Standard Operating Procedure (SOP) for Risk Management according to EN ISO 14971


This is a downloadable template for a standard operating procedure on risk management documenting a process as required by the ISO 14971. It will help you achieve conformity with most requirements in ISO 14971. The template includes instructions and information on sections that are particularly important or may require explanations.


Why it is useful

The ISO 14971 standard applies to all medical devices and in-vitro diagnostic devices put on the market in Europe regardless of classification. Having a streamlined and clear risk management procedure helps you implement the requirements from the standard and achieve compliance with the Medical Device Directive and In-Vitro Diagnostic Medical Device Directive. With the emergence of Annex Z and the NBOG Concensus paper on risk management, the challenge to draft a compliant procedure has increased. This procedure considers these aspects. The procedure works well together with the other risk management templates made available on

How to use it

1. You may use this procedure in your system after adapting it to your needs and after removal of the informative text.
2. Use the template as an inspiration while authoring your own
3. Use the template as a benchmark to check your own existing procedure

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