Re: Organization Chart - Level of Details?
Technically the FDA does not require an org chart as they don't use the "establish the interrelationship" that ISO 13485 requires they just want "an adequate organizational structure".
ISO 13485 also does not require an org chart, as the relationship mentioned is related to processes and tasks. But that´s the way people keep understanding the requirement :-)
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Last edited by Marcelo Antunes; 26th July 2012 at 06:16 PM.