ISO9001-8.3 .6

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8.3.6 设计和开发变更

组织应对产品和服务在设计和开发期间以及后续所做的更改进行适当的识别、评审和控制，以确保这些更改对满足要求不会产生不利影响。

组织应保留以下方面的成文信息：

a）设计和开发更改；

b）评审的结果；

c）更改的授权；

d）为防止不利影响而采取的措施。

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8.3.6 Design and development changes



Organizations should appropriately identify, review, and control changes made to products and services during design and development, as well as subsequent changes, to ensure that these changes do not have an adverse impact on meeting requirements.



Organizations should retain written information on:



a) Design and development changes;



b) The results of the review;



c) Authorization for changes;



d) Measures taken to prevent adverse effects.

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因为产品或服务设计和开发过程本身就是一个不断探索的活动，会针对最初的策划、后续开发过程、所开发出的新产品或服务，进行多轮次的评审、验证和确认，应参与这些评价活动的人员很多很广泛，会产生很多对策划、开发过程及其产品或服务形成过程及其本身的修改、修订与完善，理应对这些变更进行识别（如形成会议纪要）、评审（变更实施后再次评审）和控制（达成预定效果的东西保留下来形成各类输出，包括针对变更不利影响所采取的措施，并向所有相关人员传达与共享），以确保这些变更不会导致各类非预期的不利影响

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Because the product or service design and development process itself is a constantly exploring activity, multiple rounds of review, verification, and confirmation will be conducted for the initial planning, subsequent development process, and newly developed products or services.
There are many and a wide range of personnel who should participate in these evaluation activities, which will result in many modifications, revisions, and improvements to the planning, development process, and the product or service formation process itself, These changes should be identified (such as forming meeting minutes), reviewed (re evaluated after the implementation of the changes), and controlled (things that achieve the intended effect should be retained to form various outputs, including measures taken to address the adverse effects of the changes, and communicated and shared with all relevant personnel) to ensure that these changes do not cause any unexpected adverse effects