AS9100C：2009_中英文对照(2)

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

AS9100C

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

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