Can ISO 13485 Compliant QMS be completely outsourced?

Mangafanga

Starting to get Involved
I am a single person company, I designed a Medical device and plan to outsource the entire development including tests and regulatory submissions. My question is can I outsource the Quality management system as well? I dont see any sense in maintaining a QMS for a single person company. Any thoughts?
 

shimonv

Trusted Information Resource
No, you canont. As the legal entity you must be able to demonstrate how you control the QMS activities, whether you do it yourself or if it's done by third parties. As the legal entity you are responsible for the product and so you have to show how you ensure compliance with the applicable standards and regulations.


P.S. Based on my experience it is never a one man job, even with multiple sub-contractors. There is just way too many things to be done.

-Shimon
 

Mangafanga

Starting to get Involved
No, you canont. As the legal entity you must be able to demonstrate how you control the QMS activities, whether you do it yourself or if it's done by third parties. As the legal entity you are responsible for the product and so you have to show how you ensure compliance with the applicable standards and regulations.


P.S. Based on my experience it is never a one man job, even with multiple sub-contractors. There is just way too many things to be done.

-Shimon
Can I show that I ensure compliance using a contractual agreement with the outsourcing partner?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
FYI Complaints are ALWAYS part of the FDA QSIT inspection. Having that outsourced seems overly risky and I think the FDA would not approve of that. From a product management perspective though, wouldn't you want all customer feedback reported to you?

This assumes you are the manufacturer of record.

Another idea is just sell the IP to another company and be done with it.
 

shimonv

Trusted Information Resource
Can I show that I ensure compliance using a contractual agreement with the outsourcing partner?
No. Because you are the design and product owner. Besides, most subcontractor wouldn’t want to be liable for a product not their own.
 

zkinney

Starting to get Involved
I am a single person company, I designed a Medical device and plan to outsource the entire development including tests and regulatory submissions. My question is can I outsource the Quality management system as well? I dont see any sense in maintaining a QMS for a single person company. Any thoughts?
I work for a small sized company based in the US that does exactly this for people in a similar situation as you. We act as a contract manufacturer exclusively for some clients. For other clients, we are their contract manufacturer and QMS system. For the companies that we are their QMS system, you would assist in design and development and then we take care of your tech file, QMS, keeping you up-to-date on standards, etc. They are then only responsible for the "business side". There are some situations such as complaints where you will be brought in the loop and we will need you to frequently sign off on documents. We have auditors visit multiple times a year for our varios clients who sell into EU, US, UK, Canada, Brazil, Australia and formerly Taiwan. The auditors would come to us, not to your house. It can and is done.
 
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