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Author Topic: ISO 13485:2003 Audit  (Read 1894 times)

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Offline Eupher

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ISO 13485:2003 Audit
« on: July 24, 2013, 07:29:09 AM »
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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Offline BlueStateSaint

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Re: ISO 13485:2003 Audit
« Reply #1 on: July 24, 2013, 07:48:53 AM »
Do you need anyone to send you healing white light? :whistling: O-)
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Offline JohnnyReb

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Re: ISO 13485:2003 Audit
« Reply #2 on: July 24, 2013, 08:02:40 AM »
Quote from: BlueStateSaint on July 24, 2013, 07:48:53 AM
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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Offline Eupher

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Re: ISO 13485:2003 Audit
« Reply #3 on: July 24, 2013, 10:20:17 AM »
Quote from: BlueStateSaint on July 24, 2013, 07:48:53 AM
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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Adams E2 Euphonium, built in 2017
Boosey & Co. Imperial Euphonium, built in 1941
Edwards B454 bass trombone, built 2012
Bach Stradivarius 42OG tenor trombone, built 1992
Kanstul 33-T BBb tuba, built 2011
Fender Precision Bass Guitar, built ?
Mouthpiece data provided on request.

Offline Crazy Horse

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Re: ISO 13485:2003 Audit
« Reply #4 on: July 24, 2013, 03:07:19 PM »
Quote from: Eupher on July 24, 2013, 07:29:09 AM
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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Offline Eupher

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Re: ISO 13485:2003 Audit
« Reply #5 on: July 24, 2013, 03:32:32 PM »
Quote from: Crazy Horse on July 24, 2013, 03:07:19 PM
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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Adams E2 Euphonium, built in 2017
Boosey & Co. Imperial Euphonium, built in 1941
Edwards B454 bass trombone, built 2012
Bach Stradivarius 42OG tenor trombone, built 1992
Kanstul 33-T BBb tuba, built 2011
Fender Precision Bass Guitar, built ?
Mouthpiece data provided on request.

Offline Gratiot

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Re: ISO 13485:2003 Audit
« Reply #6 on: July 27, 2013, 11:12:57 PM »
Just walked a facility through an audit last week as well.  Some are far easier than others!
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Offline RobJohnson

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Re: ISO 13485:2003 Audit
« Reply #7 on: July 28, 2013, 02:38:52 AM »

I'm glad your audit went well.
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