Recommendations for online ISO 19011 training?

JJ_FDA

Involved In Discussions
#1
Have you taken an online ISO 19011 course that you can recommend? Looking to start one soon. I work in the drug development field with a number of years of internal audit experience, but no formal outside auditing training. Thanks!
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Have you taken an online ISO 19011 course that you can recommend? Looking to start one soon. I work in the drug development field with a number of years of internal audit experience, but no formal outside auditing training. Thanks!
Good day JJ_FDA, I am sorry for the delay in this response.

Auditor training is typically specific to the skill sets needed by auditors in their various specialty fields. ISO 19011 does not address that, rather that standard addresses the program that manages audit activities. That is, training will be done to ISO 1XXXX but the program will be managed as per the guidelines of ISO 19011, to include auditor qualifications.

I hope this makes sense.
 

JJ_FDA

Involved In Discussions
#3
Hi Jen, thanks for clarifying. I am indeed looking for training on ISO 19011 so that I can understand how audit programmes are run in general, and to improve the way the home-grown internal audit programme at my company is run specifcally.
 

John Broomfield

Staff member
Super Moderator
#4
Are the objectives for your internal audit programme set and reviewed by top management?

How is the internal audit programme resourced?

How is each audit planned to fulfill its objective and these wider objectives?

Learning ISO 19011 will not help anyone to answer these questions.

However, you may use these criteria to select your certified lead auditor training.
 

JJ_FDA

Involved In Discussions
#5
Thanks for the insight John.

Is there a programme that you can recommend, or a provider that you've bought an online training from in the past that you've had a good experience with?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
I did a search using key words "internal audit program iso 13485" and came up with this list of links.

I am not able to vouch for any of them, as I have never used them; they are almost all for-profit.

The ASQ Certified Auditor Handbook would make a good reference. ASQ does have a web based training for CQA; I have never tried it so I cannot vouch for its value. Disclaimer: I am an ASQ member.

I put in two Audit Program Manager attachments that I hope might be of some help to you. The 9001 attachment could be adapted for ISO 13485; I was not working in that standard at the time the tool was made.
 

JJ_FDA

Involved In Discussions
#7
Thanks for all of this information Jen! I will be reading these documents with interest. I'm more in GxP and ISO 15189 than medical devices, but I am sure that they are still very applicable to my situation.

Have you taken any trainings from ASQ? If so, what are your impressions in general?

Edit: the audit program manager attachments are gold. Thank you!
 
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