The company I work for is certified under ISO 13485 and for our product we have some specialty pieces and other items such as electronic components are just off the shelf items. For our specialty pieces we have detailed product drawings and specs. But for the off the shelf items we do not keep detailed product drawings as we are currently operating under the assumption that since it is an off the shelf part that we will accept the manufacturers description of that part. My question then is can we operate under that assumption that since it is an off the shelf item(s) we will adopt the suppliers detailed specs for that item(s) as our detailed specs or do we need to defined the specs for those off the shelf item(s) such as electronic pieces on our own?
Thanks
Hi,
It all depends on the criticality of the component. A risk analysis could help determine what characteristics (if any) of any component are important and how a deviation in them would affect these components' function and the device in whole.
I'd say that for a component deemed critical you must at least have the supplier's formal specification in YOUR files, as detailed as you can get it. For any characteristic deemed critical you must either have the supplier's specification for it, or, if not available, document in your system (be it in a drawing or in any other clear way) what are the acceptable limits to ensure proper function. Once you have all the above documented, this should be the basis for the contractual engagement with the supplier. For any component deemed critical for the device, you also better include a clause stating that the supplier must notify you in writing and in advance of any significant change in the above critical characteristics.
For all components deemed non-critical I would just try to get the supplier's standard specification (it's always good to have it on file, no matter the level of detail), and include a requirement to notify of significant changes within a reasonable time frame.
Cheers,
Ronen.