ISO13485-2016中英文对照(一)-一般要求

Quality management system质量管理体系4.1 General requirements 一般要求4.1.1 The organizationshall document a quality man

Quality management system

质量管理体系

4.1 General requirements 一般要求

 

4.1.1 The organizationshall document a quality management system and maintain its effectiveness in accordancewith the requirements of this International Standard and applicable regulatoryrequirements.

组织应当依据本国际标准和相应的法律法规文件建立质量管理体系,并形成文件以维护质量管理体系的有效性。

The organizationshall establish, implement and maintain any requirement, procedure, activity orarrangement required to be documented by this International Standard orapplicable regulatory requirements.

组织应当确定、实施和维护任何本国家标准或适用的法规要求所需的要求、程序、活动或安排。(新增)

The organizationshall document the role(s) undertaken by the organization under the applicable regulatoryrequirements.

依据相应的法律法规,组织应当明确组织中的角色,并形成文件。(新增)

NOTE Rolesundertaken by the organization can include manufacturer, authorized representative,importer or distributor.

组织中的角色可以包括生产商、受托方(授权代表)、进口商或经销商。(新增)

4.1.2 The organizationshall 组织应当:

a) determine theprocesses needed for the quality management system and the application of theseprocesses throughout the organization taking into account the roles undertakenby the organization;

基于组织所承担的角色,确定质量管理体系所需的过程以及在整个组织中应用的程序。(新增)

b) apply a riskbased approach to the control of the appropriate processes needed for thequality management system;

应用一个以风险为基础的方法来控制质量管理体系所需的相应过程。(新增,强调风险管理)

c) determine thesequence and interaction of these processes.

确定这些过程的顺序和相互作用。

4.1.3 For each qualitymanagement system process, the organization shall:

对于每个质量管理体系过程,组织应当:

  1. a)     determine criteria and methods needed toensure that both the operation and control of these processes are effective;

确定必要的标准和方法从而保证这些过程的操作和控制都是有效的;

  1. b)    ensure the availability of resources andinformation necessary to support the operation and monitoring of these processes;

确保必须的信息和资源来支持这些过程的操作和控制;

  1. c)     implement actions necessary to achieveplanned results and maintain the effectiveness of these processes;

实施必要的措施来达到预期的结果和维护这些过程的有效性。

  1. d)    monitor, measure as appropriate, and analysethese processes;

监测、测量和分析这些过程;

  1. e)     establish and maintain records needed todemonstrate conformance to this International Standard and compliance withapplicable regulatory requirements (see 4.2.5).

建立和维护用于证明符合本国际标准和适用的法律法规要求的符合性的记录(参见4.2.5)。

4.1.4 The organizationshall manage these quality management system processes in accordance with therequirements of this International Standard and applicable regulatoryrequirements. Changes to be made to these processes shall be:

组织应当依据本国际标准和适当的法规要求管理这些质量管理体系过程。这些过程的改变(变更)应当:(新增)

a) evaluated fortheir impact on the quality management system;

评价其对于质量管理体系的影响;(新增)

b) evaluated for their impact on themedical devices produced under this quality management system;

评价其对于在此质量管理体系下生产的医疗器械的影响;(新增)

c) controlled inaccordance with the requirements of this International Standard and applicable regulatoryrequirements.

依据本国际标准和适当的法规要求进行控制。(新增)

4.1.5 When theorganization chooses to outsource any process that affects product conformityto requirements, it shall monitor and ensure control over such processes. The organizationshall retain responsibility of conformity to this International Standard and tocustomer and applicable regulatory requirements for outsourced processes. Thecontrols shall be proportionate to the risk involved and the ability of theexternal party to meet the requirements in accordance with 7.4. The controlsshall include written quality agreements.

当组织选择外包(委托)任何影响产品符合要求的过程时,这些过程都应当被监控并确保这些过程控制。对于外包(委托)过程。组织应当具有符合国际标准、符合客户、符合适当法规要求的职责。控制应当与所涉的风险以及外部组织的能力相适应,并且符合7.4项下的要求。控制应当包括书面的质量协议。(新增,委托)

4.1.6 The organizationshall document procedures for the validation of the application of computer softwareused in the quality management system. Such software applications shall bevalidated prior to initial use and, as appropriate, after changes to suchsoftware or its application.

组织应当建议文件化的程序用于应用于质量管理体系计算机软件应用程序的验证。这类软件应用程序的验证应当在初始使用前进行验证,并在对该软件或其应用程序更改后进行验证。(新增,计算机系统验证)

The specificapproach and activities associated with software validation and revalidationshall be proportionate to the risk associated with the use of the software.

Records of such activities shall bemaintained (see 4.2.5).

与软件验证和再验证相关的专门方法和措施应当使用该软件的风险相适应。这类措施的记录应当被保留》(见4.2.5)(新增)

注意:涂色字体加粗部分为新增部分,其余部分与YY/T0287-2003基本一致。

笔者对原文进行翻译,有不妥之处敬请谅解。这里边笔者看到ISO13485-2016第一部分新增内容最大的变化就是近几年一直很热且一直被国内忽视的东西,被提到了法规标准层面。留心的人都会看到,那就是风险管理(文件多次提及,要与风险相适应)、变更管理(4.1.4项应尤为关注)、委托、计算机系统验证(4.1.6项应尤为关注)。好了不多说了,相信很多人都再学习,略尽绵薄之力,希望能有所帮助。承让。

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