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Need help with section 7.5 of ISO 9001:2000

al40

Quite Involved in Discussions
#1
I'm currently writing our quality manual and procedures and I'm stuck at section 7.5 Production and service provision.

Here's the problem:

We are a Design and Development firm once we design a prototype it is handled over to a manufactuer for reporduction, we do not have any production failities and the way I read this section is that it's written for a manufacturing facility not a Design and Development facility how can I address this section for a Design and Development firm? :confused:
 
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Craig H.

#2
Allen M. said:
I'm currently writing our quality manual and procedures and I'm stuck at section 7.5 Production and service provision.

Here's the problem:

We are a Design and Development firm once we design a prototype it is handled over to a manufactuer for reporduction, we do not have any production failities and the way I read this section is that it's written for a manufacturing facility not a Design and Development facility how can I address this section for a Design and Development firm? :confused:

Hi, Allen. In this case isn't the prototype the result of your production (and service, for that matter) process?

Hope this helps.
 
#3
Craig H. said:
Hi, Allen. In this case isn't the prototype the result of your production (and service, for that matter) process?
That would be my take as well. The prototype is your end product, so what you need to sort out is how to provide your customer with a good prototype. If you describe your processes for getting that done, you will probably find that you in fact cover 7.5.

/Claes
 

al40

Quite Involved in Discussions
#4
Craig H. said:
Hi, Allen. In this case isn't the prototype the result of your production (and service, for that matter) process?

Hope this helps.
You're correct we build what I call a "Pre-production prototype".

This is my thinking as well, I'm just trying to figure out how to tie the prototype into Section 7.5. :thanx:
 

Wes Bucey

Prophet of Profit
#5
In my opinion, the scope of your firm's work IS designing and turning out prototypes (one-off product), NOT the production of millions, billions, and zillions.

The REAL product you turn out is also one-off - that's the design, itself. You have responsibility AFTER the sale to service the design if the customer needs repairs or modifications. Whether you turn out the design in hard copy or electronic is immaterial to the fact it is your product; the same as if you had designed and built a production mold for someone else to make millions of copies of a product.
 

al40

Quite Involved in Discussions
#6
Claes Gefvenberg said:
That would be my take as well. The prototype is your end product, so what you need to sort out is how to provide your customer with a good prototype. If you describe your processes for getting that done, you will probably find that you in fact cover 7.5.

/Claes
In writing the QM and procedures can I use the generic word "Product" or would I have to specify "Prototype" in my procedure?
 

Wes Bucey

Prophet of Profit
#7
In my opinion, "Product" in the QM, "Product" in the Procedure, "Prototype model" in the Work Instruction, if you consider a multi-tier system of documents. If you don't use Work Instructions, then use "Prototype" in the Procedure.
 
#8
Wes Bucey said:
In my opinion, "Product" in the QM, "Product" in the Procedure, "Prototype model" in the Work Instruction, if you consider a multi-tier system of documents. If you don't use Work Instructions, then use "Prototype" in the Procedure.
That sounds good to me... Allen, just as long as you know what is what all will be well. Sticking to the vocabulary already used by your staff usually helps in avoiding unnecessary confusion.
Personally, I get confused often enough as it is... biggrin-a1.gif

/Claes
 

al40

Quite Involved in Discussions
#9
Claes Gefvenberg said:
That sounds good to me... Allen, just as long as you know what is what all will be well. Sticking to the vocabulary already used by your staff usually helps in avoiding unnecessary confusion.
Personally, I get confused often enough as it is... biggrin-a1.gif

/Claes
I've discussed this with the staff and engineers and we have agreed to use the term "product" in our QM and procedures since we all know that the ONLY product we have is a deliverable prototype. I have used the term "prototype" in a couple of procedures that clarify what a prototype is and how it relates to our QMS.

Thanks for the input.
 
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