Conflict of Interest Registrar/Notified Body/Testing House

#1
Hello All,
(My first question on the Forum... thanks in advance for your patience)
I work for a small'ish company in the painful throes of growing from a very successful startup to a profitable device company.
As such, there currently exists the mashup of both Quality and Regulatory functions & responsibilities.
This is mostly cultural, of course, and no fault of anyone's.
However, I'm considering a grooming opportunity towards upper management and although I have solid Quality Assurance experience, I'm rather weak with Regulatory.
I envision at some point in the company's growth, a clear(er) delineation between QA and RA, and that may end up in my lap if I'm put on the fast track.
All that to ask this:
We currently use the same company for CE marking, QMS/ISO certification and IEC compliance testing.
This makes me uncomfortable for several reasons: It feels like a conflict of interest, it feels like too many eggs in one basket, it feels like this company has an undue influence over our internal QMS overall.
The problem I'm grappling with is that everything "feels" negative... but is it actually?
Any advice, observations and words of wisdom would be most appreciated.
Thanks!
 
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normzone

Trusted Information Resource
#2
Some of the big companies offer all the services you reference, but they may be out of differing divisions or locations.

I would be comfortable with it but I'd keep an eye on the processes and see what potential for conflict may become evident.
 

yodon

Staff member
Super Moderator
#3
@normzone is spot on, they are generally independent divisions. It's *usually* the case that if, say, their test division did the IEC testing, the Technical File review for that part is pretty quick since they know what to expect and get it in an understood format; however, I've actually seen a case where the test shop messed up and the reviewer caught it (which was a major hit to the project as we had to re-do some testing). I've yet to see a case where I thought it looked shady.
 

CharlieUK

Quite Involved in Discussions
#5
It's *usually* the case that if, say, their test division did the IEC testing, the Technical File review for that part is pretty quick since they know what to expect
They often know the limitations of their own lab as well :)
Accredition bodies have an obligation to ensure that testing and certification are separate functions, and act as such.
There's no harm in looking at alternative test labs - if only to check the prices you're paying for the testing
 
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