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ISO13485-2016中英文对照 测量、分析和改进(8.2.1~8.2.3)
来源:中科创新次数:1979次发表时间:2022-12-09 08:58:02

As one of themeasurements of the effectiveness of the quality management system, theorganization shall gather and monitor information relating to whether theorganization has met customer requirements. The methods for obtaining and usingthis information shall be documented.


作为质量管理体系有效性的一种测量手段,组织应当收集和监控组织是否已经满足了客户需求有关的信息。获得和使用这些信息的方法应当文件化。




The organizationshall document procedures for the feedback process. This feedback process shallinclude provisions to gather data from production as well as post-production activities.


组织应当建立反馈程序。反馈程序应当包括收集生产以及生产结束以后活动的数据的规定。




The information gathered in thefeedback process shall serve as potential input into risk management formonitoring and maintaining the product requirements as well as the productrealization or improvement processes.


在反馈程序中收集到的信息应作为风险管理的潜在输入。以便控制和维持产品要求以及产品实现或改进过程。(新增)




If applicableregulatory requirements require the organization to gain specific experiencefrom postproduction activities, the review of this experience shall form partof the feedback process.


如果相应法规要求需要组织从产后处理活动中获得专门的经验,经验审核将作为反馈过程的一部分。




8.2.2 Complainthandling 抱怨(投诉)的处理




The organization shall documentprocedures for timely complaint handling in accordance with applicableregulatory requirements.


依据相应法规要求组织应当建立抱怨(投诉)及时处理程序。




These procedures shall include at aminimum requirements and responsibilities for:


该程序应当包括最低要求以及职责用于:




a) receiving and recordinginformation;


接收和记录信息;




b) evaluating information todetermine if the feedback constitutes a complaint;


评估信息来确定是否反馈是一个抱怨(投诉);




c) investigating complaints;


调查抱怨(投诉);




d) determining the need to reportthe information to the appropriate regulatory authorities;


确定向相应的药监部门报告信息的需求;




e) handling of complaint-relatedproduct;


处以与抱怨(投诉)相关的产品;




f) determining the need to initiatecorrections or corrective actions.


确定最初的纠正和纠正措施的需求;




If any complaint is notinvestigated, justification shall be documented. Any correction or corrective actionresulting from the complaint handling process shall be documented.


如果不调查抱怨(投诉),应当记录正当的理由。在抱怨(投诉)处理程序中产生的纠正和纠正措施都应当予以记录。




If an investigation determinesactivities outside the organization contributed to the complaint, relevant informationshall be exchanged between the organization and the external party involved.


如果检查确定组织以外的活动对抱怨(投诉)有帮助;检查相应的信息应当在组织和组织外部的其他机构进行交流。




Complaint handling records shall be maintained (see 4.2.5).


抱怨(投诉)处理记录应当予以保留。(见4.2.5)




8.2.3 Reporting to regulatory authorities 向药监部门报告




If applicable regulatoryrequirements require notification of complaints that meet specified reporting criteriaof adverse events or issuance of advisory notices, the organization shalldocument procedures for providing notification to the appropriate regulatoryauthorities.


如果相应法规要求需要对符合不良反应标准的抱怨(投诉)进行告知或发布公告,组织应建立向相应药监部门报告的程序。




Records of reporting to regulatoryauthorities shall be maintained (see 4.2.5).


应当保留向药监部门报告的相关记录。(见4.2.5)(新增)


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