ISO13485 scope as Legal Manufacturer

C

ClaireNO

Registered
#1
#1
HI All, I need your advice.. I am the QA Manager in a start up company that distribute a medical device Class I.
We also did the design and development for this product and today the manufacturing and Legal Manufacturer parts are subcontracted to the manufacturing site.

We are located in switzerland and currently markteing in EU, APAC, in future possibly US
I am currently preparing our QMS to get ISO13485 certified and I am trying to draft the scope.
We would like to take over the LM responsibility to be free to have additional manufacturing sites but one consultant informed me that if I want to add manufacturing in the scope of my certificaiton I need to be ready to show a lot of documents from our manufacturing , that currently is not really cooperative...(hence the need to have additonnal sites)

My question is : do I need to have "manufacturing" in the scope of my certification if I am the LM? or it is possible to be LM wihtout "manufactuuring" in the scope

Thanks a lot for your replies
 
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D

DutchMarten

Starting to get Involved
#2
#2
Hi Claire,

I'm a QA manager at a manufacturer of class I medical devices in EU.

I would say that it is imperative to have manufacturing in your scope if you are going to operate as the legal manufacturer. A legal manufacturer in ISO 13485 doesn't stop with just the name, but actually means you have to have a good grip on the manufacturing itself.
 
D

DannyK

Trusted Information Resource
#3
#3
Manufacturing should be in your scope even if you outsource the manufacturing activities.
As the legal manufacturer, you are responsible for the manufacturing of the device.

Danny
 
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