To perform a GAP analysis and verify whether your organization has a design process that includes planning—accounting for requirements, responsibilities and authorities, resources needed, and verification and validation activities—you should:

Examine Design Process Documentation

Start by reviewing your design process documentation. Look for a formal procedure or plan that outlines the design and development process. This document should clearly define the planning stages, including how requirements are identified, the roles and responsibilities assigned to team members, and the resources allocated for the design activities.

Check for Verification and Validation Activities

Confirm that the documentation specifies the verification and validation activities involved in the design process. You should find details on how these activities are planned and executed to ensure that the outputs of the design process meet the defined input requirements. Look for records of past verification and validation activities that demonstrate compliance with these requirements.

Assess Resource Allocation and Responsibility Assignment

Review how resources, both internal and external, are identified and allocated for design activities. Verify that the responsibilities and authorities of personnel involved in the design process are clearly stated in the planning documents. This should include who is accountable for different stages of the design and development process, ensuring clarity in oversight and execution.

By checking these elements, you can determine whether your organization has a compliant design process that incorporates planning in line with the requirements of the ISO 9001 standard.