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1、目錄(Contents)：Management Responsibility - Element 4.1管理責任 - 4.1Quality Policy -4.1.1品質政策 - 4.1.1Organization -4.1.2組織 - 4.1.2Responsibility and Authority 4.1.2.1責任與授權 - 4.1.2.1Resources - 4.1.2.2資源 - 4.1.2.2Management Representative - 4.1.2.3管理代表 - 4.1.2.3Organization Interfaces - 4.1.2.4組織聯系界面 - 4.1
2、.2.4Information to Management - 4.1.2.5通知管理階層 - 4.1.2.5Management Review - 4.1.3管理審查 - 4.1.3Management Review - 4.1.3.1管理審查 - 4.1.3.1Business Plan - 4.1.4經營計劃 - 4.1.4Analysis and Use of Company Level Data- 4.1.5公司層級資料的分析和應用 - 4.1.5.Customer Satisfaction - 4.1.6顧客滿意 - 4.1.6Certification Body/Registra
3、r Notification - 4.1.6.1通知認証團體 - 4.1.6.1Quality System - Element 4.2品質系統 - 4.2General - 4.2.1概述 - 4.2.1Quality System Procedures- 4.2.2品質系統程序 - 4.2.2Quality Planning - 4.2.3品質規劃 - 4.2.3Advanced Product Quality Planning - 4.2.3.1先期產品品質規劃- 4.2.3.1Special Characteristics - 4.2.3.2管制特性 - 4.2.3.2Feasibil
4、ity Reviews - 4.2.3.3可行性審查 - 4.2.3.3Product Safety - 4.2.3.4產品安全性 - 4.2.3.4Process Failure Mode and Effects Analysis (Process FMEAs) - 4.2.3.5制程的失效模式與效應分析- 4.2.3.5Mistake Proofing - 4.2.3.6錯誤防止 - 4.2.3.6The Control Plan - 4.2.3.7管制計劃 - 4.2.3.7Production Part Approval Process - 4.2.4量產零組件核准程序 - 4.2.4
5、General - 4.2.4.1概述 - 4.2.4.1Subcontractor Requirements - 4.2.4.2分包商的要求 - 4.2.4.2Engineering Change Validation - 4.2.4.3工程變更的確認 - 4.2.4.3Continuous Improvement - 4.2.5持續改善 - 4.2.5General - 4.2.5.1概述 - 4.2.5.1Quality and Productivity Improvements - 4.2.5.2品質和生產力的改進 -4.2.5.2Techniques for Continuous I
6、mprovement - 4.2.5.3持續改善的技術 - 4.2.5.3Facilities and Tooling Management- 4.2.6設施與工模具管理 - 4.2.6Facilities, Equipment, and Process Planning Effectiveness - 4.2.6.1設施 、設備及制程規劃和效益 - 4.2.6.1Tooling Management - 4.2.6.2工模具管理 - 4.2.6.2Contract Review - Element 4.3合約審查 - 4.3General - 4.3.1概述 - 4.3.1Review -
7、4.3.2審查 - 4.3.2Amendment to a Contract - 4.3.合約變更 - 4.3.3Records - 4.3.4記錄 - 4.3.4Design Control - Element 4.4設計管制 - 4.4General - 4.4.1概述 - 4.4.1Use of Design Data - 4.4.1.1設計資料的運用 - 4.4.1.1Design and Development Planning - 4.4.2設計與開發規劃 - 4.4.2Required Skills - 4.4.2.1所需技能 - 4.4.2.1Organizational an
8、d Technical Interfaces - 4.4.3組織與技術的介面 - 4.4.3Design Input - 4.4.4設計輸入 - 4.4.4Design input - Supplemental - 4.4.4.1設計輸入 - 補充 - 4.4.4.1Design Output - 4.4.5設計輸出 - 4.4.5Design Output - Supplemental - 4.4.5.1設計輸出 - 補充 - 4.4.5.1Design Review - 4.4.6設計審查 - 4.4.6Design Verification- 4.4.7設計驗証 - 4.4.7Desig
9、n Validation - 4.4.8設計確認 - 4.4.8Design Validation - Supplement -4.4.8.1設計確認 - 補充 - 4.4.8.1Design Changes - 4.4.9設計變更- 4.4.9Design Changes - Supplemental - 4.4.9.1設計變更 - 補充 - 4.4.9.1Design Change Impact - 4.4.9.2設計變更的影響 - 4.4.9.2Customer Prototype Support - 4.4.10顧客原型樣品的配合 - 4.4.10Confidentiality - 4
10、.4.11保密性 - 4.4.11Document and Data Control - Element 4.5文件與資料管制 - 4.5General - 4.5.1概述 - 4.5.1Document and Data Approval and Issue- 4.5.2文件與資料之核准與發行 - 4.5.2Engineering Specifications - 4.5.2.1工程規格 - 4.5.2.1Document and Data changes - 4.5.3文件及資料變更- 4.5.3Purchasing - Element 4.6採購 - 4.6General - 4.6.1
11、概述 - 4.6.1Approved Materials for Ongoing Production - 4.6.1.1量產中的核准物料 - 4.6.1.1Government, Safety and Environmental Regulations - 4.6.1.2政府，安全與環境法規 - 4.6.1.2Evaluation of Sub-contractors - 4.6.2分包商之評估 - 4.6.2Subcontractor Development - 4.6.2.1分包商的開發 - 4.6.2.1Scheduling Subcontractors - 4.6.2.2分包商交貨日
12、程規劃 - 4.6.2.2Purchasing Data - 4.6.3採購資料 - 4.6.3Verification of Purchased Product - 4.6.4採購產品的驗証 - 4.6.4Supplier Verification at Subcontractors Premises - ISO4.6.4.1供應商在分包商處的驗証 - ISO 4.6.4.1Customer Verification of Subcontracted Product - ISO6.4.2.2顧客以分包商產品的驗証 - ISO 6.4.2.2Control of Customer-Suppli
13、ed Product-Element 4.7顧客提供產品之管制 - 4.7Customer Owned Tooling - 4.7.1顧客所有之工模具 - 4.7.1Product Identification and Element-Element 4.8產品之識別與追溯性 - 4.8Process Control-Element 4.9制程管制 - 4.9Cleanliness of Premises - 4.9.b.1生產工場的清潔 - 4.9.b.1Contingency Plans-4.9.b.2緊急應變計劃 - 4.9.b.2Designation of Special Chara
14、cteristics-4.9.d.1管制特性的指定 - 4.9.d.1Preventive Maintenance-4.9.g.1預防保養 - 4.9.g.1Process Monitoring and Operator Instructions-4.9.1制程監測和作業指導書 - 4.9.1Maintaining Process Control-4.9.2制程控制的維持 - 4.9.2Modified Process Control Requirements-4.9.3制程管制要求的變更 - 4.9.3Verification of Job Setups-4.9.4作業設定的驗証 - 4.9
15、.4Process Changes-4.9.5制程變更 - 4.9.5Appearance Items-4.9.6外觀項目 - 4.9.6Inspection and Testing-Element 4.10檢驗與測試 - 4.10General-4.10.1概述 - 4.10.1Acceptance Criteria for Attribute Characteristics-4.10.1.1計數值允收準則 - 4.10.1.1Receiving Inspection and Testing -4.10.2收料檢驗與測試 - 4.10.2Incoming Product Quality -4.10.2.4進料產品的品質 - 4.10.2.4In-process Inspection and Testing-4.10.3制程中之檢驗與測試 - 4.10.3Final Inspection and Testing
