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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.

作為質(zhì)量管理體系有效性的一種測量手段，組織應(yīng)當收集和監(jiān)控組織是否已經(jīng)滿足了客戶需求有關(guān)的信息。獲得和使用這些信息的方法應(yīng)當文件化。

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

組織應(yīng)當建立反饋程序。反饋程序應(yīng)當包括收集生產(chǎn)以及生產(chǎn)結(jié)束以后活動的數(shù)據(jù)的規(guī)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.

在反饋程序中收集到的信息應(yīng)作為風險管理的潛在輸入。以便控制和維持產(chǎn)品要求以及產(chǎn)品實現(xiàn)或改進過程。（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.

如果相應(yīng)法規(guī)要求需要組織從產(chǎn)后處理活動中獲得專門的經(jīng)驗，經(jīng)驗審核將作為反饋過程的一部分。

8.2.2 Complainthandling 抱怨（投訴）的處理

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

依據(jù)相應(yīng)法規(guī)要求組織應(yīng)當建立抱怨（投訴）及時處理程序。

These procedures shall include at aminimum requirements and responsibilities for:

該程序應(yīng)當包括最低要求以及職責用于：

a) receiving and recordinginformation;

接收和記錄信息；

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

評估信息來確定是否反饋是一個抱怨（投訴）；

c) investigating complaints;

調(diào)查抱怨（投訴）；

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

確定向相應(yīng)的藥監(jiān)部門報告信息的需求；

e) handling of complaint-relatedproduct;

處以與抱怨（投訴）相關(guān)的產(chǎn)品；

f) determining the need to initiatecorrections or corrective actions.

確定最初的糾正和糾正措施的需求;

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

如果不調(diào)查抱怨（投訴），應(yīng)當記錄正當?shù)睦碛伞Ｔ诒г梗ㄍ对V）處理程序中產(chǎn)生的糾正和糾正措施都應(yīng)當予以記錄。

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

如果檢查確定組織以外的活動對抱怨（投訴）有幫助；檢查相應(yīng)的信息應(yīng)當在組織和組織外部的其他機構(gòu)進行交流。

Complaint handling records shall be maintained (see 4.2.5).

抱怨（投訴）處理記錄應(yīng)當予以保留。（見4.2.5）

8.2.3 Reporting to regulatory authorities 向藥監(jiān)部門報告

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.

如果相應(yīng)法規(guī)要求需要對符合不良反應(yīng)標準的抱怨（投訴）進行告知或發(fā)布公告，組織應(yīng)建立向相應(yīng)藥監(jiān)部門報告的程序。

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

應(yīng)當保留向藥監(jiān)部門報告的相關(guān)記錄。（見4.2.5）（新增）