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8.5 Improvement 改進(jìn)

8.5.1 General 總則

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.

組織應(yīng)當(dāng)通過質(zhì)量方針、質(zhì)量目標(biāo)、審計結(jié)果、上市后監(jiān)測、數(shù)據(jù)分析、糾正措施、預(yù)防措施和管理審核來界定和實施任何必要的變更來保證和維持質(zhì)量管理體系持續(xù)的有效性、適宜性和充分性，同時保證醫(yī)療器械的安全性和性能。（新增）

8.5.2 Corrective action 糾正措施

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.

組織應(yīng)當(dāng)采取措施消除不合格防止再次發(fā)生。應(yīng)當(dāng)實施必要的糾正措施不得無故拖延。糾正措施應(yīng)當(dāng)與所發(fā)生的不合格的影響相適應(yīng)。

The organizationshall document a procedure to define requirements for:

組織應(yīng)當(dāng)建立程序文件，定義如下要求：

a) reviewingnonconformities (including complaints);

審核不合格（包括抱怨（投訴））

b) determiningthe causes of nonconformities;

確定導(dǎo)致不合格的原因；（根本原因）

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

評估確保不合格不再發(fā)生的措施的需求；

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

策劃和文件化所需的措施并實施這些措施，包括，是當(dāng)時，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;

確保糾正措施不再引入新的不利影響，從而保證符合相應(yīng)法律法規(guī)要求或醫(yī)療器械的安全性和性能。（新增）

f) reviewing theeffectiveness of corrective action taken.

審核實施的糾正措施的有效性；

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

任何檢查結(jié)果和實施措施結(jié)果的相關(guān)記錄都應(yīng)當(dāng)予以保留。（見4.2.5）

8.5.3 Preventive action 預(yù)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.

組織應(yīng)當(dāng)確定消除潛在不合格的原因防止其發(fā)生的措施。預(yù)防措施應(yīng)當(dāng)與潛在問題的影響相適應(yīng)。

The organizationshall document a procedure to describe requirements for:

組織應(yīng)當(dāng)建立程序文件，定義如下要求：

a) determiningpotential nonconformities and their causes;

確定潛在不合格和他們的根本原因；

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

評估預(yù)防不合格發(fā)生的措施的需求；

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

策劃和文件化所需的措施并實施這些措施，包括，是當(dāng)時，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;

確保糾正措施不再引入新的不利影響，從而保證符合相應(yīng)法律法規(guī)要求或醫(yī)療器械的安全性和性能。（新增）

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

審核實施措施的有效性，適當(dāng)時（如適用）。

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

任何檢查結(jié)果和實施措施結(jié)果的相關(guān)記錄都應(yīng)當(dāng)予以保留。（見4.2.5）