AS9100C：2009_中英文对照(6)

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)

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