Must a Design Outsourcing Company have ISO13485?

B

bennylee

#1
Dear All,

Our company would like to send part of design to outsourcing company, may I know if such company must have ISO13485? or "approved by our company" is enough ?

"What we planed to do" is
  1. We provided our requirement in details (for hardware, software, mechanical only)
  2. such outsourcing company designed based on our requirement
  3. such outsourcing company provided samples & test report (using qualified equipment)
  4. We checked & approved & signed their document by our company

For other part of technical file (FMEA, usability, clinical evaluation & 60601-1 certification application), surely, it will be done by our company.
 
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somashekar

Staff member
Super Moderator
#2
Dear All,

Our company would like to send part of design to outsourcing company, may I know if such company must have ISO13485? or "approved by our company" is enough ?

"What we planed to do" is
  1. We provided our requirement in details (for hardware, software, mechanical only)
  2. such outsourcing company designed based on our requirement
  3. such outsourcing company provided samples & test report (using qualified equipment)
  4. We checked & approved & signed their document by our company

For other part of technical file (FMEA, usability, clinical evaluation & 60601-1 certification application), surely, it will be done by our company.
No force for the 13485.
The design and development responsibility rests with you.
It comes down to your controls on this outsourced process.
Are they having a good quality system in place ?
Do they have a good track record acceptable to you ?
.... and are you 13485 ? which makes you understand the medical device and its regulatory requirements better ...
 
B

bennylee

#3
Thanks for your feedback! I agree to your point.

I would like to provide more information, it will be easily feedback to your question.
Actually, we have office (ISO13485 Design) & factory (ISO13485 Manufacturing), they are different location, & our ISO certification including both of them.
Now, we would like to change to office (like Outsourcing Design) & factory (ISO13485 Design & Manufacturing), task is to make "Office will be no need ISO13485"

Now, I am easily to ask your question
1) Office (like Outsourcing Design) already have a good quality system in place, & have a good track record acceptable
2) Our factory is good in ISO13485

Hence, "the main things I need to do" may be
1) Inform notified body & Change in registration name of ISO13485 certification
2) Job re-location (Existing: whole design in office, Now: partial design in office)
3) Add more documentation/check point between work flow from office to factoy
 

somashekar

Staff member
Super Moderator
#4
Hence, "the main things I need to do" may be
1) Inform notified body & Change in registration name of ISO13485 certification
2) Job re-location (Existing: whole design in office, Now: partial design in office)
3) Add more documentation/check point between work flow from office to factoy
You will inform the CB (not NB) ... NB is the body that give the CE to you.
(Perhaps if you have a CE, you will take up the same with the NB as well)
This is a significant change to the certification and needs the assessment of the CB with a special audit perhaps ... OR
The change of scope can be addressed during your surveillance audit if you can time the change properly and discuss with your CB.
Your office will no more be listed in your certificate as a site.
Make a detailed plan of action which your CB will appreciate during the audit.
Understand the requirement of 5.4.2 b) of the ISO 13485.
NOTE: It is not partial design in office. The full blown QMS (design develop manufacture) is now at the factory. What process of design is outsourced is well defined and documented within your QMS
 
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