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Risk analysis/Hazard traceability matrix template


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, 2009 and 2012.

SKU: HazardTraceability_template_2017 Category: Tags: , ,

Product Description

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 particular hazard, which 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 planing 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.

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