Risk identificationĮntails listing potential hazards that could exist in the QMS process. The overall risk management process can be broken down into eight fundamental steps: 1. In this article, we’ll take a brief look at the fundamental building blocks of the risk management process, it will discuss some of the best techniques for managing risk in the context of QMS processes. ISO 13485, for example, calls for medical device manufacturers to “apply a risk-based approach to the control of appropriate processes needed for the quality management system.” (ISO 13485:2016, clause 4.1.2(b)).Įven in the absence of specific components in the quality standards to drive risk management, it still makes sense for organizations to assess potential pitfalls understand the impact they might have on the company, its products, and its customers and put measures in place to control and manage that risk. In fact, the ISO 9001:2015 standard includes an increased focus on risk management, and many of the industry-specific standards incorporate risk as a key element of success as well. Managing risk is fundamental to virtually every subdomain of management science.
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