AS9100 C 中英文標(biāo)準(zhǔn)

1、Quality Management Systems Requirements for Aviation, Space and Defense Organizations航空, 航天和國(guó)防工業(yè)組織-質(zhì)量管理體系要求AS9100 Rev C (2009)Foreword To assure customer satisfaction, aviation, space and defense organizations must produce, and continually improve, safe, reliable products that meet or exceed custome

2、r and applicable statutory and regulatory requirements. The globalization of the industry and the resulting diversity of regional and national requirements and expectations have complicated this objective. Organizations have the challenge of purchasing products from suppliers throughout the world an

3、d at all levels of the supply chain. Suppliers have the challenge of delivering products to multiple customers having varying quality requirements and expectations. Industry has established the International Aerospace Quality Group (IAQG), with representatives from companies in the Americas, Asia/Pa

4、cific and Europe, to implement initiatives that make significant improvements in quality and reductions in cost throughout the value stream. This standard has been prepared by the IAQG. This document standardizes quality management system requirements to the greatest extent possible and can be used

5、at all levels of the supply chain by organizations around the world. Its use should result in improved quality, schedule and cost performance by the reduction or elimination of organization-unique requirements and wider application of good practice. While primarily developed for the aviation, space

6、and defense industry, this standard can also be used in other industry sectors where a quality management system with additional requirements over an ISO 9001 system is needed.Revision summary/RationaleThis standard has been revised to incorporate the requirements of ISO 9001:2008. In addition, indu

7、stry requirements, definitions and notes have been revised and additional requirements have been included in response to stakeholder needs. Introduction0.1General01總則The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an org

8、anizations quality management system is influenced by 采用質(zhì)量管理體系應(yīng)當(dāng)是組織的一項(xiàng)戰(zhàn)略性決策。一個(gè)組織質(zhì)量管理體系的設(shè)計(jì)和實(shí)施受下列因素的影響。a) its organizational environment, changes in that environment, and the risks associated with that environment, 組織的環(huán)境，環(huán)境上的變化，和與該環(huán)境有關(guān)的風(fēng)險(xiǎn)b) its varying needs, 組織不斷變化的需求 c) its particular objectives, 組織

9、的具體目標(biāo)d) the products it provides, 組織所提供的產(chǎn)品e) the processes it employs, 組織所采用的過(guò)程f) its size and organizational structure. 組織的規(guī)模和組織的結(jié)構(gòu)It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation。統(tǒng)一質(zhì)量管理體系的結(jié)構(gòu)或文件不是本標(biāo)

10、準(zhǔn)的目的。The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.本標(biāo)準(zhǔn)所規(guī)定的質(zhì)量管理體系要求是對(duì)產(chǎn)品要求的補(bǔ)充?！白ⅰ笔抢斫夂驼f(shuō)明有關(guān)要求的指南。This International St

11、andard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regulatory requirements applicable to the product, and the organizations own requirements.本標(biāo)準(zhǔn)能用于內(nèi)部和外部（包括認(rèn)證機(jī)構(gòu)）評(píng)定組織滿足顧客、適用于產(chǎn)品的法令和法律法規(guī)要求，和組織自身要求的能力。Th

12、e quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard. 本標(biāo)準(zhǔn)的制定已經(jīng)考慮了ISO9000和ISO9004中所闡明的質(zhì)量管理原則。0.2 Process Approach 過(guò)程方法This International Standard promotes the adoption of a process approach when develo

13、ping, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. 本標(biāo)準(zhǔn)鼓勵(lì)在建立、實(shí)施質(zhì)量管理體系以及改進(jìn)其有效性時(shí)采用過(guò)程方法，通過(guò)滿足顧客要求，增強(qiáng)顧客滿意。For an organization to function effectively, it has to determine and manage numerous linked activitie

14、s. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.為使組織有效運(yùn)作，必須識(shí)別和管理眾多相互關(guān)聯(lián)的活動(dòng)。通過(guò)使用資源和管理，將輸入轉(zhuǎn)化為輸出的活動(dòng)可視為過(guò)程。通常，一個(gè)過(guò)程的輸出直接形成下一個(gè)

15、過(guò)程的輸入。The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”. 組織內(nèi)諸過(guò)程的系統(tǒng)的應(yīng)用，連同這些過(guò)程的識(shí)別和相互作用及其管理，可稱為“過(guò)程方法”。An advantage of th

16、e process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.過(guò)程方法的優(yōu)點(diǎn)是對(duì)諸過(guò)程的系統(tǒng)中單個(gè)過(guò)程之間的聯(lián)系以及過(guò)程的組合和相互作用進(jìn)行連續(xù)控制。When used within a quality management system, such an approach em

17、phasizes the importance of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement過(guò)程方法在質(zhì)量管理體系中應(yīng)用時(shí)，強(qiáng)調(diào)以下方面的重要性：a） 理解并滿足要

18、求；b） 需要從增值的角度考慮過(guò)程；c） 獲得過(guò)程業(yè)績(jī)和有效性的結(jié)果；d） 基于客觀的測(cè)量，持續(xù)改進(jìn)過(guò)程。The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of

19、 customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.圖1所反

20、映的以過(guò)程為基礎(chǔ)的質(zhì)量管理體系模式展示了48章中所提出的過(guò)程聯(lián)系。這種展示反映了在規(guī)定輸入要求時(shí)，顧客起著重要作用。對(duì)顧客滿意的監(jiān)視要求對(duì)顧客有關(guān)組織是否已滿足其要求的感受的信息進(jìn)行評(píng)價(jià)。該模式雖覆蓋了本標(biāo)準(zhǔn)的所有要求，但卻未詳細(xì)地反映各過(guò)程。NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows. Plan: establish the objectives an

21、d processes necessary to deliver results in accordance with customer requirements and the organizations policies. Do: implement the processes. Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results. Act: take actions to c

22、ontinually improve process performance. 注：此外，稱之為“PDCA”的方法適用于所有過(guò)程。PDCA模式可簡(jiǎn)述如下：P策劃：為符合顧客的要求和組織的方針的這個(gè)結(jié)果，建立目標(biāo)和需要的過(guò)程；D實(shí)施：實(shí)施過(guò)程；C檢查：根據(jù)方針、目標(biāo)和產(chǎn)品要求，對(duì)過(guò)程和產(chǎn)品進(jìn)行監(jiān)視和測(cè)量，并報(bào)告結(jié)果A處置：采取措施，以持續(xù)改過(guò)程業(yè)績(jī)。FIGURE 1 - Model of a Process-Based Quality Management System 圖1 以過(guò)程為基礎(chǔ)的質(zhì)量管理體系模式1. Scope 1.1 General This standard includes I

23、SO 9001:20081 quality management system requirements and specifies additional aviation, space and defense industry requirements, definitions and notes as shown in bold, italic text.本標(biāo)準(zhǔn)包括了ISO 9001：20081質(zhì)量管理體系要求并對(duì)航空, 航天和國(guó)防工業(yè)質(zhì)量管理體系規(guī)定了附加要求。附加的航空要求用斜體字表示。It is emphasized that the requirements specified i

24、n this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.必須強(qiáng)調(diào)，本標(biāo)準(zhǔn)規(guī)定的質(zhì)量管理體系要求是對(duì)合同和

25、適用的法律法規(guī)要求的補(bǔ)充（不是替代）。This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer sa

26、tisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.本標(biāo)準(zhǔn)為有以下需求的組織規(guī)定了質(zhì)量管理體系要求：a) 需要證實(shí)其有能力穩(wěn)定地提供滿足顧客和適用的法律法規(guī)要求的產(chǎn)品；b) 通過(guò)體系的有效運(yùn)用，包括體系持續(xù)改進(jìn)的過(guò)程以

27、及保證符合顧客與適用的法律法規(guī)要求，旨在增強(qiáng)顧客滿意。NOTE 1 In this International Standard, the term “product” only applies toa) product intended for, or required by, a customer, b) any intended output resulting from the product realization processes. 注1：在本標(biāo)準(zhǔn)中，術(shù)語(yǔ)“產(chǎn)品”僅適用于a) 預(yù)期提供給顧客或顧客所要求的產(chǎn)品。b) 任何產(chǎn)品實(shí)現(xiàn)過(guò)程的預(yù)期輸出結(jié)果。NOTE 2: Statutor

28、y and regulatory requirements may be expressed as legal requirements. 注2： 當(dāng)本標(biāo)準(zhǔn)的要求與適用的法律或法規(guī)要求發(fā)生沖突時(shí)，應(yīng)當(dāng)以法規(guī)要求為準(zhǔn)。1.2 Application 1.2 應(yīng)用All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. 本標(biāo)準(zhǔn)規(guī)定的所

29、有要求是通用的，旨在適用于各種類型、不同規(guī)模和提供不同產(chǎn)品的組織。Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.當(dāng)本標(biāo)準(zhǔn)的任何要求因組織及其產(chǎn)品的特點(diǎn)而不適用時(shí)，可以考慮對(duì)其進(jìn)行刪減。Where exclusions are made, claims of conformity to this Internatio

30、nal Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. 除非刪減僅限于本標(biāo)準(zhǔn)第7章那些不影響組織提供滿足顧客

31、和適用法令和法律法規(guī)要求的產(chǎn)品的能力或責(zé)任的要求，否則不能聲稱符合本標(biāo)準(zhǔn)。This standard is intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own produ

32、cts.Organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and original equipment manufacturers with maintenance, repair and overhaul operations that operate autonomously, or that are substantially different from the

33、ir manufacturing/production operations; should use the IAQG-developed 9110 standard (see Bibliography). Organizations that procure parts, materials and assemblies and resell these products to a customer in the aviation, space and defense industries, including organizations that procure products and

34、split them into smaller quantities for resale, should use the IAQG-developed 9120 standard (see Bibliography). 1With the permission of the International Organization for Standardization (ISO). The complete standard can be obtained from any ISO member or from the ISO Central Secretariat: 1, ch. de la

35、 Voie-Creuse, Case postale 56, CH-1211 Geneva 20, SWITZERLAND, or visit . Copyright remains with ISO.AS9100 now provides clarification on the scopes of three aviation, space and defense standards: AS9100 is for organizations that design, develop and produce products. 設(shè)計(jì)，開發(fā)和制造組織AS9110 is f

36、or organizations that provide maintenance, repair and overhaul services. 維修組織AS9120 is for organizations that buy products and resell them 銷售商將維修組織和銷售商單獨(dú)列出，給出其質(zhì)量管理體系具體適用的標(biāo)準(zhǔn)。2. Normative references 2 規(guī)范性引用文件The following referenced documents are indispensable for the application of this document. For

37、 dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005, Quality management systems Fundamentals and vocabulary. 下列文件中的條款通過(guò)本標(biāo)準(zhǔn)的引用而構(gòu)成為本標(biāo)準(zhǔn)的條款。凡是注日期的引用文件，其隨后所有的修改單（不包含勘誤的內(nèi)容）或修訂版均不適用于本標(biāo)準(zhǔn)，然而

38、，鼓勵(lì)根據(jù)本標(biāo)準(zhǔn)達(dá)成協(xié)議的各方研究是否可使用這些文件的最新版本。凡是不注日期的引用文件，其最新版本適用于本標(biāo)準(zhǔn)。ISO（國(guó)際標(biāo)準(zhǔn)化組織）和IEC（國(guó)際電工委員會(huì)）的成員保持先行有效的國(guó)際標(biāo)準(zhǔn)的目錄。ISO 9000：2005 質(zhì)量管理體系- 基礎(chǔ)和術(shù)語(yǔ)3. Terms and definitions 3 術(shù)語(yǔ)和定義For the purposes of this document, the terms and definitions given in ISO 9000 apply. Throughout the text of this International Standard, wher

39、ever the term “product” occurs, it can also mean “service”. ISO 9001：2000確立的以及下列術(shù)語(yǔ)適用于本標(biāo)準(zhǔn)。本標(biāo)準(zhǔn)中所出現(xiàn)的術(shù)語(yǔ)“產(chǎn)品”，也可指“服務(wù)”。 3.1 Risk 風(fēng)險(xiǎn)An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence. 3.2 Special requirements 特殊要求Those requirements identif

40、ied by the customer, or determined by the organization, which have high risks to being achieved, thus requiring their inclusion in the risk management process. Factors used in the determination of special requirements include product or process complexity, past experience and product or process matu

41、rity. Examples of special requirements include performance requirements imposed by the customer that are at the limit of the industrys capability, or requirements determined by the organization to be at the limit of its technical or process capabilities. 3.3 Critical items 關(guān)鍵項(xiàng)Those items (e.g., func

42、tions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of cri

43、tical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc. 3.4 Key Characteristic 關(guān)鍵特性An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life or producibility, that requires

44、specific actions for the purpose of controlling variation. 關(guān)鍵特性（Key Characteristics）：其波動(dòng)對(duì)產(chǎn)品的裝配、性能、使用壽命或可制造性產(chǎn)生重大影響的材料、過(guò)程或零件的特性。NOTE Special requirements and critical items are new terms and, along with key characteristics, are interrelated. Special requirements are identified when determining and rev

45、iewing requirements related to the product (see 7.2.1 and 7.2.2). Special requirements can require the identification of critical items. Design output (see 7.3.3) can include identification of critical items that require specific actions to ensure they are adequately managed. Some critical items wil

46、l be further classified as key characteristics because their variation needs to be controlled. 4 Quality management system 4 質(zhì)量管理體系4.1 General requirements 4.1 總要求The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness

47、in accordance with the requirements of this International Standard. The organizations quality management system shall also address customer and applicable statutory and regulatory quality management system requirements. 組織應(yīng)按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系，形成文件，加以實(shí)施和保持，并持續(xù)改進(jìn)其有效性。組織的質(zhì)量管理體系也應(yīng)符合顧客和適用的法令和法律法規(guī)質(zhì)量管理體系要求。The

48、 organization shall a) determine 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

49、 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 where applicable, and analyse these processes, and f) Implement actions necessary to achieve planned results and continual

50、 improvement of these processes. 組織應(yīng)：a) 確定質(zhì)量管理體系所需的過(guò)程及其在組織中的應(yīng)用（見1.2）；b) 確定這些過(guò)程的順序和相互作用；c) 確定為確保這些過(guò)程的有效運(yùn)行和控制所需的準(zhǔn)則和方法；d) 確?？梢垣@得必要的資源和信息，以支持這些過(guò)程的運(yùn)行和對(duì)這些過(guò)程的監(jiān)視；e) 適當(dāng)時(shí)監(jiān)視、測(cè)量和分析這些過(guò)程；f) 實(shí)施必要的措施，以實(shí)現(xiàn)對(duì)這些過(guò)程策劃的結(jié)果和對(duì)這些過(guò)程的持續(xù)改進(jìn)。These processes shall be managed by the organization in accordance with the requirements of

51、 this International Standard. 組織應(yīng)按本標(biāo)準(zhǔn)的要求管理這些過(guò)程。Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes 針對(duì)組織所選擇的任何影響產(chǎn)品符合要求外包過(guò)程，組織應(yīng)確保對(duì)其實(shí)施控制。The type and extent of control to be applied to these ou

52、tsourced processes shall be defined within the quality management system. 對(duì)此類外包過(guò)程的控制應(yīng)在質(zhì)量管理體系中加以確定。NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvemen

53、t. 注1：上述質(zhì)量管理體系所需的過(guò)程包括與管理活動(dòng)、資源提供、產(chǎn)品實(shí)現(xiàn)和測(cè)量，分析和改進(jìn) 有關(guān)的過(guò)程。NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. NOTE 3 Ensuring control over outsourced processes does not absolve

54、the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as a) the potential impact of the outsourced process on the organizations capability t

55、o provide product that conforms to requirements, b) the degree to which the control for the process is shared, c) the capability of achieving the necessary control through the application of Documentation requirements4.2 文件要求4.2.1 General4.2.1總則The quality management system documentation sha

56、ll includea) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures and records required by this International Standard, and d) documents, including records, determined by the organization to be necessary to ensure the effective planning, oper

57、ation and control of its processes. 質(zhì)量管理體系文件應(yīng)包括：a) 形成文件的質(zhì)量方針和質(zhì)量目標(biāo)；b) 質(zhì)量手冊(cè)；c) 本標(biāo)準(zhǔn)所要求的形成文件的程序和記錄；d) 組織為確保其過(guò)程的有效策劃、運(yùn)行和控制所需的文件，包括紀(jì)錄；The organization shall ensure that personnel have access to, and are aware of, relevant quality management system documentation and changes.組織應(yīng)確保相應(yīng)人員能接觸到并且了解相關(guān)的質(zhì)量管理體系文件和變化。

58、NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document注1：本標(biāo)準(zhǔn)出現(xiàn)“形成文件的程序”之處，即要求建立該程序，形成文件，并加以實(shí)施和保持。NOTE 2 The extent of the quality management system documentati