Today in this morning we have a meeting with the QMS team of which Im the leader, our main discussion today is to come up with justification on the DESIGN and Development (Clause 8.3 ISO 9001:2015) if it should be included or excluded from our QMS Scope. Since we have a list of mandatory documents already prepared waiting for approval and then to start the THIRD PHASE(Implementation phase) but our Director said that we need to conduct a second round of Gap analysis!(some thing that I have never heard before!) what I know is only Gap analysis that we have already conducted before, now is the time for Internal Audit for what I know.
Usually GAP analysis is conducted at the beginning of the implementation in order to know which requirements are already covered by the organization and which ones the organization still needs to comply with. That being said, you don´t need to assess another GAP analysis but you will see how your organization is doing after performing the Internal Audit.
Regarding the exclusion of design and development from your scope, if your organization does not do any design work, but strictly work from designs given to you by a customer, then these requirements can rightly be determined to be not applicable to your organization.