13485:2016 Medical Device Risk Management Worksheet

Risk management and risk analysis are required in clause 7 of the ISO 13485 standard and is required to be applied throughout product realization. Our risk management exercise will take you through the analysis of risks for the product realization steps required for your products.

Our risk analysis exercise is intended to provide a simple approach to risk management that can be applied to all types of medical products where risks can vary and be very different depending on the nature of the medical products.

For example, the risk analysis for a paper towel holder can reveal very simple conclusions with simple solutions, while more complex products such as landing gear components and assemblies can of course yield conclusions and solutions that could be very technical and complicated. Education in risk management is available through training seminars to address your specific situation.

However, a cost effective approach is to review the information that we provide on this web page and begin the process with our risk analysis exercise. The risk analysis exercise starts with the preparation of process flow diagrams to describe the activities/steps. It continues with the use of an 8-column risk management worksheet that takes you through a series of information gathering actions designed to assist you in deciding whether or not a process step is at risk and taking appropriate corrective actions.

With the risk management package, you will:

• See how flow charts play a role in risk analysis.
• Learn how risks can be introduced at the process steps.
• Describe existing and new risks.
• Assess the significance of described risks.
• Determine if a next step in the process will eliminate or reduce the risks.
• Describe the controls that are in place to eliminate or reduce the risks.
• Decide when a process step is at risk, and
• Take corrective action