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更新至第五章，内容如下，来源于网络，若有侵权，请版主下架。
5
Quality Risk Management
质量风险管理
Chapter 3 introduced the concept of QRM as part of the life cycle approach. This section gives an overview of the QRM
process and Appendix M3 provides more detail.
第 3 章介绍了 QRM 的概念，作为生命周期方法的一部分。本节概述了 QRM 过程，附录 M3 提供了更多详细信息。
This section is primarily aimed at new computerized systems. It does not imply that formal risk assessments are
required for all existing systems. The extent of risk management required for existing systems, including the need for
formal risk assessments, should be considered as part of periodic review.
本节主要针对新的计算机化系统。这并不意味着所有现有系统都需要进行正式的风险评估。应将现有系统所需的
风险管理程度，包括正式风险评估的必要性，作为定期审查的一部分加以考虑。
This section focuses on software products and custom applications rather than on infrastructure.
本节重点介绍软件产品和定制化应用程序，而不是基础架构。
5.1 Overview
概述
QRM is a systematic process for the assessment, control, communication, and review of risks. It is an iterative process
used throughout the computerized system life cycle from concept to retirement.
QRM 是用于评估，控制，沟通和审查风险的系统过程。这是一个迭代过程，用于从概念到退役的整个计算机化
系统生命周期。
Figure 5.1 indicates key areas for risk management and the benefits of the approach.
图 5.1 展示了风险管理的关键领域和该方法的收益。For a given organization, a framework for making risk-management decisions should be defined to ensure consistency
of application across systems and business functions. Terminology should be agreed upon, particularly regarding
definitions and metrics for key risk factors.
对于给定的组织，应定义一个用于制定风险管理决策的框架，以确保跨系统和业务功能的应用的一致性。术语应
统一，特别是关于关键风险因素的定义和量度。
Such a framework is most effectively implemented when it is incorporated into the overall QMS and is fully integrated
with the system life cycle.
当这样的框架被纳入整个质量管理体系并与系统生命周期完全结合时，它能得到最有效的实施。
补充内容 (2022-8-16 17:21):
6-8章及M1，请爬10楼 |
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发表于 2022-8-10 22:36:39
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