Design and Development of Products Exclusion?

[Jenilu1990]

After experiencing 3 different ISO9001:2015 auditors with the same registrar, then a couple of different contracted internal auditors, I'm being pulled in two different directions. My company designs, manufacturers, builds and samples molds for injection, thermoset and die-casting industries. Simply put, we're handed a customer designed product, we design the mold to produce it, build the mold, sample it, adjust if needed, and move on. Sometimes, we use the customer's design and re-patriate it to our CAD/CAM systems and go from there. My quality career for many years has been in automotive, and my interpretation is that if have design functions, we include 8.3...our product is the tooling; not the product it produces. Different auditors have different interpretations. I'm on the third auditor in 10 years with the same registrar; this one says we should exclude it - total 180° from the previous auditor. I just want to get it right. Thoughts and opinions? Can someone provide a case justification to the standard for inclusion or exclusion?

 

[qualitystartup]

My previous employer was a value added machine shop in the AS9100 world. We would receive a print for a customer part, build tooling to do value added machining and then complete that value added work.
From the beginning of time we had always excluded Design. Yes, we designed the tooling, but not the actual product. In the 9 or so years I was there we didn't have any issue with that exclusion and I'm not aware of it ever being an issue in the roughly 20 years that the company has been AS9100 certified.

 

[Sidney Vianna]

First of all, one must remember that in the IATF automotive sector, process design can never be excluded.

For the vanilla ISO 9001 scheme, if an organization’s product are the (in-house designed) molds, then and obviously, product design must never have a valid exclusion.

 

[Randy]

For the vanilla ISO 9001 scheme, if an organization’s product are the (in-house designed) molds, then and obviously, product design must never have a valid exclusion.

What he said!

If a product is the mold itself and you design it, a claim of "non-applicability" is out of the question....... That dog ain't gonna hunt!

But...big BUT.............If, big IF, you are given a product design by a customer for you to make, based on their design and occasionally have to fine tool something, you aren't designing, you're correcting, based on their acceptance of course.

As a customer, I don't give a flip how you make the tooling or anything else, unless I say "I want thus and so", I want the output of that tooling to meet my "expectations". The wherefore's and how to's are your business.

I've got 45.375 clients that do exactly what you do, no problem.

Here's the kicker, if you include development of product tooling in your SCOPE, all bets are off and you've been had if you claim "non-applicability"

 

[Big Jim]

To me you are obviously a design company. I suggest you have a conversation with the registrar. They should be able to correct the misunderstanding auditor.