Design/Development Output & Verification - ISO 9001 7.3.3 Design & Development Output

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Curt72

#1
I have a question about ISO 9001 7.3.3 Design and Development Outputs. Unlike the Inputs clause (which "defines" Inputs) this Output clause invokes quality requirements on the Outputs but does not address what outputs are. Looking at 9004, examples of outputs are all information items and the product itself is not included. So, the question is: Does 9001 intend that "outputs" of Design and Development include the product (e.g., pre-production item)? The is especially relevant to 7.3.5 Design and Development Verification which speaks to ensuring outputs have met inputs. It seems that if the outputs do not necessarily include the product, then the standard does not require that the product be verified against the requirements. In contrast, the validation clause does address evaluation of the product.

This is my first post to this very interesting forum; my background is system engineering and the use of capability maturity models...trying to learn something about ISO 9001.

Thanks,
Curt
 

Miner

Forum Moderator
Staff member
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#2
Curt72 said:
I have a question about ISO 9001 7.3.3 Design and Development Outputs. Unlike the Inputs clause (which "defines" Inputs) this Output clause invokes quality requirements on the Outputs but does not address what outputs are. Looking at 9004, examples of outputs are all information items and the product itself is not included. So, the question is: Does 9001 intend that "outputs" of Design and Development include the product (e.g., pre-production item)? The is especially relevant to 7.3.5 Design and Development Verification which speaks to ensuring outputs have met inputs. It seems that if the outputs do not necessarily include the product, then the standard does not require that the product be verified against the requirements. In contrast, the validation clause does address evaluation of the product.

This is my first post to this very interesting forum; my background is system engineering and the use of capability maturity models...trying to learn something about ISO 9001.

Thanks,
Curt
Design outputs are typically, but not limited to, informational documents such as engineering drawings, or specifications such as material or performance requirements. Normally the final product is not a design output, but a situation might occur where a product could be considered a design output. A product used as a color master, appearance standard or other type of master are possible examples.
 

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