Dear Friends,

I would like to have your views on exclusion of Clause 7.3.6 - Design and Development Validation of ISO 9001:2000 from our system. We are a consultancy organisation and our product is basically engineering designs, e.g. design of bridges, highways and drainage etc. Validation of design, if my interpretation is right is the process of checking that the physical product meets client's needs / intended use. We do not physically construct the product. Our designs are generally converted into physical products by contractors supervised by some other consultancy firm. Keeping this as the background, kindly give your views if we can exclude Clause 7.3.6 from our system under the provision of Clause 1.2 - Application.

Best regards,

Khetar

Hello khetar, and welcome to the Cove :bigwave:

Considering the fact that your product is more or less what is described under 7.3.3 (Design and development outputs),one could consider 7.3.6 to be your customers concern. However, you are in fact acting as the customers design dep.

ISO 9004:2000, clause 7.3.3 expands a bit on validation of design output:

Validation of the output of the design and development processes is important for the successful reception and use by customers, suppliers, people in the organization and other interested parties.

Participation by the affected parties permits the actual users to evaluate the output by such means as

—validation of engineering designs prior to construction, installation or application,

—validation of software outputs prior to installation or use, and

—validation of services prior to widespread introduction.

Partial validation of the design and development outputs may be necessary to provide confidence in their future application.

The distribution of responsibility must be the key here, and that is something you and your customer will have to agree on. You will have to look at ISO9001:2000, clause 7.2.

You may have a case for excluding 7.3.6, but that depends...

/Claes

Good answer, Claes. While reading your post it occured to me that, if you really want to improve your product not just get a cert., you would take advantage of 7.3.6 and say something like:
"Whenever possible[i.e. when we can get the customer to agree], XYZ company includes a requirement for the customer to supply XYZ with their design validation data, as agreed in the contract." Etc., etc. The point being that this data would be very valuable to your design group when improving future product.