Tips for Auditee Training


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What tips do people have for training auditees?

By this I mean, the company I am with are about to undergo a 13485 notified body audit and I would like to give training to the employees who might find themselves in front of the auditors.

As an auditor, myself, I know what things I do when auditing to try to get to the bottom of things and I am sure there are plenty of auditors on here who might have their own 'tricks of the trade'.

What things would you include in such a training session?



Not out of the crisis
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The first thing I let auditees know is that these audits are "open book tests"... meaning you don't need to have everything memorized. Especially the Quality Policy. Just know where it can be found and spend time preparing how to answer the questions about how your job supports the Quality Policy and Objectives.
Same with Procedures - no one expects people to have procedures memorized... spend time revieing how to pull them up for reference in a timely manner and don't give blank look when the auditor asks you where your work instruction is.


Fully vaccinated are you?
Some content (from: and Escort Pre-Audit Training.pptx )

Things to Do
  1. Listen closely before answering any question(s). If you are not sure you understand the question, ask the auditor to repeat it. If you still do not understand the question, tell the auditor you do not understand it. The auditor will try to better explain him/herself. Never answer a question you do not understand!
  2. Never say “Sometimes I....”. When you do something differently because of different circumstances, explain that “When ------ happens, I...., and when +++++ happens, I ....”. Be specific.
  3. Always tell the Truth. Don’t ever try to hide something. You may think you are helping someone - you are not. One lie can destroy confidence. Just like in a marriage, if one spouse lies to the other and the other finds out, the relationship may be in real danger. One lie could ruin the entire audit.
  4. Be patient. Wait for the audit to ask a question.

Things NOT to Do
  1. If you do not know the answer to a question, tell the auditor that you do not know the answer. Don’t attempt to ‘fake it’. If the auditor tries to explain again and you still do not understand the question, tell him/her again that you do not understand the question. The Escort will attempt to help if this happens.
  2. Do NOT try to hide from the auditor. All the auditor wants is to ask you about your job and how to do it. You know your job. You can tell the auditor about as easily as you can tell anyone else.
  3. Do NOT try to answer a question for another person. If the question is not about the job you are doing and you know who does that job, tell the auditor who they should ask if you know.
  4. Do NOT try to answer a question about another job. The only question an auditor is supposed to ask is about YOUR job. If the auditor asks you a question about someone else’s job, you should answer “That is not my job.” The escort or the other person with the auditor must take the lead from this point.
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