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AS9100 Syatem vs. ISO9001 and ISO13485 Systems
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dantheman
SoCal
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8 May, 2018
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8 May, 2018 - 3:00 PM
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We just finished re-certifying to ISO9001:2015 and ISO13485:2016 (I wish I would have found this website before the audits) and passed with some VERY minor findings.  Our “consultant” wrote a couple of documents including rewriting our QSM at substantial cost.  After the audit (and finding this site) I found out where she got the documents she “sold” to us.  Let’s just say the boss is upset as hell.

My question is – how much different (more stringent) will the AS9100 audit be than the last two ISO audits?  We are an electronics CM and do not have any design related activities in house – just manufacturing to customer prints/specs/BOM’s.  When I compare our docs with the template docs, we look like we have about 98% covered. 

My “tongue-in-cheek” comment: What could go wrong?  I’m recommending we just go for it and see where the chips fall.  How much different can it be?  Am I being too naive?

 

DTM

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Christopher Paris
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8 May, 2018 - 9:57 PM
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I sent you a PM re: your consultant using the Oxebridge kit. (If I read that right.)

The AS audit will be a bit more difficult, although the outcome is likely to be the same: they will give you your cert, just make more of a fuss about it and possibly try to milk you for an extra day of auditing to close out NCRs. They are so overbooked right now, though, a lot of auditors aren’t even writing NCRs, and everyone is passing audits no matter what. It’s a mess.

But they will dig deep into the areas not covered by “vanilla” ISO, such as FOD, supplier controls, counterfeit part control, etc. Also, all NCRs they write are essentially majors, since they are prohibited from issuing a cert if you have ANY nonconformities open, even the minors. So you will have to close them all before they issue the final cert. 

The auditors are also far more smug and demanding. But remember, they just want to print a cert at the end of the day. Go through the kabuki show and later you can use your QMS to improve your products.

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