7 Product realization

7 产品实现

7.1 Planning of product realization 产品实现策划

The organizationshall plan and develop the processes needed for product realization. Planningof product realization shall be consistent with the requirements of the otherprocesses of the quality management system.

组织应当策划和设计产品实现所需的过程。产品实现策划应当与质量管理体系其他的过程要有相一致。

The organizationshall document one or more processes for risk management in productrealization. Records of risk management activities shall be maintained (see 4.2.5).

基于风险管理，组织应在产品实现中应当建立一个或多个过程。风险管理措施的记录应当予以保留。（见4.2.5）类似于YY/T 0287的组织应在产品实现全过程中，建立风险管理的形成文件的要求。应保持风险管理引起的记录(见4. 2.4)

In planningproduct realization, the organization shall determine the following, asappropriate:

在产品实现策划中，组织应当确定以下适当内容：

a) qualityobjectives and requirements for the product;

产品的质量目标和要求

b) the need toestablish processes and documents (see 4.2.4) and to provideresources specific to the product, including infrastructure and workenvironment;

确定过程和文件（见4.2.4）以及为产品提供特定资源的需求，包括资源和工作环境。（新增）

c) requiredverification, validation, monitoring, measurement, inspection and test,handling, storage, distribution and traceability activities specific to theproduct together with the criteria for product acceptance;

产品所需要的确认、验证、监控、测量、检查和测试、处理，存储、分配（销售）和可追溯性措施（新增）；以及专门针对于产品的产品验收标准；

d) recordsneeded to provide evidence that the realization processes and resulting productmeet requirements (see 4.2.5).

产品实现和产品符合要求的结果得以证实所需的记录（见4.2.5）；

The output ofthis planning shall be documented in a form suitable for the organization’s methodof operations.

策划输出应当文件化（新增）并适于组织的运作方式。

NOTE Furtherinformation can be found in ISO 14971.

注：更多的信息见ISO14971。（新增）