ISO 13485-2016 中英文对照.docx

ISO 13485-2016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 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： 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； 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； 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。 d)????monitor, measure as appropriate, and analysethe