How to document "Exclusions" in the Quality Manual

S

SpaceCase

#1
We have excluded Section 7.3 ? Design and Development, what do I do with that section of our quality manual (we have downloaded the quickstart total package from the AS9100store.com)?
We have excluded it with this statement in the Application section (1.2):
? Justification of exclusion: products are built to Customer specifications and drawings.
As we only build-to-print and do not have any Design or Engineering Depts.

Do I just delete the section and just write in that we have excluded it and only build-to-print?

Thanks!
 
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S

SpaceCase

#3
Re: Exclusions question.

That's what I figured, but didn't want to File 13 the whole section if that wasn't the correct way to go.
Thank you!
 
#4
Re: Exclusions question.

In our Quality Manual, we just put:

7.3 Design and Development
EXCLUDED – (See section 1.2)
You are missing the justifications - which is a requirement! You can't simply say "excluded" because - in particular with design - some folks try to exclude it because Engineering "didn't want to be part of ISO" (as they say). Or to save money on certification!

You should have a justification: "We are a make to print shop and our customers own the designs" for example.
 
S

SpaceCase

#5
Re: Exclusions question.

Yes, this is what I have there:

▪ Section 7.3 – Design and Development
• Justification of exclusion: products are built to Customer specifications and drawings.
 

the47guy

Starting to get Involved
#6
Re: Exclusions question.

You are missing the justifications - which is a requirement! You can't simply say "excluded" because - in particular with design - some folks try to exclude it because Engineering "didn't want to be part of ISO" (as they say). Or to save money on certification!

You should have a justification: "We are a make to print shop and our customers own the designs" for example.
The justification is in 1.2 (Justifications) of the Quality Manual. That's why we put see 1.2.
 
S

SpaceCase

#7
Re: Exclusions question.

Here is section 1.2:

1.2 Application
The Company has determined that the following requirements are not applicable to the operations at this site and are documented as exclusions:

▪ Section 7.3 – Design and Development
• Justification of exclusion: products are built to Customer specifications and drawings.

And 7.3:

7.3 Design and Development
EXCLUDED – See section 1.2.
 
S

SpaceCase

#9
Re: How to document "Exclusions" in the Quality Manual ?

I kinda figured, thanks for making sure I'm on the straight and narrow!
 

dsanabria

Quite Involved in Discussions
#10
Re: Exclusions question.

Here is section 1.2:

1.2 Application
The Company has determined that the following requirements are not applicable to the operations at this site and are documented as exclusions:

▪ Section 7.3 ? Design and Development
? Justification of exclusion: products are built to Customer specifications and drawings.

And 7.3:

7.3 Design and Development
EXCLUDED ? See section 1.2.
Nice!:applause:
 
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