Since the Process Owner should be knowledgeable about the issue at hand, it seems to me that someone from the quality function would be much better positioned to lead and manage such critical process. In my experience, a typical buyer or someone representing the procurement function are, mostly ignorant about supplier performance issues and limit themselves to manage pricing, commercial agreements and delivery commitments. As an auditor, I have seen numerous cases of botched relationships with suppliers because the buyer assigned to them created all kinds of bottlenecks in the communication between the two organizations.Who is typically the process owner for Supplier Controls under ISO-13485 (ie: approval, supplier agreements, re-evaluation, etc.)?
I don't think you can necessarily define "typical" given the variety in organization sizes, management approaches, etc. The bottom line is who has the competence to do the work and if is it being effective. What may be considered "typical" may not work for your organization.
looking for opinions on how others operate, to help with our decisions.
Collaboration (also know as teamwork) is key. A Quality function typically partners with an Operations function (Purchasing, Supply Chain, Sourcing-- so many names......but I digress). for example, he Operations function would own the procedure for issuing purchase orders against specifications. Ops would lead on selection. Quality can veto suppliers not meeting expectations -- this is so important. Quality would also own procedures related to Quality Agreements., Supplier CAPA, supplier audit, etc. Ops and Quality have a voice in each others work. The mindset has to be this is "our system" and not one of yours or mine. There is a lot more detail here but hope this approach helps. Have fun, enjoy the ride!
Who is typically the process owner for Supplier Controls under ISO-13485 (ie: approval, supplier agreements, re-evaluation, etc.)? Purchasing or Quality?