ISO9001 Scope Exclusion Verification in a Design Company

[John Broomfield]

Thank you John. Sorry, I may have created confusion while trying to paint a better picture! So, perhaps brief answers to your questions may help.

1. Customers and what they need from your company

There are a couple of "potential" but serious customers. They need specific part from our company. There are variations of the part, but it is one basic kind of part. An example would be bread - there are certain requirements that are given. But customers may want, say, raisin bread. They specify, how many raisins, what kind of raisins, etc. So, design is by customers, I think.

Your goods and services to satisfy the needs of your customers -
I think my example above addresses this point

Your essential processes to assure the quality of these goods and services
We do engineering experiments to come up processing that will produce the desired "bread" that meets all requirements - "basic given" and "customer specified." The product - bread - will be manufactured by our outsourced supplier.

Hope this helps.

Thank you.

Palomar,

Sorry, I still have no idea of what your products are and how they will make your customers more successful.

John

 

[Palomar]

John,

Thank you.
I will try to keep it simple.

The product is actually just one of a kind with some variations depending on what customer's design needs for his product. Our product gets incorporated into a sub-assembly that goes into the customer's final product.

So, if our product works in the customer designed sub-assembly and the final product, then he will be successful. Otherwise, his product will only work partially.

From this viewpoint, one can say that the basic product design is no longer an activity that is ongoing. Engineering runs experiments to optimize manufacturing processes to meet the customer requirements of performance and reliability for specific versions.

Hope this information helps.

Thank you

 

[John Broomfield]

John,

Thank you.
I will try to keep it simple.

The product is actually just one of a kind with some variations depending on what customer's design needs for his product. Our product gets incorporated into a sub-assembly that goes into the customer's final product.

So, if our product works in the customer designed sub-assembly and the final product, then he will be successful. Otherwise, his product will only work partially.

From this viewpoint, one can say that the basic product design is no longer an activity that is ongoing. Engineering runs experiments to optimize manufacturing processes to meet the customer requirements of performance and reliability for specific versions.

Hope this information helps.

Thank you

Palomar,

Many thanks. I needed simple.

It seems to me that your organization retains responsibility for the design of your product even though you have (temporarily?) suspended the design process for this product.

From what you say the changes that you make to your product so it will work with your customer's product may only be for "form and fit" but not for function. Changing the form of your product may change its function but I am not sure of this.

You do however provide an Engineering Service as one of your intended products. I am guessing this service is run and delivered according to your company's design that is changed as necessary to fulfill the customer's performance spec.

Usually when you work to a performance spec you have to complete the design of a product that delivers the specified performance. Had the customer provided only a product spec then your customer owns the design.

Please note that when I say product here I am using the ISO 9000 definition of product (goods or services).

Even if you want to exclude design from the scope of your certification it is may remain a good idea to keep your design process alive and well in the scope of your management system so you are ready to innovate new products.

John

 

[Palomar]

John,

I sent two replies this morning. Not sure they are going through and getting posted, since I don't see them

So, here is third attempt.

Yes, your comments were helpful in verifying my thinking as to the approach to pursue. Will present my proposal to the management team next - Exclude 7.3 at this time considering the current organizational and business scenarios.

Thank you
Regards,
Palomar

 

[Palomar]

Thank you AndyN for all your comments and insights in response to my discussion question @ D/D exclusion.

Regards,
Palomar