ISO9001:2015-8.3.4

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8.3.4设计和开发控制

组织应对设计和开发过程进行控制，以确保：

a）规定拟获得的结果；

b）实施评审活动，以评价设计和开发的结果满足要求的能力；

c）实施验证活动，以确保设计和开发输出满足输出要求；

d）实施确认活动，以确保形成的产品和服务能够满足规定的使用要求或预期用途；

e）针对评审、验证和确认过程中确定的问题采取必要措施；

f）保留这些活动的成文信息。

注：设计和开发的评审和确认具有不同目的。根据组织的产品和服务的具体情况，可单独或以任意组合的方式进行

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8.3.4 Design and Development Control



The organization should control the design and development process to ensure that:



a) Define the results to be obtained;



b) Implement review activities to evaluate the ability of design and development results to meet requirements;



c) Implement validation activities to ensure that the design and development outputs meet output requirements;



d) Implement confirmation activities to ensure that the products and services formed can meet the specified usage requirements or expected uses;



e) Take necessary measures to address the issues identified during the review, verification, and confirmation process;



f) Keep written information about these activities.



Note: The review and confirmation of design and development have different purposes. Depending on the specific situation of the organization's products and services, they can be carried out individually or in any combination

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所谓“设计和开发控制”就是确保“设计和开发策划”的输出（例如新产品研发计划书）得到有效执行，

以便产生达到预期效果的输出（即确保新产品或服务依照输出中的规定实施后就能够达成预定的新产品或服务各项要求）

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The so-called "design and development control" is to ensure that the output of the "design and development planning" (such as the new product development plan) is effectively executed, in order to produce outputs that achieve the expected results (that is, to ensure that the new product or service can meet the predetermined requirements of the new product or service after being implemented according to the provisions in the output)