Hi, I'm having some doubts on ISO 13485, is it necessary to have QMS training once in 6 months, as per the standard?
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There is no requirement in ISO 13485:2016 that training must be every 6 months. In clause 6.2 Human resources it is only stated that the organization shall provide training or take other actions to achieve or maintain necessary competence.
For more information performing ISO 13485 training and awareness, please read the following article:
How to perform ISO 13485 training and awareness https://advisera.com/13485academy/blog/2019/10/30/iso-13485-training/
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Dec 06, 2019