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QMS training

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Guest user Created:   Dec 05, 2019 Last commented:   Dec 06, 2019

QMS training

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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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Dec 06, 2019

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 05, 2019

Dec 06, 2019