Dear ISO 13485 Team
I claim scope Develoment & manufacturing of xxx devices, (exclude 7.3),
Auditor said can not claim Development,
If someone have explanation, I will appriciate.
Design, Development what is the differance!
Thanks,
DR D DO

Dear ISO 13485 Team
I claim scope Develoment & manufacturing of xxx devices, (exclude 7.3),
Auditor said can not claim Development,
If someone have explanation, I will appriciate.
Design, Development what is the differance!
Thanks,
DR D DO

If I understand you question correctly; if you exclude clause 7.3 "Design and Development of Product", you can not state, or use the word "development" in the scope of registration. The use of that word implies that you develop product. Again, I hope I understood your question correctly.

Stijloor.

People call different things different things!

To my mind, you could define it this way:

1) DEVELOPMENT is making changes to an existing device or (manufacturing) process
2) DESIGN is the process for creation of a new device or process
3) RESEARCH is "unfocussed" efforts that (hopefully) lead to a focussed DESIGN project.

(Thus a company might have ten research projects of which eight are abandoned/combined at various points. Of the resulting two formal design projects, only one successfully results in a finished device. The finished device undergoes several modifications and range extensions over the next few years via a series of development projects).


Of course in the real world things are rarely that clear-cut, but the important thing is to have processes in place that let you identify what you have, and when to say stop/go.

Dear ISO 13485 Team
I claim scope Develoment & manufacturing of xxx devices, (exclude 7.3),
Auditor said can not claim DevelopmentISO 9001 section 7.3 deals with Design and Development of product. They go hand in hand. If your organization is design responsible and you "claim exclusion" to section 7.3, your organization can not be certified to ISO 9001.

I think you could have design/development activities within your facility and allowably exclude them under ISO13485 if design was not required for regulatory purposes (i.e. usually because you are making a low risk device), whilst applying to have those same design activities covered under ISO9001 certification.

Why you might want to do this I have no idea.