Defining the scope of qualification is the critical starting point for any successful qualification process. It ensures that all relevant technical, operational, and regulatory requirements are clearly identified and aligned from the beginning.

By linking your specific use case to the most relevant ISO/ASTM standards, and structuring requirements such as materials, system configurations, and part complexity, a clear and targeted qualification pathway is established.
Tools such as QamX can support this step by structuring requirements and ensuring traceability across the defined scope.