Quick question on the sequence of ISO 17025 external audits

[Jen Kirley]

I am a little concerned - who is your organization's Management Representative?

 

[Quality Specialist]

Hi Jen,
First, this is a very small company - 10 employees.
My boss is the company president. After the last Quality Manager (and wife) did not renew their contract, they looked for a short while to replace them but didn't find anyone to their liking I guess. I then told my boss that someone needs to be appointed the Management Representative which is usually the Quality Manager. Not wanting to volunteer myself, at my pay grade, he said that he would nominate himself. So he is the Management Representative.
I was lead to believe that I would become the Quality Manager since I am doing everything that a QM would do - managing the entire QMS and championing the MRM's. Hosting the external audits is done together with my boss and myself.
Actually, I think that they believe that as long as I'm already doing the QM job they don't see a need to have a QM which saves them a lot of money - it's not fair to me and I've made some comments to this fact to the owner of the company - no feedback yet about it.....

 

[John C. Abnet]

Hi Jen,
I then told my boss that someone needs to be appointed the Management Representative which ....

Good day @Quality Specialist
Simple reminder, that while I agree it is often helpful to have an assigned centralized coordinator of activities, there is NO requirement for a "management rep".

As you're likely aware, the only reference that compares is ...
5.2 The laboratory shall identify management that has overall responsibility for the laboratory.

Hope this helps.

Be well.

 

[Quality Specialist]

Good day @Quality Specialist
Simple reminder, that while I agree it is often helpful to have an assigned centralized coordinator of activities, there is NO requirement for a "management rep".

As you're likely aware, the only reference that compares is ...
5.2 The laboratory shall identify management that has overall responsibility for the laboratory.

Hope this helps.

Be well.

I thought about that after I posted it. I believe I recall that the AS9100D standard removed it as a requirement. However, we are certified to ISO 13485 as well which says:

 

[John C. Abnet]

I thought about that after I posted it. I recall that the AS9100D standard removed it as a requirement.

Yes, the only "place" that I know of that term still existing (in the ISO family) is within ISO 13485, where it is still a stated requirement.

Be well.