Design exclusion in AS9100D for commercial products

[PaulHarbath]

We are a small machining manufacturer that is registered to AS9100D. We make both commercial products (we call them low risk) and AS9100D qualified products (high risk) to the customer print. Up to now we have not designed products.

We have commercial customers that want to purchase some simple products we design (we control the print).

Can we still exclude "8.3 Design and Development of Products and Services" from the scope of our certificate since the products are low risk (not AS9100D based)?

Any help would be appreciated...

 

[Sidney Vianna]

We are a small machining manufacturer that is registered to AS9100D.

Help us understand this. You say you are AS9100D certified; that being the case, the information concerning your organization's certificate is available in the IAQG OASIS database, including your certificate and any allowed (and justified) exclusions. What does the OASIS database data says about your scope of certificate, when it comes to non applicable sections?

In principle, you can wordsmith the scope of certification and ensure it is understood that for the (as you call them) high risk (aviation, space and/or defense) products, you don't perform product design. For the (low risk) commercial products, do you need any QMS certification? Why not exclude them from your certificate altogether?

 

[Pjservan]

Agree with Sidney- above. It is all in how your scope is written/defined.

 

[AndyN]

we design (we control the print).

No, plain and simple. If you do design that has to be included in your QMS processes. I'm not sure why you are asking this question...

 

[Sidney Vianna]

Yes, according to the standard(s), they can not omit product design for the commercial hardware in the scope of the QMS, but let's not confuse scope of the QMS with scope of certification. The OP is asking about scope of certification.
Further, he said:

Up to now we have not designed products.

 

[PaulHarbath]

Thank all of you for your responses.

Our current AS9100D scope excludes all design.

The reason we would like to "Not" include design is because of the additional cost/administration for design. If design is included there will be additional cost from our registrar to include design in our audits, additional expectations with respect to retained documentation maintenance, process controls for design, etc.

We are trying to avoid implementing these controls on low risk (lower profit margin) product if possible.

Does this answer everyone's questions?

 

[Sidney Vianna]

Do you have to have the “commercial” products included in the scope of certification? You can exclude it.

Notwithstanding that, if you are design responsible for a product, you can’t ignore that critical fact in your QMS. If the design is simple, the associated processes should be commensurately simple as well.

 

[PaulHarbath]

My thoughts have been that it is still an ISO9001:2015 requirement which is also part of AS9100D.

So I agree that we must include it in our "Scope of Certification". Then our challenge becomes to reduce the administrative costs so that it can be

"commensurately simple as well"

as Sidney said above.