美国FDA 医疗器械体系法规QSR820中英文对照(一)

Subpart B--Quality System Requirements 质量体系要求Sec. 820.20 Management responsibility. 管理职责(a) Quality policy. 质

Subpart B--Quality System Requirements 质量体系要求

Sec. 820.20 Management responsibility. 管理职责

(a) Quality policy. 质量方针

Management with executiveresponsibility shall establish its policy and objectives for, and commitmentto, quality. Management with executive responsibility shall ensure that thequality policy is understood, implemented, and maintained at all levels of theorganization.

具有管理职责的管理者应为质量确定方针和目标,并做出承诺。管理者还应保证质量方针能够在公司各个层级被充分的理解、实施和维护。

(b) Organization. 组织

Each manufacturer shallestablish and maintain an adequate organizational structure to ensure thatdevices are designed and produced in accordance with the requirements of thispart.

每个制造商都应当建立一合适的组织结构用以保证设计和生产的器械符合本部分的要求。

(1) Responsibility and authority.职责和权限

Each manufacturer shallestablish the appropriate responsibility, authority, and interrelation of allpersonnel who manage, perform, and assess work affecting quality, and providethe independence and authority necessary to perform these tasks.

每个制造商都应当为具体管理、实施、考核影响质量工作的所有人员确立职责、权限和相互关系,并提供必要的独立性和权利来处理这些工作。

(2) Resources. 资源

Each manufacturer shallprovide adequate resources, including the assignment of trained personnel, formanagement, performance of work, and assessment activities, including internalquality audits, to meet the requirements of this part.

每个制造商都应当提供充足的资源,包括委派受训过的人员,这些人员用来进行管理、实施相应的工作、并评估相应的活动,这些活动包括为了满足本章节的要求而实施的内部的审计。

(3) Management representative.管理者代表

Management with executiveresponsibility shall appoint, and document such appointment of, a member ofmanagement who, irrespective of other responsibilities, shall have establishedauthority over and responsibility for:

具有管理职责的管理者应当任命一定数量的管理者,并形成说面的任命文件。这些管理者不管有无其他职责,都至少要具有以下明确的职责和权限:

(i) Ensuring that qualitysystem requirements are effectively established and effectively maintained inaccordance with this part; and

i)确保质体系按照本部分的要求得以有效的确定、维护;并且

(ii) Reporting on theperformance of the quality system to management with executive responsibilityfor review.

(ii)向具有审核管理职责的管理者报告质量体系的运行情况。

(c) Management review.管理审核(管理评审)

Management with executiveresponsibility shall review the suitability and effectiveness of the qualitysystem at defined intervals and with sufficient frequency according toestablished procedures to ensure that the quality system satisfies therequirements of this part and the manufacturer's established quality policy andobjectives. The dates and results of quality system reviews shall bedocumented.

具有管理职责的管理者应当依据已经确定的规程(程序)在规定的时间间隔和足够的频率下定期对质量体系的有效性和适宜性进行审核,从而保证质量体系符合本部分的规定的要求以及符合制造商已经确立的质量方针和目标。质量体系审核的结果和日期应当予以记录。

(d) Quality planning.质量策划

Each manufacturer shall establish a qualityplan which defines the quality practices, resources, and activities relevant todevices that are designed and manufactured. The manufacturer shall establishhow the requirements for quality will be met.

每个制造商应当形成一个质量策划,明确与器械设计和制造相关的质量行为、资源和活动。制造商应当明确质量需求将如何得到满足。

(e) Quality system procedures.质量体系规程(程序)

Each manufacturer shall establish qualitysystem procedures and instructions. An outline of the structure of thedocumentation used in the quality system shall be established whereappropriate.

每个制造商应当明确质量体系程序和规范。相应的应当明确用于质量体系文件结构的概述。

Sec. 820.22 Quality audit. 质量审计

Each manufacturer shallestablish procedures for quality audits and conduct such audits to assure thatthe quality system is in compliance with the established quality systemrequirements and to determine the effectiveness of the quality system. Qualityaudits shall be conducted by individuals who do not have direct responsibilityfor the matters being audited. Corrective action(s), including a reaudit ofdeficient matters, shall be taken when necessary. A report of the results ofeach quality audit, and reaudit(s) where taken, shall be made and such reportsshall be reviewed by management having responsibility for the matters audited.The dates and results of quality audits and reaudits shall be documented.

每个制造商都应当建立质量审计的规程,并实施相应的审计来保证质量体系符合已经明确的质量体系要求,并确定质量体系的有效性。质量审计应当由不直接从事即将被审计项目的人员进行。当必须实施纠正措施时,应当实施包括不合格项目重新审计的纠正措施。应当形成每次质量审计以及重新审计结果的报告,这些报告应当经过具有项目审计职责管理者的审核。质量审计和重审计的结果和日期应当予以记录。

Sec. 820.25 Personnel.人员

(a)General.概述

Each manufacturer shall havesufficient personnel with the necessary education, background, training, andexperience to assure that all activities required by this part are correctlyperformed.

每个制造商都应当具有足够的人员,这些人员应当具有相应的教育经历、工作背景、经过必要的培训、具有实际的工作经验从而保证本章节要求的所有活动得以正确实施。

(b) Training. 培训

Each manufacturer shallestablish procedures for identifying training needs and ensure that allpersonnel are trained to adequately perform their assigned responsibilities.Training shall be documented.

每个制造商应当建立培训规程,识别培训需求,并保证所有受训人员能够充分执行赋予他们的职责。培训应当予以记录。

(1)As part of their training, personnel shallbe made aware of device defects which may occur from the improper performanceof their specific jobs.

(1)作为他们培训的一部分,应使员工意识到他们的特殊工作中的不正确的操作可造成设备的缺陷。

(2)Personnel who perform verification andvalidation activities shall be made aware of defects and errors that may beencountered as part of their job functions.

2)实施确认和验证的人员应当意识到,在其工作中会遇到缺陷和错误。

分享给身边的朋友
资讯推荐
北京医改再进一步 政府定价范围将逐步缩小

北京医改再进一步 政府定价范围将逐步缩小

2017之医改:勇涉“深水区” 提升群众“获得感”

2017之医改:勇涉“深水区” 提升群众“获得感”

上海自贸区“证照分离”有了升级版 医疗器械注册证试行

上海自贸区“证照分离”有了升级版 医疗器械注册证试行

9部门联手,广东耗材大整治来了

9部门联手,广东耗材大整治来了

震撼的一天,CFDA停止两医疗器械产品进口

震撼的一天,CFDA停止两医疗器械产品进口

资讯排行