Design and Development Exclusion - ISO 9001

[Bob Davidson]

I look after our companys Quality Systems running ISO 9001:2008 although I would not class myself as a Qualiy professional. At present we have a permitted exclusion for Design and Development . My employer, a small precision engineering workshop, wishes to add to our Web Site that we can and will do Design and Development. They do not however wish our ISO registration to cover this fact ie they still want the exclusion as they feel the small volume of additional work would not justify the percieved overheads that registration would mean. My feeling is they cannot do this. If our Web page says we are registered to ISO 9001:2008 and we will carry out Design and Development work the implication is we also have registration for D & D. Am I correct. Any feedback greatly appreciated.

Bob Davidson

 

[Sidney Vianna]

Re: Design and Development

Welcome to The Cove.

The theory is very simple: either the organization does product design or it doesn't. If they do, they must not declare conformance (nor be certified) to ISO 9001 if they exclude the D&D process from their QMS.

We've had a thread on this topic already: Should Registrars "police" registrants websites?

 

[Jason PCSwitches]

Re: Design and Development

I look after our companys Quality Systems running ISO 9001:2008 although I would not class myself as a Qualiy professional. At present we have a permitted exclusion for Design and Development . My employer, a small precision engineering workshop, wishes to add to our Web Site that we can and will do Design and Development. They do not however wish our ISO registration to cover this fact ie they still want the exclusion as they feel the small volume of additional work would not justify the percieved overheads that registration would mean. My feeling is they cannot do this. If our Web page says we are registered to ISO 9001:2008 and we will carry out Design and Development work the implication is we also have registration for D & D. Am I correct. Any feedback greatly appreciated.

Bob Davidson

No dice, if you do it and you want to be certified it must be in the scope. Besides, it's not that costly anyway. If they are going to do D & D they will want to have these aspects incorporated.

Or are they just not wanting to have someone review their work!!

 

[AndyN]

Re: Design and Development

Yes, you are correct. It's simples!

It sounds as if your management have registration because they have to, not because they perceive value from the use of the Quality Management System. You mention the 'perceived overheads of registration'? Did anyone find out what they are? To add design into scope is a (small) incremental cost compared to the existing audits.. ask your CB!

However, let's say you do operate a quality system, but have never actually had verification by your CB of the design process - you 'hid' it from the CB or they 'turned a blind eye', and took on D & D work. What would be the risk consequence if the design work 'failed'? Can you quantify that? - you don't mention what products the D & D activity handles. At minimum, you could have a lot of manufacturability problems, costing you in house problems - worse the design may fail at the customers, recalls, warranty claims, et al! As you mention, you're not a Quality Professional, so who's going to confirm the design process is meeting ISO 9001 requirements?

The costs of design failure will far outweigh the incremental audit costs, for sure! Been there, done that!

 

[somashekar]

My employer, a small precision engineering workshop, wishes to add to our Web Site that we can and will do Design and Development.

Can and will do means that it is in your scope of activity leading to audit of the scope and logically certification with no exclusions.

They do not however wish our ISO registration to cover this fact ie they still want the exclusion as they feel the small volume of additional work would not justify the percieved overheads that registration would mean.

Is your process design competency misunderstood by you as product / service design which is the requirement under the design and development. The registration costs would be nil to marginal increase. Talk with your CB.

My feeling is they cannot do this. If our Web page says we are registered to ISO 9001:2008 and we will carry out Design and Development work the implication is we also have registration for D & D. Am I correct

Yes. You are correct by the simplest of thinking.
Now D&D is an other step by step PDCA process, like any of your other processes that are covered in your QMS scope. What is the fear ?
If you design and develop, be proud of it, however small be the design and development task. If you are systamatically applying the stages of D&D in your process, say to the world.

 

[Big Jim]

I suggest you have a talk with your certification body.

Your scope statement defines what portions of your business are included in the registration. For example, a company might manufacture ball bearings and also manufacture sheet metal fabricated assemblies, both in the same facility. They can choose to register either one of them, or both, and that is defined in the scope statement.

It is conceivable to keep design and development out of your certification. I would think for it to be even considered there would need to be adequate separation between what is registered and what is not. Most certainly your use of the certification marks would need to be carefully done so it does not look like things that are outside of the scope are included.

What I'm suggesting here is not the same as exclusions as defined in element 1.2 of the standard.

Talk to your certification body and see if they would accept what you have in mind.

And just to be very clear, I'm not saying that I recommend that you try to do what you have suggested. I'm only saying that it is in the realm of conceivability and needs to be discussed with your certification body.

 

[JaneB]

The most critical issue is that you cannot and must not mislead customers when using or promoting your registration.
Putting up something about D&D on your website that in any way suggested or implied or led people to believe that this too is covered by your ISO 9001 registration would be distinctly misleading.

You might - for example - put up something to the effect that 'we do D&D but this isn't part of our ISO 9001 registration and isn't covered by it'. My guess is that no one would want to do that. (hmm... wonder why? )

I concur with the good advice given already by various people, including that believing that to include 'design' in scope is an expensive/difficult option is wrong/a misunderstanding.

 

[SilkTie]

[..]
I concur with the good advice given already by various people, including that believing that to include 'design' in scope is an expensive/difficult option is wrong/a misunderstanding.

I have the feeling the answer lies here ...

[..]
Or are they just not wanting to have someone review their work!!

In my experience this happens when the CEO is also the (former) chief engineer/R&D manager.

I've had it that CB also inspected and certified our new designed products, but D&D never was part of the scope ...

In the 'good old days' the company was certified according to 9002 and 13488, in 2003 that became 13485 without D&D, no questions asked (but by then D&D really started to hit a low, volume and quality-wise ... so it was not a real problem imho). And I can't say that the CB was a flimsy easy-going just-collect-the-money-and-give-a-certificate organisation. They did give me on all kinds of things, rightfully so. They just chose their 'wars' with us and knew what to comment on and what not.

 

[AndyN]

And I can't say that the CB was a flimsy easy-going just-collect-the-money-and-give-a-certificate organisation. They did give me on all kinds of things, rightfully so. They just chose their 'wars' with us and knew what to comment on and what not.

OK - but I will! Clearly, if your organization does product design and the CB didn't 'choose' that 'war', then they ARE a "collect the money and give a certificate organization"! Or the auditor is incompetent!

 

[SilkTie]

OK - but I will! Clearly, if your organization does product design and the CB didn't 'choose' that 'war', then they ARE a "collect the money and give a certificate organization"! Or the auditor is incompetent!

Nah, the CEO managed to sell it in such a way that it wasn't to be considered D&D.
And in all honesty, by 2003 nothing was really developed and design was an overstatement for the look that the former Russian tank engineer would give a device.

When we came to recertification in 2006, I tried including D&D. It was duly noted but nothing was done with it. After that I left the company (not only because of that) and guess what, they lost their certification.

And the auditor? I've seen many over the years, he was the best. The only one that took the full time alotted to production auditing for really walking the floor (and after him I've seen two of his colleagues do the same; all other CBs I've been with performed a meeting room audit only). He could read people, the production floor and documents like no one else. Not once did I get an undeserved NC, not once did he let an NC slip through where one should be given. He was cooperative but not lenient.