Hazard Traceability Matrix 3 Examples (ISO 14971, Medical Device)

29  (excl. GST/VAT)

This downloadable template 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.

SKU PT-HTM3 Category Tags , ,


Why it is useful

You need to maintain records from your risk management activities and be able to demonstrate traceability all the way from hazards to the residual risk for that particular hazard. This is easily done using the Hazard trace matrix table.

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 only the Hazard trace matrix contains a header which would satisfy requirements on document control. You may consider implementing similar headers or your own on other pages that you will print and make part of your risk management file.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before review of the document. All texts that are not blue are example texts that can and should be edited by you. Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customized to work with the current project.



If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on this link when you are logged into your Medical Device HQ account.

Need risk management training and a course certificate?

If you should want to learn more about using the template or risk management in general, it is covered in our online Introduction to Risk Management for Medical Devices and ISO 14971 course and our public Risk Management for Medical Devices and ISO 14971 blended course. Our blended courses combine a self-paced online course followed by a live virtual classroom session. You can also save money by purchasing our Advanced Risk Management course bundle which includes 3 online courses at a reduced price.


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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course. These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.