The company I work for is in the final stages of implementing ISO 9001. On a recent visit to a potential customer (a medical device company) they provided some insight to what would be involved in adding the 13485 certification. Their understanding was that we would really only be responsible for traceability due to the nature of our services. This traceability would encompass sending material certs, batch tracking, etc. We would simply be producing parts from a drawing another company provides. These parts are sent to another company for completion (welding, sterilization, etc.) so it seems like a large portion of 13485 would not apply to us, although I do not have a copy of the standard to verify this with. So...is all of this true? Thanks in advance for the help!