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With the emphasis of risk management in the ISO 9001 and ISO/IEC 17025:2017 quality standards, calibration providers are required to address risks to ensure quality for the customer. FMEA (Failure Mode and Effects Analysis) is a tool that has been used in industry for evaluating risk in the design of products. It is also useful as a tool for evaluating risk in a calibration process or any other quality-related process. In this presentation, you will learn about the risk analysis requirements for the new 2017 version of ISO 17025. An overview of various tools that may be used for risk analysis will be covered. The FMEA tool will be explained and shown how it applies to a calibration process.