ISO TS16949中英对照4-8章 - 图文

4. Quality management system 4.1 General requirements 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. The organization shall: a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard. 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. NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 4.品質管理系統 4.1一般要求 組織頇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 組織頇： 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) 決定此等過程之順序與交互作用， 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) 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) 監督、量測與分析此等過程，及 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。 此等過程頇由組織依照本國際標準之要求加以管理。 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，組織頇確保此等過程的管制。此等來自外部過程之管制，頇在品質管理系統內加以鑑別。 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。 6

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. NOTE See also 7.4.1 and 7.4.1.3 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this International Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see 4.2.4). NOTE 1 Where the term ―documented procedure‖ appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium. 4.2.2 Quality Manual The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, 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。

備註 請同時參照第7.4.1節和第7.4.1.3節。 4.2 文件化要求 4.2.l 概述 品質管理系統文件頇包括 a) 品質政策與品質目標之書面敘述， b) 品質手冊， c) 本國際標準要求之書面程序， 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) 本國際標準要求之紀錄(參照第4.2.4節)。 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。 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) 組織之規模大小與活動之型態， b) 過程與其交互作用之複雜性，及 c) 人員之能力。 備註3： 文件可以為任何形式或型態之媒體。 4.2.2品質手冊 組織頇建立及維持一品質手冊，並包括下述 a) 品質管理系統之範圍，包括任何排除之細節及調 7

including details of and justification for any exclusions (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. 4.2.3 Control of documents 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. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 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.

整(參照第1.2節)， b) 品質管理系統所建立之書面程序或對其之引用，及 c) 品質管理系統各項過程間交互作用的描述。 4.2.3文件管制 品質管理系統所需之文件頇加以管制。紀錄是文件之一種特殊型態，其頇依照第4.2.4節所定的要求加以管制。 書面程序頇建立，以界定所需之管制 a) 在文件發行前批准其適切性， b) 在必要時，審查與更新以及重新批准文件， c) 確保文件之變更與最新修訂狀況，已加以識別， d) 確保在使用場所可取用相關版本之適用文件， e) 確保文件易於閱讀與容易識別， f) 確保外來之文件已加以識別，並對其分發加以管制，及 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，頇加以適當之識別。 4.2.3.1 工程規格

組織頇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。

組織頇保存一份記載每項生產變更生效日期的記錄。所謂「執行」，頇包括更新相關文件。

The organization shall maintain a record of the

date on which each change is implemented in

8

production. Implementation shall include updated documents.

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.

4.2.4 Control of records 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. NOTE 1: ―Disposition‖ above includes disposal. NOTE 2: ―Records‖ also include customer-specified records.

4.2.4.1 Records retention

The control of records shall satisfy regulatory and customer requirements. 5. Management responsibility 5.1 Management commitment Top management shall provide evidence of its commitment to the development and 5.管理責任 5.1管理承諾 高階管理階層頇藉由下列各項，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 4.2.4.1紀錄保存

紀錄之管制頇滿足法規和顧客之要求。 備註 1 上述之「處理」包括廢棄。 備註 2 「紀錄」亦包括顧客指定之紀錄。 4.2.4記錄管制 紀錄頇加以建立及維持，以提供品質管理系統符合要求及有效運作之證據。紀錄頇易於閱讀、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，書面程序頇加以建立，以界定所需之管制。 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。

implementation of the quality management system and continually improving its effectiveness by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 5.1.1 Process efficiency

b) 建立品質政策， c) 確保品質目標已加以建立， d) 執行管理階層審查，及 e) 確保資源之可取用性。 5.1.1 流程效率

9

a) 在組織內傳達符合顧客，以及法令與法規要求之重要性， Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency. 5.2 Customer focus 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). 5.3 Quality policy

高階管理階層頇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顧客導向 高階管理階層頇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品質政策

Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability. 5.4 Planning

5.4.1 Quality objectives 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. 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. NOTE Quality objectives should address customer expectations and be achievable within a defined time period.

5.4.2 Quality management system planning

高階管理階層頇確保品質政策 a) 對組織之目的是適切的， 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) 提供一個建立與審查品質目標之架構， d) 在組織內已被溝通與瞭解，及 e) 審查其持續的適用性。 5.4規劃 5.4.1品質目標 高階管理階層頇確保品質目標，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。品質目標頇可量測，且與品質政策一致。 5.4.1.1品質目標—補述

高階管理階層頇定義品質目標和量度指標，且頇將其納入經營計畫，並運用該目標和指標來展開品質政策。

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品質管理系統規劃

10

本文来源：https://www.bwwdw.com/article/4e8d.html