We once had an ISO 9001 and 13485 system together but our NB auditor said no, we had to separate them. Make sure your NBs are ok with this.
Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025
- Thread starter SGquality
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We once had an ISO 9001 and 13485 system together but our NB auditor said no, we had to separate them. Make sure your NBs are ok with this.
Curiosity: On what basis?
Auditorsaurus Rex still roam the wild wild world of swampy systems making victims along the way. Any organization that has 9001 system, 13485 system, 14001 system, etc. has not understood what a business management system is and how to standard-proof its operations. Sad state of affairs.
Huh? Not sure what that means. Care to elaborate?
Tagin
Trusted Information Resource
My first question is: what is happening with the scope statements for each of the certs?
Any organization has a (business) management system (let's call it a BMS). A quality management system (QMS) is a subset of the BMS. Any QMS that adds value to the BMS should be able to incorporate and comply with different quality management system standards, such as 9001, 13485, AS9100, 16949, etc....
So, there should be NO ISO 9001 system, but, and instead, a QMS. If an organization does not understand the hierarchy of requirements, we end up like in the old days of asinine quality that they had multiple quality manuals, each one for a different customer/program/project, etc...insanity on steroids.
Tagin
Trusted Information Resource
Is the top-down design and operation of a general QMS (i.e., agnostic to any particular standard) taught anywhere? Or is this found only in the lore of the grizzled veterans of quality who have in the past battled and slain the hydra of multiple standards?
Or have we all (or most) learned from the bottom-up, typically by mgmt saying 'here is a standard we need to comply with, so it says we need something called a "QMS" - go build it'? Then, when another standard becomes an additional requirement, the extant QMS may be so tailored to the first standard and ill-fitting for the new standard that - for a moment - it seems almost more practical to make a second system side-by-side. And thus the struggle to generalize the QMS begins anew for each org; some with duct tape and staples to just barely make the second standard fit, others with more grandiose hopes of a QMS paradise where all standards are equal and welcome; all of us striving to reinvent the wheel of a general QMS a thousand times over.
Johnnymo62
Haste Makes Waste
I always thought QMS=BMS.
Kind of along the lines that if a company is doing more or other than specified in the QMS it's waste or it need to be in the QMS.
Kind of along the lines that if a company is doing more or other than specified in the QMS it's waste or it need to be in the QMS.
Agreed. I always said the QMS should serve the company; it should add value. Our 13485 auditor didnt care some documents (Like change control) were the same for 9001 and 13485 but our 9001 auditor had a fit. The process we had met both standards so I thought it would be ok to have a single process to train on; less risk right?
We have two QMS systems because our business had multiple products and various customer requirements for each.
We have two QMS systems because our business had multiple products and various customer requirements for each.
Where, in your QMS, do you deal with cash flow? Or waste management?
The BMS is enterprise-wide and goes way beyond the issues related to customer satisfaction and product conformity, since, there is so much more to run a business than to keep customers happy.
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