Risk Analysis/Hazard Traceability Matrix Template Free
This is a downloadable template which applies to medical devices, including in-vitro diagnostic medical devices and active implantable medical devices. It includes useful spreadsheets to document the outputs from your risk management activities. It will help you achieve conformity with clauses 4.2, 4.3, 4.4, 5, 6.1, 6.2, 6.3, 6.4 and 6.7 of the ISO 14971:2007 and EN ISO 14971:2012.
Why it is useful
You need to maintain records from your risk management activities and also achieve traceability all the way from hazards to the residual risk for that all risks. This is easily done using the Hazard traceability matrix table (risk analysis).
How to use it
1. Use the hazard id sheet to identify hazards early in your project (during planning phase).
2. Maintain records of participation in the various risk management activities in the Participation records sheet, remember that this preferably should match what you said in the risk management plan.
3. Fill in your hazards and so on in the risk analysis columns of the hazard traceability matrix.
4. Evaluate the risks.
5. Fill in risk controls and estimate the residual risk.
6. Check that you have implemented all the risk controls.
Please note that questions that can help to identify hazards from Annex C of the ISO 14971 have not been included in full due to copyright restrictions.
File format: .xlsx
Need risk management training and a course certificate?
Take a look at our online course: Introduction to Risk Management for Medical Devices and ISO 14971. Learn about the overall process of risk management, the tools and techniques used and how to develop a safe medical device according to regulatory requirements. Created by industry experts. Certification on successful completion of course.