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Taking exceptions in the scope statement for registration

C

CHoullion

#1
Hello!

Question - Currently we do design at our facility but want to know if we can take an exception to design in our scope statement?
 

dsanabria

Quite Involved in Discussions
#2
Hello!

Question - Currently we do design at our facility but want to know if we can take an exception to design in our scope statement?
Short answer: if you do it - NO

"1.2 Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations. regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements."

So what you are asking is for an auditor to ignore the scope statement - he will ask you why it is not there and what is going to be your answer???
 
#3
Hello!

Question - Currently we do design at our facility but want to know if we can take an exception to design in our scope statement?
Of course you can't! It's clearly stated in ISO 9001 and the product design process is the cornerstone of defining (product) quality. To leave it out is to abrogate and abdicate responsibility for quality of a core business process.
 

insect warfare

QA=Question Authority
Trusted
#7
Hello!

Question - Currently we do design at our facility but want to know if we can take an exception to design in our scope statement?
Did you mean exception as in omitting the word "design" from your scope statement, or exclusion as in excluding the activity of "design" from the scope of your management system, or both? It really doesn't matter either way....

A simple assessment should go like this:
  • If you design your product, the answer is NO (even if you are an OEM and you outsource the activity of "design" to another provider)
  • If you do not design your product, the answer is (unequivocally) YES
Brian :rolleyes:
 
#9
I see that the OP has not returned. I hope he hasn't been scared away.

I would be curious to know what do they do that he thinks is design?

Perhaps what they are doing is actually planning for production and not design. I remember a few years ago working with a foundry who made castings to customer design, but to ensure that the castings properly filled they designed the gates and risers needed to ensure that when the molten metal was poured into the mold, it was distributed evenly and completely with no voids.

The activity of designing gates and risers is not design, as it is only what they need to do to ensure that the product comes out meeting print specifications.

Creating a CNC program to ensure that machined parts meet print requirements is another example of an activity that is performed to ensure the parts are made correctly but is not design.

Design of tooling to make parts is another example of planning of production, not parts design.

So, OP, if you are still around, we can help you more if you explain what the actual activity is that you are concerned about.
 

John Broomfield

Staff member
Super Moderator
#10
Just to counter "what is not design" in terms of ISO 9001.

Service and product design:

A process that translates the needs of customers (or a customer) into the specifications for services and products that will satisfy those needs including compliance with legal requirements.
 
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