註：各位讀者朋友大家好、今天給大家展示的是第四版第三章《
Relationship with other management system standards與其他管理體系標準的關係…….11
QUALITY MANAGEMENT SYSTEMS—REQUIREMENTS 質量管理體系 要求
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This International Standard applies the framework developed by ISO to improve alignment among its International Standards for management systems (see Clause A.1).本標準採用ISO制定的管理體系標準框架，以提高與其他管理體系標準的協調一致性（見9001附錄A.1)。
This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards.本標準使組織能夠使用過程方法，並結合PDCA循環和基於風險的思維，將其質量管理體系與其他管理體系標準要求進行協調或整合。
This International Standard relates to ISO 9000 and ISO 9004 as follows:本標準與ISO 9000和ISO 9004 存在如下關係：
— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard;ISO 9000質量管理體系 基礎和術語為正確理解和實施本標準提供必要基礎；
— ISO 9004 Managing for the sustained success of an organization — A quality management approachprovides guidance for organizations that choose to progress beyond the requirements of this International Standard. ISO 9004追求組織的持續成功 質量管理方法 為選擇超出本標準要求的組織提供指南。
Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC 176.附錄 B 給出了 ISO TC/176 開發的與質量管理和質量管理體系有關的其他標準的信息。
This International Standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management.本標準不包括針對其他管理體系的特定要求，如環境管理、職業健康安全管理或財務管理。
Sector-specific quality management system standards based on the requirements of this International Standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this International Standard within the particular sector.在本標準的基礎上，已經制定了若干行業特定要求的質量管理體系標準。其中的某些標準規定了質量管理體系的附加要求，而另一些標準則僅限於提供在特定行業應用本標準的指南。
A matrix showing the correlation between the clauses of this edition of this International Standard and the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at: www.iso.org/tc176/sc02/public.本標準的章節內容與之前版本（ISO 9001：2008）章節內容之間的對應關係見ISO/TC176/SC2（國際標準化組織/質量管理和質量保證技術委員會/質量體系分委員會）
Quality management systems — Requirements質量管理體系要求
1 Scope範圍
This International Standard specifies requirements for a quality management system when an organization:本標準為下列組織規定了質量管理體系要求：
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and需要證實其具有穩定地提供滿足顧客要求及適用法律法規要求的產品和服務的能力；
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.通過體系的有效應用，包括體系改進的過程，以及保證符合顧客和適用法律法規要求，旨在增強顧客滿意。
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.本標準規定的所有要求是通用的，旨在適用於各種類型、不同規模和提供不同產品和服務的組織。
NOTE 1 In this International Standard, the terms 「product」 or 「service」 only apply to products and services intended for, or required by, a customer.注1 在本標準中的術語「產品」或「服務」僅適用於預期提供給顧客或顧客所要求的產品和服務；
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements注2 法律法規要求可稱作法定要求。
1.1 Scope— automotive supplemental to ISO 9001:2015 範圍—汽車行業對ISO9001：2015的補充
This Automotive QMS standard defines the quality management system requirements for the design anddevelopment, production and, when relevant, assembly, installation, and services of automotive-relatedproducts, including production with embedded software.本汽車QMS標準規定了汽車相關產品（包括裝有嵌入式軟體的產品）的設計和開發、生產，以及（相關時）裝配、安裝和服務的質量管理體系要求。
This Automotive QMS standard is applicable to sites of the organization where manufacturing ofcustomer-specified production parts，service parts，and/or accessory parts occur.本汽車QMS標準適用於製造顧客指定生產件、服務件和/或配件的組織的現場。
This Automotive QMS standard should be applied throughout the automotive supply chain.應當在整個汽車供應鏈中實施本汽車QMS標準。
2 Normative references 規範性引用文件
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.下列文件對於本文件的應用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用於本文件。凡是不注日期的引用文件，其最新版本（包括所有的修改單）適用於本文件。
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary ISO 9000：2015 質量管理體系 基礎和術語
2.1 Normative and informative references 規範性引用標準和參考性引用標準
Annex A (Control Plan) is a normative part of this Automotive QMS standard.附錄A（控制計劃）為本汽車QMS標準的規範性部分。
Annex B (Bibliography - Automotive supplemental) is informative，which provides additional informationintended to assist the understanding or use this Automotive QMS standard.附錄B（參考書目–汽車行業補充）為參考性部分，提供了有助於理解或使用本汽車QMS標準的附加信息。
3 Terms and definitions 術語和定義
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.ISO 9000：2015界定的術語和定義適用於本文件。
3.1 Terms and definitions for the automotive industry汽車行業的術語和定義
Accessory part 配件
Customer- specified additional component(s) that are either mechanically or electronically connected to the vehicle or powertrain before (or after) delivery to the final customer (e.g., customer floor mats，trunk bed liners，wheel covers，sound system enhancements，sunroofs，spoilers，super-chargers，etc.)在交付給最終顧客之前（或之後），與車輛或動力總成以機械或電子方式相連的顧客指定的附加部件（如：定製地墊、車廂襯、輪罩、音響系統加強件、天窗、尾翼、增壓器等等）。
Advanced product quality planning (APQP) 產品質量先期策劃(APQP)
Product quality planning process that supports development of a product or service that will satisfycustomer requirements; APQP service as a guide in the development process and also a standard way toshare results between organizations and their customers;APQP covers design robustness，design testing and specification compliance，production process design，quality inspection standards，process capability，production capacity，production packing，product testing and operator training plan，among other items對開發某一滿足顧客要求的產品或服務提供支持的產品質量策划過程；APQP對開發過程具有指導意義，並且是組織與其顧客之間共享結果的標準方式；APQP涵蓋的項目包括設計穩健性，設計試驗和規範符合性，生產過程設計，質量檢驗標準，過程能力，生產能力，產品包裝，產品試驗和操作員培訓計劃。
Aftermarket part 售後市場零件
Replacement part(s) not procured or released by an OEM for service part applications, which may or maynot be produced to original equipment specifications並非由OEM為服務件應用而採購或放行的替換零件，可能按照或未按照原始設備規範進行生產。
Authorization 授權
Documented permission for a person(s) specifying rights and responsibilities related to giving or denyingpermissions or sanctions within an organization對某（些）人的成文許可，規定了其在組織內部授予或拒絕權限或制裁有關的權利和責任。
Challenge (master) part 挑戰（原版）件
Part(s) of known specification, calibrated and traceable to standards, with expected results(pass or fail)that are used to validate the functionality of an error-proofing device or check fixtures( e.g., go/no-gogauging)具有已知規範、經校準並且可追溯到標準的零件，其預期結果（通過或不通過）用於確認防錯裝置或檢具（如通止規）的功能性。
Control plan 控制計劃
Documented description of the systems and processes required for controlling the manufacturing ofproduct (see Annex A)對控制產品製造所要求的系統及過程的成文描述（見附錄A）。
Customer requirements 顧客要求
all requirements specified by the customer (e.g., technical, commercial, product and manufacturing process-related requirements, general terms and conditions, customer-specific requirements, etc.)
Where the audited organization is a vehicle manufacturer, vehicle manufacturer subsidiary, or joint venture with a vehicle manufacturer, the relevant customer is specified by the vehicle manufacturer, their subsidiaries, or joint ventures.
顧客要求
顧客規定的一切要求（如：技術、商業、產品及製造過程相關要求，一般條款與條件，顧客特殊要求等）。
當被審核單位是汽車製造企業、汽車製造企業的子公司、或者與汽車製造企業的合資企業時，相關顧客由汽車製造商、其子公司或合營企業指定。
Customer-specific requirements(CSRs) 顧客特定要求（CSRs）
Interpretations of or supplemental requirements linked to a specific clause(s) of this Automotive QMSStandard對本汽車QMS標準特定條款的解釋或與該條款有關的補充要求。
Design for assembly (DFA) 裝配設計(DFA)
Process by which products are designed with ease of assembly considerations. (e.g., if a product containsfewer parts it will take less time to assemble, thereby reducing assembly costs)
出於便於裝配的考慮設計產品的過程。（例如，若產品含有較少零件，產品的裝配時間則較短，從而減少裝配成本。）
Design for manufacturing（DFM）製造的設計(DFM)
integration of product design and process planning to design a product that is easily and economically manufactured產品設計和過程策劃的整合，用於設計出可簡單經濟地製造的產品。
Design for manufacturing and assembly（DFMA）製造和裝配的設計(DFMA)
combination of two methodologies：Design for Manufacture (DFM), which is the process of optimizing thedesign to be easier to produce, have higher throughput, and improved quality; and Design for Assembly (DFA), which is the optimization of the design to deduce risk of error, lowering costs, and making it easierto assemble兩種方法的結合：製造的設計(DFM)— 為更易生產，更高產量及改進的質量的優化設計的過程，裝配的設計(DFA)為減少出錯風險、降低成本並更易裝配的設計優化。
Design for six sigma (DFSS) 六西格瑪設計(DFSS)
Systematic methodology, tools, and techniques with the aim of being a robust design of products orprocesses that meets customer expectations and can be produced at a six sigma quality level系統化的方法、工具和技術，旨在穩健設計滿足顧客期望並且能夠在六西格瑪質量水平生產的產品或過程的。
Design-responsible organization 具有設計職責的組織
Organization with authority to establish a new, or change an existing, productspecification. 有權制定一個新的或更改現有的產品規範的組織。
NoteThis responsibility includes testing and verification of design performance within the customer’sspecified application.該職責包括在顧客指定的應用範圍內，試驗並驗證設計性能。
Error proofing 防錯
Product and manufacturing process design and development to prevent manufacture of nonconformingproducts為防止製造不合格品而進行的產品和製造過程的設計及開發。
Escalation process 升級過程
Process used to highlight or flag certain issues within an organization so that the appropriate personnel canrespond to these situations and monitor the resolutions用於在組織內部強調或觸發特定問題的過程，以便適當人員可對這些情況做出響應並監控其解決。
Fault tree analysis (FTA) 故障樹分析法（FTA）
Deductive failure analysis methodology in which an undesired state of a system is analysed； fault tree analysis maps the relationship between faults, subsystems, and redundant design elements by creating a logic diagram of the coverall system分析系統非理想狀態的演繹故障分析法；通過創建整個系統的邏輯框圖，故障樹分析法顯示出各故障、子系統及冗餘設計要素之間的關係。
Laboratory 試驗室
Facility for inspection, test, or calibration that may include but is not limited to the following: chemical, metallurgical, dimensional, physical, electrical,or reliability testing用於檢驗、試驗或校準的設施，可能包括但不限於，化學、冶金、尺寸、物理、電性能或可靠性試驗。
Laboratory scope試驗室範圍
Controlled document containing包含下列內容的受控文件：
●specific test, evaluations, and calibrations that a laboratory is qualified to perform;試驗室有資格進行的特定試驗、評價或校準
●a list of the equipment that the laboratory uses to perform the above；and用來進行上述活動的設備的清單；以及
●a list of methods and standards to which the laboratory performs the above用來進行上述活動的方法和標準的清單。
Manufacturing 製造
Process of making or fabricatin製作或加工的過程
●production materials；生產原材料
●production parts or service parts; 生產件或服務件
●assemblies；or 裝配；或
●heat treating, welding, painting, plating, or other finishing services. 熱處理、焊接、塗漆、電鍍或其他表面處理服務。
Manufacturing feasibility 製造可行性
an analysis and evaluation of a proposed project to determine if it is technically feasible to manufacture theproduct to meet customer requirements. This includes but is not limited to the following (as applicable):within the estimated costs, and if the necessary resources, facilities, tooling, capacity, software, andpersonnel with required skills, including support functions, are or are planned to be available對擬建項目的分析和評價，以確定該項目是否在技術上是可行的，能夠製造出符合顧客要求的產品。這包括但不限於以下方面（如適用）：在預計成本範圍內；是否必要的資源、設施、工裝、產能、軟體及具有所需技能的人員，包括支持功能，是或者計劃是可用的。
Manufacturing services 製造服務
Companies that test, manufacture, distribute, and provide repair services for components and assemblies
試驗、製造、分銷部件和組件並為其提供維修服務的公司。
Multi-disciplinary approach 多方論證方法
Method to capture input from all interested parties who may influence how a process is administered by ateam whose members include personnel from the organization and may include customer and supplierrepresentatives; team members may be internal or external to the organization; either existing teams or adhoc teams may be used as circumstances warrant; input to the team may include both organization andcustomer inputs從可能會影響一個團隊如何管理過程的所有相關方獲取輸入信息的方法，團隊成員包括來自組織的人員，也可能包括顧客代表和供應商代表；團隊成員可能來自組織內部或外部；若情況許可，可採用現有團隊或特設團隊；對團隊的輸入可能同時包含在組織輸入和顧客輸入。
No trouble found (NTF) 未發現故障（NTF）
Designation applied to a part replaced during a service event that, when analysed by the vehicle or partsmanufacturer, meets all the requirements of a good part (also referred to as 「No Fault Found」 or 「Trouble NotFound」)表示針對服務期間被替換的零件，經車輛或零件製造商分析，滿足「良品件」的全部要求（亦稱為「未發現錯誤」或「故障未發現」）。
Outsourced process 外包過程
Portion of an organization『s function (or processes) that is performed by an external organization由外部組織履行的一部分組織功能（或過程）。
Periodic overhaul 周期性檢修
maintenance methodology to prevent a major unplanned breakdown where, based on fault or interruptionhistory, a piece of equipment, or subsystem of the equipment, is proactively taken out of service anddisassembled, repaired, parts replaced, reassembled, and then returned to service用於防止發生重大意外故障的維護方法，此方法根據故障或中斷歷史，主動停止使用某一設備或設備子系統，然後對其進行拆卸、修理、更換零件、重新裝配並恢復使用。
Predictive maintenance 預測性維護
An approach and set of techniques to evaluate the condition of in-service equipment by performing periodicor continuous monitoring of equipment conditions, in order to predict when maintenance should beperformed通過對設備狀況實施周期性或持續監視來評價在役設備狀況的一種方法或一套技術，以便預測應當進行維護的具體時間。
Premium freight 超額運費
extra costs or charges incurred in addition to contracted delivery合同交付之外發生的超出成本或費用。
NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc.
注: 它可能是由於方法、數量、未按計劃或延遲交付等原因引起的。
Preventive maintenance 預防性維護
Planned activities at regular intervals( time-based, periodic inspection, and overhaul) to eliminate causes ofequipment failure and unscheduled interruptions to production, as an output of the manufacturing processdesign為了消除設備失效和非計劃性生產中斷的原因而策劃的定期活動（基於時間的周期性檢驗和檢修），它是製造過程設計的一項輸出。
Product 產品
Applies to any intended output resulting from the product realization process適用於產品實現過程產生的任何預期輸出。
Product safety產品安全
Standards relating to the design and manufacturing of products to ensure they do not represent harm orhazards to customers與產品設計和製造有關的標準，確保產品不會對顧客造成傷害或危害。
Production shutdown 生產停工
Condition where manufacturing processes are idle; time span may be a few hours to a few months製造過程空閒的狀況，時間跨度可從幾個小時到幾個月不等。
Reaction plan 反應計劃
Action or series of steps prescribed in a control plan in the event abnormal or nonconforming events aredetected檢測到異常或不合格事件時，控制計劃中規定的行動或一系列步驟。
Remote location 外部場所
Location that supports manufacturing sites and an which non-production processes occur支持現場並且為非生產過程發生的場所。
Service part 服務件
Replacement part(s) manufactured to OEM specifications that are procured or released by the OEM forservice part applications, including remanufactured parts按照OEM規範製造的，由OEM為服務件應用而採購或放行的替換件，包括再製造件。
Site 現場
Location an which value-added manufacturing processes occur發生增值製造過程的場所。
Special characteristic 特殊特性
Classification of a product characteristic or manufacturing process parameter that can affect safety orcompliance with regulations, fit, function, performance, requirements, or subsequent processing of product可能影響安全性或產品法規符合性、可裝配性、功能、性能、要求或產品的後續處理的產品特性或製造過程參數。
Special status 特殊狀態
Notification of a customer-identified classification assigned to an organization where one or more customerrequirements are not being satisfied due to a significant quality or delivery issue一種顧客識別分類的通知，分配給由於重大質量質量或交付問題，未能滿足一項或多項顧客要求的組織。
Support function 支持功能
Non-production activity (conducted on site or at a remote location) that support one(or more)manufacturing sites of the same organization對同一組織的一個(或多個)製造現場提供支持的（在現場或外部場所進行的）非生產活動。
Total productive maintenance 全面生產維護
A system of maintaining and improving the integrity of production and quality systems through machines,equipment, processes, and employees that add value to the organization一個通過為組織增值的機器、設備、過程和員工，維護並改善生產及質量體系完整性的系統。
Trade-off curves 權衡曲線
Tool to understand and communicate the relationship of various design characteristics of a product to eachother, a product's performance on one characteristic is mapped one the Y-axis and another on the x-axis,then a curve is plotted to illustrate product performance relative to the two characteristics用於理解產品各設計特性的關係並使其相互溝通的一種工具；產品一個特性的性能映射於Y軸，另一特性的性能映射於X軸，然後可繪製出一條曲線，顯示產品相對於這兩個特性的性能。
Trade-off process 權衡過程
Methodology of developing and using trade-off curves for products and their performance characteristicsthat establish the customer， technical，and economic relationship between design alternatives繪製並使用產品及其性能特性的權衡曲線的一種方法，這些特性確立了設計替代方案之間的顧客、技術及經濟關係。
embedded software嵌入式軟體：
Embedded software is a specialized programme stored in an automotive component (typically computer chip or other non-volatile memory storage) specified by the customer, or as part of the system design, to control its function(s). To be relevant in the scope of IATF 16949 certification, the part that is controlled by embedded software must be developed for an automotive application (i.e., passenger cars, light commercial vehicles, heavy trucks, buses, and motorcycles; see Rules for achieving and maintaining IATF Recognition, 5th Edition, Section 1.0 Eligibility for Certification to IATF 16949, for what is eligible for 「Automotive」).
嵌入式軟體是存儲在客戶指定的汽車部件（通常是計算機晶片或其他非易失性存儲器)中，或作為系統設計的一部分來控制其功能的專門程序。為了符合IATF 16949認證的範圍，由嵌入式軟體控制的部件必須為汽車應用而研發(即客車、輕型商用車、重型卡車、客車以及摩託車;參見《獲得並保持IATF認可的規則》，第5版，第1.0節IATF 16949認證資格，以符合「汽車」資格）。
NOTE: Software to control any aspect of the manufacturing process (e.g., machine to manufacture a component or material) is not included in the definition of embedded software.
注:用於控制製造過程的任何方面的軟體(如用於製造部件或材料的機器)不包括在嵌入式軟體的定義中。
4 Context of the organization 組織的環境
4.1 Understanding the organization and its context 理解組織及其環境
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.組織應確定與其宗旨和戰略方向相關並影響其實現質量管理體系預期結果的能力的各種外部和內部因素。
The organization shall monitor and review information about these external and internal issues.組織應對這些內部和外部因素的相關信息進行監視和評審。
NOTE 1 Issues can include positive and negative factors or conditions for consideration.注1：這些因素可能包括需要考慮的正面和負面要素或條件。
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.注2：考慮來自於國際、國內、地區和當地的各種法律法規、技術、競爭、市場、文化、社會和經濟環境的因素，有助於理解外部環境。
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.注3：考慮與組織的價值觀、文化、知識和績效等有關的因素，有助於理解內部環境。
4.2 Understanding the needs and expectations of interested parties理解相關方的需求和期望
Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:由於相關方對組織穩定提供符合顧客要求及適用法律法規要求的產品和服務的能力具有影響或潛在影響，因此，組織應確定：
a) the interested parties that are relevant to the quality management system;與質量管理體系有關的相關方；
b) the requirements of these interested parties that are relevant to the quality management system.與質量管理體系有關的相關方的要求。
The organization shall monitor and review information about these interested parties and their relevant requirements.組織應監視和評審這些相關方的信息及其相關要求。
4.3 Determining the scope of the quality management system確定質量管理體系的範圍
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.組織應確定質量管理體系的邊界和適用性，以確定其範圍。
When determining this scope, the organization shall consider:在確定範圍時，組織應考慮：
a) the external and internal issues referred to in 4.1; 4.1中提及的各種外部和內部因素；
b) the requirements of relevant interested parties referred to in 4.2; 4.2中提及的相關方的要求；
c) the products and services of the organization.組織的產品和服務。
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.如果本標準的全部要求適用於組織確定的質量管理體系範圍，組織應實施本標準的全部要求。
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.組織的質量管理體系範圍應作為成文信息，可獲得並得到保持。該範圍應描述所覆蓋的產品和服務類型，如果組織確定本標準的某些要求不適用於質量管理體系範圍，應說明理由。
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.只有當所確定的不適用的要求不影響組織確保其產品和服務合格的能力或責任，對增強顧客滿意也不會產生影響時，方可聲稱符合本標準的要求。
4.3.1 Determining the scope of the quality management system-supplemental 確定質量管理體系的範圍–補充
Supporting functions, whether on-site or remote (such as design centers, corporate headquarters, anddistribution centers), shall be included in the scope of the Quality Management System (QMS).支持功能，無論其在現場或外部場所（例如：設計中心、公司總部和配送中心），應包含在質量管理體系（QMS）的範圍中。
The only permitted exclusion for this automotive QMS standard relates to the product design anddevelopmentrequirements within ISO 9001, Section 8.3. The exclusion shall be justified and maintained asdocumented information (see ISO 9001, section 7.5.)本汽車QMS標準唯一允許的刪減是ISO 9001第8.3條中的產品設計和開發要求。刪減應以形成文件的信息（見ISO9001第7.5條）的形式進行聲明和保持。
Permitted exclusions do not include manufacturing process design.允許的刪減不包括製造過程設計。
4.3.2 Customer-specific requirements顧客特定要求
Customer-specific requirements shall be evaluated and included in the scope of the organizations qualitymanagement system.應對顧客特定要求進行評價，並將其包含在組織的質量管理體系範圍內。
4.4 Quality Management System and its Processes質量管理體系及其過程
4.4.1 The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.組織應按照本標準的要求，建立、實施、保持和持續改進質量管理體系，包括所需過程及其相互作用。
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:組織應確定質量管理體系所需的過程及其在整個組織應的應用，且應：
a) determine the inputs required and the outputs expected from these processes;確定這些過程所需的輸入和期望的輸出；
b) determine the sequence and interaction of these processes;確定這些過程的順序和相互作用；
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;確定和應用所需的準則和方法（包括監視、測量和相關績效指標），以確保這些過程的有效運行和控制；
d) determine the resources needed for these processes and ensure their availability;確定這些過程所需的資源並確保其可獲得；
e) assign the responsibilities and authorities for these processes;分配這些過程的職責和權限；
f) address the risks and opportunities as determined in accordance with the requirements of 6.1; 按照6.1的要求應對風險和機遇；
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;評價這些過程，實施所需的變更，以確保實現這些過程的預期結果；
h) improve the processes and the quality management system.改進過程和質量管理體系。
4.4.1.1 Conformance of products and processes產品和過程的符合性
The organization shall ensure conformacne of all products and processes, including service parts andthose that are outsourced, to all applicable customer, statutory, and regulatory requirements (see section8.4.2.2.).組織應確保所有產品和過程，包括服務件及外包的產品和過程，符合一切適用的顧客和法律法規要求（見第8.4.2.2條）。
4.4.1.2 Product Safety產品安全
The organization shall have documented processes for the management of the product-safety relatedproducts and manufacturing processes, which shall include but not be limited to the following, whereapplicable:組織應有形成文件的過程，用於與產品安全有關的產品和製造過程管理；形成文件的過程應包括但不限於（在適用情況下）：
a) identification by the organization of statutory and regulatory product-safety requirement;組織對產品安全法律法規要求的識別；
b)customer notification of requirements in item a);向顧客通知a）項中的要求；
c) special approvals for design FMEA;設計FMEA的特殊批准；
d)identification of product safety-related characteristics;產品安全相關特性的識別；
e)identification and controls of safety-related characteristics of product and at the point of manufacture;產品及製造時安全相關特性的設別和控制；
f) special approval of control plans and process FMEAs;控制計劃和過程FMEA的特殊批准；
g) reaction plans (see section 9.1.1.1);反應計劃（見第9.1.1.1條）；
h) defined responsibilities, definition of escalation process and flow of information, including topmanagement, and customer notification;包括最高管理者在內的，明確的職責，升級過程和信息流的定義，以及顧客通知；
i) taining identified by the organization or customer for personnel involved in product-safety relatedproducts and associated manufacturing processes;組織或顧客為與產品安全有關的產品和相關製造過程中涉及的人員確定的培訓；
j) changesof product or process shall be approved prior to implementation, including evaluation ofpotential effects on product safety from process and product changes (see ISO 9001, Section 8.3.6.);產品或過程的更改在實施之前應獲得批准，包括對過程和產品更改帶給產品安全的潛在影響進行評價（見ISO 9001第8.3.6條）；
k) transfer of requirements with regard to product safety throughout the supply chain, includingcustomer-designated sources ( see Section 8.4.3.1);整個供應鏈中關於產品安全的要求轉移，包括顧客指定的貨源（見第8.4.3.1條）；
l) product traceability by manufactured lot (at a minimum) throughout the supply chain (see section8.5.2.1);整個供應鏈中按製造批次（至少）的產品可追溯性（見第8.5.2.1條）；
m) lessons learned for new product introduction.為新產品導入的經驗教訓。
NOTE: Special approval of safety related requirements or documents may be required by the customer or the organization’s internal processes. 註：與安全有關的要求或文件的特殊批准可以由顧客或組織的內部過程要求。
4.4.2To the extent necessary, the organization shall:在必要的範圍和程度上，組織應：
a) maintain documented information to support the operation of its processes;保持成文信息以支持過程運行；
b) retain documented information to have confidence that the processes are being carried out as planned.保留成文信息以確信其過程按策划進行。