Last Updated on March 22, 2023 by Ossian Muscad
ISO 14971 is an international standard designed to ensure the safety of medical devices. It provides a framework and requirements for manufacturers to assess, monitor, and control risks associated with their products.
A key component of ISO 14971 is the creation of a risk management checklist that helps ensure all risks are identified and managed properly. This article will discuss an ISO 14971 checklist, its essentials, and how you can create one for your organization.
What is ISO 14971?
ISO 14971 is an international standard that specifies the requirements for risk management of medical devices. The standard provides a framework for identifying, evaluating, and controlling risks associated with medical devices throughout their entire lifecycle, from design and development to post-market surveillance.
The purpose of ISO 14971 is to help medical device manufacturers ensure that their products are safe for patients, users, and others and to reduce the likelihood of harm caused by potential hazards associated with using the devices. The standard also provides guidance for medical device manufacturers on how to communicate risks and manage the risk-benefit trade-offs associated with their products.
ISO 14971 is widely recognized as the international standard for the risk management of medical devices and is required by regulatory agencies in many countries to approve medical devices. It is essential for medical device manufacturers to follow ISO 14971 to ensure compliance with regulatory requirements and to provide safe and effective medical devices to patients.
What Industries is ISO 14971 Applicable?
ISO 14971 is primarily applicable to the medical device industry. This includes manufacturers, distributors, and importers of medical devices and those involved in the design, development, and production of medical devices.
The standard also applies to organizations that provide services related to medical devices, such as testing and calibration laboratories, certification bodies, and other third-party service providers.
ISO 14971 is not limited to any particular type of medical device. Still, it applies to all medical devices, including in vitro diagnostic (IVD), active implantable, and non-active medical devices. It also applies to software used in medical devices and accessories used in combination with medical devices.
In addition to the medical device industry, ISO 14971 can also be applied to other industries where risk management is essential, such as the pharmaceutical industry, the food and beverage industry, and the automotive industry, among others. However, in such cases, the standard may need to be adapted to suit the specific needs and requirements of the industry in question.
What is an ISO 14971 Checklist?
An ISO 14971 checklist is a tool that medical device manufacturers can use to ensure that they have implemented all of the necessary steps and requirements for risk management, as specified by the ISO 14971 standard. The checklist systematically identifies, evaluates, and controls risks associated with medical devices throughout their entire lifecycle.
An ISO 14971 checklist typically includes a series of questions or prompts that cover various aspects of risk management, such as risk identification, risk analysis, risk evaluation, risk control, risk communication, and risk monitoring. The checklist may also include references to the relevant sections of the ISO 14971 standard and guidance and best practices for implementing each step of the risk management process.
By using an ISO 14971 checklist, medical device manufacturers can ensure that they have considered all relevant risks associated with their products and have implemented appropriate measures to mitigate or eliminate those risks. This can help ensure the medical device’s safety and effectiveness, as well as compliance with regulatory requirements.
What Items To Include in an ISO 14971 Checklist?
An ISO 14971 checklist should include all of the key steps and requirements for risk management, as specified by the standard. Here are some of the items that should be included in an ISO 14971 checklist:
- [ ] Pinpoint hazards that are associated with the device
- [ ] Estimate the probability and severity of harm caused by each hazard
- [ ] Determine the risk acceptability criteria
- [ ] Assess the possible risks and hazards associated with the device
- [ ] Develop a risk control plan to mitigate or eliminate risks
- [ ] Implement the risk control measures identified in the plan
- [ ] Verify that the risk control measures have been effective
- [ ] Document and record the risk management process and results
- [ ] Review and update the risk management process periodically
- [ ] Ensure that risk management is integrated into the overall quality management system
In addition to these key steps, an ISO 14971 checklist may also include additional items or questions to ensure that all aspects of risk management have been considered, such as:
- Have all relevant stakeholders been involved in the risk management process?
- Has the risk management process been applied throughout the device’s entire lifecycle?
- Has the risk management process been adequately documented and communicated to relevant parties?
- Have any residual risks been identified and addressed?
- Have any changes to the device or its intended use been evaluated for potential new risks?
The specific items included in an ISO 14971 checklist may vary depending on the nature of the device and the organization’s risk management processes. Still, the overall goal should be to ensure that all relevant risks have been identified, evaluated, and controlled to an acceptable level.
How To Create an ISO 14971 Checklist?
Creating an ISO 14971 checklist involves several steps. Here are some useful steps to consider when creating an ISO 14971 checklist:
- Review the ISO 14971 standard and familiarize yourself with the key requirements and steps for risk management.
- Determine the scope of the checklist by identifying the types of medical devices or product families that the checklist will cover.
- Identify the key stages of the device lifecycle that will be covered by the checklist (e.g., design and development, production, post-market surveillance).
- Develop a list of hazards and potential risks associated with each stage of the device lifecycle. This can be done by conducting a risk analysis or reviewing previous risk assessments.
- Identify risk control measures that can be implemented to mitigate or eliminate each identified risk.
- Develop a list of questions or prompts that cover each step of the risk management process and any additional items relevant to the specific device or organization.
- Organize the questions or prompts into a logical sequence corresponding to the stages of the device lifecycle and the risk management process.
- Test the checklist by applying it to a representative sample of devices or product families, and make any necessary revisions based on feedback and results.
- Implement the checklist into your organization’s risk management processes and periodically review and update it.
When creating an ISO 14971 checklist, it’s essential to keep in mind that the checklist should be tailored to the specific needs and risks associated with the devices or product families being covered. The checklist should also be reviewed and updated periodically to ensure that it remains relevant and effective in managing risks associated with the devices.
Create an ISO 14971 Checklist Using a Low-code Platform
If you’re looking for a faster and easier way to create an ISO 14971 checklist, consider using a low-code platform like DATAMYTE. With DATAMYTE, you can quickly and easily build customized ISO 14971 checklists tailored to your organization’s needs.
The DataMyte Digital Clipboard is a workflow automation software that features a checklist builder. This tool lets you create comprehensive ISO 14971 checklists in minutes.
To create a checklist or form template using DATAMYTE, follow these steps:
- Log in to the DATAMYTE software platform and navigate to the Checklist module.
- Click on “Create Checklist” to create a new checklist.
- Define the title of the checklist and the category in which it belongs.
- Use DATAMYTE’s low-code capabilities by adding items to the checklist; click “Add Item.” You can define the description of the item, the type of answer required, and any other specifications, such as reference documents, acceptance criteria, or limits.
- Assign appropriate personnel responsible for completing the checklist, as well as any required approvals, such as supervisors or quality assurance personnel.
- Save the checklist, and it will be available for use.
DATAMYTE also lets you conduct layered process audits, a systematic and regular review of critical process steps, focusing on the areas with the highest risk of failure or non-compliance. By conducting LPA with DATAMYTE, you can effectively identify and correct defects before they become major quality issues.
With DATAMYTE, you have an all-in-one solution for creating and implementing ISO 14971 checklists. Book a demo with our team today to learn how DATAMYTE can help you ensure quality and compliance.
Conclusion
By implementing an ISO 14971 checklist, you can have peace of mind that your medical devices are being safely and effectively used and that risks associated with them are being managed. With a low-code platform like DATAMYTE, you can easily create and implement comprehensive ISO 14971 checklists tailored to your organization’s needs. Get started today!
