ISO13485：2016标准中英文对照整理版
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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 Roles undertaken by the organization can include manufacturer, authorized representative, importer or distributor.
b)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 the sequence and interaction of these processes.
c)确定这些过程的顺序和相互作用。
4.1.3For each quality management system process, the organization shall:
b）ensure the availability of resources and information necessary to support the operation and monitoring of these processes;
b）确保必须的信息和资源来支持这些过程的操作和控制；
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 organization shall document the role(s) undertaken by the organization under the applicable regulatory requirements.
d）监测、测量和分析这些过程；
e）establish and maintain records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements (see4.2.5).
e）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）。
4.1.4The organization shall manage these quality management system processes in accordance with the requirements of this International Standard and applicable regulatory requirements. Changes to be made to theBaidu Nhomakorabeae processes shall be:
a)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 risk based approach to the control of the appropriate processes needed for the quality management system;
4.1.4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）
4.1.3对于每个质量管理体系过程，组织应当：
a）determine criteria and methods needed to ensure that both the operation and control of these processes are effective;
a）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；
c）implement actions necessary to achieve planned results and maintain the effectiveness of these processes;
c）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。
d）monitor, measure as appropriate, and analyse these processes;
注：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）
4.1.2The organization shall
4.1.2组织应当：
a) determine the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization;
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 organization shall establish, implement and maintain any requirement, procedure, activity or arrangement required to be documented by this International Standard or applicable regulatory requirements.
ISO13485-2016正文中英文对照整理版
英文
中文
4.Quality management system
4.质量管理体系
4.1 General requirements
4.1一般要求
4.1.1The organization shall document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements.
NOTE Roles undertaken by the organization can include manufacturer, authorized representative, importer or distributor.
b)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 the sequence and interaction of these processes.
c)确定这些过程的顺序和相互作用。
4.1.3For each quality management system process, the organization shall:
b）ensure the availability of resources and information necessary to support the operation and monitoring of these processes;
b）确保必须的信息和资源来支持这些过程的操作和控制；
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 organization shall document the role(s) undertaken by the organization under the applicable regulatory requirements.
d）监测、测量和分析这些过程；
e）establish and maintain records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements (see4.2.5).
e）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）。
4.1.4The organization shall manage these quality management system processes in accordance with the requirements of this International Standard and applicable regulatory requirements. Changes to be made to theBaidu Nhomakorabeae processes shall be:
a)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 risk based approach to the control of the appropriate processes needed for the quality management system;
4.1.4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）
4.1.3对于每个质量管理体系过程，组织应当：
a）determine criteria and methods needed to ensure that both the operation and control of these processes are effective;
a）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；
c）implement actions necessary to achieve planned results and maintain the effectiveness of these processes;
c）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。
d）monitor, measure as appropriate, and analyse these processes;
注：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）
4.1.2The organization shall
4.1.2组织应当：
a) determine the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization;
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 organization shall establish, implement and maintain any requirement, procedure, activity or arrangement required to be documented by this International Standard or applicable regulatory requirements.
ISO13485-2016正文中英文对照整理版
英文
中文
4.Quality management system
4.质量管理体系
4.1 General requirements
4.1一般要求
4.1.1The organization shall document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements.