ISO 13485 Clause 1.2 Application Clarification

"The processes required by this international standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organizations quality management system......" -ISO 13485

is this applicable downstream and upstream or just downstream, ie, if you have a subcontractor who sterilizes then you are responsible, but if your customer sterilizes the finished product, ie, product is out of your hands, then you are responsible or not.

Which is it? Seems common sense to me, but sometimes the standard can throw me for a loop.

Thanks.

Re: 1.2 Application Clarification

It means that responsibility is not abdicated or avoided by outsourcing processes. If a critical process is sourced by a supplier, then supplier control and management needs to be implemented to ensure the product meets requirements.