To perform GAP analysis and verify if your process for managing changes to the design during or after the initial design phase is adequate, you should:

1. Examine Change Control Procedures

Review your documented procedures for design and development changes to confirm that they define a structured process for managing modifications during and after the initial design phase. Verify that the process includes steps to identify, review, and authorize changes, ensuring each step is consistently applied to maintain control over changes and their potential impacts.

2. Assess Impact Evaluation and Approval of Changes

Check that each change undergoes an evaluation process to assess its potential impact on conformity to requirements. Look for evidence that changes are reviewed not only for feasibility but also for their impact on the product or service’s specifications, safety, and intended use. Confirm that there is a clear procedure for authorizing changes only when they meet the necessary requirements and do not negatively affect the design’s intended outcomes.

3. Verify Documented Information

Ensure that records of all design changes are retained, including details of the review process, approvals, and actions taken to prevent adverse impacts. This documentation should show that each change has been properly managed and controlled, with documented evidence of decision-making and any mitigation actions taken where risks were identified.

By following these steps, you can verify that your process for managing design changes is both systematic and controlled, helping to ensure compliance with ISO 9001 requirements.