qs9000中英文版（DOC 46）.docx

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 - 4.1.2.4Information 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/Registrar 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 - 4.2.3.2Feasibility 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 - 4.2.4General - 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 Improvement - 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 - 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 and 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 - 4.4.7Design 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 - 4.4.11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 Subcontractor's 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-Supplied 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 Characteristics-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 - 4.9.4Process 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 -4.10.4最終檢驗與測試 - 4.10.4Layout Inspection and Functional Testing -4.10.4.1全盤尺寸檢驗與機能測試 - 4.10.4.1Final Product Audit -4.10.4.2最終產品稽核 - 4.10.4.2Inspection and Test Records -4.10.5檢驗及測試記錄 - 4.10.5Supplier Laboratory Requirements -4.10.6供應商的實驗室要求 - 4.10.6Laboratory Quality Systems -4.10.6.1實驗室品質系統 - 4.10.6.1Laboratory Personnel -4.10.6.2實驗室人員 - 4.10.6.2Laboratory Product Identification and Testing - 4.10.6.3實驗室被測產品的識別與測試 - 4.10.6.3Laboratory Process Control - 4.10.6.4實驗室流程管制 - 4.10.6.4Laboratory Testing and Calibration Methods - 4.10.6.5實驗室測試與校正的方法 - 4.10.6.5Laboratory Statistical Methods - 4.10.6.6實驗室統計方法 - 4.10.6.6Accredited Laboratories - 4.10.7驗証的實驗室 - 4.10.7Control of Inspection, Measuring and Test Equipment-Element 4.11檢驗、量測與試驗設備的管制 - 4.11General-4.11.1概述 - 4.11.1Control Procedure- 4.11.2管制程序-4.11.2Calibration Services - 4.11.2.b.1校正服務-4.11.2.b.1Inspection, Measuring, and Test Equipment Records -4.11.3檢驗，量測及與試驗設備之記錄 - 4.11.3Measuring System Analysis-4.11.4量測系統分析 - 4.11.4Inspection and Test Status - Element 4.12檢驗與測試狀況 - 4.12Supplemental Verification - 4.12.1額外驗証 - 4.12.1Control of Nonconforming Product - Element 4.13不合格品之管制 - 4.13General - 4.13.1概述 - 4.13.1Suspect Material or Product - 4.13.1.1可疑材料或產品 - 4.13.1.1Visual Identification - 4.13.1.2視覺識別 - 4.13.1.2Review and Disposition of Nonconforming Product - 4.13.2不合格產品之檢討與處理 - 4.13.2Prioritized Reduction Plans-4.13.2.1不合格品優先減量計劃 - 4.13.2.1Control of Reworked Product - 4.13.3重工產品之管制 - 4.13.3Engineering Approved Product Authorization - 4.13.4工程認可產品的授權 - 4.13.4Corrective and Preventive Action - Element 4.14矯正與預防措施 - 4.14General - 4.14.1概述 - 4.14.1Problem Solving Methods - 4.14.1.1解決問題的方法 - 4.14.1.1Mistake Proofing-4.14.1.2錯誤防止 - 4.14.1.2Corrective Action - 4.14.2矯正措施 - 4.14.2Returned Product Test/Analysis - 4.14.2.1退回產品的測試 /分析 - 4.14.2.1Corrective Action Impact - 4.14.2.2矯正行動的影響 - 4.14.2.2Preventive Action-4.14.3預防措施 - 4.14.3Handling, Storage, Packaging, Preservation and Delivery-Element 4.15搬運、儲存、包裝、保存與交貨 - 4.15General - 4.15.1概述 - 4.15.1Handling - 4.15.2搬運 - 4.15.2Storage - 4.15.3儲存 - 4.15.3Inventory - 4.15.3.1庫存量 - 4.15.3.1Packaging-4.15.4包裝 - 4.15.4Customer Packaging Standards-4.15.4.1顧客包裝標準 - 4.15.4.1Labeling-4.15.4.2標識 - 4.15.4.2Preservation-4.15.5防護 - 4.15.5Delivery-4.15.6交貨 - 4.15.6Supplier Delivery Performance Monitoring -4.15.6.1供應商交貨績效監測 - 4.15.6.1Production Scheduling - 4.15.6.2生產排程 - 4.15.6.2Electronic Communication - 4.15.6.3電子通訊 - 4.15.6.3Shipment Notification System - 4.15.6.4交貨通知系統 - 4.15.6.4Control of Quality Records- Element 4.16品質記錄的管制 - 4.16Record Retention - 4.16.1Internal Quality Audits - Element 4.17內部品質稽核 - 4.17Internal Audit Schedules-4.17.1稽核計劃排程 - 4.17.1Training Element 4.18訓練 - 4.18Training Effectiveness-4.18.1訓練的有效性 - 4.18.1Servicing -Element 4.19服務 - 4.19Feedback of Information from Service-4.19.1服務資訊的回饋 - 4.19.1Statistical Techniques -Element 4.20統計技術 - 4.20Identification of Need -4.20.1需求的確定 - 4.20.1Procedure 4.20.2程序 - 4.20.2Selection of Statistical Tools-4.20.3統計工具的選擇 - 4.20.3Knowledge of Basic Statistical Concepts-4.20.4基本統計概念的知識 - 4.20.4Management Responsibility - Element 4.1管理責任 - 4.1Quality Policy -4.1.1 品質政策 - 4.1.1The Supplier's management with executive responsibility shall define and document its policy for quality, including objectives for quality and its commitment to quality. The quality policy shall be relevant to the supplier's organizational goals and the expectations and needs of its customers. The supplier shall ensure that this policy is understood, implemented and maintained at all levels of the organization.供應商負經管責任之管理階層應界定並明文記載其對品質所持之政策，包含品質目標與對品質之承諾。該品質政策必須相關於供應商之組織目標與顧客需求與期望，供應商應確保該組織內之所有階層均了解，實施與維持此品質政策。Organization -4.1.2組織 - 4.1.2Responsibility and Authority 4.1.2.1責任與授權 - 4.1.2.1Tile responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organizational freedom and authority to:a) initiate action to prevent the occurrence of any nonconformity relating to product, process and quality system;從事影響品質之管理、執行與工作人員均應予以界事實上和明文記載其責任，授權與相互關系，尤其是那些需要組織賦予自由度授權以從事下列活動人員：a) 發起行動以預防任何有關產品、流程、品質系統不合格事情的發生；NOTE:It is recommended that the personnel responsible for quality have the authority to stop production, if necessary to correct quality problems.備注：建議負有品質責任的人員，如需處理品質問題時，可被授予停止生產的權限。b) identify and record any problems relating to the product, process and quality system; 鑑定並記錄任何有關產品、流程 及品質系統的問題；c) initiate, recommend or provide solutions through designated channels; 循既定管道發起、建議或提供解決d) verify the implementation of solutions;驗証解決方案之執行；e) control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.管制不合格產品被進一步加、交貨或安裝，直到缺點或不滿意情況被矯正為止。f) represent the needs of the customer in internal functions in addressing QS-9000 requirements (e.g. selection of special characteristics, setting quality objectives, training, corrective & preventive actions, product design and development) .在內部組織機能中代表顧客的需求以對應QS-9000的要求（即管制特性的選擇、設定品質目標，訓練，矯正與預防行動，產品設計與發展）。Resources - 4.1.2.2資源 - 4.1.2.2The supplier shall identify resources requirements and provide adequate resources, including the assignment of trained personnel (see 4.18) for management, performance of work and verification activities including internal quality audits. 供應商應鑑定資源的需求，並提供適當資源，包括指派經訓練的人員（參閱4.18）以從事管理、執行工作與包含內部品質稽核在內的各項驗証活動。Management Representative - 4.1.2.3管理代表 - 4.1.2.3The supplier's management with executive responsibility shall appoint a member of the supplier's own management who, irrespective of other responsibilities, shall have defined authority for 供應商負經營責任之管理階層應指派供應商管理階層其中一員，明定其授權且不受其它職務責任影響以從事下列活動a) ensuring that a quality system is established, implemented and maintained in according with this international Standard, and確保品質系統依本國際標準建立、實施與維持，及b) reporting on the performance of quality system to the supplier's management for review and as a basis for improvement of the quality system.將品質系統的運作成效向供應商管理階層報告以供其審查，並作為品質系統改善之依據。Note 5: the responsibility of a management representative may also include liaison with external parties on matters relating to the supplier's quality system. 備注5：管理代表的責任亦可包含就供應商品質系統有關事務與外界團體的聯系。Organization Interfaces - 4.1.2.4組織聯系界面 - 4.1.2.4The supplier shall have systems in place to ensure management of appropriate activities during concept development through production (refer to Advanced Product Quality Planning and Control Plan reference manual) . The supplier shall use a multi-disciplinary approach for decision-making and have the ability to communicate necessary information and data in the customer-prescribed format.供應商於概念研發直到生產等階段，應建立系統確保對各項適當活動的管理（參考先期產品品質規劃和管制計劃參考手冊）。供應商決策時應採用跨功能群組討論模式，且有能力使用顧客規定格式溝通必要的資訊和數據。NOTE:Typical function to be included are:備注：典型的組織機能包括：Engineering/technical工程/技術Manufacturing/Production制造/生產Industrial Engineering工業工程Purchasing/Materials Management採購/物料管理Quality/Reliability品質/可靠度Cost Estimating成本預估Product Service產品服務Management Information Systems/Data Processing管理資訊系統/資料處理Packaging Engineering包裝工程Tooling Engineering/Maintenance工模具工程 /保養Marketing and Sales市場及行銷Subcontractors, as necessary分包商（必要時）Information to Management - 4.1.2.5通知管理階層 - 4.1.2.5Management with responsibility and authority for corrective action shall be promptly informed of products or processes which become noncompliant with specified requirements.當產品或制程無法符合特定要求時，該項資訊應迅即通知負責與授權矯正行動的管理階層。Management Review - 4.1.3管理審查 - 4.1.3The supplier's management with executive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this International Standard and the supplier's stated quality policy and objectives (see 4.1.1) . Records of such reviews shall be maintained (see 4.16) 供應商負經營責任之管理階層每隔規定期間應審查品質系統，且其間隔應足以確保品質系統持續適切與有效符合本國際標準要求及供應商即定之品質政策及目標（參閱4.1.1）。此項審查的記錄應予以維持（參閱4.16）。Management Review - 4.1.3.1管理審查 - 4.1.3.1This Management review requirement shall include all elements of the entire quality system, not only those specifically required in other elements (e.g. 4.l4.3.d) .本項管理審查應包括整體品質系統的所有要項，而非僅限於如4.14.3.d (預防行動）要項中所特別指定者。NOTE:Management Review should be conducted with a multi-disciplinary approach (see Glossary) .備注： 管理審查需以跨功能的團體方式來舉行（參閱詞匯）。Business Plan - 4.1.4經營計劃 - 4.1.4The supplier shall utilize a formal, documented, comprehensive business plan. The Business Plan shall be a controlled document. The content of the Business Plan is not subject to third party audit.供應商必須應用一份正式明文規定且完整的經營計劃。此項經營計劃應為管制文件。經營計劃的內容不提供予第三者稽核。This plan may typically include as applicable:這個計劃通常可能包含下列適用項目：Market-related issues市場相關的事務Financial planning and cost財務規劃與成本Growth projections企業成長預期Plant/facilities plans工廠/設施計劃Cost objectives成本目標Human resource development人力資源開發R & D plans, projections, and projects with appropriate funding研發計劃，企劃，專案及其適當的財源Projected sales figures預期銷售成果Quality objectives品質目標Customer satisfaction plans顧客滿意計劃Key internal quality and operational performance measurables內部品質和作業績效的主要指標Health, Safety and Environmental issues安全衛生及環保議題Goals and plans shall cover short term (1-2 years) and longer-term (3 years or more) . The goals and plans should be based on analysis of competitive products and on bench-marking inside and outside the automotive industry and the supplier's commodity. Methods to determine current and future customer expectations shall be in pl