Exclusion of Design - Problem if we were to design? & Sample exclusion Text

[Bob_M]

Our small company (somehow) got the ISO:9001:1994 certificate even though we had no "design" history.

We are considering excluding it for our 9k2k update.

Can someone provide some "text" examples of how they worded their exclusion.

What happens/what do we need to do if we start to design on a regular basis or a one time basis after certified w/o design?

Is the exclusion stated on the certificate?

Note:
We provide input on customer designs are do not envision designing our "own" products any time soon.

I do not wish to get rid of our "design" forms and documents, but if I can exclude a big chunk, I will.

Thanks in advance
Bob_M

 

[Jimmy Olson]

We also give inputs and are involved in the design process, but are not responsible for the design. This is the text that we have in our quality manual:

Design and Development

This section does not apply to the ATS quality system. ATS’ customers are responsible for the control and verification of the design of their product, and therefore this portion is excluded.

Our auditor had no problem with this. Hope this helps.

 

[Bob_M]

Thanks Richard. Based on past discussion I know your company is in a similar situation. I did not think the "exclusion" clauses could be so simple. (I'm probably over thinking some of this ISO update stuff and my only references are "passable" 1994 docs.

I did mention dropping design with my boss/company owner recently. He wanted to know what happens if we want/need to design something after being certified w/o design?

What are the risks/problems that are associated with being ISO w/o design if you suddenly NEED or want to design? Simply expand scope and un-exclude during next 3rd party audit?

Like I posted earlier, I LIKE some of our (APQP and QS style) design forms but updating and maintaining a "chunk" of the system we don't use does not seem worth the time. (I may use some of them for RFQ and Product introduction still).

Am I making a bigger deal of this than it needs to be?
Any good real-life and certified design procedures/forms I can view?

Thanks in advance
Bob_M

 

[David Mullins]

Alternatively, don't exclude design.
Have a simple procedure for dealing with design.
Tell your external auditor that you're not currently doing design work, but have the allowance there should it be required.
The auditor should verify this as being true.
S/He will then confirm this at each visit, so if design work is done, they can audit it.
No Problem!

 

[Bob_M]

David Mullins said:

Alternatively, don't exclude design.
Have a simple procedure for dealing with design.
Tell your external auditor that you're not currently doing design work, but have the allowance there should it be required.
The auditor should verify this as being true.
S/He will then confirm this at each visit, so if design work is done, they can audit it.
No Problem!

Thanks for the feedback.

Your comment also was not a surprise.

Realistically, I'll probably need to keep the "simple" design procedures to keep the boss happy.

Oh Well

THanks Bob_M

 

[David Mullins]

You need more surprises in your life.

 

[Bob_M]

David Mullins said:

You need more surprises in your life.

No I hate surprises.

Regardless what I expected to "hear" I still need to know:

What happens/what do we need to do if we start to design on a regular basis or a one time basis after certified w/o design?

Regardless what the company choses to do I still need the answer to this question for my boss. *shrug*

Thanks
Bob_M

 

[Jimmy Olson]

The best way to answer this might be to talk to your registar. Most of the are pretty cooperative.

I don't know for sure, but I would imagine that you would just add that portion to your system when you start doing design and then the registar would audit the design portion next time they visit.

 

[Lisa]

Hi Bob,

I currently work for a 9001 company that is a spinoff of a company that was 9002 certified.

To upgrade our certification we;

1. informed our registrar of our intent,
2. set up our system to comply with the design requirement, &
3. had Design & Development audited during the next survelliance.

The whole process took a little over 6 months (we had to have evidence of design review) and there were no problems with the registrar. I believe we did have to pay for a new certificate.

Lisa

 

[David Mullins]

Bob_M said:

No I hate surprises.

Regardless what I expected to "hear" I still need to know:

What happens/what do we need to do if we start to design on a regular basis or a one time basis after certified w/o design?

Regardless what the company choses to do I still need the answer to this question for my boss. *shrug*

Thanks
Bob_M

Then, as I said before, the auditor will start auditing that "element".
(ou should have audited it internally as well to keep things tidy)