ISO13485-2016中英文对照(九)-测量、分析和改进

8 Measurement, analysis and improvement8 测量、分析和改进8.1 General总则The organizationshall plan and implement the mon

8 Measurement, analysis and improvement

8 测量、分析和改进

8.1 General总则

The organizationshall plan and implement the monitoring, measurement, analysis and improvement processesneeded to:

组织应当策划和实施监控、测量、分析和改进程序以便:

a) demonstrateconformity of product;

证明产品的一致性;

b) ensureconformity of the quality management system;

保证质量管理体系的符合性;

c) maintain theeffectiveness of the quality management system.

保持质量管理体系的有效性。

This shallinclude determination of appropriate methods, including statistical techniques,and the extent of their use.

这些程序包括确定的适宜的方法,包括分析技术以及使用的范围。

8.2Monitoring and measurement 监控和测量

8.2.1Feedback 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)

8.2.4Internal 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

8.2.5Monitoring 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。

8.2.6Monitoring 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)

8.3 Controlof nonconforming product 不合格品的控制

8.3.1General 总则

The organizationshall ensure that product which does not conform to product requirements is identifiedand controlled to prevent its unintended use or delivery. The organizationshall document a procedure to define the controls and related responsibilitiesand authorities for the identification, documentation, segregation, evaluationand disposition of nonconforming product.

组织应确保标识和控制不符合产品要求的产品从而阻止非预期的使用和交付。组织应当建立一个程序来明确用于控制以及界定、记录、控制、隔离、评估(新增)、处置不合格品相应的职责和权限。

The evaluation of nonconformityshall include a determination of the need for an investigation and notificationof any external party responsible for the nonconformity.

不合格品的评估应包括明确的用于检查的需求,并针对不合格尽责的向外部进行告知。(新增)

Records of thenature of the nonconformities and any subsequent action taken, including theevaluation, any investigation and the rationale for decisions shall bemaintained (see 4.2.5)

不合品的性质以及任何后续措施的相关记录(包括评估、任何检查和决定的理由)都应当予以保留。(见4.2.5

8.3.2Actions in response to nonconforming product detected before delivery 放行前不合格品的处置

The organizationshall deal with nonconforming product by one or more of the following ways:

组织应当通过以下一种或多种方式处理不合格品:

a) taking actionto eliminate the detected nonconformity;

采取措施以消除所发现的不合格;

b) taking actionto preclude its original intended use or application;

采取措施以阻止其原预期的使用或应用。

c) authorizingits use, release or acceptance under concession.

批准其让步使用、放行或接收。

The organizationshall ensure that nonconforming product is accepted by concession only if the justificationis provided, approval is obtained and applicable regulatory requirements aremet. Records of the acceptance by concession and the identity of the personauthorizing the concession shall be maintained (see 4.2.5).

组织应当确保只有当能够提供正当理由、获得批准和符合相应法律法规要求的前提下,不合格产品才可以让步接收。

8.3.3Actions in response to nonconforming product detected after delivery

放行后不合格品的处置

Whennonconforming product is detected after delivery or use has started, theorganization shall take action appropriate to the effects, or potentialeffects, of the nonconformity. Records of actions taken shall be maintained(see 4.2.5).

当在销售和开始后发现了不合格品,组织应当采取与影响或潜在影响相适应的不合品处理措施。处理措施的相关记录应当予以保留。(见4.2.5(新增)

The organizationshall document procedures for issuing advisory notices in accordance withapplicable regulatory requirements. These procedures shall be capable of beingput into effect at any time. Records of actions relating to the issuance ofadvisory notices shall be maintained (see 4.2.5).

组织应当建立依据相应法律法规要求发出忠告性通知的程序。这些程序应当在任何时候都能得以实施。与发布忠告性通知有关的措施的记录应当予以保留。(见4.2.5)(新增)

8.3.4Rework 返工

The organizationshall perform rework in accordance with documented procedures that takes into accountthe potential adverse effect of the rework on the product. These procedures shallundergo the same review and approval as the original procedure.

After thecompletion of rework, product shall be verified to ensure that it meetsapplicable acceptance criteria and regulatory requirements.

组织应当按照事先规定好的文件化的充分考虑了产品返工的潜在不利影响的程序进行返工。这些程序应当与原始程序一样经过审核和批准。返工完成后,应当对产品进行验证以保证产品符合可接受标准和法律法规要求。

Records ofrework shall be maintained (see 4.2.5).

返工记录应予以保留。(见4.2.5

8.4Analysis of data 数据分析

The organizationshall document procedures to determine, collect and analyse appropriate data todemonstrate the suitability, adequacy and effectiveness of the qualitymanagement system. The procedures shall include determination of appropriatemethods, including statistical techniques and the extent of their use.

组织应当建相应的程序以确定、收集、分析相应的数据从而证明质量管理体系适宜性、充分性和有效性。程序应到包括适当的方法学,包括分析技术以及其使用的范围。(新增)

The analysis ofdata shall include data generated as a result of monitoring and measurement andfrom other relevant sources and include, at a minimum, input from:

数据分析应当包括监控和测量过程中和来源于其他资源所产生的数据,同时包括最少来源于以下输入的内容:

a) feedback; 反馈

b) conformity toproduct requirements;  符合产品要求;

c)characteristics and trends of processes and product, including opportunitiesfor improvement; 过程和产品的特性和趋势,包括改进的条件。

d) suppliers; 供应商

e) audits; 审核(审计)

f) service reports, as appropriate.服务报告,如适用。(新增)

If the analysis of data shows thatthe quality management system is not suitable, adequate or effective, theorganization shall use this analysis as input for improvement as required in 8.5.

如果数据分析显示质量管理体系不适宜、充分和有效,组织应当将此分析作为改进(8.5项下要求)的输入。(新增)

Records of theresults of analyses shall be maintained (see 4.2.5).

分析结果的记录应当予以保留。(见4.2.5

8.5Improvement 改进

8.5.1General 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)

8.5.2Corrective 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

8.5.3Preventive 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

总结:测量、分析和改进部分最大的亮点,就是将抱怨(投诉)作为一个部分单独拿出来进行了大篇幅的描述。同样的整个分析、测量和改进部分也贯穿了风险管理的影子,请大家重点关注。

分享给身边的朋友
资讯推荐
科技部“点名”辅助生殖技术

科技部“点名”辅助生殖技术

打通商保后,医生集团能从高端医疗变成大众医疗吗?

打通商保后,医生集团能从高端医疗变成大众医疗吗?

趋势!北京15家医疗机构转型康复医院

趋势!北京15家医疗机构转型康复医院

CFDA调整药物临床试验审评:受理60日内未收到否定或质疑意见,申请人可开展试验

CFDA调整药物临床试验审评:受理60日内未收到否定或质疑意见,申请人可开展试验

年薪30万起!深圳罗湖全科医生模式亮了

年薪30万起!深圳罗湖全科医生模式亮了

资讯排行