ISO13485-2016中英文對照 測量、分析和改進（8.2.1~8.2.3）

8.2 Monitoring and measurement 監控和測量

8.2.1 Feedback 反饋

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.

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

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

組織應當建立反饋程序。反饋程序應當包括收集生產以及生產結束以后活動的數據的規定。

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作為風險管理的潛在輸入。以便控制和維持產品要求以及產品實現或改進過程。（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.

如果相應法規要求需要組織從產后處理活動中獲得專門的經驗，經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.

依據相應法規要求組織應當建立抱怨（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;

調查抱怨（投訴）；

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

確定向相應的藥監部門報告信息的需求；

e) handling of complaint-relatedproduct;

處以與抱怨（投訴）相關的產品；

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.

如果不調查抱怨（投訴），應當記錄正當的理由。在抱怨（投訴）處理程序中產生的糾正和糾正措施都應當予以記錄。

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；檢查相應的信息應當在組織和組織外部的其他機構進行交流。

Complaint handling records shall be maintained (see 4.2.5).

抱怨（投訴）處理記錄應當予以保留。（見4.2.5）

8.2.3 Reporting to regulatory authorities 向藥監部門報告

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.

如果相應法規要求需要對符合不良反應標準的抱怨（投訴）進行告知或發布公告，組織應建立向相應藥監部門報告的程序。

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

應當保留向藥監部門報告的相關記錄。（見4.2.5）（新增）