Scope of ISO 13485 certification as legal manufacturer

#1
Hello all,

We are a medical device company are are gearing up for the registration of a combination product.

We are the legal manufacturers but since we are a start-up our manufacturing is looked after by our contract manufacturing organization who are ISO 13485 certified.

I am currently filling out the application for ISO certification for our company and want to understand how I can describe the scope of certification in this case?

Thank you.
 
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shimonv

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#2
hi @Anushna,
You scope should also include manufacturing because you have the ultimate responsibility and means of controlling the manufacturing which is done by one of your suppliers (contact manufacturer).

Shimon
 
#4
Thank you for your answers. Is there a guidance document or template you can guide me to where I can see how to prepare a scope of ISO 13485 certification?
Thank you.
 

DannyK

Trusted Information Resource
#5
Usually the scope for ISO 13485:2016 starts with " Design, manufacturing and servicing of (your medical device)" If installation is applicable, add it to the scope.
You want to be general in your scope to cover the products that you will distribute.
 
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