ISO 9001 Clause 7.3 Design and Development Sub-Clause Exclusions

[Wendy2]

Long time reader (lurker), first time poster: Currently I'm in the process of writing a quality manual and ISO9001:2008 setting up the certification process for a company that puts together demo kits for in-store promotions. It's put together with customer product (samples, coupons, handouts) all to the customers' spec's. We decide the box it goes in and supply the generic tools for the demo (fork/spoon, napkin, etc) based on what the customer called out in their job. We ship them out across the country to where the customer specified. This is done with customer's approval as they gave us the specs. Do we need to include Clause 7.3, Design & Development, in all its clauses? Most of what I've read so far seems to indicate justifiable exclusions, but then I read something else that contradicts that. Guidance is most appreciated. Thanks.

 

[Duke Okes]

Sounds to me like you can probably exclude, but talking with your registrar would be an easy way to avoid any surprises.

 

[Wendy2]

Sounds to me like you can probably exclude, but talking with your registrar would be an easy way to avoid any surprises.

Thank you for replying so quickly...we do not have a registrar as of yet, we're still working on documentation.

 

[Duke Okes]

Selecting your registrar early in the process provides you with the opportunity to get clarity from them. They can't consult, but they can answer questions. If they're not willing to do this then you probably don't want to do business with them.

 

[Colin]

I agree with Duke, I can't see design being a requirement for you. Also, make sure you get at least 3 quotations from registrars, it is a competitive business and you should get the one that best suits your needs.

 

[harry]

..................................Most of what I've read so far seems to indicate justifiable exclusions, but then I read something else that contradicts that. Guidance is most appreciated. Thanks.

Welcome to the Cove.

As a user of the standard, I've always contend that the standard had to be interpreted in conjunction with 'intent' and the business you are in. I see two scenarios:

1. If the packaging (box) helps in the sales of the product, its design is evidently important and hence the clause applies. It is common business sense to exercise control over the design in order to attract potential customers.

2. If the box is simply for containing the goods (like your case), then the clause makes no sense and shouldn't apply.

 

[John Broomfield]

Long time reader (lurker), first time poster: Currently I'm in the process of writing a quality manual and ISO9001:2008 setting up the certification process for a company that puts together demo kits for in-store promotions. It's put together with customer product (samples, coupons, handouts) all to the customers' spec's. We decide the box it goes in and supply the generic tools for the demo (fork/spoon, napkin, etc) based on what the customer called out in their job. We ship them out across the country to where the customer specified. This is done with customer's approval as they gave us the specs. Do we need to include Clause 7.3, Design & Development, in all its clauses? Most of what I've read so far seems to indicate justifiable exclusions, but then I read something else that contradicts that. Guidance is most appreciated. Thanks.

Wendy2,

Here is the only design decision I can see in the information you have provided:

"We decide the box it goes in".​

Do the box selection criteria address the weight and other characteristics of the contents?

Are the boxes standard boxes? Is a box selection table used or is it not that complicated?

John

 

[Wendy2]

Wendy2,

Here is the only design decision I can see in the information you have provided:

"We decide the box it goes in".​

Do the box selection criteria address the weight and other characteristics of the contents?

Are the boxes standard boxes? Is a box selection table used or is it not that complicated?

John

They are standard cardboard boxes, packing the demo kit products inside for the best fit and least amount of wasted space that needs to be buffeted with paper. We do inspections along the way to make sure things are correct in the packed boxes, but have no after shipment responsibility.

 

[John Broomfield]

They are standard cardboard boxes, packing the demo kit products inside for the best fit and least amount of wasted space that needs to be buffeted with paper. We do inspections along the way to make sure things are correct in the packed boxes, but have no after shipment responsibility.

Wendy2,

In that case you have no need to further design the goods part of your product.

How important are your customer services (before orders, during fulfillment and after delivery) to the success of your business?

If important, who designs the service part of your products?

John

 

[Wendy2]

Thank you John, I'll be asking that question of the VP and see where we need to go from that. Wendy