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IATF 16949 Design Exclusion Clauses which can be N/A

#1
Can anyone tell be which clauses are N/A for a design exclusion in section 8.3 of the ISO 9001 standard? It is very confusing to me trying to separate product and process requirements. 8.3.1.1 in IATF states section 8.3.1 shall apply.

Thanks.
 

jfries2

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#2
Re: IATF 16949 Design Exclusion

You probably already know this, but just to clarify, per IATF 16949 4.3.1 the only permitted exclusion is product design with appropriate justification. Exclusions are not permitted for manufacturing process design. So any paragraph in 8.3 that exclusively mentions product design would not be applicable. From my view this includes paragraphs 8.3.2.2 Product Design Skills, 8.3.2.3 Development of Products with Embedded Software, 8.3.3.1 Product design input, and 8.3.5.1 Design and development outputs - Supplemental. There are also a few paragraphs where specific references would not apply, such as in 8.3.2.1 b) and c) where DFM, DFA, and DFMEA are mentioned.
 

malasuerte

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#3
Re: IATF 16949 Design Exclusion

You probably already know this, but just to clarify, per IATF 16949 4.3.1 the only permitted exclusion is product design with appropriate justification. Exclusions are not permitted for manufacturing process design. So any paragraph in 8.3 that exclusively mentions product design would not be applicable. From my view this includes paragraphs 8.3.2.2 Product Design Skills, 8.3.2.3 Development of Products with Embedded Software, 8.3.3.1 Product design input, and 8.3.5.1 Design and development outputs - Supplemental. There are also a few paragraphs where specific references would not apply, such as in 8.3.2.1 b) and c) where DFM, DFA, and DFMEA are mentioned.

Are you merely reading/quoting the standard or do you have confirmation from registrars?

I have multiple registrars stating that if we are "design responsible" then we cannot exclude anything. I can't get a straight answer anywhere! :(
 

Blaest

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#4
If you DO have 'design responsibility' nothing can be left out.

The question would be what can be left out if you DO NOT have 'design responsibility'
 

Blaest

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#5
Re: IATF 16949 Design Exclusion

You probably already know this, but just to clarify, per IATF 16949 4.3.1 the only permitted exclusion is product design with appropriate justification. Exclusions are not permitted for manufacturing process design. So any paragraph in 8.3 that exclusively mentions product design would not be applicable. From my view this includes paragraphs 8.3.2.2 Product Design Skills, 8.3.2.3 Development of Products with Embedded Software, 8.3.3.1 Product design input, and 8.3.5.1 Design and development outputs - Supplemental. There are also a few paragraphs where specific references would not apply, such as in 8.3.2.1 b) and c) where DFM, DFA, and DFMEA are mentioned.
I agree,

And in additon to that you can leave out every "design and" for the rest of the clauses.
 
#6
It's pretty clear. If you don't do product design, you can exclude. But you can't exclude manufacturing process design.
 
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