Training documentation - ISO 13485 audit and the auditor had questions

Jnks_Meddev

Involved In Discussions
#1
We recently had an ISO 13485 audit and the auditor had the questions below. Are there different ways to make sure the candidate is competent in the particular standard?
  • How did you update to new standard? How do you know the candidate is good for internal audit for ISO: 2016 standard? Does he/she have 13485 competence?
  • The basic ISO trainings were updated and he/she is trained for that. SOP along with test taken was provided for documentation.
what are better ways to document trainings?
 
Elsmar Forum Sponsor
#2
We recently had an ISO 13485 audit and the auditor had the questions below. Are there different ways to make sure the candidate is competent in the particular standard?
  • How did you update to new standard? How do you know the candidate is good for internal audit for ISO: 2016 standard? Does he/she have 13485 competence?
  • The basic ISO trainings were updated and he/she is trained for that. SOP along with test taken was provided for documentation.
what are better ways to document trainings?
Wow. The auditor was asking these questions? Why? WHat's it to them HOW you updated? Either your QMS has been changed to meet the new requirements or it hasn't. Asking HOW you did it, is of zero consequence. Is it REQUIRED to be competent in ISO 13485? I'm thinking this CB auditor isn't competent...
 

Golfman25

Trusted Information Resource
#3
The context of the questions would help. It sounds like it was in respect to internal audits. Training isn't competence. The way you document competence is let them to an audit and review their work.
 

Jnks_Meddev

Involved In Discussions
#4
yes, that's correct! But after seeing the SOP and test sign off training sheet they were still looking for more information.
Not sure what was being asked. Thanks for your input though :)
 

Golfman25

Trusted Information Resource
#5
yes, that's correct! But after seeing the SOP and test sign off training sheet they were still looking for more information.
Not sure what was being asked. Thanks for your input though :)
Right, because you haven't determined their competence. You showed the auditor that they have been "trained." Now, how do you know they are competent -- that the training actually did something?
 
#7
From memory, what's needed is for you to a) define competency requirements and b) have the candidates demonstrate that competency. I cannot find a reason why any "normal" member of staff needs to be competent in ISO 13485. It's simply not useful. Someone needs to be, for sure. Management might need to be for parts relevant to them. If the auditor is putting competency in ISO 13485 in the general populations, they are WRONG... As far as specific internal auditor(s) go, my position is that even they don't need to be "chapter and verse" on 13485, either...
 
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