Julia123xyz
Registered
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!
(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!