4. Quality management system 4.品質管理系統 4.1 General requirements 4.1一般要求 The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. 組織須依照本國際標準之要求，建立、文件化、實施與維持一品質管理系統，及持續改進其有效性 The organization shall: 組織須： a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), a) 鑑別此品質管理系統與其應用於整個組織所需之過程(參照第1.2節)， b) determine the sequence and interaction of these processes, b) 決定此等過程之順序與交互作用， c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, c) 決定所需之準則與方法，以確保此等過程的運作與管制兩者均有效， d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, d) 確保必要資源與資訊之可取用性，以支援過程的運作與監督， e) monitor, measure and analyse these processes, and e) 監督、量測與分析此等過程，及 f) implement actions necessary to achieve planned results and continual improvement of these processes. f) 實施必要措施，以達成此等過程所規劃的結果與持續改進。 These processes shall be managed by the organization in accordance with the requirements of this International Standard. 此等過程須由組織依照本國際標準之要求加以管理。 Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. 當組織選擇來自外部會影響產品要求符合性之任何過程時，組織須確保此等過程的管制。此等來自外部過程之管制，須在品質管理系統內加以鑑別。 NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 備註：品質管理系統所需之過程參考上述，應包括管理階層活動、資源之提供、產品實現及量測之過程。 4.1.1 General requirements—Supplemental Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customer requirements. 4.1.1 一般要求—補述 確保對外包過程的控制，不能免除組織符合顧客所有要求的責任。 NOTE See also 7.4.1 and 7.4.1.3 備註 請同時參照第7.4.1節和第7.4.1.3節。 4.2 Documentation requirements 4.2 文件化要求 4.2.1 General 4.2.l 概述 The quality management system documentation shall include 品質管理系統文件須包括 a) documented statements of a quality policy and quality objectives, a) 品質政策與品質目標之書面敘述， b) a quality manual, b) 品質手冊， c) documented procedures required by this International Standard, c) 本國際標準要求之書面程序， d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and d) 組織為確保其過程之有效規劃、運作與管制所需的文件，及 e) records required by this International Standard (see 4.2.4). e) 本國際標準要求之紀錄(參照第4.2.4節)。 NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. 備註1： 本國際標準內所出現之名詞“書面程序”，係指此程序被建立、文件化、實施及維持。 NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to 備註2： 品質管理系統文件之程度，各組織間可由於下列而有所不同 a) the size of organization and type of activities, a) 組織之規模大小與活動之型態， b) the complexity of processes and their interactions, and b) 過程與其交互作用之複雜性，及 c) the competence of personnel. c) 人員之能力。 NOTE 3 The documentation can be in any form or type of medium. 備註3： 文件可以為任何形式或型態之媒體。 4.2.2 Quality Manual 4.2.2品質手冊 The organization shall establish and maintain a quality manual that includes 組織須建立及維持一品質手冊，並包括下述 a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2), a) 品質管理系統之範圍，包括任何排除之細節及調整(參照第1.2節)， b) the documented procedures established for the quality management system, or reference to them, and b) 品質管理系統所建立之書面程序或對其之引用，及 c) a description of the interaction between the processes of the quality management system. c) 品質管理系統各項過程間交互作用的描述。 4.2.3 Control of documents 4.2.3文件管制 Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4. 品質管理系統所需之文件須加以管制。紀錄是文件之一種特殊型態，其須依照第4.2.4節所定的要求加以管制。 A documented procedure shall be established to define the controls needed 書面程序須建立，以界定所需之管制 a) to approve documents for adequacy prior to issue, a) 在文件發行前批准其適切性， b) to review and update as necessary and re-approve documents, b) 在必要時，審查與更新以及重新批准文件， c) to ensure that changes and the current revision status of documents are identified, c) 確保文件之變更與最新修訂狀況，已加以識別， d) to ensure that relevant versions of applicable documents are available at points of use, d) 確保在使用場所可取用相關版本之適用文件， e) to ensure that documents remain legible and readily identifiable, e) 確保文件易於閱讀與容易識別， f) to ensure that documents of external origin are identified and their distribution controlled, and f) 確保外來之文件已加以識別，並對其分發加以管制，及 g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. g) 防止失效文件被誤用，以及這些文件若為任何目的而保留時，須加以適當之識別。 4.2.3.1 Engineering specifications The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer-required schedule. Timely review should be as soon as possible, and shall not exceed two working weeks. The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents. 4.2.3.1 工程規格 組織須有一套流程以確保對所有顧客的工程標準／規格，及其變更，得以根據顧客要求的時程，適時的審查、分發及執行。適時的審查應儘快執行，且不得超過二個工作週。
組織須保存一份記載每項生產變更生效日期的記錄。所謂「執行」，須包括更新相關文件。 NOTE A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc. 備註 當這些規格是被設計資料所引述或當其會影響生產性零件核准程序的文件（例如管制計畫，FMEA等）時，這些標準/規格的變更，需要同時更新顧客生產性零件核准的紀錄，亦即re-PPAP。 4.2.4 Control of records 4.2.4記錄管制 Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 紀錄須加以建立及維持，以提供品質管理系統符合要求及有效運作之證據。紀錄須易於閱讀、容易識別及取用。為了紀錄之鑑別、儲存、保護、取用、保存期限及處理，書面程序須加以建立，以界定所需之管制。 NOTE 1: “Disposition” above includes disposal. 備註 1 上述之「處理」包括廢棄。 NOTE 2: “Records” also include customer-specified records. 備註 2 「紀錄」亦包括顧客指定之紀錄。 4.2.4.1 Records retention The control of records shall satisfy regulatory and customer requirements. 4.2.4.1紀錄保存 紀錄之管制須滿足法規和顧客之要求。 5. Management responsibility 5.管理責任 5.1 Management commitment 5.1管理承諾 Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by 高階管理階層須藉由下列各項，提供其對品質管理系統發展與實施，以及對有效性持續改進承諾的證據 a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, a) 在組織內傳達符合顧客，以及法令與法規要求之重要性， b) establishing the quality policy, b) 建立品質政策， c) ensuring that quality objectives are established, c) 確保品質目標已加以建立， d) conducting management reviews, and d) 執行管理階層審查，及 e) ensuring the availability of resources. e) 確保資源之可取用性。 5.1.1 Process efficiency Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency. 5.1.1 流程效率 高階管理階層須審查產品實現流程和支援流程，以確保其有效性和效率。 5.2 Customer focus 5.2顧客導向 Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). 高階管理階層須確保顧客要求已被決定與符合，並提高顧客滿意的目標(參照第7.2.1及8.2.1節)。 5.3 Quality policy 5.3品質政策 Top management shall ensure that the quality policy 高階管理階層須確保品質政策 a) is appropriate to the purpose of the organization, a) 對組織之目的是適切的， b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, b) 包括品質管理系統符合要求與有效性持續改進之承諾， c) provides a framework for establishing and reviewing quality objectives, c) 提供一個建立與審查品質目標之架構， d) is communicated and understood within the organization, and d) 在組織內已被溝通與瞭解，及 e) is reviewed for continuing suitability. e) 審查其持續的適用性。 5.4 Planning 5.4規劃 5.4.1 Quality objectives 5.4.1品質目標 Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a]], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. 高階管理階層須確保品質目標，包括產品符合要求之需求[參照第7.1 a]節]，已在組織內相關部門及階層加以建立。品質目標須可量測，且與品質政策一致。 5.4.1.1 Quality objective--Supplemental Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy. 5.4.1.1品質目標—補述 高階管理階層須定義品質目標和量度指標，且須將其納入經營計畫，並運用該目標和指標來展開品質政策。 NOTE Quality objectives should address customer expectations and be achievable within a defined time period. 備註 品質目標應強調顧客的期望，且應是在預定期間內可以達成的。 5.4.2 Quality management system planning 5.4.2品質管理系統規劃 Top management shall ensure that 高階管理階層須確保 a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and a) 品質管理系統規劃已加以完成，以符合第4.1節所定要求與品質目標，及 b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. b) 當規劃與實施品質管理系統變更時，品質管理系統完整性仍得以維持。 5.5 Responsibility, authority and communication 5.5職責、權限與溝通 5.5.1 Responsibility and authority 5.5.1職責與權限 Top management shall ensure that responsibilities and authorities are defined and communicated within the organization. 高階管理階層須確保職責及權限，已在組織內加以界定及溝通。 5.5.1.1 Responsibility for quality Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements. Personnel responsible for product quality shall have the authority to stop production to correct quality problems. Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality. 5.5.1.1品質責任 負有權責執行矯正措施的管理人員，須被立即告知不符合規定的產品或製程。
負責產品品質之人員須被授權可以停止生產以矯正品質問題。
跨越所有班次之生產線(作業)均須配置負責產品品質之人員 (e.g. QA人員) 。
5.5.2 Management representative 5.5.2管理代表 Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes 高階管理階層須在管理階層中指派一員擔任管理代表，其不受其他職責所影響，明訂其職責及權限，此職責及權限包括 a) ensuring that processes needed for the quality management system are established, implemented and maintained, a) 確保品質管理系統所需之過程，已加以建立、實施及維持， b) reporting to top management on the performance of the quality management system and any need for improvement, and b) 向高階管理階層報告品質管理系統之績效與改進之任何需求，及 c) ensuring the promotion of awareness of customer requirements throughout the organization. c) 確保促進組織全盤認知顧客之要求。 NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. 備註：管理代表之職責，可包括與外部團體在品質管理系統相關事務之聯繫。 5.5.2.1 Customer representative Top management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development. 5.5.2.1顧客代表 高階管理階層須指定人員，並賦予其權責用以確保顧客的要求受到重視。本項包括管制特性的選擇，設定品質目標及相關訓練，矯正及預防措施，產品的設計與開發。 5.5.3 Internal communication 5.5.3內部溝通 Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 高階管理階層須確保組織內已建立適當的溝通過程，以及進行與品質管理系統有效性有關的溝通。 5.6 Management review 5.6管理審查 5.6.1 General 5.6.1概述 Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. 高階管理階層須在規劃之期間內，審查組織品質管理系統，以確保其持續的適用、適切及有效。審查須包括改進時機之評估，以及品質管理系統，包括品質政策及品質目標，變更的需求。 Records from management reviews shall be maintained (see 4.2.4).. 管理階層審查紀錄須加以維持(參照第4.2.4節) 5.6.1.1 Quality management system performance These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process. Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1). These results shall be recorded to provide, as a minimum, evidence of the achievement of - the quality objectives specified in the business plan, and - customer satisfaction with product supplied. 5.6.1.1 品質管理系統績效 此等審查須包括品質管理系統的所有要求及其績效趨勢，因其為持續改善流程的重要部分。
此等結果須加以紀錄，至少可以提供作為下述成果(達成)的佐證： --經營計畫規定的品質目標，以及 --交運產品之顧客滿意度。 5.6.2 Review input The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement.
5.6.2.1 Review input-Supplemental Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment. 5.6.3 Review output The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. 5.6.2審查輸入 管理階層審查輸入須包括下列資訊
a) 稽核之結果， b) 顧客之回饋， c) 過程績效與產品符合性， d) 預防及矯正措施之狀況， e) 先前管理階層審查之跟催措施， f) 可能影響品質管理系統之變更，及 g) 改進之建議。
5.6.2.1審查輸入—補述 管理審查輸入須包含對實際的與潛在的產品售後(使用)失效之分析，以及這些失效對品質、安全或環境的衝擊分析。 5.6.3審查輸出 管理階層審查之輸出須包括下列有關之任何決定及措施 a) 品質管理系統與其過程有效性之改進， b) 顧客要求有關產品之改進，及 c) 資源之需求。 6. Resource management 6. 資源管理 6.1 Provision of resources 6.1資源提供 The organization shall determine and provide the resources needed 組織須決定及提供所需之資源， a) to implement and maintain the quality management system and continually improve its effectiveness, and a) 以實施與維持品質管理系統，以及持續改進其有效性，及 b) to enhance customer satisfaction by meeting customer requirements. b) 以藉由符合顧客要求提高顧客滿意度。 6.2 Human resources 6.2 人力資源 6.2.1 General 6.2.1概述 Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. 執行會影響產品品質工作的人員，須以適當之教育、訓練、技術及經驗為基準，勝任其工作。 6.2.2 Competence, awareness and training 6.2.2能力、認知與訓練 The organization shall 組織須 a) determine the necessary competence for personnel performing work affecting product quality, a) 決定執行會影響產品品質工作之人員必要的能力， b) provide training or take other actions to satisfy these needs, b) 提供訓練或採行其他措施以滿足這些需求， c) evaluate the effectiveness of the actions taken, c) 評估所採行措施之有效性， d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and d) 確保人員認知其從事之活動的關連性與重要性，以及他們如何在品質目標之達成有所貢獻，及 e) maintain appropriate records of education, training, skills and experience (see 4.2.4). e) 維持適當之教育、訓練、技術及經驗的紀錄(參照第4.2.4節)。 6.2.2.1 Product design skills The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques. Applicable tools and techniques shall be identified by the organization. 6.2.2.1產品設計技術 組織須確保負產品設計責任之人員有能力達到設計要求，且對需要的應用工具和技術十分嫻熟。
組織須界定需要的應用工具和技術 6.2.2.2 Training The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements. 6.2.2.2 訓練 組織須制定並維持一套用於鑑定訓練需求以及使影響產品品質之所有人員可以勝任其工作之書面程序。對執行特定工作之人員須依需求審定其資格，尤其須特別注意滿足顧客的要求。
NOTE 1 This applies to all employees having an effect on quality at all levels of the organization. NOTE 2 An example of the customer specific requirements is the application of digitized mathematically based data. 備註 1 上述要求適用於組織內各階層所有會影響品質的員工。
備註 2 顧客特定要求的例子比如數位化數學資料的應用。 6.2.2.3 Training on the job The organization shall provide on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements. 6.2.2.3 職前（在職）訓練 組織須提供會影響產品品質的人員，包括約聘人員或代理人員，任何新作業或變更的作業的職前（在職）訓練。擔任會影響品質工作的人員須被告知當不合格發生時對顧客造成的影響(後果)。 6.2.2.4 Employee motivation and empowerment The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization. The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives [see 6.2.2 d]. 6.2.2.4 員工激勵和授權 組織須有一套流程以激勵員工達成品質目標、進行持續改善以及塑造創新之環境。此流程須包含整個組織的品質與科技意識的宣導。
6.3 Infrastructure 6.3基礎架構 The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable 組織須決定、提供及維持所需之基礎架構，以達成符合產品要求。適用時，基礎架構包括 a) buildings, workspace and associated utilities, a) 建築物、工作空間與相關之公共設施， b) process equipment (both hardware and software), and b) 過程設備（硬體與軟體兩者），及 c) supporting services (such as transport or communication). c) 支援服務（諸如輸送或通訊）。 6.3.1 Plant, facility and equipment planning The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value-added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations. 6.3.1 工廠、設施及設備規劃 組織須採用跨功能小組的做法(參考第7.3.1.1節)，以制定工廠，設施及設備計畫( i.e.與先期產品品質規劃程序相結合)。工廠的配置須使物料流動、搬運和現場空間使用附加價值達到最佳化，且須促進同步物流。須制定及實施一套方法以評估及監督現行作業的有效性。
NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system. 備註 此等要求應強調精簡生產原則以及與品質管理系統有效性之連結。 6.3.2 Contingency plans The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns. 6.3.2緊急應變計畫 組織須準備應變計畫以便在緊急事件中（例如設施中斷、勞工短缺、主要設備故障和產品售後/使用退貨）能滿足顧客要求。 6.4 Work environment 6.4工作環境 The organization shall determine and manage the work environment needed to achieve conformity to product requirements. 組織須決定及管理工作環境所需，以達成符合產品要求。 6.4.1 Personnel safety to achieve product quality Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially in the design and development process and in manufacturing process activities. 6.4.1為達成產品品質之人員安全 組織須強調產品安全和減少員工潛在危機的方法，特別在設計與開發流程以及製造流程活動中。 6.4.2 Cleanliness of premises The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs. 6.4.2工作場所(環境)之整潔 組織須保持其工作環境處於一種與其產品和製程需要相稱的、井然有序、乾淨且維修良好的狀態。 7. Product realization 7. 產品實現 7.1 Planning of product realization 7.1產品實現之規劃 The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1). 組織須規劃及開發產品實現所需之過程。產品實現之規劃，須與品質管理系統其他過程的要求一致（參照第4.1節）。 In planning product realization, the organization shall determine the following, as appropriate: 在規劃產品實現時，適當時，組織須決定下列： a) quality objectives and requirements for the product; a) 產品之品質目標及要求； b) the need to establish processes, documents, and provide resources specific to the product; b) 建立過程、文件之需求及提供產品特定之資源； c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; c) 產品所需之特定的查證、確認、監督、檢驗與測試活動，以及產品允收標準； d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4). d) 所需之紀錄，以提供證明實現過程及最終產品達成要求（參照第4.2.4節）。 The output of this planning shall be in a form suitable for the organization's method of operations. 規劃的結果須為適合於組織運作方法之一種形式。 NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. 備註1： 一份規定品質管理系統過程（包括產品實現過程）及資源，應用於某一特定產品、專案或合約的文件，可視為一份品質計畫。 NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes. 備註2： 對於產品實現過程之開發，組織亦可應用第7.3節所定之要求。 NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product realization. Advanced product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection, and is based on a multidisciplinary approach. 備註 某些顧客採用專案管理或先期產品品質規劃作為達成產品實現的方式。相對於偵測錯誤，先期產品品質規劃體現了預防錯誤與持續改善的觀念，並且是以跨功能小組方法為基礎。 7.1.1 Planning of product realization--Supplemental Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan. 7.1.1產品實現之規劃—補述 顧客要求以及其引申之技術規格要求，須被納入產品實現計劃之中，以作為品質計畫的一部份。 7.1.2 Acceptance criteria Acceptance criteria shall be defined by the organization and, where required, approved by the customer. For attribute data sampling, the acceptance level shall be zero defects (see 8.2.3.1). 7.1.2允收標準 組織須界定允收標準 (Note: 通常是在APQP時界定！), 並且, 若需要時,須取得顧客核准。 對於計數值抽樣, 允收標準須為零缺點（參照第8.2.3.1節）。 7.1.3 Confidentiality The organization shall ensure the confidentiality of customer-contracted products and projects under development, and related product information. 7.1.3 機密性 組織對於已與顧客簽約之開發中的產品和專案，以及與產品相關的資訊，須確保其機密性。 7.1.4 Change control The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation. For proprietary designs, impact on form, fit and function (including performance, and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated. When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met. 7.1.4變更管制 組織須有一套流程來管制及反應會影響產品實現的變更。任何變更所造成的影響，包括那些由供應商所引起的變更，都須加以評估，且須界定驗證與驗收的作業，以確保符合顧客的要求。變更在實施之前須加以驗收完成。
當顧客提出要求時，須符合所增加的查證／識別要求，譬如：新產品引進之要求。 NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer. 備註1 任何會影響顧客要求的產品實現變更都需要通知顧客，並取得顧客同意 NOTE 2 The above requirement applies to product and manufacturing process changes. 備註 2 上述要求適用於產品變更與製程變更。 7.2 Customer-related processes 7.2顧客相關之作業流程 7.2.1 Determination of requirements relating to the product 7.2.1產品有關要求的決定 The organization shall determine 組織須決定 a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, a) 顧客所定之要求，包括交貨與交貨後活動的要求， b) requirements not stated by the customer but necessary for specified or intended use, where known, b) 非顧客所陳述之要求，但為已知特定用途或為預期用途所必須者， c) statutory and regulatory requirements related to the product, and c) 與產品有關之法令與法規要求，及 d) any additional requirements determined by the organization. d) 組織所決定之任何附加的要求。 NOTE 1 Post-delivery activities include any after-sales product service provided as part of the customer contract or purchase order. 備註 1 交貨後活動包括屬於與客戶的合約或購買訂單一部份的任何產品售後服務活動。 NOTE 2 This requirement includes recycling, environmental impact and characteristics identified as a result of the organization’s knowledge of the product and manufacturing processes (see 7.3.2.3) 備註 2 上述要求包括回收、環境衝擊以及根據組織對產品與製程的瞭解所鑑別出之特性（參照第7.3.2.3節）。 NOTE 3 Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials. 備註 3 上述c)項之符合應包括將適用的政府法令、安全與環保法規，適用 於材料的取得、儲存、搬運、回收、廢棄或處理。
7.2.1.1 Customer-designated special characteristics The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics. 7.2.1.1 顧客指定的管制特性 組織須展現能符合客戶對管制特性之「指定/命名」(e.g. 賦予持定符號…等)，「文件化」及「管制」之要求。
7.2.2 Review of requirements relating to the product 7.2.2產品要求審查 The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that 組織須審查與產品有關之要求。此審查須在組織承諾供應給顧客一項產品之前執行（例如：標單之送出、合約或訂單之接受、合約或訂單變更之接受），且須確保 a) product requirements are defined, a) 產品要求已加以界定， b) contract or order requirements differing from those previously expressed are resolved, and b) 與先前表達不同之合約或訂單要求已加以解決，及 c) the organization has the ability to meet the defined requirements. c) 組織有能力符合所界定之要求。 Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4). 審查結果及審查產生措施之紀錄，均須予以維持（參照第4.2.4節）。 Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance. 當顧客提供非書面敘述之要求時，組織在接受顧客要求前須加以確認。 Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. 當產品要求變更時，組織須確保相關文件已加以修訂，以及將變更之要求知會相關人員。 NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. 備註： 在某些情況，諸如網際網路之銷售，正式的審查對每一訂單言，可能並不實際。替代之審查可包含相關的產品資訊，諸如型錄、廣告資料等。 7.2.2.1 Review of requirements related to the product--Supplemental Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer authorization. 7.2.2.1 產品要求審查—補述 免除第7.2.2節中敘及的正式審查（參照備註），需要有顧客的授權。 7.2.2.2 Organization manufacturing feasibility The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis. 7.2.2.2 組織的製造可行性 組織在合約審查過程中須針對提議之產品進行調查，確認與記錄其製造可行性，包括風險分析。
7.2.3 Customer communication 7.2.3顧客溝通 The organization shall determine and implement effective arrangements for communicating with customers in relation to 組織須決定及實施有效的安排，以便就下列相關項目與顧客溝通 a) product information, a) 產品資訊， b) enquiries, contracts or order handling, including amendments, and b) 查詢、合約或訂單之處理，包括修訂時，及 c) customer feedback, including customer complaints. c) 顧客回饋，包括顧客抱怨。 7.2.3.1 Customer communication-Supplemental The organization shall have the ability to communicate necessary information, including data, in a customer-specified language and format (e.g. computer-aided design data, electronic data exchange). 7.2.3.1顧客溝通—補述 組織須具備以顧客規定的語言與格式溝通必要資訊的能力（例如電腦輔助設計資料、電子資料交換）。 7.3 Design and development 7.3設計和開發 NOTE The requirements of 7.3 include product and manufacturing process design and development, and focus on error prevention rather than detection. 備註 第7.3節的要求包括產品與製程的設計與開發，並應將焦點放在預防錯誤而非偵測錯誤。 7.3.1 Design and development planning 7.3.1設計和開發規劃 The organization shall plan and control the design and development of product. 組織須規劃與及管制產品之設計及開發。 During the design and development planning, the organization shall determine 當設計及開發規劃時，組織須決定 a) the design and development stages, a) 設計及開發階段， b) the review, verification and validation that are appropriate to each design and development stage, and b) 審查、查證與確認活動，對每一個設計及開發階段是適切的，以及 c) the responsibilities and authorities for design and development. c) 設計及開發之職責與權限。 The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. 組織須管理參與設計及開發之不同小組間的介面，以確保有效的溝通與職責的明確指派。 Planning output shall be updated, as appropriate, as the design and development progresses. 適當時，在設計及開發過程中，規劃輸出須加以更新。 7.3.1.1 Multidisciplinary approach The organization shall use a multidisciplinary approach to prepare for product realization, including - development/finalization and monitoring of special characteristics, - development and review of FMEAs, including actions to reduce potential risks, and - development and review of control plans. 7.3.1.1 跨功能小組的方式 組織須利用跨功能小組的方式籌備產品實現，包括： – 各項管制特性的建立／定案和監督， – 各項失效模式與效應分析的建立和審查，包含降低潛在風險之各種行動方案，以及 – 各項管制計畫的建立和審查。 NOTE A multidisciplinary approach typically includes the organization’s design, manufacturing, engineering, quality, production and other appropriate personnel. 備註 典型的跨功能小組成員包括組織內的設計、製造、工程、品質、生產和其他適當人員。 7.3.2 Design and development inputs 7.3.2設計和開發輸入 Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include 與產品要求相關之輸入，須加以決定及紀錄加以維持（參照第4.2.4節）。此等輸入須包括 a) functional and performance requirements, a) 功能與績效之要求， b) applicable statutory and regulatory requirements, b) 適用的法令與法規之要求， c) where applicable, information derived from previous similar designs, and c) 當適用時，源自以往類似設計之資訊，及 d) other requirements essential for design and development. d) 其他設計及開發所不可或缺之要求。 These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 此等輸入之適切性須加以審查。要求應完整、明確及不會互相矛盾。 NOTE Special characteristics (see 7.2.1.1) are included in this requirement. 備註 管制特性（參照第7.2.1.1節）亦包含於上述要求。 7.3.2.1 Product design input The organization shall identify, document and review the product design inputs requirements, including the following: - customer requirements (contract review) such as special characteristics (see 7.3.2.3), identification, traceability and package; - use of information: the organization shall have a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature; - targets for product quality, life, reliability, durability, maintainability, timing and cost. 7.3.2.1產品設計輸入 組織須對產品設計輸入的要求加以鑑別、文件化和審查，包括下列項目： – 顧客要求（合約審查）：例如管制特性（參照第7.3.2.3節）、識別、追溯性和包裝； – 資訊的使用：組織須備有一流程以便將得自先前設計專案、競爭者分析、供應商回饋、內部輸入、產品售後(使用)資料和其他相關來源的資訊，應用到具類似性質的現有及未來專案之中。 – 產品品質、壽命、可靠度、耐久性、可維護性、時效性和成本的目標。 7.3.2.2 Manufacturing process design input The organization shall identify, document and review the manufacturing process design input requirements, including - product design output data, - targets for productivity, process capability and cost, - customers requirements, if any, and - experience from previous developments. 7.3.2.2製程設計輸入 組織須對製程設計輸入的要求加以鑑別、文件化和審查，包括 – 產品設計輸出資料， – 生產力、製程能力和成本的目標， – 顧客的要求（若有的話），和 – 先前開發案的經驗。 NOTE The manufacturing process design includes the use of error-proofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered. 備註 製程設計包括視問題的大小程度及所面對風險的相當性採用適切的防錯法。 7.3.2.3 Special characteristics The organization shall identify special characteristics [see 7.3.3 d] and - include all special characteristics in the control plan, - comply with customer-specified definitions and symbols, and - identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer’s special characteristics symbol or the organization’s equivalent symbol or notation to include those process steps that affect special characteristics. 7.3.2.3 管制特性 組織須鑑別出管制特性（參照第7.3.3 d節），並且 將所有管制特性納入管制計劃中 符合顧客規定的定義和標誌，並且 在製程管制文件上 (包括圖面、FMEA's，管制計畫，作業指導書)標記顧客的管制特性符號或組織的相對等符號或註記，用以清楚指出那些會影響管制特性的製程步驟。 NOTE Special characteristics can include product characteristics and process parameters. 備註 管制特性可能包括產品特性和製程參數。 7.3.3 Design and development outputs 7.3.3設計和開發輸出 The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. 設計及開發之輸出，須以一種能夠查驗設計及開發輸入之形式加以提供，以及在發行前須加以核准。 Design and development outputs shall 設計及開發輸出須 a) meet the input requirements for design and development, a) 符合設計及開發輸入之要求， b) provide appropriate information for purchasing, production and for service provision, b) 提供採購、生產及服務提供之適當資訊， c) contain or reference product acceptance criteria, and c) 包含或引用產品之允收標準，及 d) specify the characteristics of the product that are essential for its safe and proper use.. d) 規定產品之安全及適合使用的必要特性。 7.3.3.1 Product design outputs –Supplemental The product design output shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include - design FMEA, reliability results, - product special characteristics and specifications, - product error-proofing, as appropriate, - product definition including drawings or mathematically based data, - product design reviews results, and - diagnostic guidelines where applicable. 7.3.3.1 產品設計輸出—補述 產品設計輸出須以一種能夠查驗或驗收產品設計輸入要求的語句加以表達。產品設計輸出須包括 – 設計FMEA、可靠度結果； – 產品的管制特性和規格； – 適當時，產品的防錯法； – 產品定義，包括圖面或數學資料； – 產品的設計審查結果；以及 – 適用時，診斷指導綱要。 7.3.3.2 Manufacturing process design output The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design output shall include - specification and drawings, - manufacturing process flowchart/layout, - manufacturing process FMEAs, - control plan (see 7.5.1.1) - work instructions, - process approval acceptance criteria, - data for quality, reliability, maintainability and measurability, - results of error-proofing activities, as appropriate, and - methods of rapid detection and feedback of product/manufacturing process nonconformities. 7.3.3.2 製程設計輸出 製程設計輸出須以一種能夠查驗製程設計輸入要求和驗收的語句加以表達。製程設計輸出須包括 – 規格和圖面； – 製造流程圖/平面佈置圖； – 製程FMEA； – 管制計畫（參照第7.5.1.1節）； – 作業指導書； – 製程認可的允收標準； – 品質、可靠度、可維護性和可量測性的資料； – 適當時，防錯法活動的結果；以及 – 快速偵測與回饋產品/製程不良的方法。 7.3.4 Design and development review 7.3.4設計和開發審查 At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) 在適當階段，須依照所規劃之安排（參照第7.3.1節）執行設計及開發之系統性審查， a) to evaluate the ability of the results of design and development to meet requirements, and a) 以評估設計及開發結果符合要求之能力，及 b) to identify any problems and propose necessary actions. b) 以鑑別任何問題及提出必要之措施。 Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4). 參與此審查者，須包括與被審查之設計及開發階段有關部門的代表。審查結果及任何必要措施之紀錄，均須加以維持（參照第4.2.4節）。 NOTE These reviews are normally coordinated with the design phases and include manufacturing process design and development. 備註 此等審查通常需要配合設計之各個不同階段且應含製程設計與開發。
7.3.4.1 Monitoring Measurements at specified stages of design and development shall be defined, analysed and reported with summary results as an input to management review. 7.3.4.1 監測 於特定的設計與開發階段必須執行的衡量須加以界定、分析，並報告總結結果，以作為管理審查的輸入。 NOTE These measurements include quality risks, costs, lead-times, critical paths and others, as appropriate. 備註 此等衡量包含品質風險、成本、前置時間、關鍵路徑和其他適切項目。
7.3.5 Design and development verification 7.3.5設計及開發查證 Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4). 查證須依照所規劃之安排（參照第7.3.1節）執行，以確保設計及開發輸出符合設計及開發輸入要求。查證結果及任何必要措施之紀錄，均須加以維持（參照第4.2.4節）。 7.3.6 Design and development validation 7.3.6設計和開發驗收 Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4). 設計及開發驗收須依照所規劃的安排（參照第7.3.1節）執行，以確保產品之結果有能力符合已知特定應用或預期用途的要求。當可行時，確認須在產品交貨或實施之前予以完成。確認結果及任何必要措施之紀錄，均須加以維持（參照第4.2.4節）。 NOTE 1 The validation process nromally includes an analysis of field reports for similar products. 備註 1 驗收過程通常包含類似產品的「產品售後(使用)」報告分析。 NOTE 2 The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing processes. 備註 2 上述第7.3.5節和第7.3.6節的要求同時適用於產品與製程。 7.3.6.1 Design and development validation-Supplemental Design and development validation shall be performed in accordance with customer requirements including programme timing. 7.3.6.1設計和開發驗收—補述 設計和開發驗收的執行須根據顧客要求（包含顧客的方案中對時程的要求）。 7.3.6.2 Prototype programme When required by the customer, the organization shall have a prototype progrmme and control plan. The organization shall use, wherever possible, the same suppliers, tooling and manufacturing processes as will be used in production. All performance testing activities shall be monitored for timely completion and conformity to requirements. While services may be outsourced, the organization shall be responsible for the outsourced services, including technical leadership. 7.3.6.2 原型樣品方案 顧客要求時，組織須有一份原型樣品方案與管制計畫。組織須儘可能使用與正式生產時相同的供應商，工模具和製程。
所有的性能測試活動須監測是否及時的完成和符合要求。
當上述服務可能外包時，組織須對外包的服務負責，包括提供技術指導。 7.3.6.3 Product approval process The organization shall conform to a product and manufacturing process approval procedure recognized by the customer. 7.3.6.3 產品核准流程 組織須符合顧客認可之「產品和製程核准程序」。 NOTE Product approval should be subsequent to the verification of the manufacturing process. 備註 產品核准須在製程查證之後。
This product and manufacturing process approval procedure shall also be applied to suppliers. 此種產品和製程核准程序也須適用於供應商。 7.3.7 Control of design and development changes 7.3.7設計和開發變更管制 Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. 設計及開發變更須加以鑑別與紀錄應加以維持。變更須加以審查、查證及確認，適當時，在實施前須加以核准。設計及開發變更之審查，須包括變更對構成零組件及已交運產品之影響的評估。 Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4). 變更審查結果及任何必要措施之紀錄，均須加以維持（參照第4.2.4節）。 NOTE 1 Design and development changes include all changes during the product progrmme life (see 7.1.4) 備註 1 設計和開發變更包含規劃的產品壽命期間所有的變更（參照第7.1.4節）。 7.4 Purchasing 7.4採購 7.4.1 Purchasing process 7.4.1採購流程 The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. 組織須確保所採購之產品符合採購規定要求。對供應者及所採購產品使用之管制方式與程度，須視所採購產品對後續產品實現或最終產品的影響而定。 The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4). 組織須以供應者依照組織之要求供應產品的能力為基礎，來評估及選擇供應者。選擇、評估及再評估之標準須予以建立。評估結果及評估所產生之任何必要措施的紀錄，均須加以維持（參照第4.2.4節）。 NOTE 1 Purchased products above include all products and services that affect customer requirements such as sub-assembly, sequencing, sorting, rework and calibration services. 備註 1 上述要求提及的採購之產品包含會影響顧客要求之所有產品與服務，例如小組裝、配送、篩選、重工及校正服務。
NOTE 2 When there are mergers, acquisitions or affiliations associated with suppliers, the organization should verify the continuity of the supplier’s quality management system and its effectiveness. 備註 2 當供應商有合併、併購或分割的情形時，組織應驗證供應商的品質管理系統及其有效性之持續性。
7.4.1.1 Regulatory conformity All purchased products or materials used in product shall conform to applicable regulatory requirements. 7.4.1.1 法規之符合 所有採購之產品或用於產品的材料須符合適用的法規要求。 7.4.1.2 Supplier quality management system development The organization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001:2000 is the first step in achieving this goal. 7.4.1.2 供應商品質系統的開發(建立)
組織須以供應商符合本技術規範為目標來執行供應商品質管理系統的開發(建立)。符合ISO 9001:2000的要求是達成目標的第一步 NOTE The prioritization of suppliers for development depends upon, for example, the supplier’s quality performance and the importance of the product supplied. 備註 供應商開發的優先順序視其，舉例而言，品質表現和所提供的產品的重要性而定。 Unless otherwise specified by the customer, suppliers to the organization shall be third party registered to ISO 9001:2000 by an accredited third- party certification body. 除非顧客另有規定，否則組織的供應商須取得由「國際承認的」第三者認証公司所認証通過的ISO 9001:2000認證。 7.4.1.3 Customer-approved sources Where specified by the contract (e.g. customer engineering drawing, specification), the organization shall purchase products, materials or services from approved sources. The use of customer-designated sources, including tool/gauge suppliers, does not relieve the organization of the responsibility for ensuring the quality of purchased products. 7.4.1.3 顧客核准的來源 當合約中（例如顧客的工程圖面、規範）要求時，組織須自核准的來源採購所需的產品、材料或服務。
採用顧客指定來源，包括工模具/檢具供應商，並不能免除組織確保採購產品的品質的責任。 7.4.2 Purchasing information 7.4.2採購資訊 Purchasing information shall describe the product to be purchased, including where appropriate 採購資訊須描述所採購之產品，適當時包括 a) requirements for approval of product, procedures, processes and equipment, a) 產品、程序、過程及設備要求之核准， b) requirements for qualification of personnel, and b) 人員資格之要求，及 c) quality management system requirements. c) 品質管理系統之要求。 The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 採購規定要求傳達給供應者前，組織須確保其適切性。 7.4.3 Verification of purchased product 7.4.3採購產品的驗證 The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. here the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information. 組織須建立及實施必要之檢驗或其他活動，以確保所採購產品符合採購規定要求。 當組織或其顧客意圖在供應者場所執行查證時，組織須於採購資訊中，敘述所計劃之查證安排及產品放行之方法。 7.4.3.1 Incoming product quality The organization shall have a process to assure the quality of purchased product (see 7.4.3) utilizing one or more of the following methods:
- receipt of, and evaluation of, statistical data by the organization; - receiving inspection and/or testing such as sampling based on performance; - second- or third-party assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality; - part evaluation by a designated laboratory; - another method agreed with the customer.
– 由組織接收並評估(由供應商所提供的)統計數據； – 接收檢驗與／或測試（譬如：依據進料品質表現之優劣來決定抽樣鬆緊）； – 在供應商處執行第二者或第三者的評鑑或稽核，且須搭配可接受的交運產品品質紀錄； – 委由指定的實驗室所實施的零組件評估； – 其他經顧客同意的方法。 7.4.3.2 Supplier monitoring Supplier performance shall be monitored through the following indicators: - delivered product quality; - customer disruptions including field returns; - delivery schedule performance (including incidents of premium freight); - special status customer notifications related to quality or delivery issues. The organization shall promote supplier monitoring of the performance of their manufacturing processes. 7.4.3.2 供應商監測 供應商的績效(表現)須透過下列指標加以監測： – 交運產品的品質; – 顧客(生產) 干擾/停頓，含產品售後(使用)退回(退貨); – 交期表現（含發生超額運費之事件）； – 因品質或交期問題所造成之「特別狀況之通知顧客」
組織須鼓勵供應商監測其製程績效(表現)。 7.5 Production and service provision 7.5生產與服務提供 7.5.1 Control of production and service provision 7.5.1生產及服務提供之管制 The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable 組織須在管制之情況下規劃及完成生產及服務提供。當適用時，管制情況須包括 a) the availability of information that describes the characteristics of the product, a) 描述產品特性之資訊的可取用性， b) the availability of work instructions, as necessary, b) 工作說明書之可取用性，當必要時， c) the use of suitable equipment, c) 適當設備的使用， d) the availability and use of monitoring and measuring devices, d) 監督及量測裝置之可取用性及使用， e) the implementation of monitoring and measurement, and e) 監督及量測之實施，及 f) the implementation of release, delivery and post-delivery activities. f) 放行、交貨及交貨後活動之實施。 7.5.1.1 Control plan The organization shall – develop control plans (see annex A) at the system, subsystem, component and/or material level for the product supplied, including those for processes producing bulk materials as well as parts, and – have a control plan for pre-launch and production that takes into account the design FMEA and manufacturing process FMEA outputs, The control plan shall – list the controls used for the manufacturing process control, – include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both the customer and the organization, – include the customer-required information, if any, and – initiate the specified reaction plan (see 8.2.3.1) when the process becomes unstable or not statistically capable. Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources or FMEA (see 7.1 .4). 7.5.1.1 管制計畫 組織須 – 對所供應的產品按照系統、子系統、組件及（或）物料的級別研擬適當的管制計畫（參照附錄A），包含生產散裝物質的製程以及生產零組件的製程；以及 – 備有量產前與量產階段的管制計畫，此管制計畫需將設計FMEA與製程FMEA的輸出納入考慮。
NOTE Customer approval may be required after review or update of the control plan.
7.5 1.2 Work instructions The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality. These instructions shall be accessible for use at the work station.
These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process.
7.5.1.3 Verification of job set-ups Job set-ups shall be verified whenever performed, such as an initial run of a job, material changeover or job change. Work instructions shall be available for set-up personnel. The organization shall use statistical methods of verification where applicable. 備註 管制計畫檢討及更新後，可能需要經過顧客的核准。
7.5.1.3 作業條件設定的驗證 只要是執行作業條件的設定（例如每一工作起始時，原料轉換，工作變更）就須驗證作業條件的設定。 有關的指導書須提供給執行設定之人員。凡適用時，組織須進行統計方法的驗證。 NOTE Last-off-part comparisons are recommended. 7.5.1.4 Preventive and predictive maintenance The organization shall identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system. As a minimum, this system shall include the following: - planned maintenance activities; - packaging and preservation of equipment, tooling and gauging; - availability of replacement parts for key manufacturing equipment; - documenting, evaluating and improving maintenance objectives. The organization shall utilize predictive maintenance methods to continually improve the effectiveness and the efficiency of production equipment. 7.5.1.5 Management of production tooling The organization shall provide resources for tool and gauge design, fabrication and verification activities. The organization shall establish and implement a system for production tooling management including :
- maintenance and repair facilities and personnel; - storage and recovery; - set-up; - tool-change programmes for perishable tools; - tool design modification documentation, including engineering change level; - tool modification and revision to documentation; - tool identification, defining the status, such as production, repair or disposal.
The organization shall implement a system to monitor these activities if any work is outsourced.
如果任何這方面之作業係屬外包性質者，組織須有一套監測的系統，用以監測這些外包作業。 NOTE This requirement also applies to the availability of tools for vehicle service parts. 備註 上述要求亦適用汽車服務性零件的工模具之取得。 7.5.1.6 Production scheduling Production shall be scheduled in order to meet customer requirements, such as just-in-time supported by an information system that permits access to production information at key stages of the process and is order driven. 7.5.1.6 生產排程 生產進度須妥善安排以符合顧客的要求，例如資訊系統支援下的及時性生產(JIT)，該系統允許在製程的重要階段取得生產資訊，而且生產排程應是訂單導向(e.g. 拉式系統)。 7.5.1.7 Feedback of information from service A process for communication of information on service concerns to manufacturing, engineering and design activities shall be established and maintained. 7.5.1.7 服務資訊的回饋 須制定並維持一套溝通流程將有關售後服務關切事項的資訊，通報給製造、工程及設計單位。 NOTE The intent of the addition of “service concerns" to this subclause is to ensure that the organization is aware of nonconformities that occur external to its organization. 備註 於此要項中增加〝售後服務關切事項〞的目的是為了確保組織知道發生在自己組織外部的不符合事項。 7.5.1.8 Service agreement with customer When there is a service agreement with the customer, the organization shall verify the effectiveness of - any organization service centres, - any special-purpose tools or measurement equipment, and - the training of service personnel. 7.5.1.8 與顧客之服務協議 當與顧客有服務協議時，組織須確認下列項目的有效性： – 組織的服務中心, – 特殊用途的工模具或量測設備, 以及 – 服務人員的訓練。 7.5.2 Validation of processes for production and service provision 7.5.2生產及服務提供流程之驗收 The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. 組織須確認輸出結果無法經由後續的監督或量測加以查證之任何生產及服務提供的過程。此包括唯有在產品使用後或服務已交貨後，才會顯現缺陷之任何過程。 Validation shall demonstrate the ability of these processes to achieve planned results. 確認須展示這些過程達成規劃結果之能力。 The organization shall establish arrangements for these processes including, as applicable 組織須建立這些過程之安排，當適用時，包括 a) defined criteria for review and approval of the processes, a) 界定過程審查及核准之標準， b) approval of equipment and qualification of personnel, b) 設備之核准及人員之資格， c) use of specific methods and procedures, c) 特定方法及程序之使用， d) requirements for records (see 4.2.4), and d) 要求之紀錄（參照第4.2.4節），及 e) revalidation. e) 再確認。 7.5.2.1 Validation of processes for production and service provision -- Supplemental The requirements of 7.5.2 shall apply to all processes for production and service provision. 7.5.2.1生產及服務提供流程之驗收—補述 第7.5.2節的要求須適用於所有的生產及服務提供流程。 7.5.3 Identification and traceability 7.5.3識別和追溯性 Where appropriate, the organization shall identify the product by suitable means throughout product realization. 適當時，組織須藉由適宜之方法，對產品實現全盤加以鑑別。 The organization shall identify the product status with respect to monitoring and measurement requirements. 組織須對有關於監督及量測要求之產品狀況加以鑑別。 Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4). 當追溯性為一要求時，組織須管制及記錄產品之唯一識別（參照第4.2.4節）。 NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained. 備註： 在某些產業領域，型態管理係藉由識別及追溯性加以維持之一種方法。 NOTE Inspection and test status is not indicated by the location of product in the production flow unless inherently obvious, such as material in an automated production transfer process. Alternatives are permitted, if the status is clearly identified, documented and achieves the designated purpose. 備註 產品在正常生產流中的位置，並不能作為檢驗與測試狀況的適當指標，除非為先天明顯易見者（例如：在自動生產的轉換過程中的物料）。除了自動生產的轉換過程之外，若測試狀況可清楚地識別、文書化並能達到指定的目的，則其他替代方式是被允許的。 7.5.3.1 Identification and traceability - Supplemental The words "Where appropriate" in 7 5.3 shall not apply. 7.5.3.1識別和追溯性—補述 上述第7.5.3節中的〝適當時〞不適用本規範。 7.5.4 Customer property 7.5.4顧客財產 The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4). 當顧客財產在組織之管制下，或正由組織使用時，組織須確實加以管理。組織對提供作為使用，或組合成為產品之顧客財產，須加以識別、查證、保護及防護。假如任何顧客財產發生遺失、損壞或發現不適合使用時，須向顧客報告及紀錄須加以維持（參照第4.2.4節）。 NOTE Customer property can include intellectual property. 備註：顧客財產可包括智慧財產。 NOTE Customer-owned returnable packaging is included in this clause. 備註 本要項包括那些屬於顧客之可回收的包裝材料。 7.5.4.1 Customer-owned production tooling Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that the ownership of each item is visible, and can be determined. 7.5.4.1顧客擁有的生產用工模具 屬於顧客的工具、製造用工模具、測試、檢驗量具和設備須予以永久標記，使每一物件的所有權，能夠一目了然且能夠確定。 7.5.5 Preservation of product 7.5.5產品防護 The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. 組織須在內部過程及交貨至計劃目的地之期間，防護產品之符合性。此防護須包括識別、運搬、包裝、儲存及保護。防護也須適用於構成一項產品之零組件。 7.5.5.1 Storage and inventory In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals. The organization shall use an inventory management system to optimize inventory turns over time and assure stock rotation, such as "first-in-first-out" (FIFO). Obsolete product shall be controlled in a similar manner to nonconforming product. 7.5.5.1 儲存和存貨 為測知庫存品之變質狀況，庫存品須適時作定期評鑑。 組織須使用一套存貨管理系統，以使存貨週轉時間達到最佳化，同時確保存貨的週轉，例如”先進先出”。過期之產品須比照不良品的方式管制。 7.6 Control of monitoring and measuring devices The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1). 7.6監督和量測儀器之管制 組織須決定所從事之監督及量測，及所需的監督及量測裝置，以提供所定產品符合性要求之證據（參照第7.2.1節）。 The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. 組織須建立過程以確保監督及量測可加以完成，並且以與監督及量測要求一致之一種方式完成。 Where necessary to ensure valid results, measuring equipment shall 當為確保有效結果所必須，量測設備須 a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; a) 在規定期間及使用前，針對追溯至國際或國家量測標準之量測標準，加以校正或查證；若無此等標準存在，亦須將所使用之校正或查證基準加以記錄； b) be adjusted or re-adjusted as necessary; b) 當必要時加以調整或重調整； c) be identified to enable the calibration status to be determined; c) 加以識別，使校正狀況可以判定； d) be safeguarded from adjustments that would invalidate the measurement result; d) 加以防護，以免於不當之調整而使其量測結果失效； e) be protected from damage and deterioration during handling, maintenance and storage. e) 加以保護，以免在運搬、維護及儲存時損壞及變質。 In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4). 除此之外，當設備被發現不符要求時，組織須評估及記錄先前量測結果之有效性。組織須對此設備及任何被影響之產品，採行適當之措施。校正及查證結果之紀錄須加以維持（參照第4.2.4節）。 When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. 當使用於規定要求之監督及量測時，電腦軟體滿足預期用途之能力，須加以確認。此須在初次使用前著手完成，及必要時予以再確認。 NOTE See ISO 10012-1 and ISO 10012-2 for guidance. 備註：參照ISO 10012-1及ISO 10012-2作為指引。 NOTE A number or other identifier traceable to the device calibration record meets the intent of requirement c) above. 備註 使用可追溯至該儀器校正記錄的序號的作法，符合上述 c) 項規定的精神。 7.6.1 Measurement system analysis Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer. 7.6.1 量測系統分析 須實施適當的統計研究，以分析每一種形式的量測及試驗設備系統的結果中所呈現的變異。這項要求須適用於管制計畫裡所列的量測系統。所採用的分析方法和允收標準，須符合顧客有關量測系統分析參考手冊中的規定。若顧客核准，可使用其他的分析方法和允收標準。 7.6.2 Calibration/verification records Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment, shall include - equipment identification, including the measurement standard against which the equipment is calibrated, - revisions following engineering changes, - any out-of-specification readings as received for calibration/verification, - an assessment of the impact of out-of-specification condition, - statements of conformity to specification after calibration/verification, and - notification to the customer if suspect product or material has been shipped. 7.6.2 校正/驗証記錄 提供產品符合既定要求證據所需的所有量具、量測及試驗設備，包括員工自己的量具和屬於顧客的量具在內，其校正/驗証活動的記錄須包括下列各項：
– 設備的識別，包含該設備校正所依據的量測標準， – 根據各工程變更所作之修正， – 校正/驗証接收當時（亦即調整前）任何超出允收標準的讀值， – 超出允收標準狀況的影響評估， – 校正/驗証後，符合允收標準的說明， – 當可疑的物料或產品可能已經出貨時，通知顧客的記錄。 7.6.3 Laboratory requirements 7.6.3.1 Internal laboratory An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, technical requirements for - adequacy of the laboratory procedures, - competency of the laboratory personnel, - testing of the product, - capability to perform these service correctly, traceable to the relevant process standard (such as ASTM, EN, etc.), and - review of the related records. 7.6.3 實驗室的要求 7.6.3.1 內部實驗室 組織的內部實驗室設施須界定其執行被要求的檢驗、測試或校正服務的能力範圍。此實驗室能力範圍須納入品質管理系統的文件中。實驗室須規定和執行下述的技術要求（至少）：
– 實驗室程序的適切性， – 實驗室人員的勝任性， – 產品的測試， – 正確執行此等服務的能力、且能追溯至相關標準（例如ASTM, EC等），以及 – 相關記錄的審查。 NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this requirement but is not mandatory. 備註 供應商的內部實驗室取得ISO/IEC 17025的認證符合上述要求，但取得認證並非必要。 7.6.3.2 External laboratory External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either - there shall be evidence that the external laboratory is acceptable to the customer, or - the laboratory shall be accredited to ISO/IEC 17025 or national equivalent. 7.6.3.2 外部實驗室 組織所使用的外部的/營業的/獨立的實驗室設施須界定其執行被要求的檢驗、測試或校正服務的能力範圍，並符合下述兩者之一的要求：
– 須有證據顯示顧客接受該外部實驗室，或 – 實驗室須取得ISO/IEC 17025或相對等的國家標準的認證。 NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer- approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. 備註1 舉例而言，上述所提之證據可以是顧客的評鑑或是顧客認可的第二者的評鑑，以證明該實驗室符合ISO/IEC 17025或相對等的國家標準的精神。
NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 7 6.3.1 have been met. 備註 2當某一設備，並無合格的實驗室可提供校正服務時，可由原設備製造商執行。在此情形下，組織應確保符合第7.6.3.1節的要求。 8. Measurement, analysis and improvement 8. 量測、分析和改善 8.1 General 8.1概述 The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed 組織須規劃及實施所需之監督、量測、分析及改善過程 a) to demonstrate conformity of the product, a) 以展示產品的符合性， b) to ensure conformity of the quality management system, and b) 以確保品質管理系統之符合性，及 c) to continually improve the effectiveness of the quality management system. c) 以持續改善品質管理系統之有效性。 This shall include determination of applicable methods, including statistical techniques, and the extent of their use.. 此須包括適當方法，含統計技術，及其使用程度之決定。 8.1.1 Identification of statistical tools Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan. 8.1.1 統計工具的鑑別 在先期品質規劃階段期間，須先針對每項製程，決定適當的統計工具，並須納入管制計畫內。 8.1 2 Knowledge of basic statistical concepts Basic statistical concepts, such as variation, control (stability), process capability and over-adjustment shall be understood and utilized throughout the organization. 8.1.2基本統計概念的知識 基本統計概念，譬如變異、管制狀態（穩定性）、製程能力及過度調整，須為組織內的全體人員週知並使用。 8.2 Monitoring and measurement 8.2監督和量測 8.2.1 Customer satisfaction 8.2.1顧客滿意度 As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. 不論組織是否符合顧客要求，組織須監督與顧客感受有關之資訊，以作為品質管理系統績效的一種量測。取得及使用此資訊之方法，須加以決定。 NOTE Consideration should be given to both internal and external customers. 備註 應同時顧及內部和外部顧客。 8.2.1.1 Customer satisfaction -- Supplemental Customer satisfaction with the organization shall be monitored through continual evaluation of performance of the realization processes. Performance indicators shall be based on objective data and include, but not be limited to: - delivered part quality performance, - customer disruption including field returns, - delivery schedule performance (including incidents of premium freight), and - customer notifications related to quality or delivery issues. The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process. 8.2.1.1 顧客滿意度—補述 顧客對組織的滿意度須透過實現流程績效的持續評估加以監測。績效的指標須根據客觀資料且包括（但不限於）下述資料： – 交貨品質表現， – 顧客(生產)干擾/停頓，含產品售後(使用)退回(退貨)， – 交期表現（含發生超額運費之事件）， – 因品質或交期問題所造成之「特別狀況之通知顧客」。 組織須監測製程的表現以展現符合顧客對產品品質與製程效率的要求。 8.2.2 Internal audit 8.2.2內部稽核 The organization shall conduct internal audits at planned intervals to determine whether the quality management system 組織須在規劃之期間內執行內部稽核，以決定品質管理系統是否 a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and a) 符合所規劃之安排（參照第7.1節）、本國際標準之要求及組織所建立之品質管理系統要求，以及 b) is effectively implemented and maintained. b) 有效地實施及維持。 An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. 稽核計畫須加以規劃，並考慮被稽核之過程與區域的狀況與重要性，以及先前稽核結果。稽核準則、範圍、頻率及方法須加以界定。稽核員之遴選及稽核之執行，須確保稽核過程的客觀性及公正性。稽核員不得稽核其本身之工作。 The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. 規劃與執行稽核，及報告結果與維持紀錄（參照第4.2.4節）之職責與要求，須以書面程序加以界定。 The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2). 被稽核區域管理階層之責任，須確保採行措施沒有不當之延誤，以消除所發現之不符合及其原因。後續跟催活動須包括所採行措施之查證，及查證結果之報告（參照第8.5.2節）。 NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.. 備註：參照ISO 10011-1、ISO 10011-2及ISO 10011-3作為指引。 8.2.2.1 Quality management system audit The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements. 8.2.2.1 品質管理系統的稽核 組織須稽核其品質管理系統以確認符合本技術規範以及任何額外的品質管理系統的要求。 8.2.2.2 Manufacturing process audit The organization shall audit each manufacturing process to determine its effectiveness. 8.2.2.2 製程的稽核 組織須稽核每一個製造流程以確定其有效性。 8 2.2.3 Product audit The organization shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labeling, at a defined frequency. 8.2.2.3 產品的稽核 組織須在生產與交貨的適當階段，按照界定的頻率稽核產品，以確認符合所有規定的要求，例如產品尺寸、功能、包裝和標籤。 8.2.2.4 Internal audit plans Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan. When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately increased. 8.2.2.4 內部稽核計畫 內部稽核須涵蓋所有品質管理相關的流程、活動和班次，並且須按照年度計畫安排稽核時程。 當發生內部／外部不符合事項或顧客抱怨時，須適當地增加稽核頻率。 NOTE Specific checklists should be used for each audit. 8.2.2.5 Internal auditor qualification The organization shall have internal auditors who are qualified to audit the requirements of this Technical Specification ( see 6.2.2.2). 8.2.3 Monitoring and measurement of processes The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. 備註 特定的查核表必應為每次內部稽核所使用。
8.2.3.1 Monitoring and measurement of manufacturing processes The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria. The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified - measurement techniques, - sampling plans, - acceptance criteria, and - reaction plans when acceptance criteria are not met.
Significant process events, such as tool change or machine repair, shall be recorded. The organization shall initiate a reaction plan from the control plan for characteristics that are either not statistically capable or are unstable. These reaction plans shall include containment of product and 100% inspection as appropriate. A corrective action plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable end capable. The plans shall be reviewed with and approved by the customer when so required. The organization shall maintain records of effective dates of process changes.
組織須保存製程變更生效日期的記錄。 8.2.4 Monitoring and measurement of product 8.2.4產品的監督和量測 The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). 組織須監督及量測產品之特性，以查證產品要求已符合。此須在產品實現過程之適當階段，依照所規劃之安排予以完成（參照第7.1節）。 Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4). 符合性與允收標準之證據，須予以維持。紀錄須顯示產品放行人員之授權（參照第4.2.4節）。 Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. 除非相關權責人員及，當適當時，顧客之核准，否則須直到全部所規劃的安排（參照第7.1節）已經完全滿意，才可進行產品放行及服務交運。 NOTE When selecting product parameters to monitor compliance to specified internal and external requirements, the organization determines the types of product characteristics, leading to - the types of measurement, - suitable measurement means, and - the capability and skills required. 備註 當選擇產品參數以監測是否符合內部與外部規定時，組織應(先)決定產品特性之種類，因其會導致於下列事項的決定：
– 測量的類型， – 合適的測量方法， – 需要的能力與技能。 8.2.4.1 Layout inspection and functional testing A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans. Results shall be available for customer review. 8.2.4.1 全尺寸檢查與性能測試 每個產品均須根據管制計畫的規定，按照適用的顧客工程物料和性能標準，實施全盤尺寸檢驗和機能驗證。檢查結果須可隨時供顧客審查。 NOTE Layout inspection is the complete measurement of all product dimensions shown on the design records 8.2.4.2 Appearance items For organizations manufacturing parts designated by the customer as "appearance items", the organization shall provide – appropriate resources including lighting for evaluation, – masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate, – maintenance and control of appearance masters and evaluation equipment, and – verification that personnel making appearance evaluations are competent and qualified to do so. 備註 「全尺寸檢查」是指對設計資料上標示的所有產品尺寸全部加以檢查。
8.2.4.2 外觀件(品目) 凡組織製造的零件，被顧客認定屬於〝外觀件(品目)〞時，組織須提供： – (外觀)評鑑用之適當資源(包含照明亮度) ， – 適當地設置評估顏色、紋理、光澤、金屬亮度、質地及影像差別(DOI)的比對標準件， – 外觀比對標準件和評鑑設備的維護保養與管制， – 從事外觀評鑑作業的人員可以勝任且已具有擔任該項工作資格的驗證合格資料。 8.3 Control of nonconforming product 8.3不合格品之管制 The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. 組織須確保不合格產品要求之產品已加以識別及管制，以防止其被誤用或交貨。此項管制與處理不合格品有關之職責及權限，須以書面程序加以界定。 The organization shall deal with nonconforming product by one or more of the following ways: 組織須藉由下列一項或數項方法，處理不合格品： a) by taking action to eliminate the detected nonconformity; a) 採行措施以消除所發現之不符合； b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; b) 由相關權責人員，及當適當時顧客之核准，授權其使用、放行或特採允收； c) by taking action to preclude its original intended use or application. c) 採行措施以防止其被誤用或應用。 Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4). 不符合特質之紀錄及任何後續採行措施，包括特採之獲准，均須加以維持（參照第4.2.4節）。 When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. 當不合格品已矯正，其須予以重新查證以展示符合要求。 When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. 當不合格品在交貨或開始使用後才被發現，組織須對不符合之影響，或可能之影響，採行適當的措施。 8.3.1 Control of nonconforming product- Supplemental Product with unidentified or suspect status shall be classified as nonconforming product (see 7.5.3). 8.3.1不合格品之管制—補述 未識別或是處於可疑狀態的產品都須被歸類為不合格品。 8.3.2 Control of reworked product Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the appropriate personnel. 8.3.2 重新加工品的管制 重新加工之指導書，包括重新檢驗的要求，須讓適當人員很容易地取得及使用。 8.3.3 Customer information Customers shall be informed promptly in the event that nonconforming product has been shipped. 8.3.3 通知顧客 倘若不合格品不慎出貨(流出去)時，須立即通知顧客。 8.3.4 Customer waiver The organization shall obtain customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved. The organization shall maintain a record of the expiration date or quantity authorized. The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped on an authorization shall be properly identified on each shipping container. This applies equally to purchased product. The organization shall agree with any requests from suppliers before submission to the customer. 8.3.4顧客的特採 無論何時，只要產品或製程跟目前核准者不一致時，組織均需於進行下一流程步驟前，獲得顧客的特採(concession)或核准(deviation permit)。 組織須維持一份此項特採或核准的有效期限或被授權數量的記錄。組織也須確保當被授權的有效期限屆滿時，恢復跟原來的或替代的規格與要求一致。在這種授權情況下所交運的物料，其每件交運的容器，都須適當標示。此項要求也適用於(對供應商)採購的產品。在提交任何特採要求給顧客之前，組織須同意供應商的任何(特採)請求。
8.4 Analysis of data 8.4資料分析 The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. 組織須決定、蒐集及分析適當之資料，以展示品質管理系統的適用性及有效性，以及評估品質管理系統之有效性何處可完成持續改進。此須包括從監督及量測之結果，以及其他相關來源所產生之資料。 The analysis of data shall provide information relating to 資料分析須提供與下列相關之資訊 a) customer satisfaction (see 8.2.1), a) 顧客滿意度（參照第8.2.1節）， b) conformity to product requirements (see 7.2.1), b) 符合產品要求（參照第7.2.1節）， c) characteristics and trends of processes and products including opportunities for preventive action, and c) 過程及產品之特性與趨勢，包括預防措施之時機，及 d) suppliers. d) 供應者。 8.4.1 Analysis and use of data Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following: - development of priorities for prompt solutions to customer-related problems; - determination of key customer-related trends and correlation for status review, decision-making and longer term planning; - an information system for the timely reporting of product information arising from usage. 8.4.1 資料的分析與使用 品質與營運績效之趨勢須與經營目標的進度相比較，並且導引出行動支援下列事項：
針對顧客相關的問題方面，研究出迅速解決此等問題的優先順序； – 找出與顧客相關的主要趨勢和相互關係，以協助檢討現狀、作成決策以及進行長程規劃； – 發展一套資訊系統，可以及時報告產品使用時的資訊。 NOTE Data should be compared with those of competitors and/or appropriate benchmarks. 備註 資料應與競爭對手和/或適當的標竿比較。 8.5 Improvement 8.5改善 8.5.1 Continual improvement 8.5.1持續改善 The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. 組織須建藉由品質政策、品質目標、稽核結果、資料分析、矯正及預防措施，以及管理階層審查之使用，持續改進品質管理系統之有效性。 8.5.1.1 Continual improvement of the organization The organization shall define a process for continual improvement (see examples in annex B of ISO 9004 : 2000). 8.5.1.1 組織的持續改善 組織須定義一套流程以進行持續改善 (參考ISO 9004:2000附錄B之例子) 。
8.5.1.2 Manufacturing process improvement Manufacturing process improvement shall continually focus upon control and reduction of variation in product characteristics and manufacturing process parameters. 8.5.1.2 製程改善 製程改善的重點須持續放在控制與降低產品特性與製程參數的變異。 NOTE 1 Controlled characteristics are documented in the control plan. NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements.
8.5.2 Corrective action The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see 4.2.4), and f) reviewing corrective action taken. 8.5.2.1 Problem solving The organization shall have a defined process for problem solving leading to root cause identification and elimination. If a customer-prescribed problem-solving format exists, the organization shall use the prescribed format. 8.5.2.2 Error-proofing The organization shall use error-proofing methods in their corrective action process. 8.5.2.3 Corrective action impact The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity. 備註 1 需要控制的特性於管制計畫中應已列出。
8.5.2.4 Rejected product test/analysis The organization shall analyse parts rejected by the customer's manufacturing plants, engineering facilities and dealerships. The organization shall minimize the cycle time of this process. Records of these analyses shall be kept and made available upon request. The organization shall perform analysis and initiate corrective action to prevent recurrence. NOTE Cycle time related to rejected product analysis should be consistent with the determination of root cause, corrective action and monitoring the effectiveness of implementation. 備註 與退回產品分析相關的處理時間須包含從確定根本原因、矯正措施到監測實施成效的時間。 8.5.3 Preventive action 8.5.3預防措施 The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. 組織須決定措施，以消除潛在不符合之原因，以防止其發生。預防措施須與潛在問題之影響相適切。 A documented procedure shall be established to define requirements for 書面程序須加以建立，以界定下列各項要求 a) determining potential nonconformities and their causes, a) 判定潛在不符合及其原因， b) evaluating the need for action to prevent occurrence of nonconformities, b) 評估措施之需求，以預防不符合之發生， c) determining and implementing action needed, c) 決定及實施所需之措施， d) records of results of action taken (see 4.2.4), and d) 所採行措施結果之紀錄（參照第4.2.4節），及 e) reviewing preventive action taken. e) 審查所採行之預防措施。
Annex A (normative) Control Plan 附錄 A 管制計畫 A.1 Phases of the control plan The control plan shall cover three distinct phases as appropriate. a) Prototype: a description of the dimensional measurements, material and performance tests that will occur during building of the prototype. The organization shall have a prototype control plan if required by the customer. b) Pre-launch: a description of the dimensional measurements, material and performance tests that occur after prototype and before full production. Pre-launch is defined as a production phase in the process of product realization which may be required after prototype build. c) Production: documentation of product/process characteristics, process controls, tests, and measurement systems that occur during mass production. Each part shall have a control plan but, in many cases, family control plans may cover a number of similar parts produced using a common process. Control plans are an output of the quality plan. A.2 Elements of the control plan The organization shall develop a control plan that includes, as a minimum, the following contents. a) General data - control plan number, - issue date, and revision date, if any, - customer information (see customer requirements), - organization’s name/site designation, -part number(s), -part name/description, -engineering change level, -phase covered (prototype, pre-launch, production), -key contact, -part/process step number, -process name/operation description. b) Product control - product-related special characteristics, - other characteristics for control (number, product or process), - specification/tolerance. c) Process control - process parameters, - process-related special characteristics, -machines, jigs, fixtures, tools for manufacturing. d) Methods - evaluation measurement technique, - error-proofing, - sample size and frequency, - control method e) Reaction plan and corrective actions - reaction plan (include or reference), - corrective action. A.1 管制計畫的階段 管制計畫須適當地涵括三種不同的階段： 原型樣品－說明在原型樣品製作期間，所發生各項尺寸量測、材料及性能測試等。如顧客要求時，組織須建立原型樣品的管制計畫。 量產前－說明介於原型樣品製作和全面量產之間，所發生的各項尺寸量測、材料及性能測試。「量產前」是指於產品實現流程中可定義為建立原型樣品後所需的一個生產階段。 量產－書面記載在大量生產期間，所發生的各項產品／製程特性、製程管制、測試和量測系統。 每個單一產品須有其個別的管制計畫，但是許多情形下，可以使用系列產品共用的管制計畫來涵蓋許多共通製程下生產出來的類似產品。管制計畫是品質計畫的輸出之一。
