AS9100C：2009_中英文对照

AS9100C

1. Scope

Quality Management Systems – Requirements for Aviation, Space and Defense Organizations

质量管理体系－

航空,航天和国防组织的要求

1范围

1.1 总则

1.1 General

This standard includes ISO 9001:2008 quality management system requirements and specifies additional aviation, space and defense industry requirements, definitions and notes as shown in bold, italic text.

It is emphasized that the requirements specified in 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.

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 satisfaction 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.

NOTE 1

In this International Standard, the term “product” only applies to

a) product intended for, or required by, a customer,

b) any intended output resulting from the product realization processes.

NOTE 2

Statutory and regulatory requirements may be expressed as legal requirements.

本标准包括ISO9001：2008质量管理体系要求,规定了附加的航空,航天和国防的行业要求,定义和注释.释.附加要求以加粗斜体表示。

要强调的是本标准所规定的质量管理体系要求是对合同和适用法律法规要求的补充（不是取代）。如果本标准的要求和适用法律法规之间有冲突,以后者优先.先.

本国际标准为有下列需求的组织规定了质量管理体系要求:

a) 需要证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品;

b) 通过对体系的有效应用,包括体系持续改进的过程以及保证符合顾客与适用的法律法规要求,旨在增强顾客满意。

注1：

在本国际标准中，术语“产品”仅适用于

a) 预期提供给顾客或顾客所要求的产品。

b) 产品实现过程所产生的任何预期输出。

注2：

法律法规要求可称作法定要求。

1.2 应用 1.2 Application

All requirements of this International Standard are generic and are 本国际标准规定的所有要求是通用的，旨在适用intended to be applicable to all organizations, regardless of type, 于各种类型、不同规模和提供不同产品的组织。 size and product provided. 本国际标准的任何要求因组织及其产品的特点而Where any requirement(s) of this International Standard cannot

不适用时，可以考虑对其进行删减。

be applied due to the nature of an organization and its product,

this can be considered for exclusion.

除非删减仅限于本国际标准的第7章中那些不影Where exclusions are made, claims of conformity to this

International Standard are not acceptable unless these exclusions 响组织提供满足顾客及适用法律法规要求的产are limited to requirements within clause 7, and such exclusions do 品的能力或责任的要求，否则不可以声称符合本not affect the organizations ability, or responsibility, to provide

国际标准。

product that meets customer and applicable statutory and

regulatory requirements.

计，开发，发，和/或生产航空，This standard is intended for use by organizations that design, 这个标准意图用于设计，

develop and/or produce aviation, space and defense products; 航天和国防产品，以及提供售后支持的组织，包

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and by organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own products.

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 their 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 split them into smaller quantities for resale, should use the IAQG-developed 9120 standard (see Bibliography).

括给自己的产品提供维修，备件，或材料的组织使用。

主要业务是给民用和军用航空产品提供维护，护，修理和大修服务的组织;和独立地进行维护，修理和大修活动，或者明显不同于他们自己的制造/生产活动的原始设备厂家，应当采用IAQG开发的9110标准(见参考目录)。

采购部件，材料和组件，并销售这些部件给航空，航天和国防工业的组织，包括采购产品并分组成小额的数量进行买卖的组织，应当采用IAQG开发的9120标准（见参考目录），

2 引用标准

2. Normative references

下列文件中的条款通过本标准的引用而成为本The following referenced documents are indispensable for the

标准的条款。凡是注日期的引用文件,只有这个

application of this document. For dated references, only the edition

版本适用。凡是不注日期的引用文件，其最新版cited applies. For undated references, the latest edition of the

本适用于本标准。 referenced document (including any amendments) applies.

ISO 9000:2005, Quality management systems — Fundamentals ISO 9000:2005，质量管理体系–基础与词汇 and vocabulary.

3．术语与定义

3. Terms and definitions

For the purposes of this document, the terms and definitions given 本国际标准采用ISO9000中的术语与定义。

in ISO 9000 apply.

Throughout the text of this International Standard, wherever the 本国际标准所出现的术语“产品”，也可指“服务”。 term “product” occurs, it can also mean “service”.

3.1风险： 3.1 Risk

一种不需要的情况或环境,可能是事故的初期和An undesirable situation or circumstance that has both a

likelihood of occurring and a potentially negative 会有潜在负面结果.果. consequence. 3.2特殊要求 3.2 Special requirements

Those requirements identified by the customer, or determined 由顾客识别或组织自己确定的要求,这些要求的by the organization, which have high risks to being achieved, 实现由高风险,因而要求它们包含在风险管理过thus requiring their inclusion in the risk management process. 程中.中.确定特殊要求的因素包括产品或过程的复Factors used in the determination of special requirements 杂性,过去的经验和产品或过程的成熟性.性.特殊include product or process complexity, past experience and 要求的例子包括顾客强加的业绩要求,而这是行product or process maturity. Examples of special

业接受的最高能力或是组织确定的技术或过程

requirements include performance requirements Imposed by

能. the customer that are at the limit of the industry’s capability, 能力的最高能.

or requirements determined by the organization to be at the

limit of its technical or process capabilities. 3.3关键项目 3.3 Critical items

对产品的实现和使用有重要影响的项目(如功

Those items (e.g., functions, parts, software, characteristics,

processes) having significant effect on the product realization 能，零件,软件,特性,过程),包括安全，性能，and use of the product; including safety, performance, form, 形成，安装，功能,可生产性，服务寿命等，这

些特定要求要被足够地管理。fit, function, producibility, service life, etc.; that require 理。举例如关键项目包

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specific actions to ensure they are

adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc.

3.4 Key Characteristic

An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life or producibility, that requires specific actions for the purpose of controlling variation.

NOTE Special requirements and critical items are new terms and, along with key characteristics, are interrelated. Special requirements are identified when determining and reviewing 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 will be further

classified as key characteristics because their variation needs to be controlled.

括安全临界项目，目，破损关键项目，目，任务关键项目,关键特性,等。

3.4 关键特性

是一种特性或性能，其变化将对产品装配 ,形式，功能，性能 ,服务寿命或制造性产生重大影响，因而要求采取特殊措施对其变化进行控制。

注：特殊要求和关键项目以及关键特性是相互关联的新术语，语，特殊要求是在确定和评审与产品有关的要求时识别的（。特的（见7.2.1和7.2.2）。特殊要求可能要求识别关键项目。设计输出（见7.2.3)可能包括识别要求采取特殊措施保证其得到充分管理的关键项目。目。一些关键项目由于需要对其变化进行控制会被进行一步划分为关键特性。

4 质量管理体系

4.1总要求

The organization shall establish, document, implement and 组织应按本国际标准的要求建立质量管理体系，maintain a quality management system and continually improve its 形成文件，加以实施和保持，并持续改进其有效effectiveness in accordance with the requirements of this 性。 International Standard.

组织的质量管理体系必须考虑顾客和适用法律

The organization’s quality management system shall also

法规的质量管理体系要求.求. address customer and applicable statutory and regulatory

quality management system requirements.

组织应： The organization shall

a) determine the processes needed for the quality management a) 确定质量管理体系所需的过程及其在组织中system and their application throughout the organization (see 1.2), 的应用(见1.2)； b) determine the sequence and interaction of these processes, b) 确定这些过程的顺序和相互作用； c) determine criteria and methods needed to ensure that both c) 确定为确保这些过程的有效运行和控制所需the operation and control of these processes are effective, 的准则和方法；

d) ensure the availability of resources and information necessary

d) 确保可以获得必要的资源和信息，以支持这to support the operation and monitoring of these processes,

些过程的运行和对这些过程的监视；

e) monitor, measure where applicable, and analyse these processes, and e) 监视、适用时测量和分析这些过程； f) implement actions necessary to achieve planned results and

f) 实施必要的措施，以实现对这些过程策划的

continual improvement of these processes.

结果和对这些过程的持续进。

These processes shall be managed by the organization in

组织应按本国际标准的要求管理这些过程。 accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that 针对组织所选择任何影响产品符合要求的外包过affects product conformity to requirements, the organization shall 程，组织应确保对其实施控制。 ensure control over such processes.

4 Quality management system

4.1 General requirements

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对这些外包过程的控制类型和程度应在质量管理体系中加以识别。

注1：上述质量管理体系所需的过程应当包括管理活动、资源提供、产品实现,测量,分析和改进的过程。

注2：外包过程是经组织识别为质量管理体系所需的，但选择由组织的外部方实施的过程。

注3：确保对外包过程的控制并不免除组织满足顾客和法律法规要求的责任。对外包过程控制的类型和程度可受下列因素影响：

a) 外包过程对组织提供满足要求的产品的能力的潜在影响；

b) 对外包过程控制的分担程度；

c) 通过应用7.4条款实现所需控制的能力。

4.2文件要求

4.2 Documentation requirements 4.2.1 总则 4.2.1 General

质量管理体系文件应包括： The quality management system documentation shall include

a) documented statements of a quality policy and quality objectives, a)形成文件的质量方针与质量目标； b) a quality manual, b)质量手册；

c) documented procedures and records required by this

c)本国际标准要求的形成文件的程序和记录； International Standard, and

d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and d)组织确定的为确保其过程的有效策划、运行和control of its processes. 控制所需的文件,包括记录； The organization shall ensure that personnel have access to,

组织应确保人员可以接触到并知道相关质量管and are aware of, relevant quality management system

理体系文件和更改。 documentation and changes.

NOTE 1 Where the term “documented procedure” appears within 注1：本国际标准中出现“形成文件的程序”之this International Standard, this means that the procedure is 处，即要求该程序必须被建立、形成文件、并加established, documented, implemented and maintained. A single 以实施及维持。。一个文件可包括一个或多个程document may address the requirements for one or more 序的要求。一个形成文件的程序的要求可以被包procedures. A requirement for a documented procedure may be

含在多个文件中。

covered by more than one document.

注2：不同组织的质量管理体系文件的多少和详NOTE 2 The extent of the quality management system

documentation can differ from one organization to another due 略程度取决于： to a) 组织的规模及活动的类型， a) the size of organization and type of activities,

b) 过程及其相互作用的复杂程度， b) the complexity of processes and their interactions, and

The type and extent of control to be applied to these outsourced

processes shall be defined within the quality management system.

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 improvement.

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 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 organization’s capability to 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 7.4.

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c) 人员能力。 c) the competence of personnel.

注3：文件可采用任何形式或类型的媒体。

NOTE 3 The documentation can be in any form or type of medium.

4.2.2 质量手册 4.2.2 Quality manual

组织应建立并保持质量手册，其包括： The organization shall establish and maintain a quality manual

that includes

a) 质量管理体系的范围，包括任何删减的细节a) the scope of the quality management system, including 与合理性 (见1.2); details of and justification for any exclusions (see 1.2),

b) 为质量管理体系编制的形成文件的程序，或

b) the documented procedures established for the quality

对其引用;以及 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 determined by the organization to be necessary for the planning and operation of the quality management system 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.

c) 质量管理体系过程之间的相互作用的表述。

4.2.3 文件控制

质量管理体系所要求的文件应加以控制。记录是一种特殊形式的文件，应依据4.2.4的要求加以控制。

应建立形成文件的程序，以规定以下方面必需的控制：

a) 文件发布前得到批准，以确保文件是充分和

适宜的；

b) 必要时对文件进行评审和更新，并再次批准； c) 确保文件的更改和现行修订状态得到识别；

d) 确保在使用处可获得适用文件的有关版本；

e) 确保文件保持清晰、易于识别；

f) 确保组织所确定的策划和运行质量管理体系所需的外来文件得到识别，并控制其分发；

g) 防止作废文件的非预期使用，若因任何原因而要保留作废文件时，对这些文件进行适当的标识。

4.2.4 Control of records

Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.

The documented procedure shall define the method for controlling records that are created by and/or retained by suppliers.

Records shall remain legible, readily identifiable and retrievable.

4.2.4 记录控制

为符合要求和质量管理体系有效运行提供证据而建立的记录，应予以控制。

组织应编制形成文件的程序，以规定记录的标识、贮存、保护、检索、保存和处置所需的控制。

形成文件的程序应规定由供方生成的记录和/或保存的控制方法。

记录应保持清晰，易于识别和检索。

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5 Management responsibility

5.1 Management commitment

Top management shall provide evidence of its commitment to the development and 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.

5.2 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).

Top management shall ensure that product conformity and on-time delivery performance are measured and that

appropriate action is taken if planned results are not, or will not be, achieved.

5 管理职责

5.1 管理承诺

最高管理者应通过以下活动，对其建立、实施质量管理体系并持续改进其有效性的承诺提供证据：

a) 向组织传达满足顾客和法律法规要求的重

要性；

b) 制定质量方针；

c) 确保质量目标的制定；

d) 进行管理评审；

e) 确保资源的获得。

5.2以顾客为关注焦点

最高管理者应以增强顾客满意为目的，确保顾客的要求得到确定并予以满足。 (见7.2.1和8.2.1)。

最高管理者必须确保产品符合性和及时交付业绩被测量，如果策划的结果不能取得时，应当采取适当的措施

5.3 质量方针

最高管理者应确保质量方针

a) 与组织的宗旨相适应，

b) 包括对满足要求和持续改进质量管理体系有

效性的承诺；

c) 提供制定和评审质量目标的框架，

d) 在组织内部得到沟通和理解，以及

e) 在持续适宜性方面得到评审。

5.4 策划

5.4.1 质量目标

最高管理者应确保在组织内部的相关职能和层次上建立质量目标，质量目标包括满足产品要求(见7.1.a)所需的内容。质量目标应是可测量的，并与质量方针保持一致。

5.4.2 质量管理体系策划

最高管理者应确保：

5.3 Quality policy

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.

5.4.2 Quality management system planning

Top management shall ensure that

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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

b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Top management shall ensure that the responsibilities and

authorities are defined and communicated within the organization.

5.5.2 Management representative

Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes

a) ensuring that processes needed for the quality management system are established, implemented and maintained,

b) reporting to top management on the performance of the quality management system and any need for improvement,

c) ensuring the promotion of awareness of customer requirements throughout the organization, and

d) the organizational freedom and unrestricted access to top management to resolve quality management issues. 决有关质量问题。

NOTE The responsibility of a management representative can

include liaison with external parties on matters relating to the quality 注：管理者代表的职责可包括与质量管理体系有

关事宜的外部联络。 management system.

a) 对质量管理体系进行策划，以满足质量目标

以及4.1的要求，和

b) 在对质量管理体系的变更进行策划和实施

时，保持质量管理体系的完整性。

5.5职责、权限与沟通

5.5.1 职责与权限

最高管理者应确保组织内的职责、权限得到规定和沟通。

5.5.2管理者代表

最高管理者应指定一名组织的管理者，无论该成员在其他方面的职责如何，应具有以下方面的职责和权限：

a) 确保质量管理体系所需的过程的得到建立、

实施和保持；

b) 向最高管理者报告质量管理体系的业绩和

任何改进的需求；

c) 确保在整个组织内提高满足顾客要求的意

识。

d) 不受组织干预和直径面对最高管理层地解

5.5.3 Internal communication

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.

5.5.3 内部沟通

最高管理者应确保在组织内建立适当的沟通过程，并确保对质量管理体系的有效性进行沟通。

5.6 管理评审

5.6.1 总则

最高管理者应按策划的时间间隔评审质量管理体系，以确保其持续的适宜性、充分性和有效性。管理评审应包括评价质量管理体系改进的机会和变更的需要，包括质量方针和质量目标。

应保持管理评审的记录(见4.2. 4)。

5.6.2 管理评审的输入

管理评审的输入应包括以下方面的信息：

5.6 Management review

5.6.1 General

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.

Records from management reviews shall be maintained (see 4.2.4).

5.6.2 Review input

The input to management review shall include information on

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a) 审核结果；

b) 顾客反馈；

c) 过程的业绩和产品的符合性；

d) 预防和纠正措施状况；

e) 以往管理评审的跟踪措施；

f) 可能影响质量管理体系的变更；

g) 改进的建议。

5.6.3 Review output

5.6.3 管理评审输出

The output from the management review shall include any decisions

管理评审的输出应包括与以下方面有关的任何决and actions related to

定和措施：

a) improvement of the effectiveness of the quality management a)质量管理体系及其过程有效性的改进； system and its processes, b)与顾客要求有关的产品的改进； b) improvement of product related to customer requirements, and

c)资源需求。 c) resource needs.

6.资源管理 6 Resource management

6.1 资源提供

6.1 Provision of resources

组织应确定并提供以下方面所需的资源: The organization shall determine and provide the resources

needed

a) 实施、保持质量管理体系并持续改进其有效

a) to implement and maintain the quality management system

性；

and continually improve its effectiveness, and

b) 通过满足顾客要求，增强顾客满意。

b) to enhance customer satisfaction by meeting customer requirements. 6.2 人力资源

6.2 Human resources

6.2.1 总则 6.2.1 General 基于适当的教育、培训、技能和经验，从事影响Personnel performing work affecting conformity to product 产品与要求符合性工作的人员应是能够胜任的。 requirements shall be competent on the basis of appropriate education, training, skills and experience. NOTE Conformity to product requirements can be affected 注 ：在质量管理体系中承担任何任务的人员都

可能直接或间接地影响产品与要求的符合性。 directly or indirectly by personnel performing any task within the

quality management system.

6.2.2 能力、意识和培训

6.2.2 Competence, training and awareness

组织应： The organization shall

a) determine the necessary competence for personnel performing a) 确定从事影响产品与要求的符合性工作的人

员所必要的能力；

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.

AS9100C

work affecting conformity to product requirements,

b) where applicable, provide training or take other actions to achieve the necessary competence,

c) evaluate the effectiveness of the actions taken,

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

e) maintain appropriate records of education, training, skills and experience (see 4.2.4).

6.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) buildings, workspace and associated utilities,

b) process equipment (both hardware and software), and

c) supporting services (such as transport, communication or information systems).

6.4 Work environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

NOTE The term "work environment" relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather).

7 Product realization

7.1 Planning of product realization

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).

In planning product realization, the organization shall determine the following, as appropriate:

a) quality objectives and requirements for the product;

NOTE Quality objectives and requirements for the product

注: 产品的质量目标和要求包括考虑下述方面,

include consideration of aspects such as

如：

- product and personal safety,

b) 适用时，提供培训或采取其他措施以获得所

需的能力；

c) 评价所采取措施的有效性；

d) 确保员工认识到所从事活动的相互性和重要

性，以及如何为实现质量目标作出贡献；

e) 保持教育、培训、技能和经验的适当记录(见

4.2.4)。

6.3 基础设施

组织应确定、提供并维护为达到产品符合要求所需的基础设施。适用时，基础设施包括：

a) 建筑物、工作场所和相干的设施；

b) 过程设备(硬件和软件)；

c) 支持性服务( 例如运输,通讯或信息系统)。

6.4 工作环境

组织应确定并管理为达到产品符合要求所需的工作环境。

注：术语“工作环境”是指工作时所处的条件，包括物理的、环境的和其他因素（如噪音、温度、湿度、照明或天气）。

7 产品实现

7.1 产品实现的策划

组织应策划和开发产品实现所需的过程。产品实现的策划应与质量管理体系其他过程的要求相一致（见4.1）。

在对产品实现进行策划时，组织应确定以下方面的适当内容：

a) 产品的质量目标和要求；

-产品和人员安全；

AS9100C

- - - - -

b) the need to establish processes and documents, and to provide b) 针对产品确定过程、文件和资源的需求； resources specific to the product; c) required verification, validation, monitoring, measurement, c) 产品所要求的验证、确认、监视、测量、检

验和试验活动，以及产品接收准则； inspection and test activities specific to the product and the criteria

for product acceptance;

d) records needed to provide evidence that the realization d) 为实现过程及其产品满足要求提供证据所processes and resulting product meet requirements (see 4.2.4); 需的记录(见 4.2.4)。 e) configuration management appropriate to the product; e) 适合于产品的技术状态管理；

f) resources to support the use and maintenance of the f) 支持产品使用及维护的资源。 product.

The output of this planning shall be in a form suitable for the 策划的输出形式应适合于组织的运作方式。 organization’s method of operations.

NOTE 1 A document specifying the processes of the quality 注1：对应用于特定产品、项目或合同的质量管management system (including the product realization processes) 理体系的过程(包括产品实现过程)和资源

作出规定的文件可称之为质量计划。 and the resources to be applied to a specific product, project or

contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 注2：组织也可将7.3的要求应用于产品实现过7.3 to the development of product realization processes. 程的开发。 7.1.1 Project Management 7.1.1 项目管理

As appropriate to the organization and the product, the 当适合于组织和产品时，组织应以一种结构化的organization shall plan and manage product realization in a 和受控的方式去策划和管理产品实现，现，并在限定structured and controlled manner to meet requirements at 资源和时间周期内,用一种可接受的风险来满足acceptable risk, within resource and schedule constraints. 要求。 7.1.2 Risk Management 7.1.2 风险管理

The organization shall establish, implement and maintain a 组织应建立、实施和保持风险管理过程，以实现process for managing risk to the achievement of applicable 适用的要求，适当时包括对组织和产品的要求： requirements, that includes as appropriate to the organization and the product. a) assignment of responsibilities for risk management, a) 风险管理的职责分配；

b) definition of risk criteria (e.g., likelihood, consequences, b) 风险准则的确定（如：可能性、后果,风险risk acceptance), 接受程度）；

c) identification, assessment and communication of risks c) 在产品实现全过程中风险的识别、别、评估和交throughout product realization, 流；

d) identification, implementation and management of actions d) 对于超过确定的风险接受准则时，减轻风险

reliability, availability and maintainability, producibility and inspectability,

suitability of part and materials used in the product, selection and development of embedded software, and recycling or final disposal of the product at the end of its life.

-可靠性、可用性和可维护性； -可生产性和可检验性；

-使用在产品中的零件和材料的适宜性； -嵌入式软件的选择和开发；

-产品在寿命结束时的回收和最终处理。

AS9100C

AS9100C

under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

7.2.2 Review of Requirements Related to the Product

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

a) product requirements are defined,

b) contract or order requirements differing from those previously expressed are resolved,

c) the organization has the ability to meet the defined requirements

d) special requirement of the product are determined, and

e) risks (e.g., new technology, short delivery time frame ) have been identified (see7.1.2)

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

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.

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.

7.2.3 Customer communication

The organization shall determine and implement effective arrangements for communicating with customers in relation to:

a) product information,

b) enquiries, contracts or order handling, including amendments, and

c) customer feedback, including customer complaints.

7.3 Design and Development

7.3.1 Design and Development Planning

合同义务如维修服务,以及附加的服务如回收或最终处置。

7.2.2 与产品有关的要求的评审

织应评审与产品有关的要求。评审应在组织向顾客作出提供产品的承诺之前进行(如：提交标书、接受合同或订单及接受合同或订单的更改)，并应确保： a) 产品要求得到规定； b) 与以前表述不一致的合同或订单的要求已予

解决; c) 组织有能力满足规定的要求，以及

d) 产品的特殊要求已得到确定， e) 风险已被识别（如：新技术，短的交付期） (见7.1.2)

评审结果及评审所引起的措施的的记录应予保持(见4.2.4)。

若顾客提供的要求没有形成文件，组织在接受顾客要求前应对顾客要求进行确认。

若产品要求发生变更，组织应确保相关文件等到修改，并确保相关人员知道已变更的要求。

注：在某些情况下，例如网上销售，对每一个订

单进行正式的评审可能是不实际的。而代之对有关的产品信息，如产品目录、产品广告内容等进行评审。

7.2.3 顾客沟通

组织应对以下有关方面确定并实施与顾客沟通的有效的安排：

a) 产品信息；

b) 问询、合同或订单的处理，包括对其修改；

c) 顾客反馈，包括顾客抱怨。

7.3 设计和开发

7.3.1 设计和开发策划

AS9100C

The organization shall plan and control design and development of product.

During the design and development planning, the organization shall determine

a) the design and development stages,

b) the review, verification and validation that are appropriate to each design and development stage, and

c) the responsibilities and authorities for design and development.

Where appropriate, the organization shall divide the design and development effort into distinct activities and, for each activity, define the tasks, necessary resource, responsibilities, design content, input and output data and planning constraints.

The different design and development tasks to be carried out shall be based on the safety and functional objectives of the product in accordance with customer, statutory and regulatory requirements.

Design and development planning shall consider the ability to produce, inspect, test and maintain the product.

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

Planning output shall be updated, as appropriate, as the design and development progresses.

NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination as suitable or the product and the organization.

7.3.2 Design and Development Inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These input shall include

a) functional and performance requirements,

b) applicable statutory and regulatory requirements,

c) where applicable, information derived from previous similar designs, and

d) other requirements essential for design and development.

The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.

组织应对产品的设计和开发进行策划和控制。

在进行设计和开发策划时，组织应确定：

a) 设计和开发阶段；

b) 适合于每个设计和开发阶段的评审、验证和确

认活动；

c) 设计和开发的职责和权限。

在适用的场合，合，组织应将设计和开发工作分解为明显的活动，对每项活动，确定任务、必需的资源、职责、设计内容、输入和输出数据以及策划限制条件。

应基于符合顾客和法律法规要求的产品安全和功能目标之上，完成不同的设计和开发任务。

设计和开发策划应考虑生产、检验、试验和维护产品的能力。

组织应对参与设计和开发的不同小组之间的接口进行管理，以确保有效的沟通，并明确职责分工。

随设计和开发的进展，在适当时，策划的输出应予更新。

注：设计和开发评审、验证和确认具有不同的目的。根据产品和组织的具体情况，可以单独或任意组合的形式进行并记录。

7.3.2 设计和开发输入

应确定与产品要求有关的输入，并保持记录(见4.2.4)。这些输入应包括： a) 功能和性能要求； b) 适用的法律、法规要求； c) 适用时，以前类似设计提供的信息； d) 设计和开发所必需的其他要求。

应对这些输入进行评审，以确保输入是充分的。要求应完整、清楚，并且不能自相矛盾。

AS9100C

7.3.3 Design and Development Outputs

The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release.

Design and development outputs shall

a) meet the input requirements for design and development,

b) provide appropriate information for purchasing , production and service provision,

c) contain or reference product acceptance criteria,

d) specify the characteristics of the product that are essential for its safe and proper use, and

e) specify, as applicable, any critical items, including any key characteristics, and specific actions to be taken for these items.

The organization shall define the data required to allow the product to be identified, manufactured, inspected, used and maintained including for example:

- the drawings, part lists and specifications necessary to

define the configuration and the design features of the product, and

- the material, processes, manufacturing and assembly data

needed to ensure conformity of the product.

NOTE information for production and service provision can include details for the preservation of product.

7.3.4 Design and Development Review

At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)

a) to evaluate the ability of the results of design and development to meet requirements,

b) to identify any problems and propose necessary actions, and

c) to authorize progression to the next stage.

Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the result of the reviews and any necessary actions shall be maintained (see 4.2.4)

7.3.5 Design and Development Verification

7.3.3 设计和开发输出

设计和开发输出的方式应适合于针对设计和开发的输入进行验证, 并应在放行前得到批准。

设计和开发输出应：

a) 满足设计和开发输入的要求；

b) 给出采购、生产和服务提供的适当信息；

c) 包含或引用产品接收准则；

d) 规定对产品的安全和正常使用所必需的产品特性,和

e) 适用时，规定任何关键项目，包括任何关键

特性，以及对这些项目要采取的特殊措施

组织应确定对产品进行标识、制造、检验、使用和维护所要求的数据，包括例如：

-定义产品技术状态和设计特性所必需的图纸，零件清单和规范；

-保证产品符合性所需的材料、过程、制造和装配数据。

注：生产和服务提供的信息可能包括产品防护的细节。

7.3.4设计和开发评审

在适宜的阶段，应依据所策划的安排(见7.3.1)对设计和开发进行有系统的评审，以便：

a) 评价设计和开发的结果满足要求的能力；

b) 识别任何问题并提出必要的措施，和

c) 授权进入下一阶段。

评审的参加者应包括与所评审的设计和开发阶段有关的职能的代表。评审结果及任何必要措施的记录应予保持。(见4.2.4)

7.3.5 设计和开发验证

AS9100C

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)

7.3.6 Design and Development Validation

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).

7.3.6.1 Design and Development Verification and Validation Testing

Where tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed, and documented to ensure and prove the following:

a. test plans or specifications identify the product being

tested and the resources being used, define test objectives and conditions, parameters to be recorded, and relevant acceptance criteria;

b. test procedures describe the method of operation, the

performance of the test, and the recording of the results;

c. the correct configuration of the product is submitted for

the test;

d. the requirements of the test plan and the test procedures

are observed, and

e. the acceptance criteria are met.

7.3.6.2 Design and Development verification and Validation Documentation

At the completion of design and/or development, the organization shall ensure that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions.

7.3.7 Control of Design and Development Changes

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

为确保设计和开发输出满足输入的要求，应依据所策划(见7.3.1)的安排对设计和开发进行验证。验证结果及任何必要措施的记录应予保持(见4.2.4)。

7.3.6 设计和开发确认

为确保产品能够满足规定的使用要求或已知的预期用途的要求，应依据所策划(见7.3.1)的安排对设计和开发进行确认。只要可行，确认应在产品交付或实施之前完成。确认结果及任何必要措施的记录应予保持。(见4.2.4)。

7.3.6.1 设计和开发文件的验证和确认试验

当验证和确认必须进行试验时，应对这些试验进行策划、控制、评审并形成文件，以确保和证实：

a.试验计划或规范确定了要进行试验的产品和使用的资源；规定了试验目的和条件、要记录的参数以及相关接收准则；

b.试验程序描述了操作方法、试验的性能和记录的结果；

c.提交试验的产品的样品技术状态正确；

d. 遵守了试验计划和试验程序的要求；

e. 满足了接收准则。

7.3.6.2 设计和开发验证和确认试验的文件

在设计和/或开发完成时，组织必须确保报告、 计算、试验结果等能够证实在所规定的运行条件下，产品的定义符合规范的要求。

7.3.7 设计和开发更改的控制

应识别设计和开发的更改，并保持记录。适当时，应对设计和开发的更改进行评审、验证和确认，并在实施前得到批准。设计和开发更改的评审应包括评价更改对产品组成部分和已交付产品的影响。

AS9100C

delivered. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4)

Design and development changes shall be controlled in accordance with the configuration management process (see 7.1.3)

Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).

7.4 Purchasing

7.4.1 Purchasing process

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.

The organization shall be responsible for the conformity of all products purchased from suppliers, including product from sources defined by the customer.

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)

NOTE One factor that can be used during supplier selection and evaluation is supplier quality data from objective and reliable external sources, as evaluated by the organization (e.g., information from accredited quality management system or process certification bodies, organization approvals from government authorities). Use of such data would be only one component of an organization’s supplier control process and the organization remains responsible for verifying that purchased product meets specified purchase requirements.

The organization shall:

a. maintain a register of its suppliers that includes approval

status (e.g., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process family),

b. periodically review supplier performance; the result of

these reviews shall be used as a basis for establishing the level of controls to be implemented;

c. define the necessary actions to take when dealing with

suppliers that do not meet requirements;

d. ensure where required that both the organization and all

suppliers use customer-approved special process

设计和开发的更改应按技术状态管理过程（见7.1.3）进行控制。

更改的评审结果及任何必要措施的记录应予保持。(见4.2.4)。

7.4 采购

7.4.1 采购过程

组织应确保采购的产品符合规定的采购要求。对供方及采购的产品控制的类型和程度应取决于采购的产品对随后的产品实现或最终产品的影响。

组织必须对所有从供应商采购的产品的符合性负责，包括从顾客指定的来源采购的产品。

组织应根据供方按组织的要求提供产品的能力评价和选择供方。应制定选择、评价和重新评价的准则。评价结果及评价所引起的任何必要措施的记录应予保持(见4.2.4)。

注：在选择和评价供应商过程中，可使用来自客观和可靠的外部来源的供应商质量数据作为组织自己的评估,（例如：来自授信的质量管理体系或过程认证机构,来自政府机构对组织的批准）。使用这种数据只能是组织对供应商控制过程的一个组成部分，分，组织仍然负责验证采购的产品满足规定采购要求的责任。

组织应：

a) 保持一份批准的供方名录，包括批准状态

（如：批准，有条件批准，不批准）和批准范围（如：产品类型、过程类别）；

b) 周期性地评估供方的业绩；应使用这些评审

结果作为确定实施控制程度的依据；

c) 当供应商不能满足要求时，规定采取必要的

措施；

d) 当要求时，确保组织和所有供应商都使用顾

客批准的特殊过程资源；

AS9100C

e. Define the process, responsibilities and authority for the e) 对于批准状态决定、批准状态更改以及根据

供应商批准状态对供应商进行控制使用的条approval status decision, changes of the approval status

件确定过程、职责和权力。 and conditions for a controlled use of suppliers depending on the supplier’s approval status, and

f. determine and manage the risk when selecting and using f) 选择和使用供应商时，确定和管理风险(见

7.1.2)。 suppliers (see 7.1.2).

sources,

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate

a) requirements for approval of product, procedures, processes and equipment,

b) requirements for qualification of personnel,

c) quality management system requirements,

d) the identification and revision status of specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data,

e) requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance by the organization, and as applicable critical items including key characteristics,

f) requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection/verification, investigation or auditing,

g) requirements regarding the need for the supplier to - notify the organization of nonconforming product,

- obtain organization approval for nonconforming product

disposition,

- notify the organization of changes in product and/or

process, change of suppliers, changes of manufacturing facility location and, where required, obtain organization approval, and

- flow down to the supply chain the applicable requirements

including customer requirements,

h) records retention requirements, and

i) right of access by the organization, their customer and regulatory authorities to the applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records,

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

7.4.2 采购信息

采购信息应表述拟采购的产品，适当时包括：

a) 产品、程序、过程和设备的批准要求；

b) 人员资格的要求；

c) 质量管理体系的要求；

d) 规范、图样、过程要求、检验/验证说明书和其他有关的技术资料的标识和修订状态；

e）组织的设计、试验、检验、验证的要求（包括生产过程的验证），用于产品接收的统计技术的使用，和有关组织接收的指导书，以及适用的关键项目包括关键特性；

f）用于设计批准、检验/验证、调查或审核的

试验样件的要求（例如，生产方法，数量。储存条件）。

g)需要考虑对供应商的下述要求： -向组织通报不合格产品，

-不合格品处理得到组织批准；

-将产品和/或过程的更改，供应商更改，生产设施地点更改应报告组织，织，并且在要求时获得组织的批准；

-向供应链传达适用要求，包括顾客要求；

h) 记录保存要求；

i) 组织及其顾客,和法规性机构可接触涉及订

单的任何层次的供应链所有设施的适用区域,和所有适用记录的权利。

在与供方沟通前，组织应确保所规定的采购要求是充分与适宜的。

AS9100C

7.4.3 Verification of Purchased Product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

NOTE 1 Customer verification activities performed at any level of the supply chain should not be used by the organization or the supplier as evidence of effective control of quality and does not absolve the organization of its responsibility to provide acceptable product and comply with all requirements.

NOTE 2 Verification activities can include

a. obtaining objective evidence of the conformity of the

product from suppliers (e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control records),

b. inspection and audit at the supplier’s premises,

c. review of the required documentation,

d. inspection of products upon receipt, and

e. delegation of verification to the supplier or supplier

certification.

Where purchased product is released for production use pending completion of all required verification activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements.

Where the organization delegates verification activities to the supplier, the requirements for delegation shall be defined and a register of delegations maintained.

Where 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.

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable

a) the availability of information that describes the characteristics of the product,

NOTE This information can include drawings, parts lists,

7.4.3 采购产品的验证

组织应确定并实施检验或其他必要的活动，以确保采购的产品满足规定的采购要求。

注1 组织或供方不应该把顾客对任何层次的供应链所做的验证活动用作质量有效控制的证据，据，也不能免除组织提供可接受产品和符合所有要求的责任。

注2验证活动可以包括

a) 从供应商处获得产品符合性的客观证据（如

随产品文件，合格证明，试验报告，统计记录，过程控制记录）；

b) 在供应商处的检验和审核；

c) 对要求的文件的评审；

d) 按收货单检验产品，

e) 对供方委托验证代表，或要求供方认证。

在等待所有要求的验证活动完成前，前，如果采购的产品被发放用于生产，应对其进行标识和记录，做到如果验证结果发现产品不符合要求，求，能够对其进行召回和更换。

在组织派人员去供应商处进行验证时，时，应规定委派的要求并保持委派人员的记录。

当组织或其顾客拟在供方的现场实施验证时，组织应在采购信息中对拟验证的安排和产品放行的方法作出规定。

7.5 生产和服务提供

7.5.1 生产和服务提供的控制

组织应策划并在受控条件下进行生产和服务提供。适用时，受控条件应包括：

a) 获得表述产品特性的信息；

注：信息可包括图纸、零件清单、材料和工艺规

AS9100C

materials and process specifications.

b) the availability of work instructions, as necessary,

NOTE Work instructions can include process flow charts, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards) and inspection documents.

c) the use of suitable equipment,

NOTE Suitable equipment can include product specific tools (e.g., jigs, fixtures, molds) and software programs.

d) the availability and use of monitoring and measuring equipment,

e) the implementation of monitoring and measurement,

f) the implementation of product release, delivery and post-delivery activities,

g) accountability for all product during production(e.g., parts quantities, split orders, nonconforming product),

h) evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized,

i) provision for the prevention, detection, and removal of foreign objects,

j) monitoring and control of utilities and supplies (e.g., water, compressed air, electricity chemical products) to the extent they affect conformity to product requirements, and

k) criteria for workmanship, specified in the clearest practical way (e.g., written standards, representative samples or illustrations).

Planning shall consider, as appropriate,

- establishing, implementing and maintaining appropriate

processes to manage critical items, including process controls where key characteristics have been identified.

- designing, manufacturing and using tooling to measure

variable data,

- identifying in-process inspection/verification points when

adequate verification of conformance cannot be performed at a later stage of realization, and

- special processes (see 7.5.2).

7.5.1.1 Production Process Verification

范。

b) 必要时，获得作业指导书；

注：作业指导书可包括过程流程图、生产文件（如：制造计划、路线图、流程卡、生产指令和过程卡）和检验文件。

c) 使用适宜的设备；

注：适宜的设备可包括产品专用工装（型架、夹具、模具）和软件程序。

d) 获得和使用监视和测量设备；

e) 实施监视和测量；

f) 产品放行、交付和交付后活动的实施；

g）在生产过程中对所有的产品负有责任（例 如：零件数量、分作业指令、不合格品等）；

h）所有生产和检验/验证操作已经按计划或其他文件完成的证据并被认可；

i）预防、检测和去除外来物的措施；

j）对会影响产品要求符合性的用品和供给物（物（如

水、压缩空气、电及化学产品）进行监视和控制，

k）以最清楚实用的方式（例如，文字标准、样件或图示）规定工艺准则。

适用时，策划应考虑：

-建立、实施和保持适当的过程来管理关键项目，包括对识别出关键特性的过程控制；

-设计、制造和使用工具以测量变量数据；

-当适宜的符合性验证不能在产品实现的后面阶段进行时，识别过程中的检验/验证点。

-特殊过程(见7.5.2）。

7.5.1.1 生产过程的验证

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