GAP analysis and exclusions from QMS

Answer:

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.

Here you can find a free ISO 9001 GAP analysi s tool: https://advisera.com/9001academy/iso-9001-gap-analysis-tool/

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.

To learn more about the exclusion of design and development from the scope, you can see this article - What clauses can be excluded in ISO 9001:2015: https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/

To learn more GAP analysis and exclusions from the scope you can see this materials:
- Book - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free on-line course - ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/