How to document "Exclusions" in the Quality Manual

[SpaceCase]

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!

 

[the47guy]

Re: Exclusions question.

In our Quality Manual, we just put:

7.3 Design and Development
EXCLUDED – (See section 1.2)

 

[SpaceCase]

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!

 

[AndyN]

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.

 

[SpaceCase]

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]

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.

 

[SpaceCase]

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.

 

[AndyN]

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

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

 

[SpaceCase]

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

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

 

[dsanabria]

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!