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Are flowcharts mandatory for every process?

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Guest user Created:   Jul 29, 2020 Last commented:   Jul 30, 2020

Are flowcharts mandatory for every process?

Is it a must to have flowcharts for every single process?

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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 Jul 30, 2020

No, there is no strict requirement to have flowcharts for every single process. In ISO 13485:2016 requirement 4.1.2 is stated that organization shall determine the sequence and interaction of the processes. So, flowchart is only one ways to do that. If you can prove that you have determine sequence and interaction on some other ways, it is apsolutly acceptable. 

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Jul 30, 2020