ISO 9001 scope and clause exclusions

We do not have a formal procedure written for design work BUT we have a gateway for products we produce
this, to us, means that we regard our Operations as the customer of design. Our Operations ensures that the design is correct to achieve the end product through operations....
Can we then state that the scope of our ISO 9001 certification application is our Operations only?
We have procedures which control the drawings and Bills of Material that are used to make our products
Scope of the Quality Management System.... I need to know what to include in the scope and how to write what we exclude

Answer:

If your company does not conduct design and development of products, you can exclude clause 8.3 of ISO 9001:2015. Reviewing your customer design prior to production is part of clause 8.2.3 Review of requirements related to products and services so they are not di smissed once the clause 8.3 Design and development of product and services is excluded.

In the document about scope of QMS or in Quality Manual, you can write that clause 8.3 is not applicable to your business because you do not conduct design and development and this will be enough.

For more information, see:
- How to define the scope of the QMS according to ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- 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/