We are looking at implementing ISO13485 in the near future, we will be using a 3rd party manufacturer to make our products (we will be the licence holder). Can anyone advise on what aspects can need to be included for implementation, i.e. most of the product realization is done at the 3rd party site, hence can this be excluded from our Quality Manual or do we reference to the 3rd party site? They are already certified and experienced, we would essentially be the virtual company with the licence....
Thanks, P

You can't exclude those things because you are still responsible. If you are directing what your supplier makes, and possibly how he makes it, you will need to show strong controls over outsourcing.

If you buying finished / near-finished product, out of a "catalogue", there is less (but not zero) onus on you, especially if the supplier is also certified.

The attached GHTF guidance may be of assistance.

Thanks Roland, I thought that this would be the case, so i guess we can make references to our supplier/3rd base controls etc...when it comes product relisation but we would still create all the relevant requirements. Thanks for the document, will have a good read of this...P

You mention being a license holder. Who is marketing the product? Are you having the product contract manufactured and then provided to you for marketing, or are you licensing a product design or some other form of intellectual property to another company that will make the product and then market it themselves?

In the latter case, you are not a manufacturer/marketer, and don't have any of the associated responsibilities.

In the former case:

If your product's realization by the contract manufacturer cannot be effectively 100% verified by you upon product receipt to meet your specifications, and/or if your product requires validated processes for which 100% verification is not an acceptable substitute, you will be responsible for control of your contract manufacturer's process validations.

You will be responsible for incorporation of product-realization-caused product hazards, and their control/mitigation, into your risk management.

If your contract manufacturer provides design services, you will be responsible for their conformance. Your product's Technical File will be your responsibility, even if you arrange for your Contract Manufacturer to construct and maintain it. You will be responsible for your product's labels/labeling.

Yes we will be the licence holder and marketing the product, we understand that the technical file is our responsibility (we will construct this) even though alot of the work is done at the 3rd party.
Thanks for the constructive comments.

Just wondering are there any sample/example 13485 manuals out to reference against what we are constructing? Any information would be helpful, regards, P

You will have to define how you ae monitoring and controlling the manufacturing of the product you are putting on the market.

You should be in control of all specification; inspection methods; acceptance criteria
you must have assured that (if needed) clean room validation and sterilization validation is appropiate
non-conformities during manufacturing should be reported/monitored for risk managment purpose
You must be able to put products on quality hold