7 Product realization

7 產品實現

7.1 Planning of product realization 產品實現策劃

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.

組織應當策劃和設計產品實現所需的過程。產品實現策劃應當與質量管理體系其他的過程要有相一致。

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

基于風險管理，組織應在產品實現中應當建立一個或多個過程。風險管理措施的記錄應當予以保留。（見4.2.5）類似于YY/T 0287的組織應在產品實現全過程中，建立風險管理的形成文件的要求。應保持風險管理引起的記錄(見4. 2.4)

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

在產品實現策劃中，組織應當確定以下適當內容：

a) qualityobjectives and requirements for the product;

產品的質量目標和要求

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

確定過程和文件（見4.2.4）以及為產品提供特定資源的需求，包括資源和工作環境。（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;

產品所需要的確認、驗證、監控、測量、檢查和測試、處理，存儲、分配（銷售）和可追溯性措施（新增）；以及專門針對于產品的產品驗收標準；

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

產品實現和產品符合要求的結果得以證實所需的記錄（見4.2.5）；

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

策劃輸出應當文件化（新增）并適于組織的運作方式。

NOTE Furtherinformation can be found in ISO 14971.

注：更多的信息見ISO14971。（新增）