Guidance on ISO 9001 Clause 7.3 Design and Development Exclusions

[huntdux]

We are a small build-to-print business where design and development work is extremely rare and almost exclusively for fixtures or testing. I can't say we do absolutely no design, but it is extraordinarily rare. Since all our product requirements are customer provided, is there any chance we can claim exemption from 7.3? Just curious...

 

[AndyN]

Re: Guidance on exclusions, please

We are a small build-to-print business where design and development work is extremely rare and almost exclusively for fixtures or testing. I can't say we do absolutely no design, but it is extraordinarily rare. Since all our product requirements are customer provided, is there any chance we can claim exemption from 7.3? Just curious...

Yes! Unless you really have a product to design and have control over specification/changes you should exclude the design requiements.

 

[SteelMaiden]

Re: Guidance on exclusions, please

agreed. you may exclude design from your scope.

 

[huntdux]

Re: Guidance on exclusions, please

Thank you for your prompt replies. You made my day, my poilcy manual is now complete and my finally procedures have been submitted for approval. Now the fun can begin...

 

[Marc]

<snip> I can't say we do absolutely no design, but it is extraordinarily rare. <snip>

You do design things but rarely - What happens when you DO design something (even fixtures)?

As to exclusion from the scope of registration, I'd have a close chat with your registrar. If it was me, I'd say if you do design, even "rarely", you have to at least have a system by which to do so.

 

[AndyN]

You do design things but rarely - What happens when you DO design something (even fixtures)?

As to exclusion from the scope of registration, I'd have a close chat with your registrar. If it was me, I'd say if you do design, even "rarely", you have to at least have a system by which to do so.

Good point, however, if we're leading up to a system certification and there hasn't been a design go through the process, there will be no evidence of implementation and hence no certificate - for 'design' scope - catch 22!

 

[Marc]

Since I have seen different registrars take different interpretations, I have only made my comment. If the company has no records of any design at this time, they may be able to take it as an exclusion, but when the time comes for them to do a design, they will have to have a system ready to deal with it so it's not really a catch 22.

I have also seen registrars which consider fixture design as part of the service design.

This has long been an area of contention and many disagreements have arisen from, for example, whether service companies are design responsible. The elimination of the old ISO 9002 was in part recognition that service companies do design (they design their services).

I'll stick with my earlier post - I would have a serious discussion with the registrar before unilaterally claiming a design exemption.

 

[John Broomfield]

We are a small build-to-print business where design and development work is extremely rare and almost exclusively for fixtures or testing. I can't say we do absolutely no design, but it is extraordinarily rare. Since all our product requirements are customer provided, is there any chance we can claim exemption from 7.3? Just curious...

huntdux,

Consider two scope statements:

1. For certification of the management system
2. For the management system

Exclude design from the scope of certification (in consultation with your registrar).

Include an "if... then" statement in your quality planning procedure (7.1) or manual to describe how the design of fixtures and testing is addressed when required by the customer.

The second scope statement would include design of fixtures and testing when required but make it clear that that part of your management system is not certified.

After using and improving your design process after awhile you may see marketing benefits in broadening the scope of your certification to include design.

John