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ISO13485认证辅导---ISO13485-2016中英文对照 测量、分析和改进(8.2.1~8.2.6)

日期:2018-05-01 11:41:17 来源:本站原创   【字体:

8.2 Monitoring and measurement 监控和测量

 

8.2.1 Feedback 反馈

 

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)

 

8.2.4 Internal audit 内审

 

The organizationshall conduct internal audits at planned intervals to determine whether thequality management system:

组织应当在策划好的规定时间间隔内实施内审以确定质量体系是否:

 

a) conforms toplanned and documented arrangements, requirements of this InternationalStandard, quality management system requirements established by theorganization, and applicable regulatory requirements;

符合策划好的文件化的安排、符合本国际标准要求、符合经组织确定的质量管理体系要求以及相应法律法规的要求;

 

b) iseffectively implemented and maintained.

予以有效的实施和维护。

 

The organizationshall document a procedure to describe the responsibilities and requirementsfor planning and conducting audits and recording and reporting audit results.

组织应当建立一个用于描述实施和策划审核、记录和报告审核结果相应要求和职责的程序。

 

An audit programshall be planned, taking into consideration the status and importance of theprocesses and area to be audited, as well as the results of previous audits.The audit criteria, scope, interval and methods shall be defined and recorded(see 4.2.5). The selection of auditors and conduct ofaudits shall ensure objectivity and impartiality of the audit process. Auditorsshall not audit their own work.

审计计划应当予以策划,并应考虑过程状况和重要性、审核区域以及以往审核结果。审计的标准、范围、时间间隔、方法应当予以明确并记录(见4.2.5)。审核员的选择和审核的实施应保证审核过程的客观性和公正性。审核员不应当审核与自身工作相关的内容。

 

Records of the audits and theirresults, including identification of the processes and areas audited and theconclusions, shall be maintained (see 4.2.5).

审核记录以及审核结果,包括过程的识别、审核的区域以及结论,都应当予以保留(见4.2.5)(新增)

 

The managementresponsible for the area being audited shall ensure that any necessarycorrections and corrective actions are taken without undue delay to eliminatedetected nonconformities and their causes. Follow-up activities shall includethe verification of the actions taken and the reporting of verificationresults.

被审核区域的管理者应当保证实施相应的纠正和纠正措施,应确保及时采取措施消除已发现的不合格及其产生的原因。后续措施应当包括对所采取的行动的确认和确认结果的报告。

 

NOTE Furtherinformation can be found in ISO 19011.

注:详细信息见ISO19011。

 

8.2.5 Monitoring and measurement of processes  过程的监控和测量

 

The organizationshall apply suitable methods for monitoring and, as appropriate, measurement ofthe quality management system processes. These methods shall demonstrate theability of the processes to achieve planned results. When planned results arenot achieved, correction and corrective action shall be taken, as appropriate.

组织应当采用合适的方法来监控质量管理体系的过程,适当时进行相应的测量。这些方法应当证明过程能够到达已策划结果的能力。当不能达到已策划结果,应当采取相应的纠正和纠正措施。

 

8.2.6 Monitoring and measurement of product 产品的监控和测量

 

The organizationshall monitor and measure the characteristics of the product to verify thatproduct requirements have been met. This shall be carried out at applicablestages of the product realization process in accordance with the planned anddocumented arrangements and documented procedures.

组织应当监控和测量产品的特性来证明产品要求已经得到满足。应当依据经策划的文件化的安排以及文件化的程序在产品实现过程的相应阶段实施这些监控和测量。

 

Evidence ofconformity to the acceptance criteria shall be maintained. The identity of theperson authorizing release of product shall be recorded (see 4.2.5). Asappropriate, records shall identify the test equipment used to performmeasurement activities.

Product releaseand service delivery shall not proceed until the planned and documentedarrangements have been satisfactorily completed.

符合可接受标准的证据应当予以保留。放行产品人员的签字应当予以记录(见4.2.5)。相应的,记录应当包含实施测量活动所使用的检测设备。直到经策划的文件化的安排得以满意的实施后,产品才能进行放行和服务交付。

 

For implantable medical devices, theorganization shall record the identity of personnel performing any inspectionor testing.

对于植入式医疗器械而言,组织应当记录实施检查或测试人员的签名。(新增)

上一篇:ISO13485认证辅导---ISO13485-2016中英文对照 产品实现(7.6) 下一篇:ISO13485认证辅导---ISO13485-2016中英文对照 测量、分析和改进(8.3)
 
 

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