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Our company is a component manufacturer, supplying components to the Medical industry. We recently went through our ISO13485 and ISO9001 certification audits and one of the minor findings noted was that our Risk Management Process was not comprehensive enough (did not cover all processes within 7.0)
In the developement of our Quality Systems, we chose to establish seperate processes for our Inquiry, Quote and Order Management Processes.
While establishing potential risks in other process seems pretty straight forward, we are struggling with what Risks might come out of the Inquiry and or Quote processes. We have had a number of meetings, but always end up back where we started as there does not seem to be any risks that link back to the definition of "harm" as defined by the standard.
Any insight or examples out there that might help guide us thru this process?
In the developement of our Quality Systems, we chose to establish seperate processes for our Inquiry, Quote and Order Management Processes.
While establishing potential risks in other process seems pretty straight forward, we are struggling with what Risks might come out of the Inquiry and or Quote processes. We have had a number of meetings, but always end up back where we started as there does not seem to be any risks that link back to the definition of "harm" as defined by the standard.
Any insight or examples out there that might help guide us thru this process?
