How to document "Exclusions" in the Quality Manual

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!

Re: Exclusions question.

In our Quality Manual, we just put:

7.3 Design and Development
EXCLUDED – (See section 1.2)

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!

Re: Exclusions question.

the47guy said:

In our Quality Manual, we just put:

7.3 Design and Development
EXCLUDED – (See section 1.2)

Click to expand...

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.

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.

Re: Exclusions question.

AndyN said:

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.

Click to expand...

The justification is in 1.2 (Justifications) of the Quality Manual. That's why we put see 1.2.

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.

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

Aha! That helps... difficult to know from your post.

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

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

Re: Exclusions question.

SpaceCase said:

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.

Click to expand...

Nice!