Quick Guide to ISO 14971:2019 Risk Management
A high-level overview of the medical device standard
ISO 14971:2019 is a globally recognized standard to help medical device manufacturers apply risk management principles to their processes. Risk management needs to continue throughout the life cycle of a device, not just during design or manufacture. To help you do this, we’ve summarized the main requirements of ISO 14971 and how technology can help you meet them.
- ISO 14971 risk management system requirements.
- How software aids in ISO 14971 compliance.
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Answers to Your ISO 14971 Risk Management Compliance Questions
Is ISO 14971 mandatory for life science manufacturers, and what are the regulatory implications if we don't comply with it?
It depends on where you’re selling your medical device. Regulations vary from country to country. If ISO standards are part of those requirements, not adhering to them means you’re not compliant.
How can a digital quality management system assist us in implementing ISO 14971 effectively and efficiently?
The biggest benefit of a digital QMS is being able to automate, track, and record processes related to ISO 14971 risk management. Adherence to the standard is much more difficult when done manually.
How does ISO 14971 intersect with other quality management standards and regulations that medical device manufacturers must adhere to?
ISO standards have the same high-level structure, making it easier to meet the requirements of multiple standards. A good example of this is ISO’s other medical device standards, such as ISO 13485.
What are the best practices to implement ISO 14971 within the life sciences manufacturing sector?
You need management and IT support to effectively implement ISO 14971. It’s hard to make any organizational change without management support, but having the IT resources simplifies implementation.
ISO 14971 Risk Management System Requirements
ISO 14971 lays out the process for identifying, controlling, and monitoring risk. As part of your risk management system, ISO requires medical device companies to carry out and document the following.
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Risk Analysis
Risk analysis includes intended use and reasonably foreseeable misuse, characteristics related to safety, identification of hazards and hazardous situations, and risk estimation.
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Risk Evaluation
Identified hazardous situations are evaluated for risk. Acceptable risk can be treated as residual risk. Otherwise, risk control measures need to be implemented.
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Risk Control
Risk control is meant to reduce risk to an acceptable level by building safety features into the device and/or including safety information for end users.
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Evaluation of Overall Residual Risk
Evaluate the entirety of residual risk, not just that related to a specific hazard. If the residual risk is acceptable, the manufacturer needs to inform end users.
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Risk Management Review
The risk management plan and its execution are reviewed before commercial distribution of the medical device to ensure the plan was appropriately carried out, residual risks are acceptable, and measures are in place to collect more information.
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Production and Post-Production Activities
The manufacturer collects information during production and post-production, reviewing the information to determine if there is an effect on safety and if more action is needed.
The QMS to help you with ISO 14971 risk management.
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Resources for Medical DeviceHow Software Helps With ISO 14971 Compliance
A comprehensive document management system is critical for creating, approving, and keeping track of all the documents demonstrating compliance.
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Create and Approve Online
A digital system lets you collaborate online, giving people the flexibility to give input when they can rather than looking for a blank hour in everyone’s schedule for a meeting.
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Version Control
Throughout risk management, associated documents will be updated, and old versions need to be archived. A digital system can ensure only the newest approved versions are accessible.
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Incorporation in the QMS
ISO 14971 can easily be incorporated into a QMS for manufacturers that have one. This is further simplified if you use a digital QMS that has document management capabilities.
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Single Source of Truth for Risk
Effectively managing risk requires that everyone measure risk the same way and use the same definition for acceptable risk. A digital system ensures everyone can access and uses the same criteria.
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Audit Readiness
A digital system greatly simplifies passing an audit by making the risk management file easily accessible and giving employees assurance that they have the complete, up-to-date documents.
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