To perform GAP analysis and verify whether your organization’s design and development outputs are documented, retained, and sufficient to ensure they meet the input requirements, you should:

1. Review Documentation of Outputs

Start by reviewing the documented information related to design and development outputs. This documentation should clearly specify how each output meets the initial input requirements. Ensure that these outputs include details on product or service characteristics, monitoring or measuring requirements, and acceptance criteria, as stated in clause 8.3.5 of ISO 9001.

2. Evaluate Sufficiency and Traceability

Check that the design outputs are not only retained but are also sufficient to guide subsequent processes, such as production or service provision. Each output should demonstrate a clear connection to its corresponding input requirement, with traceability showing how the input was addressed. This ensures that all necessary elements of the final product or service were considered during the design phase.

3. Confirm Retention of Relevant Documentation

Ensure that documented information for design outputs is retained as required. This documentation should include records showing reviews, acceptance criteria, and any related control measures applied to the outputs. Verify that these records are stored and accessible for future reference, audits, or any required follow-up actions.

By following these steps, you can confirm that design and development outputs are adequately documented, retained, and effective in meeting the input requirements, thereby ensuring compliance with ISO 9001 requirements.