Are flowcharts mandatory for every process?
Is it a must to have flowcharts for every single process?
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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.
More information regarding this topic you can find on the following links:
- How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/
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ISO 9001: The importance of the process approach https://advisera.com/9001academy/blog/2015/12/01/iso-9001-the-importance-of-the-process-approach/
- How links between processes can increase level of quality https://advisera.com/9001academy/blog/2015/04/07/how-links-between-processes-can-increase-level-of-quality/
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Jul 30, 2020