ISO 13485 Certification in company without manufacturing processes

Yes, it is possible to certify a company with outsourced production of devices. Actually, it is rather common these days. Company A first has to have a proper quality agreement with company B. In this agreement will be stated all mutual responsibility.   

The most important thing is that Company B undertakes to carry out production as Company A tells it and in accordance with the necessary regulations. If Company B does not have any of the documents according to ISO 13485, either Company A or Company B must prepare them.  Next, it is important to define who is responsible for what - for ordering bulk materials, for control points, releasing the product, and the like.   

The next important item is that Company B agrees to the audits that will be conducted for Company A on the premises of Company B. These are both announced audits and unannounced audits.

All these elements, as well as some others, are included in the Quality agreement and are in our toolkit: 

https://advisera.com/13485academy/documentation/quality-agreement-for-subcontractor/