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ISO 13485:2016 sample exam/test

J

jkc3usc

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#1
#1
Anyone one have a sample 13485 exam or test for training. Will be heading to BSI training and I know they have t/f and multiple choice exams throughout the week. Anyone have any examples?
 
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Ed Panek

Ed Panek

QA RA Small Med Dev Company
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#2
#2
Lots of the questions regard writing NCs. Remember to be patient when reviewing records. Understand the requirements being asked and how they impact product qc and the customer. If you find something that seems wrong investigate with more samples and see if its systemic. An error may or may not require an NC depending on the details.
 
A

Ankage

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#3
#3
Hi everyone,

I will be attending the BSI Auditor training (ISO 13485) soon and I was wondering the same question as jkc3usc. Does anyone have test questions or something like that?
@ jkc3usc: how was the training do you have any information/test questions etc. for me?
 
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