To perform a GAP analysis and verify whether design inputs have been determined—including functional and performance requirements, customer requirements, statutory and regulatory requirements, and information from similar design and development activities—you should:

Review Design Input Documentation

Begin by examining the documentation related to design inputs for your products and services. Look for a comprehensive list that explicitly outlines the functional and performance requirements, as well as customer specifications and any applicable statutory or regulatory requirements. This documentation should provide clarity on what is required for each product or service being developed.

Check for Evidence of Previous Design Insights

Ensure there is documented information that references learnings or insights from previous design and development activities. This might include lessons learned, design reviews, or evaluations that inform the current project. Verify that the information is relevant and has been integrated into the design input requirements.

Confirm Resolution of Conflicting Inputs

Look for records that demonstrate how any conflicting design inputs have been identified and resolved. This could involve meeting minutes, issue logs, or decision records that show how conflicts were discussed and addressed, ensuring that the design inputs are adequate, complete, and unambiguous.

By systematically reviewing these elements, you can determine whether your organization is compliant with the requirement to establish and maintain clear and comprehensive design inputs as outlined in the ISO 9001 standard.