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to assist their application as a consistent pair. 雖然兩項標準具有不同的范圍,但都具有相似的結構,以有助于它們作為協(xié)調(diào)一致的一對標準的應用。在滿足顧客要求方面, ISO9001所關注的是質(zhì)量管理體系 的有效性。除了有效性,該標準還特別關注持續(xù)改進一個組織的總體業(yè)績與效率。然而,用于認證或合同不是 ISO9004 的目的。 IATF Guidance to ISO/TS 16949:2020 IATF 的 ISO/TS16949: 2020 指南 “IATF Guidance to ISO/TS 16949:2020”is a document containing remended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application to conform to the requirements of this Technical Specification. 《 IATF 的 ISO/TS16949: 2020 指 南》是一項文件,包括推薦的汽車行業(yè)的實踐、范例、圖解、解釋,并對實施提供幫助以滿足該技術規(guī)范。 Compatibility with other management system 與其他管理體系的相容性 ISO9001:2020, Quality management systemsRequirements ISO9001: 2020,質(zhì)量管理體系 — 要求 Compatibility with other management systems 與其它管理體系的相容性 This International Standard has been aligned with ISO14001:1996 in order to enhance the patibility of the two standards for the benefit of the user munity. 本國際標準已與 ISO14001: 1996 相互調(diào)整以增強這兩個 標準的相容性,以便于所有使用者。然而本標準容許組織將質(zhì)量管理體系與相關的管理體系要求盡可能結合或一體化。 Goal of this Technical Specification 本技術規(guī)范的目的 The goal of this Technical Specification is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. 本技術規(guī)范的目的 在于在供應鏈中提供持續(xù)改進、加強缺陷預防和減少浪費的質(zhì)量管理體系的開發(fā)。 This Technical Specification is intended to avoid multiple certification audits and provide a mon approach to a quality management system for automotive production, and relevant service part anizations. 本技術規(guī)范是為了避免多重認證,并為汽車生產(chǎn)件和相關的服務件生產(chǎn)的組織,提供了質(zhì)量管理體系的共同方法。 NOTE In this international Standard, the term ”product” applies only to the product intended for , or required by , a customer. 注 在本標準中,術語“產(chǎn)品”僅適用于預期提供給顧客或顧客所要求的產(chǎn)品。 This Technical Specification is applicable to sites of the anization where customerspecified parts, for production and/or service, are manufactured. 本技術規(guī)范適用于組織的顧客指定生產(chǎn)件或服務件的制造現(xiàn)場。 8 8 the site, but cannot obtain standalone certification to this Technical Specification. This Technical Specification can be applied throughout the automotive supply chain. 本技術規(guī)范適用于整個汽車供應鏈。汽車行業(yè)應用過程導向的審核方法包括評審、識別和管理聯(lián)接的活動。特別應該獲得受審核的現(xiàn)場識別的過程與支持性實體(例如,設計中心、總部、配送中心等輸出直接形成輸入的實體)識別的過程之間的聯(lián)接的證據(jù)。 Where any requirement(s) of this International Standard cannot be applied due to the nature of an anization and its product, this can be considered for exclusion. 如果一個組織的性質(zhì)或其產(chǎn)品決定了本標準的任何要求不能適用,可以考慮刪減 。 The only permitted exclusions for this Technical Specification relate to where the anization is not responsible for product design and development. 本技術規(guī)范中,當組織沒有產(chǎn)品設計和開發(fā)職責,只有 中有關的部分是允許的排除。 IATF 的 ISO/TS16949: 2020 指南( 應用): 對 ISO/TS16949: 2020 要求的豁免僅限于以下: 1)對于沒有 產(chǎn)品 設計和開發(fā)職責的組織,包含在 ; 2)車輛裝配組織僅限于由 IATF 在ISO/TS16949: 2020 的第一版“規(guī)則”中所規(guī)定的豁免 。 過程存在,但目前沒有應用的情況下,可能發(fā)生不適用,例 如:在被審核現(xiàn)場不存在顧客所有的工裝,或顧客和組織間不存在書面服務協(xié)議。對版本明確的引用標準,該標準的增補或修訂不適用。對于未標日期的引用標準,有關最新版本是適用的。 10 10 investigate the possibility of applying the most recent edition of the normative document indicated below. For undated reference, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standard. ISO9001:2020, Quality management systemFundamentals and vocabulary ISO9000: 2020 質(zhì)量管理體系 — 基礎和術語 3 Terms and definitions 3 術語和定義 ISO9001:2020, Quality management systemRequirements ISO9001: 2020,質(zhì)量管理體系 — 要求 3 Terms and definitions 3 術語和定義 For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. 為了本國際標準的目的, ISO9000 中給出了術語和定義適用。 Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. 在本國際標準中,當出現(xiàn)術語“產(chǎn)品”時,也能表示“服務”。 11 11 given in ISO 9000:2020 and the following apply. Control plan 控制計劃 Documented description of the systems and processes required for controlling product(see annex A) 對控制產(chǎn)品所要 求的體系和過程的文件化的描述(見附錄 A)。 NOTE This responsibility includes testing and verification of design performance within the customer’s specified application. 注 本職責包括按顧客指定方法進行設計性能的試驗和驗證。 Laboratory 實驗室 Facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical or reliability testing. 進行包括但不限于化學、冶金、尺寸、物理、電性能或可靠性試驗在內(nèi)的檢驗、試驗和校準的設施。 Manufacturing 制造 Process of making of fabricating 制造或裝配以下事項的過程: — production materials, — 生產(chǎn)材料, — production or service parts, — 生產(chǎn)件或服務件, — assemblies, or — 裝配, 或 — heat treating, welding, paining, plating or other finishing services — 熱處理、焊接、噴漆、電鍍或其它最終服務。 Preventive maintenance 預防性維護 Planned action to eliminate cause of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design. 為消除設備失效和非計劃的生產(chǎn)中斷而策劃的活動,是制造過程設計 的輸出。 NOTE This can be caused by method, quality, unscheduled or late deliveries, etc. 注 這可能會因方法、數(shù)量、非計劃或延遲交付等而導致。 Site 現(xiàn)場 Location at which valueadded manufacturing processes occur 增值制造過程發(fā)生的場所。 4 Quality management system 4 質(zhì)量管理體系 General requirements 總要求 ISO 9001:2020, Quality management systemRequirements ISO9001: 2020,質(zhì)量管理體系 — 要求 4 Quality management system 4 質(zhì)量管理體系 General requirements 總要求 The anization 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 anization shall: 組織必須按本標準的要求建立質(zhì)量管理體系,形成文件,加以實施和保持,并持續(xù)改進其有效性。 These processes shall be managed by the anization in accordance with the requirements of this I