I would like to ask you about ISO 13485 certification. Is it possible to certify a company that will outsource the production of devices? I am referring to the following business model as follows.
Company A implements and certifies the ISO 13485 system and outsources all production and quality control to its subcontractor company B, which has ISO 9001. Can the company A certify itself in such a case, or if it does not have production (manufacturing) processes will the certification company not be able to carry out ISO 13485 certification audits?
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: