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ISO13485-2016中英文对照 测量、分析和改进(8.5)
来源:中科创新次数:1846次发表时间:2023-03-10 17:39:07

8.5 Improvement 改进


8.5.1 General 总则


The organizationshall identify and implement any changes necessary to ensure and maintain the continuedsuitability, adequacy and effectiveness of the quality management system aswell as medical device safety and performance through the use of the qualitypolicy, quality objectives, audit results, postmarket surveillance, analysis ofdata, corrective actions, preventive actions and management review.

组织应当通过质量方针、质量目标、审计结果、上市后监测、数据分析、纠正措施、预防措施和管理审核来界定和实施任何必要的变更来保证和维持质量管理体系持续的有效性、适宜性和充分性,同时保证医疗器械的安全性和性能。(新增)


8.5.2 Corrective action 纠正措施


The organizationshall take action to eliminate the cause of nonconformities in order to preventrecurrence. Any necessary corrective actions shall be taken without unduedelay. Corrective actions shall be proportionate to the effects of thenonconformities encountered.

组织应当采取措施消除不合格防止再次发生。应当实施必要的纠正措施不得无故拖延。纠正措施应当与所发生的不合格的影响相适应。


The organizationshall document a procedure to define requirements for:

组织应当建立程序文件,定义如下要求:


a) reviewingnonconformities (including complaints);

审核不合格(包括抱怨(投诉))


b) determiningthe causes of nonconformities;

确定导致不合格的原因;(根本原因)


c) evaluatingthe need for action to ensure that nonconformities do not recur;

评估确保不合格不再发生的措施的需求;


d) planning anddocumenting action needed and implementing such action, including, asappropriate, updating documentation;

策划和文件化所需的措施并实施这些措施,包括,是当时,文件的更新;


e) verifying that the correctiveaction does not adversely affect the ability to meet applicable regulatoryrequirements or the safety and performance of the medical device;

确保纠正措施不再引入新的不利影响,从而保证符合相应法律法规要求或医疗器械的安全性和性能。(新增)


f) reviewing theeffectiveness of corrective action taken.

审核实施的纠正措施的有效性;


Records of theresults of any investigation and of action taken shall be maintained (see 4.2.5).

任何检查结果和实施措施结果的相关记录都应当予以保留。(见4.2.5)


8.5.3 Preventive action 预防措施


The organizationshall determine action to eliminate the causes of potential nonconformities inorder to prevent their occurrence. Preventive actions shall be proportionate tothe effects of the potential problems.

组织应当确定消除潜在不合格的原因防止其发生的措施。预防措施应当与潜在问题的影响相适应。


The organizationshall document a procedure to describe requirements for:

组织应当建立程序文件,定义如下要求:


a) determiningpotential nonconformities and their causes;

确定潜在不合格和他们的根本原因;


b) evaluatingthe need for action to prevent occurrence of nonconformities;

评估预防不合格发生的措施的需求;


c) planning and documenting actionneeded and implementing such action, including, as appropriate, updatingdocumentation;

策划和文件化所需的措施并实施这些措施,包括,是当时,文件的更新;(新增)


d) verifyingthat the action does not adversely affect the ability to meet applicableregulatory requirements or the safety and performance of the medical device;

确保纠正措施不再引入新的不利影响,从而保证符合相应法律法规要求或医疗器械的安全性和性能。(新增)


e) reviewing theeffectiveness of the preventive action taken, as appropriate.

审核实施措施的有效性,适当时(如适用)。


Records of theresults of any investigations and of action taken shall be maintained (see 4.2.5).

任何检查结果和实施措施结果的相关记录都应当予以保留。(见4.2.5)


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