4 ms·
> What if ISO 9001 certification also created individual criminal liability for conformance? I worked at an ISO-13485 certified company, and actually had "crim
by ok_dad 4y ago
> What if ISO 9001 certification also created individual criminal liability for conformance?
I worked at an ISO-13485 certified company, and actually had "criminal liability for conformance" for some work I did there, due to the FDA's regulations. I can say, for certain, that it does not matter if you raise issues for legal obligations with even one of the largest medical device manufacturers in the USA. I had some HR issues there with my boss which edged into the region of not doing our jobs properly for important quality inspections. He did eventually get fired, but not for risking the lives of patients but he was instead fired for missing some milestone obligations on an important project. I was turned into a pariah with management for trying to fix this particular issue, and later I quit my management position there in order to live a life of simplicity as a solo-contributor of software for my remaining days.
I say that you absolutely cannot push the liability down to the worker level, it has to be on management and on the executives of a company. It would be much easier for workers to raise safety and HR issues at a company if they knew that their medical coverage and salary were safe, such as with universal healthcare or UBI...