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How's the transition going?

Hows the transition to ISO 9001:2000 going?

  • We will not transfer

    Votes: 0 0.0%

  • We have not started

    Votes: 1 20.0%

  • We're working on it

    Votes: 4 80.0%

  • Done it...

    Votes: 0 0.0%
  • Total voters
    5
  • Poll closed .
QMS for Medical Device Companies
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G

gpainter

Quite Involved in Discussions
#3
#3
There will be a charge at the end and most are adding an extra day to the surveillance to convert. Too many companies and not enough auditors. Some that want it will have to wait. It is going to be interesting
 
A

Aaron Lupo

#4
#4
Where I work we have not transitioned yet, however, the QM has already been re-written to the 9K2K standard as well as 13485:2003. The reason we have not switched yet is we are waiting for the official release of 13485:2003, which should be January 2003 this way we can have it all done and over with at the same time. I would have to say another reason we have not switched is heck I am the only one in the company that knows anything about 9K2K, which will slow things down a bit. I guess that gives me a little job security???
 
D

db

#5
#5
didn't vote

I didn't vote, but we are seeing a lot more interest. Most of our customers are QS, and they are now starting to worry about their non-automotive base. The interest in upgrading the ISO part is increasing.

I am the only one in the company that knows anything about 9K2K
Click to expand...
Yes, ISO Guy, but is it on your license plate? :rolleyes:
 
J

Jimmy Olson

#6
#6
ISO GUY

I can sympathize with you. I'm the only one in my company that understands 9K2K as well. Some people know about it and think they understand, which makes things real scary sometimes.

We are currently in the process of transition and have a majority of the paperwork side of things done (new QM, new policy, objectives, revised procedures, etc...), but don't have much of it implemented yet. Some people are too busy arguing over the wording of how to do something, rather than just doing it. Oh well.:rolleyes:

Hopefully we should be done with it all pretty soon. We have our regular assesment audit next month and everyone wants to go for 9K2K at that time. I think some people will be in for a surprise. :D
 
T

tarheel

#7
#7
Claes Gefvenberg said:


How's your progress in the transition from the 1994 to the 2000 version? Time for a poll.
Click to expand...
Audit scheduled for Dec. Almost done with all the documentation, I don't honestly think it is any big deal. I may be surprised but I think 2000 is easier than 1994. The only reason I changed a lot of my documents is that my predecessor did not know what he was doing so the document control made no sense. Other than that, I could have coasted. I think more and more people are going to come to the conclusion third party is not worth the cost.
 
RoxaneB

RoxaneB

Super Moderator
Super Moderator
#8
#8
Having just completed Surveillance Audit #7 and the last one before our scheduled transition to ISO 9001:2000, our Auditor provided many "insightful" hints to help make the transition easier for us, while also mentioning some of the gaps that seemed apparent.

It was all I could not to shout out that we had already addressed the gaps and in some cases already implemented our plans. The majority, however, are waiting for October to be implemented (i.e., after the Surveillance Audit). So while the auditor talked on and on, I just sat there, poker face in full effect and mentally checked off each item mentioned as being "Done". :cool:
 
J

Joe Cruse

#9
#9
We are looking to be audited to the new one next spring. We just finished a surveillance audit, and the auditor kind of hinted that late 2003 will be very busy for his company, and was glad to hear we were not waiting that long.

Joe
 
C

Carl Exter

#10
#10
We completed our certification audit last Friday. We received four minor corrective action requests, all of which are easy to correct. Our CAR responses are going to the registrar today and we should have our ISO9001:2000 cert in hand shortly.

It wasn't that difficult a transition all-in-all. Our documentation, such as the quality manual, was revised to make it easier for the registrar to audit to it.

We had to clarify some things, but much of the requirements of the standard was already implemented so it was mostly updating the documents to show what we do in compliance with 9K2K.

Overall a pretty painless process. :)

But the registrar did say they were expecting quite a rush come this time next year so it may prudent to transition sooner if possible.
 
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