Apply to the risk management process of all medical devices.
适用于公司所有医疗器械产品风险管理过程。
The risk management process should be aligned with the organization's culture, processes, structure and strategy.
风险管理流程应该与组织的文化、流程、组织结构和战略相匹配。
Communication and consultation with external and internal stakeholders should take place during all stages of the risk management process.
与内外部利益相关者的沟通和协商贯穿于风险管理的每个阶段。
In many cases, the risk management process is seen more as a nuisance, often no more than an accommodation to the process assurance organization.
在许多情况下，风险管理过程更类似危害，常常不过是对过程担保组织的顺应。
Special Requirements are those requirements that have high risks to being achieved, hence requiring their inclusion in the risk management process.
特殊要求是指那些要想达到这些要求具有高风险的那些要求。因此，必须对这些要求包括在风险管理过程之中。
These models are the promotion of classical risk model, that provide more risk models of objective reality for the risk management process, which have certain practical value.
这些模型是对经典风险模型的推广，为风险经营过程提供更为客观实际的风险经营模型，它在保险公司实际操作中具有一定的实用价值。
The relationship between the principles for managing risk, the framework in which it occurs and the risk management process described in this International Standard are shown in Figure 1.
本标准描述了风险管理的原则、框架、风险管理的流程之间的关系，如图1所示。
The framework assists in managing risks effectively through the application of the risk management process (see Clause 5) at varying levels and within specific contexts of the organization.
该框架通过风险管理流程(见第5款)在不同层级在组织特定环境的实施，确保管理风险的有效性。
The objectives, strategies, scope and parameters of the activities of the organization, or those parts of the organization where the risk management process is being applied, should be established.
组织的目标、战略、活动的范围和因素，或者其他部分，都应该建立风险管理流程。
Mitigation of this risk includes ensuring that the process is clear, and approved by the management board in areas where conflict may occur.
此风险的缓解包括确保过程是明确的，并且在冲突可能出现的区域得到管理委员会的批准。
At the risk of using a word that disturbs many in the field of software engineering, requirements management is just a process.
冒险使用的这个可能会搅乱软件工程，需求管理领域的单词其实就是过程。
But for risk management to be effective, the entire board needs to own the process.
但是要想获得有效的风险管理，整个董事会都需要全程掌握主动权。
There is a need to balance the risk and the value of service reuse, and that process is known as SOA Quality Management.
需要平衡风险与服务复用的价值，而该过程已经作为SOA质量管理了。
Risk management drives the overall process of developing an enterprise architecture.
风险管理推进了企业架构开发的整个过程。
Mitigation of this risk involves making sure the process is unambiguous and approved by the management chain, at the C-level (CIO, COO, etc.), in areas where conflict may arise.
此风险的缓解包括确保过程是明确的，并且在冲突可能出现的区域，在C级别(CIO,COO，等)上得到管理委员会的批准。
Proactive management of the test process and applying a risk-based approach, as TMap describes, is therefore mandatory.
因此，测试过程的提前管理并应用一种基于风险的方法，如TMap所描述的，是必须的。
Standard PDCA process model, the introduction of risk assessment and management process, emphasizing the continuous improvement of the system.
标准采用PD CA的过程模型，引入风险评估和管理过程，强调体系的持续改进。
An introduction of risk management in space program, its content, requirements and process are introduced, and some exemples of the application of risk management are also given.
文章介绍了在航天项目中风险管理的内容、要求和过程，并介绍了一些国际上应用的情况。
Management of risk is a continue process and the cornerstone of all the SAFETY Elements.
风险管理是一个持续的过程，是所有安全要素的基础。
Later, the research aim and process about environmental risk information management system of hazardous materials railway transportation are put forward.
随后，提出铁路危险货物运输环境风险管理信息系统的设计目标以及研究思路。
Next, the key technologies of NPD is studied sequentially, which model founding of NPD project, process management technologies basing on BOM and project risk management are studied in detail.
然后对流程管理的实现的关键技术进行了研究，分别对新产品开发项目模型的建立，基于BOM的流程管理技术和流程管理的项目风险管理进行了讨论。
The governance structure and process are based on the management of risk.
治理结构和过程是基于风险管理。
Therefore, a key feature of this International Standard is the inclusion of "establishing the context" as an activity at the start of this generic risk management process.
因此，这一国际标准的主要特点是将风险管理“环境建设”列入其管理过程的开始活动。
The risk analysis process is an important part of software project risk management. It is significant for the risk control and related decisions.
风险分析过程是软件项目风险管理中的重要组成部分，对后期的风险控制以及相关决策都具有极为重要的意义。
The process of risk management and its application in quality management and certification are introduced in this paper.
介绍了风险管理的过程及其在质量管理和认证中的应用。
Risk is existing in the management process of every enterprise, so risk management is needed.
任何企业在经营过程中都存在着风险，需要进行风险管理。
A structured change management process reduces the risk of productivity loss.
结构化的变更管理流程降低了生产力损失风险。
In this paper, a customer needs analysis, classification, introduced the implementation process of software products, and needs assessment methodology in the process, the management of demand risk.
本文对客户需求进行了分析、归类，介绍了产品化软件的实施过程，以及在这过程中对需求进行评估的方式、需求风险的管理。
How to reduce management risk deserves attention throughout the process of the project establishment.
如何减少管理风险亦是本项目建设过程中必须予以关注的。
How to reduce management risk deserves attention throughout the process of the project establishment.
如何减少管理风险亦是本项目建设过程中必须予以关注的。
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