ISO 14971 – Risk Management
30 May 2011
Over the last few weeks, this blog has reviewed ISO 14971 and what it covers and what it does not. This blog also has taken a closer look as to why it is important to medical device manufacturers, health care providers and regulatory bodies. Even though ISO 14971 is voluntary, it forces manufacturers to establish a formal process for dealing with risk management and focuses on how manufacturers can produce safer products.
The Third Edition of IEC 60601-1 creates a risk management requirement for a large segment of the medical device industry. Because of this requirement, the ISO 14971 registration activity is expected to increase significantly. While this is an important element for many manufacturers to consider, third-party organizations can play a key role in assisting companies with risk management under ISO 14971. But how?
Many clauses of the ISO 14971 standard are categorized as pass or fail. The rationale for pass or fail is based on whether they are included and adequately addressed in the Risk Management File (RMF). A testing/certification organization can be helpful to manufacturers as it will need to evaluate whether the manufacturer's RMF makes sense in the context of the 60601-1 standards.
Third-parties also may be involved beyond the review of the RMF, by auditing the processes that form the risk management system. In other words, a third-party can provide value by assessing both the risk management process and the output of that process.
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