback. The audit is also to include surveys and tests of the approved products in the presence of the Surveyor, if deemed necesssary by the Society. The samples for surveys and tests are to be selected in the presence of the Surveyor, with the number of samples being determined by the Surveyor depending on the complexity, production scale and type of the products.
中期稽核執行時間為證書第二週年日前後 3 個月內，或證書第三週年日的前後 3 個月內。中期稽核包含但不受 限於：確認製造廠之品質系統營運狀況，其製造技術符合於型式認可申請時為本中心所接受之技術文件內容，
原物料、組件及零件之採購管理，檢驗標誌及認可產品標記之使用，名牌及操作手冊使用規定之語言，產品品 質回饋。若本中心認為必要，該稽核亦包含在驗船師見證下之檢驗與測試。而檢驗與測試之樣本也應在驗船師 在場時挑選，且依據該產品複雜度、生產規模與產品型式挑選指定數量之樣本。
3.5.2 In the case of non-continuous production, no intermediate audit is needed for the period of no production.
However, at least one audit is to be carried out when the production is re-started.
若非連續生產之狀況，於無生產的期間不需執行中期稽核，然而，當產品重新啟動生產時，至少必須執行一次 稽核。
3.5.3 In case where the intermediate audit items in 3.5.1 are not practical, considerations will be given by the Society on a case-by-case basis.
若 3.5.1 規定之中期稽核無法實行，本中心得依個案採取適當考量。
3.5.4 Where the manufacturer is found to comply with the conditions for maintaining the certificate at the intermediate audit, a confirmation letter for the intermediate audit will be issued by the Society.
於中期稽核時確認該製造廠符合維持證書狀況時，本中心將簽發中期稽核證明書。
3.5.5 Where the audit is not completed before the date 3 months after the third anniversary date of the certificate, the Product Type Approval Certificate will be invalidated and the CR Lists of Approved Marine Products will be revised accordingly.
若稽核未於證書第三周年日後 3 個月內執行完畢，該產品型式認可證書將失效，且 CR 認可海事產品清單也將 隨之修改。
3.6 Renewal Audit 換證稽核
3.6.1 The renewal audit for the Product Type Approval Certificate is to be carried out within 3 months before the expiry date of the certificate. The manufacture is to send a written application to the Society and inform the Society of any change to the product design. The Society is to:
產品型式認可證書需於證書到期日前 3 個月執行換證稽核，製造廠需向本中心提交申請書，並告知本中心於產 品設計所做之任何變更，本中心將：
(a) re-examine the drawings to check any change to CR Rules or standards applicable to the design or specifications of the products;
重新檢閱圖面以確認任何變更符合 CR 規範，或依適用標準審核產品設計與產品規格；
(b) re-approve the test program in case of any change; and
3.7 Change of Approved Products 認可產品修改
(c) assess the manufacturing according to 3.3.
依據 3.3 之規定重新評估製造
3.6.2 Where there is no change to the design, the type approval test may in general be dispensed with and if necessary, the Society may require a retest.
若設計上無任何修改，一般而言型式認可測試可不執行，但若必要時本中心可要求重新測試。
3.6.3 Where the manufacturer is found to remain in compliance with the conditions for type approval upon check, a new Product Type Approval Certificate will be issued.
若製造廠經確認發現符合型式認可所應維持之狀況，本中心即簽發新的產品型式認可證書。
3.6.4 In case where the renewal audit items in 3.6.1 are not practical, considerations will be given by the Society on a case-by-case basis.
若 3.6.1 規定之換證評估項目無法實行，本中心得依個案採取適當考量。
3.6.5 Where the above audit and assessment is not completed before the expiry date of the certificate, the Product Type Approval Certificate will be invalidated and the CR Lists of Approved Marine Products will be revised accordingly.
若上述之稽核與評估未於證書到期日前執行完畢，該產品型式認可證書將失效，且 CR 認可海事產品清單也將 隨之修改。
3.7 Change of Approved Products 認可產品修改
3.7.1 The manufacturer is to supervise any change to the products or their manufacturing process, inform the Society of any major change and receive CR assessment thereof.
製造廠必須監督產品的任何變更或其製造流程，通知本中心任何重大修改事項，並接受本中心評估。
3.7.2 Where any change is made to the design of the approved products and their components and parts, materials used or manufacturing method and this affects the main characteristics and features of the products or leads to any change of any performance criterion of the products, a new type approval is to be carried out.
當認可產品與其組件及零件、使用原料或製造方法之任何變更，並會對其主要產品特性產生影響，或將會改變 產品之性能準則，則需執行新的型式認可。