ISO13485-2016中英文对照(五)-产品实现7.1-7.2

7 Product realization7 产品实现7.1-7.27.1Planning of product realization 产品实现策划The organizationshall plan and deve

7 Product realization

7 产品实现

7.1-7.2

7.1Planning 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(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)

7.2Customer-related processes 与顾客有关的过程

7.2.1Determination of requirements related to product 与产品有关的要求的确定

The organizationshall determine: 组织应当确定

a) requirementsspecified by the customer, including the requirements for delivery andpost-delivery activities;

顾客规定的要求,包括对交付及交付后活动的要求;

b) requirementsnot stated by the customer but necessary for specified or intended use, asknown;

顾客虽然没有明示,但规定的用途或已知的预期用途所必需的要求;

c) applicableregulatory requirements related to the product;

与产品有关的法律法规要求;

d) any usertraining needed to ensure specified performance and safe use of the medicaldevice;

任何用于保证医疗器械安全使用和特定性能的用户培训需求;(新增)

e) anyadditional requirements determined by the organization.

组织确定的任何附加要求。

7.2.2Review of requirements related to product 与产品相关的需求的审核

The organizationshall review the requirements related to product. This review shall beconducted prior to the organization’s commitment to supply product to thecustomer (e.g. submission of tenders, acceptance of contracts or orders,acceptance of changes to contracts or orders) and shall ensure that:

组织应当审核与产品有关的要求。审核应在组织向顾客作出提供产品的承诺之前进行(如:提交标书、接受合同或订单及接受合同或订单的更改),并应确保:

a) productrequirements are defined and documented;

产品需求必须得到明确并形成文件;

b) contract ororder requirements differing from those previously expressed are resolved;

与以前表述不一致的合同或订单的要求得到解决;

c) applicableregulatory requirements are met;

符合相应的法律法规要求;

d) any usertraining identified in accordance with 7.2.1 is available orplanned to be available;

按照7.2.1项要求确定的任何用户培训是可行的或是计划可行。(新增)

e) theorganization has the ability to meet the defined requirements.

组中有能力符合确定的需求;

Records of theresults of the review and actions arising from the review shall be maintained(see 4.2.5).

审核结果和因审核而产生措施的记录应当予以保留(见4.2.5

When the customerprovides no documented statement of requirement, the customer requirements shallbe confirmed by the organization before acceptance.

若顾客提供的要求没有形成文件,组织在接受顾客要求前应对顾客要求进行确认。

When productrequirements are changed, the organization shall ensure that relevant documentsare amended and that relevant personnel are made aware of the changedrequirements.

若产品要求发生变更,组织应确保相关文件得到修改。并确保相关人员知道已变更的要求。

YY/0287备注项目(删除)

7.2.3Communication 沟通

The organizationshall plan and document arrangements for communicating with customers in relationto:

组织应对以下有关方面确定并实施与顾客沟通的有效安排:

a) productinformation;

产品信息;

b) enquiries,contracts or order handling, including amendments;

问询、合同或订单处理、包括修订;

c) customerfeedback, including complaints;

顾客反馈,包括抱怨;

d) advisorynotices.

忠告性通知。

The organizationshall communicate with regulatory authorities in accordance with applicable regulatoryrequirements.

组织依据相应的法规要求与药监局进行沟通。

 

总结:风险管理描述略有差异。7.1产品实现策划b)项中强调了资源和环境;c)中强调了处理,存储、分配(销售)和可追溯性措施;新增注意事项。7.2.1d)项新增培训、7.2.2d)项新增培训,且备注项删剪。

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