Quality manual & Procedure under the ISO 13485:2016

ISO 13485:2016 is a standard that is specifically designed to cover all requirements necessary for the manufacturing of medical devices. If you take off the production of the medical devices from your business strategy, does it mean that you are not producing any more medical devices? If that is the case, then you do not need any more ISO 13485. 

If you have outsourced the production of medical devices to another company and you are still in charge of putting the medical device on the market, then ISO 13485:2016 still implies to you. 

Can you please answer is this still applies to you, so that I can continue with my answer.   

Well, the current business strategy is to outsourced the production of the medical devices however, the company is continuing their responsibility for the design and development of the medical device. Previously the design + production is under the company activities. 

If only the design of the medical device become the company activities, the current QMS should change accordingly?

Yet, my answer is YES, that the company still in charge of putting the medical device on the market.

In this situation, your QMS will slightly change. If youa re putting device on the market o+under your own name, than you are still resposnible for the production part as well. This means that in your Quality manual you will describe that you are directly perfroming the design and devleopment, but that you outsoruced the production. You need to state in the Quality manual name of the company who make production, do they have implemented any kind of quality managmeent system, are they in complaince with ISO 13485. You also need to have quality agreement with them where you will state mutual responsibilities and where you will describe what kind of control you will have over them: will you go to the audit them periodically, what kind of documentation they need to provide to you, how soon they need to resposnse to any non-conformity and so on. 

Considering the documented procedure – if outsourced comapny has their own quality management system covering all necessary processes to prove traceability for your medical device, than you can delete all documented procedure for production from your QMS. But, if they do not have QMS; they you need to provide them with all necessary documentation to ensure traceability. 

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