Design controls

For example, if we have an excising product (tubing), but want to make it in a different size, does it need to go through the design controls, or would the excising one cover it? If i want our design controls to cover different sizes, can the design drawings be made without measurements to accommodate all? any advice would be greatly appreciated.

Answer:

From the information provided, that you will make changes to the size of the product, I would say that you can´t exclude the clause 8.3 - Design and development of products and services, therefore you need to apply controls to th e process. The reason is that your organization have to conduct reviews of the product (tubing) , and other verification and validation activities.

Regarding your second question and if I understood correctly, I think you can make controls to cover different sizes as long as you comply with the requirements of the standard. But then you will need to make some kind of design process in order to "accommodate" the product to customer needs. Also, remember you must keep records of the controls applied.

For more information about design process you can see the following materials:
- 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/
- Article - ISO 9001 design process explained: https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
- Book – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free on-line training – ISO 9001:2015 Foundations: https://advisera.com/training/iso-9001-foundations-course/