Training or Retraining for Changes to External Standards?

Does your Notified Body Auditor require you to train to external standards?


  • Total voters
    6

Cari Spears

Super Moderator
Staff member
Super Moderator
#11
Recently our notified body auditor wrote a minor obsveration regarding ongoing training or maintaining familiarity with regulations and QS standards.
Hi, Gary -

I always ask this - but here goes anyway.:D

Can you give us the exact words of the finding and what clause the auditor cited, please?
 
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gdwaikle

Involved In Discussions
#12
As stated in the first post.

The exact finding is as follows:
"The process for identifying who must be familiar with regulations and QS standards and the process on how the familiarity is updated when standards and regulations change, is not clearly defined."

Clause 6.2.2
 
R

RosieA

#13
Gary, another thought:

I've had auditors question how we determined the effect on our products when an external standard is revised. We had one Engineer who was fluent in standards reading go through the revisions and write a memo to file that said, "No effect" or else he introduced the changes to the rest of the manufacturing staff through training.

Perhaps this was the root of the auditor's finding? If so, that would be a valid issue, I think. But I would expect that to be cited under 7.3.2, Input requirements...
 

SteelMaiden

Super Moderator
Super Moderator
#14
I've been asked what our practice is for training for ISO 9001/quality system. I just show the records that everyone has gone through our orientation and part of that is an ISO 9001 overview (among a myriad of other topics). We also have a quality system refresher each year. And then I can show them exactly who has or has not reviewed their new/revised area documents. Our system is set up so when you review a new or revised document you click a button that shows you have read, understand, (or have gone to your supervisor, manager, MR to have the changes explained) and agree to follow the instructions. Supervisors assess people constantly, but record an awareness/competency review yearly. In some ways I feel that the awareness and competency requirements in the standard are kind of silly. After all, if you run your business the right way, you are going to be sure that your people are competent anyway. oh well.
 
K

kgott

#15
May be they mean training people in the changes between the ISO 9001 2000 standard and the 2008 standard?

If so, it seems like you have a good system in place for making your various players aware of those changes so I'm not sure what your auditor means. Perhaps you might like to go back to the auditor and ask for a clarification and re-explain how your process works?
 
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