Documenting clause 6.3

Answer:

The standard does not require organization to document clause 6.3, but if you choose to do it, the best way to do it is by documenting procedure and conducting risk assessment for the planned change.

The procedure can describe how the organization is planning the changes, how the organization considers the purpose and consequences of the changes, integrity of the QMS, availability of resources and roles and responsibilities for the actions taken to make the changes in the QMS. Additionally, you can conduct risk assessment using FMEA or some other methodology to demonstrate that the consequences of the change are examined and actions to mitigate consequences are taken.