8.3产品和服务的设计和开发

8.3.4.1、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、评审和形成文件，以确保和证实：

a. 试验计划或规范识别了要进行试验的产品和使用的资源；确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的方法、试验的实施以及结果的记录；

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. 满足接收准则。

用于实验的监视和测量装置应按条款7.1.5进行控制。

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，产品或服务的设计符合规范的要求。

8.3.4.1、When 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 test item 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 test methods to be used, how to perform the test, and how to record the results;

c. the correct configuration of the test item is submitted for the test;

d. the requirements of the test plan and the test procedures are observed;

e. the acceptance criteria are met.

Monitoring and measuring devices used for testing shall be controlled as defined in clause 7.1.5.

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