AS9100C：2009_中英文对照(5)

-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。

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