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We originally started with NB "X", then concluded that their business model was too oriented toward giving us a certificate no matter what. So we asked some of our larger multinational customers who was tough, they recommended NB "Y", and we switched.
In another thread pertaining to ISO 9001 and other standards, Sidney Vianna commented regarding audit rigor:
I apologize for this quote being out of context, but it addresses an important point for me.
We seem to have topped out in our NB's rigor capability within their normal business model, and they certainly haven't yet attained a systematic grasp of what we're doing. Our last two audits clearly were snapshots, with the auditor not impressing us with having attained a particularly deep grasp of what we do and where our structural shortcomings may be. I'm not confident that they're going to get there.
We're unusually complicated...we have something over 3000 medical-device products under our name and that we make on a private label business, and at least a thousand or two products that we make as a contract manufacturer. We also have non-medical activities. We've been in business for 30+ years, so many products have legacy design and manufacturing histories. Our QMS is also US FDA and HC focused, so a number of its methods and structural approaches are esoteric.
I can't do anything about our complexity level. The NB just has to deal with it.
We've talked to our NB about additional services, but they don't seem to be able to make their business structure respond to our non-standard inquiries. How would we get an NB to "delve deeper into the effectiveness of the system being assessed"? If we were to be interested in switching NBs again, how would we objectively identify one that could deal with us effectively?
In another thread pertaining to ISO 9001 and other standards, Sidney Vianna commented regarding audit rigor:
I vehemently disagree with the position that audits are snapshots which can not be validated. That kind of mindset (shared by many people in the CB community) is one of the fundamental problems we have in the certification sector. Many insiders like to hide behind the disclaimer that audits are limited, sample-based, time-constrained exercises and the absence of written non-conformities does not mean a healthy management system, blah blah blah. Anyone trying to defend that positions leaves the door open for people to question the value of such audits, if no sensible conclusion can be reached, after reading an audit report.
CB audit results are supposed to be representative of the management system efficacy. If aerospace suppliers with chronic quality escape problems undergo AS9100 audits and are consistently given high scores, and no nonconformities reported, we have an OBVIOUS mismatch between audit results and reality.
Furthermore, CBs (if they are doing their job in a proper manner) should not have disconnected "snapshot in time" audits, but a program of continuous and consistent audits, where, each time, we learn more and more about the registered organization, and have a chance to delve deeper in the effectiveness of the system being assessed.
I apologize for this quote being out of context, but it addresses an important point for me.
We seem to have topped out in our NB's rigor capability within their normal business model, and they certainly haven't yet attained a systematic grasp of what we're doing. Our last two audits clearly were snapshots, with the auditor not impressing us with having attained a particularly deep grasp of what we do and where our structural shortcomings may be. I'm not confident that they're going to get there.
We're unusually complicated...we have something over 3000 medical-device products under our name and that we make on a private label business, and at least a thousand or two products that we make as a contract manufacturer. We also have non-medical activities. We've been in business for 30+ years, so many products have legacy design and manufacturing histories. Our QMS is also US FDA and HC focused, so a number of its methods and structural approaches are esoteric.
I can't do anything about our complexity level. The NB just has to deal with it.
We've talked to our NB about additional services, but they don't seem to be able to make their business structure respond to our non-standard inquiries. How would we get an NB to "delve deeper into the effectiveness of the system being assessed"? If we were to be interested in switching NBs again, how would we objectively identify one that could deal with us effectively?