What constitutes design under 9001?

KarenA01

Involved In Discussions
You and your colleagues need to defend your own system during the audit. Relying on your consultant to do this suggests your organization’s system is not ready for certification.

When we got certified we were not planing on doing development ... just contract manufacturing. So there was no issue justifying the exclusion.

As I said, to me it seems like what management wants to do now is product development, so i would have a hard time justifying why we should still be able exclude design, unless i can understand why it legitimately is not.


Don’t forget that you also design your service to satisfy your customer’s needs (needs are unspecified requirements BTW).
So, design is a process that translates customer/user needs into specified requirements for a service, product or a process.

For contract manufacturing they provide us with the with an outline of the manufacturing process and we translate to a Batch Record with the specifics of doing it in our facility. They approve it before we do the manufacturing. We don't set specs, we don't develop the process or "design" the product.

On that basis we excluded design...

-Karen
 
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KarenA01

Involved In Discussions
Sounds to me like process development, not product development.

If it is just considered to be process development, despite the fact that it would be a new product for us, I could get behind that as the from the link from @Randy says:
ISO 9001clause 8.3 refers only to design and development of products and services. In some organizations it can be beneficial, but not required, to apply the same methodology to design and development of processes.

But then in the next paragraph it says:
Product and service design and development is the set of processes for transforming requirements for the products and services (for example specifications, statutory requirements and specific or implied customer requirements) into specified product/ service characteristics (“distinguishing features of the product”).

Which for me muddies the water logically.

I could understand it if were developing a new process to make a product we were already making, but I may just be missing a definitional subtlety...

Can someone explain to me, why developing a manufacturing process for a product we never made before, despite the fact that others make and sell the product, may not fall under the second paragraph?

If I can understand that, I would have no problem justifying maintaining the exclusion.

BTW one of our current customers said they would buy all of this we could make, but it would not necessarily be exclusive to them.

Thanks,
- Karen
 
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John Broomfield

Leader
Super Moderator
Karen,

I am not referring to the past but we are trying to help you to prepare for the future.

For this you will need to bring your design process into the scope of your management system.

You may also need to bring design into the scope of your certification; especially if you plan to grow this part of your business. It’s a marketing decision.

John
 

KarenA01

Involved In Discussions
For this you will need to bring your design process into the scope of your management system.

Thanks John,

That seems right to me in principle, but If @Al Rosen is correct, and it can be considered process development not product development, it would not be covered by the standard...

It seems to me It comes down to semantics... coming from an extensive scientific/technical/R&D background I find some aspects of Quality a bit frustrating ... I like things to be a bit more definitive!

Our ISO9001 consultant told us quality is not black and white, but is grey... This may be one of those areas.

Thanks again
-Karen
 

Sidney Vianna

Post Responsibly
Leader
Admin
Our ISO9001 consultant told us quality is not black and white, but is grey... This may be one of those areas.
As in this case and many other things in 9001, conflicting opinions abound. That's why I have already mentioned that the only opinion that really matters in this case is the one authoritative person at the CB you contract with. If they ok the exclusion of product design, you demand that ruling in writing and, should a future auditor disagree with the exclusion, you shove it show it to his/her face. :naughty:
 

John Broomfield

Leader
Super Moderator
Karen,

Many quality professionals have invested their professional lives to help leaders and managers to reduce the cost of fulfilng customer requirements while creating more successful customers.

In doing this we would show there is no real difference between design and development.

Either way the designer is responsible for the performance of their designs. And we must be clear who is design responsible.

John
 
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