7 Product realization
7 产品实现
7.2 Customer-related processes 与顾客有关的过程
7.2.1 Determination 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。
7.2.2 eview 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）
7.2.3 Communication 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。7.2.1中d）项新增培训、7.2.2中d）项新增培训，且备注项删剪。
