What to "un-exception" for DFM (Design for Manufacturability)

Project Man

Involved In Discussions
#1
We are a machine shop and currently certified to ISO13485 with the following exclusions: 7.3, 7.5.1.2.2, 7.5.1.2.3, 7.5.1.3, 7.5.2.2, 7.5.3.2.2, 8.2.4.2

We would like to include DFM in the scope of our cetification so my question is, What part(s) of 7.3 do I need to 'un-exception'?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: What to "un-exception" for DFM

Hi,

In my opinion, the whole of s. 7.3. Design For Manufacturing (DFM) is a result of a specific design input, but other than that it is a design endeavor just the same.

Cheers,
Ronen.
 

Project Man

Involved In Discussions
#3
Re: What to "un-exception" for DFM

Thanks Ronen. I should include that we would be submitting our suggestions to our customer and they would ultimately be responsible for the verification and validation.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: What to "un-exception" for DFM

Thanks Ronen. I should include that we would be submitting our suggestions to our customer and they would ultimately be responsible for the verification and validation.
Hi,

Whoever actually performs and reports the verification and validation, your procedure should highlight the arrangement. As much as possible, you should have copies of the reports on file.

Cheers,
Ronen.
 
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