Design alterations

Answer:

Yes! If your company alters the original design, it must include clause 8.3

The following material will provide you information about design and development:

- ISO 9001 – Specific use of ISO 9001 design and development in the machining process - https://advisera.com/9001academy/blog/2017/03/14/specific-use-of-iso-9001-design-and-development-in-the-machining-process/
- Procedure for Design and Development [ISO 9001:2015] - https://advisera.com/9001academy/documentation/procedure-design-development/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

New question:
"Thanks for this information – You’ve answered my Question.

I’ve asked this question as Company 1 is the Head Office and they do the design – Thus Holding the ISO Certificate for Design & Development– Company B is the Sister company which only does repairs and they claim they are not doing design but my argument was that they are redesigning the Original Design down to something else therefore their ISO Certificate should include design even if they use the design engineers at company A but documented Information must be in place.

Do you agree?"

My answer:
If Company B only does repairs, repairs are not considered design. Perhaps one should clarify the meaning of “repairs”, presently I’m working with a company that sell new machines, buy used machines from customers, if both parts agree, and then they repair them and sometimes do changes because, for example, new safety requirements, better components, to sell them as second-hand machines. In tha t case design is a must!

Another important point is: who is ordering the design changes? If they do the design changes but the order with the indications come from Company 1, design is not an issue for Company B.