Training Records - How detailed? ISO 13485 Requirements

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Training Records - How detailed? ISO 13485 Requirements

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27th January 2008, 10:40 PM

JoeQNovice JoeQNovice is offline

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Training Records - How detailed? ISO 13485 Requirements

I am somewhat familiar with the requirements of 6.2.2 under ISO 9001:2000 for competence, awareness and training, but recently underwent an audit for ISO 13485 where the auditor said that the Standard (ISO 13485) required specific job descriptions for each employee down to the work instruction level. Not unlike those required by ISO 16949. Does anyone have thoughts as to how accurate this is and how detailed job descriptions have to be under 13485 beyond what ISO 9001 will allow?

Joe:

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		The Elsmar Cove Forum > Common Quality Assurance Processes and Tools > Training - Internal, External and Distance Learning
Training Records - How detailed? ISO 13485 Requirements

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