Is a vendor of Class ll (Orthodontic Adhesive) required to be ISO certified

We are in the process of securing an OBL from a vendor of adhesive (we use for Orthodontia) I don't believe this company is ISO certified and kind of sketchy on their Quality System. We have purchased from this company for a number of years without incident and their product meets our specifications.
Is this Vendor required to be ISO certified to link with our Own Brand Label?

Re: Does vendor of class ll (orthodontic adhesive) required to be ISO certified

There is no ISO/FDA requirement that a vendor must be ISO certified... but what requirements does your supplier management system have for a supplier of this kind? Do you require ISO certification for vendor approval? How risky/critical is the product? I've been in this situation before, and we have done an on-site audit of the non-certified supplier to our requirements (ISO 13485 and 21CFR820) to make sure we were comfortable with their systems. If they pass, then we proceed and have documented evidence that we found their system to be adequate to our needs.

Re: Does vendor of class ll (orthodontic adhesive) required to be ISO certified

A good QA & RA agreement covering applicable clauses in ISO 13485 should be good enough, mostly change control, CAPA, complaint handling, lot traceability, audit etc.