Does ISO 9001 Clause 7.3 Design and Development apply?

S

Stanpro01

#1
Hi folks,
I need some help... again (sigh).

ISO 9001-2008
Let's say my company designed and manufactured a cart (similar to a two-wheeled dolly), and met all the 7.3 requirements.

Now a customer calls and says "hey, nice cart, can you make it for me with 14- 1/2" wheels and inflatable tires instead of the hard tires?"

That is not a catalog offered option, but easy enough to do.

Is 7.3 required to modify this existing design?

Why or why not? (ie- how do I argue the point?)
Is the answer different if it were my company deciding to provide the option rather than a request for quote from a customer?

I'd appreciate any assistance. Thanks!
 
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D

Duke Okes

#3
Re: Does (7.3) design and development apply?

Yes. 7.3 applies. Doesn't matter where it's initiated. However, knowing what they plan to do with the different design would be important.
 
#4
Re: Does (7.3) design and development apply?

And any regs - there might be some liability in inflatable tires, if you don't put a warning about over inflation on the cart (if the tires also don't have it on them...)
 
S

samsung

#5
Re: Does (7.3) design and development apply?

Additionally you may also wish to look at the following definitions (ISO 9000:2005) which may help you understand the requirement:

design and development
set of processes that transform requirements into specified characteristics or into the specification of a product, process or system.

characteristic
distinguishing feature
NOTE 1 A characteristic can be inherent or assigned.
NOTE 2 A characteristic can be qualitative or quantitative.
NOTE 3 There are various classes of characteristic, such as the following:
— physical (e.g. mechanical, electrical, chemical or biological characteristics);
— sensory (e.g. related to smell, touch, taste, sight, hearing);
— behavioral (e.g. courtesy, honesty, veracity);
— temporal (e.g. punctuality, reliability, availability);
— ergonomic (e.g. physiological characteristic, or related to human safety);
— functional (e.g. maximum speed of an aircraft).
 
T

trainerbob

#7
It certainly seems that you have most of the work already done. You are adding another version to the same family. And it shouldn't take a whole lot to follow the same process you had with your present product to create the new product with the different wheels. And it is always good to have another product in your line that there seems to be a demand for. Design and development is something that people should spend time on rather than trying to find a way to get around it. I am not necessarily putting you in the "get around it" group, but sometimes it is hard to separate the soap box me from the normal conversation me.
 
P

Phiobi

#8
This is the kind of question I hear quite often now. I wonder why it is people try so hard to exclude 7.3?
I feel that best practice is to apply 7.3 to internal processes not just product and that it should cover any changes!!
 
M

machrk

#9
:bigwave::thanx:please don't sigh for asking questions when you need help

I find many questions raise issues that I hadn't thought of and I realise I need to know about those issues

I follow Marc on Twitter and so I see the different questions being raised - that's how I just saw your question mentioned by Marc in Twitter actually

- I describe them as being sort of like newspaper headlines and I can click on their link through here to Elsmar Cove site - if Marc wasn't doing the Twitter thing I reckon I'd have missed out on a lot of things because I was too narrowly focused on just the areas that I'd set up weekly email alerts for

so thanks to all those who ask questions

and Marc please keep doing the Twitter "headlines"

@KerrieAnn aka machrk
 
J

JaneB

#10
Is 7.3 required to modify this existing design?
In one word: yes.

Why? Because you are making a change ... in your very own words "to modify this existing design''.

But it doesn't have to become a humungous exercise... eg, it may be able to be covered off quite easily and quickly, by having someone with the appropriate skills / experience review the proposed changed design and sign off the job sheet/PO/whatever to that effect.

As Phiobi says, you cannot and should not exclude the requirements of 7.3. But apply them intelligently - it's a different thing setting out to make a modification of a mission-critical part for a jet fighter, for example, to making a relatively minor change to a product such as yours. All requirements still apply - what differs is the amount of time required and probably the volume of record-keeping.
 
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