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Hello all,
I'm trying to make a Q1 manual so my company can get 6D approval at our factory in china. Problem is we don't do design and development but according to Q1 we need "control features" for it.
How do I address this in my Q manual?
There is an old post with a sample Q1 manual I have seen here: (elsmar.com/Forums/showthread.php?t=11885&highlight=api)
Could I use the same text from that manual and then address the fact that we outsource D&D but we use the following XYZ procedures in order to verify / validate the designs we have bought?
And to what detail do I have to go into in explaining that. Can I just say "we perform the following tests on X% of new designs until we have determined the design works for to suit the needs of our customers, and that any changes to the design will receive the battery of tests and records of the changes will be kept".
Does that work?
thx!
I'm trying to make a Q1 manual so my company can get 6D approval at our factory in china. Problem is we don't do design and development but according to Q1 we need "control features" for it.
How do I address this in my Q manual?
There is an old post with a sample Q1 manual I have seen here: (elsmar.com/Forums/showthread.php?t=11885&highlight=api)
Could I use the same text from that manual and then address the fact that we outsource D&D but we use the following XYZ procedures in order to verify / validate the designs we have bought?
And to what detail do I have to go into in explaining that. Can I just say "we perform the following tests on X% of new designs until we have determined the design works for to suit the needs of our customers, and that any changes to the design will receive the battery of tests and records of the changes will be kept".
Does that work?
thx!
