Designing and building our own machines

R

Rosana

#1
Hi everybody

I am working in a company that designs its products and also we design and build the machines to make our products.
Do I need to do something to meet with the ISO/TS requirements? if there is any requirement about this what is it?

Thanks in advance :bigwave:

Rosana
 
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R

Rosana

#2
I see nobody can help me with this. Any idea where I can find information about this?

Thanks

Rosana
 
D

D.Scott

#3
Rosa - depending on the industry you are in, you may be required to comply with various requirements. If for example you are in automotive, you may need QS or 16949 which has a lot on not only product but process design. ISO 9001:2000 which probably applies in most industries has similar requirements.

Without knowing the details, I would say yes, you definately need to meet certain requirements if your customers are expecting you to be ISO compliant.

Dave
 
S
#4
If the equipment that you are building is used ti verify/validate the product you are selling it will require calibration. This is a basic requirement of any quality system.
Since you are talking TS I will assume you are automotive, in which case you would be required to submit a PPAP. Re-submittal would be required if you made changes to any of the machines that you have designed for the particular product.
The real question: is this machine required to build your product or can I buy an off-the-shelf machine and do the same thing. You may need to address this question with your STA.
 
R

Rosana

#5
Dave and Sam

Thank you for answering.

The company where I am working makes brakes for trucks. I started working from almost nothing in quality and we would like to certify ISO/TS 16949:2002.
The company makes the products and when the customer asks for something different then we have, the eng. department designs it.
We design machines and we buy machines from the store. In same cases we design machines that we can find in the store. In other cases we have to design because we don't have a choice.
Like you said Sam, I need to submit a PPAP for every machine I design and if I make changes to it I need to re-submit.
Where are those requirements in the Standard?
What else do I need to do?
I am new to this standard so it is hard to find many of the details.

Thanks in advance for answering

Rosana
 
S
#6
Rosana,
Refer to the third edition PPAP manual tables 1.3.1, 1.3.2, 1.3.3 for the standard requirements for re-submittal and to section II of the same for customer specific requirements.
Also, refer to 7.3.6.3. This gives you leeway to negotiate the product and process approval process with your STA
 
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