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FDA认证咨询--美国FDA 医疗器械体系法规QSR820中英文对照(十)|QSR820体系文件如何处理

来源:本站 作者:ADMIN 发布时间:2019-05-08

Subpart N--Servicing  服务


Sec. 820.200 Servicing.服务


(a) Where servicing is a specified requirement, eachmanufacturer shall establish and maintain instructions and procedures forperforming and verifying that the servicing meets the specified requirements.


(a)当服务作为一种特定要求时,制造商应当建立和维护用以实施和确认器械符合特定要求的规程和规范。


(b) Each manufacturer shall analyze service reports withappropriate statistical methodology in accordance with 820.100.


(b)制造商应依据820.100里的统计方法分析服务报告。


(c) Each manufacturer who receives a service report thatrepresents an event which must be reported to FDA under part of this chaptershall automatically consider the report a complaint and shall process it inaccordance with the requirements of 820.198.


(c)当制造商接收到一个表现为事故并依据本章节803部分应向FDA报告的服务报告时,制造商应当自动的将该报告作为一个投诉,并按照Sec.820.198的要求进行处理。


(d) Service reports shall be documented and shall include:


(d)服务报告应当予以记录,并包括以下内容:


(1) The name of the device serviced; 被服务器械的名称;


(2) Any unique device identifier (UDI) or universal product code(UPC), and any other device identification(s) and control number(s) used;


(2)使用的UDI或UPC、其他的器械标识和控制码;


(3) The date of service; 服务的日期;


(4) The individual(s) servicing the device; 服务器械的人员;


(5) The service performed; and 操作的器械;并且


(6) The test and inspection data. 测试和检查的数据。


修订说明:


[61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10,2004; 78 FR 55822, Sept. 24, 2013]


Subpart O--StatisticalTechniques 统计技术


Sec. 820.250 Statistical techniques.统计技术


(a) Where appropriate, each manufacturer shall establish andmaintain procedures for identifying valid statistical techniques required forestablishing, controlling, and verifying the acceptability of processcapability and product characteristics.


(a)适用时,制造商应建立和维护用于识别适当的统计技术要求的规程,来确定、控制和确认过程能力和产品特性的可接受性。


(b) Sampling plans,when used, shall be written and based on a valid statistical rationale. Eachmanufacturershall establish and maintain procedures to ensure that sampling methods areadequate for their intended use and to ensure that when changes occur the samplingplans are reviewed. These activities shall be documented.


(b)应制定基于某个适用的统计原理取样计划(如使用)。制造商应建立和维护相应的规程来保证取样的方法满足其预期的用途,并确保取样计划的变更经过审核,所有活动都应当予以记录。


Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j,360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

Source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.

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