Is it required to mention another non certified organization in our Quality Manual ?

cubix rube

Involved In Discussions
#1
Our company has two facilities. Our headquarters, in California is certified to ISO 9001:2008, and ISO 13485:2003. Our automotive division in Kentucky is not certified.
Our Org Chart was recently updated, to show all of the "dotted line" reporting structures from the Kentucky plant to our headquarters, since we perform many of the administrative functions for that plant here.
My question is this: If I put this updated org chart in our quality manual, do I have to indicate on it that the organization in Ky. isn't certified? Also, if I just assign it a document number, like any of the other forms or logs in our system, and control it, what's the best way to integrate it into our manual (because I THINK it has to be included in the manual. If that's not right, please set me straight)? Do I have to call it an appendix? If I just paste it to a page in the manual, do I have to show the form number and rev level in the manual?
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Org chart in Quality Manual

Good day cubix rube,

There is no requirement to have an organization chart in your quality manual, as an appendix or other form. Nor does it need to be a controlled document simply for the sake of ISO registration. But if you did and it dotted-line linked to offsite assist groups that are not certified, that is okay EXCEPT that processes included in your scope need to be a part of the QMS. In other words, you can't say "The design, manufacture and distribution of widgets" and leave the design or distribution group out.

Please notice there are some links to related threads at the bottom of this page.
 

cubix rube

Involved In Discussions
#4
Re: Org chart in Quality Manual

Cubix Rube,

Are you refering to the Quality Manual for California or Kentucky ?
I'm referring to the Quality Manual for California, where we are certified. Can I include an org chart that shows lines of reporting to our certified plant, from our non-certified plant?
 
M

MichelleN

#6
Re: Org chart in Quality Manual

Or maybe create only your own org chart, and show somewhere how many facilities you have and where they are and where the headquarter is located and that the manual is applicable only for...
 
M

MichelleN

#7
Re: Is it required to mention another non certified organization in our Quality Manua

But you don't need to create a form for the org chart! In my opinion it's good to have the org chart in the manual because it shows the responsibility...
 

Big Jim

Super Moderator
#8
Re: Is it required to mention another non certified organization in our Quality Manua

Although I believe it is not required, it never hurts to provide an explanation when you believe some clarity would be beneficial.

I would be inclined to have a note on the page with the scope statement to the effect of "ABC Company also has a facility in Kentucky that is outside the scope of this registration".

I usually include an address with the scope statement for the facility that is certified (or will be certified if you are just getting started).
 

Helmut Jilling

Auditor / Consultant
#9
Re: Is it required to mention another non certified organization in our Quality Manua

Although I believe it is not required, it never hurts to provide an explanation when you believe some clarity would be beneficial.

I would be inclined to have a note on the page with the scope statement to the effect of "ABC Company also has a facility in Kentucky that is outside the scope of this registration".

I usually include an address with the scope statement for the facility that is certified (or will be certified if you are just getting started).

I agree. If there are relationships, it is better to make it clear what is in or what is out. If that uncertified site has any involvement in your operations, it will be likely that it would be included as a remote support location.

PS: If KY site is automotive, I am surprised it is not already certified. Is it a new site, or did someone drop the ball somewhere?
 

somashekar

Staff member
Super Moderator
#10
Re: Org chart in Quality Manual

I'm referring to the Quality Manual for California, where we are certified. Can I include an org chart that shows lines of reporting to our certified plant, from our non-certified plant?
Go ahead, Include it.
No compulsion though.
It is your QMS and you know best how your responsibilities and authorities are linked. If including the org chart showing the line of reporting makes the A & R communication easy for you all and that is how you are operating, it is worth being there. Include a clear note as suggested.
 
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