The Conservative Cave
The Bar => The Lounge => Topic started by: Eupher on July 24, 2013, 07:29:09 AM
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In Day 2 of this audit.
Looking good so far.
For those who don't know, ISO 13485:2003 is the international quality standard for medical devices. My plant is certified to this standard; this is a surveillance audit.
As said, no observations so far. Our use of risk analysis has been noted as being above par, which is a good thing and a necessary thing since our products are essentially commodities and there isn't the interest in investing a lot of time, money and effort in an inexpensive technology.
Let's see what the rest of the day brings.
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Do you need anyone to send you healing white light? :whistling: O-)
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Do you need anyone to send you healing white light? :whistling: O-)
Hey, that's what I thought they were bottling and selling.
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Do you need anyone to send you healing white light? :whistling: O-)
Not yet, but if I do, could you send a note to Galadriel? She's halfway expecting to hear from me anyway..... :-)
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In Day 2 of this audit.
Looking good so far.
For those who don't know, ISO 13485:2003 is the international quality standard for medical devices. My plant is certified to this standard; this is a surveillance audit.
As said, no observations so far. Our use of risk analysis has been noted as being above par, which is a good thing and a necessary thing since our products are essentially commodities and there isn't the interest in investing a lot of time, money and effort in an inexpensive technology.
Let's see what the rest of the day brings.
How's it at the end of day 2?
We just got through ISO 9001, 14001 and AS9100 and AS9110 two weeks ago.
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How's it at the end of day 2?
We just got through ISO 9001, 14001 and AS9100 and AS9110 two weeks ago.
It's a surveillance audit, and we're a small plant (82 employees), so we're done.
ZERO OBSERVATIONS OF ANY TYPE. :yahoo:
Next year is the full recert audit - 3 days.
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Just walked a facility through an audit last week as well. Some are far easier than others!
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I'm glad your audit went well.