Printed Circuit Board Assembly & PCB Design Forum
SMT electronics assembly manufacturing forum.
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I just assigned to make an IQ/PQ/OQ validation report to pre...
- Apr 09, 2019
by
Thomas
Here's a good summary: https://www.fda.gov/downloads/Drugs/D...
- Apr 10, 2019
by
davef
Are you currently ISO 13485 certified, or are you just tryin...
- Apr 12, 2019
by
Steve Thomas
We are ISO 13485 Certified. The previous PE who handles such...
- Apr 12, 2019
by
Thomas
Do you have some IQ/OQ/PQ records for other validations that...
- Apr 12, 2019
by
Steve Thomas
That's the most difficult part I am trying to figure it out....
- Apr 12, 2019
by
Thomas
To qualify the equipment for production use, you need to onl...
- Apr 15, 2019
by
Sr. Tech
Sorry that list is supposed to be bulleted. Site is acting w...
- Apr 15, 2019
by
Sr. Tech
"To qualify the equipment for production use, you need to on...
- Apr 15, 2019
by
Steve Thomas
You demonstrate it and record it by the report. The report c...
- Apr 15, 2019
by
Sr. Tech
The reason I asked is that in every AS9100 or ISO13485 envir...
- Apr 15, 2019
by
Steve Thomas