Why was ISO Updated? One pain point with previous versions of the ISO standard was that finding information was inefficient, and documentation was difficult to navigate. There was a perceived lack of guidance on risk management, and several definitions used in the documentation were outdated. This technical report is not as widely known as the standard itself and provides useful guidance information for medical device manufacturers to follow. Because of this vote, the ISO and IEC committees decided to update the standard to better address the issues raised in these comments. Both committees opted to maintain the key concepts and core approach associated with risk management.
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If you already know the basics, skip to the second post on risk management planning. Download it here. From a distance, risk management seems straightforward. Seems easy, right? Ah, if only life were so straightforward. The reality is that risk management is one of the more complex aspects of regulatory compliance, simply because risk comes in so many flavors and perceptions of severity, and probability can be interpreted quite differently.
Fortunately, there is a systematic process you can establish to estimate, evaluate, control, and monitor risks. Medical device risk and risk management defined Risk is the combination of probability of occurrence of harm and the severity of that harm.
Risk management is the systematic application of management policies, procedures, and practices to the tasks of analyzing, controlling, and monitoring risk. Why is risk management needed? Simply put, we have a collective interest in ensuring that medical devices are safe and effective. Risk management is not optional — it is a regulatory requirement worldwide. The role of the ISO standard Fortunately, national governments have NOT created their own guidelines telling you how to how to perform risk management.
Instead, they all defer to ISO , the global standard for medical device risk management. The intent of the standard is to identify hazards associated with medical devices at all stages in its life cycle, from product design to procurement to production and postmarket use. In all cases, the goal is to estimate, evaluate, control, and monitor the risks associated with each life-cycle stage.
There are two versions of this standard in use today: ISO — The US FDA and most other markets recommend this version of the standard to meet national risk management requirements. It differs only the front matter describing how ISO deviates from the device directives in Europe. If you are just getting started implementing risk management for your company, purchase the ISO standard and its guidance ISO It is brief but provides excellent guidance for dealing with specific areas of ISO Both are copyrighted documents and you can purchase them online from ISO.
ISO was first introduced in and has expanded in scope during subsequent releases. Work on an updated version is underway. An updated dated ISO is underway and expected to be complete sometime in The focus of the revision is not on revising the risk management process but rather to improve the information on implementation of the life cycle risk management process. Sections of ISO Although risk management can be complex, the main body of the ISO standard is a scant 14 pages and consists of 9 clauses: Scope General requirements for risk management Risk analysis.
The request went to the national committees of ISO and IEC, as the medical device risk management standard was jointly developed by the two organizations. The parent committees submitted votes on the currency of the document, as well as comments for its improvement. When the votes were counted, the standard was reaffirmed as being current, but a significant number of comments requested additional information on implementation of the standard. As a result, ISO issued a call for an update to the document. At the same time, it was recognized that a little-known guidance document on medical device risk management, ISO TR , needed to be included in the review-and-update activity. A requirement to move most of the informative annexes to the TR also was included, as the TR could be more easily revised as the need arises, thus negating the requirement to reopen the standard each time informative annexes need revision. The process to revise and update began in Tampa, Fla.
Revision of ISO 14971 and ISO/TR 24971 is underway
ISO 14971 and the Basics of Medical Device Risk Management Explained