Electronics Forum | Fri Apr 12 11:37:59 EDT 2019 | slthomas
Are you currently ISO 13485 certified, or are you just trying to meet compliance standards for a certified customer?
Electronics Forum | Fri Apr 12 14:17:40 EDT 2019 | tey422
We are ISO 13485 Certified. The previous PE who handles such technician things is no longer working with us. I am not sure where to start at, and what exactly needs to be done. Current, my main question is there some sort of a list what would be the
Electronics Forum | Mon Apr 15 12:45:49 EDT 2019 | slthomas
The reason I asked is that in every AS9100 or ISO13485 environment where I've been employed our equipment qualifications have included a PQ in order to provide evidence that the machine can (and did) produce product that meets or exceeds the pass/fai
Electronics Forum | Tue Feb 09 16:04:06 EST 2010 | frankalbiter
Hi there, From the ISO 13485: 2003 std. standpoint, there is a special requirement which states: "The following requirements shall apply. d) If appropriate, special arrangements shall be established and documented for the control of contaminated or
Electronics Forum | Sat Dec 22 03:09:26 EST 2018 | nniculita
Check us out: https://www.srxglobal.com/ Great quality, all ISO accreditation (9001, 13485, 140001). DFM and DFT using Valor MSS.
Electronics Forum | Fri Jun 21 11:42:12 EDT 2013 | hegemon
It is an audit of every assembly process. Think of how ISO 9001 or 13485(for Medical Devices) might go through your Quality system, documentation, training records, etc. and apply that scenario to your actual processes and documentation of the same.
Electronics Forum | Tue Jul 23 18:19:30 EDT 2019 | slthomas
It depends on what you mean by "going from....to....". If I just decided that I wanted to try a Type 4 paste on something that I'd been having problems printing, I'd probably just grab one (edited to add that we have a couple of re
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