Design & Development Clause 7.3, Applicable or not, What is rule?

[Varadarajan]

Not true, Jim. You can't get registered to ISO 9001 including design - unless you have design change authority!

Having input to a customer's design process is nice (a 'mutually beneficial supplier relationship) but it won't allow you to claim design in your scope! Sorry!

If you have experience where a CB had approved a scope like that, then a complaint to ANAB is in order........

I also agree with AndyN

For exapmle -The product drawings are given to various suppliers for manufacture of parts.

The Drawing title block at the bottom gives the details of the owner of the design-Drawn by,Checked by & Approved by(Design authority).
The customer here is the Design & change authority.
This company who is the customer for various suppliers cannot claim exclution from D&D

But those suppliers manufacturing parts as per that drawing can claim exclution from D&D(7.3)

 

[xavierFR]

Why not talk about the real technical activity on the daily of your company Varadarajan?

Do you participate on the design process of the related products? do you edit drawings on your behavior?

Do you deal with specifications at the entry of the process?

don't let us scaring you with responsabilities or strong theory...

the answer is on your desk and shelves.

 

[Varadarajan]

Why not talk about the real technical activity on the daily of your company Varadarajan?

Do you participate on the design process of the related products? do you edit drawings on your behavior?

Do you deal with specifications at the entry of the process?

don't let us scaring you with responsabilities or strong theory...

the answer is on your desk and shelves.

Thats good,
I will give all the details while I was a designer for Fuel pumps for Diesel engines for various Euro & US customers.

I was at R & D / BOSCH WORKS AT BANGALORE -INDIA

The answer is yes for most of them.


I am leaving urgently, I will get back to you.

Varadarajan

 

[howste]

That case does not address partial design.

Please explain what you mean by partial design.

If you mean that the organization has some authority to change the design without customer approval, then they must include 7.3 in their scope. If they have no authority to change the design, even if they provide advice to their customer, then 7.3 should be excluded.

 

[AndyN]

Jim:

Are you thinking TS 16949, where an organization, although not responsible for product design, must still include process design within its QMS?

If not, then I'm afraid it'll be a long day before you can convince 98% of the world that an organization having some input to anothers product design process, allows that (first) organization to claim responsibility for 'design' in their scope. Are you seriously suggesting that if a supplier is invited to particiapte in a design review at a customer, they can have 'design' on their certificate?

My parent company NTS, is a network of labs who have the (extensive) ability to perform design validation testing for their clients. Does that mean the lab can claim 'design' on their certifications?

 

[Big Jim]

Jim:

Are you thinking TS 16949, where an organization, although not responsible for product design, must still include process design within its QMS?

If not, then I'm afraid it'll be a long day before you can convince 98% of the world that an organization having some input to anothers product design process, allows that (first) organization to claim responsibility for 'design' in their scope. Are you seriously suggesting that if a supplier is invited to particiapte in a design review at a customer, they can have 'design' on their certificate?

My parent company NTS, is a network of labs who have the (extensive) ability to perform design validation testing for their clients. Does that mean the lab can claim 'design' on their certifications?

I think you may be mixing design (7.3) with planning for production (7.1). Companies can perform activity, including engineering, to determine how to produce something without impinging on design. Looking further at one of the notes for 7.1, "The organization may also apply the requirements given in 7.3 to the development of product realization processes." This can be done without altering design.

 

[AndyN]

Not really, Jim. TS is very specific, you can't exclude design - for processes - are you familiar with these requirements?

 

[Sidney Vianna]

Whenever I hear these odd theories and proposals, I always think where does the idea come from. The idea of an organization giving suggestions as design input allowing them to claim design in their scope statement, although original, is nonsensical.

It might be connected with organizations that typically don't have design processes in their system, such, as e.g., build to print machine shops, foundries, forging houses, etc..., but want to use their ISO 9001 certificate as a form of marketing and, by (nonsensically) including design, they claim to be a notch up their competitors. I have seen cases like that in the past. Obviously, the misleading registrant would have to find a CB that would go along with such misapplication of the standard.

It is amazing how some ideas get propagated.

 

[Big Jim]

Not really, Jim. TS is very specific, you can't exclude design - for processes - are you familiar with these requirements?

No, I don't work with TS.

 

[vijaysonawane]

Dear Sidney Vianna

Agreed ! but i want slight differnt view, actually design applicablity can be judge by understanding actual application onsite , that is why iso certification process of Two stages in the first stage ( pre audit) one has to check .

What is your opinion about foundry/ melter where organization changes material composition they mixup material and make the different application and Customer are not aware about chemistry then what?

what design applicability ?.