I need to define and document authorities in regards to yes/no and accept/reject scenarios. My plan is to create an organizational chart, and also to update all job descriptions to include their immediate supervisor. Is that adequate, or do I need to create a flowchart for each process, showing who has authority at each stage?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, you can do it with an organizational chart and updating the job descriptions. There is no requirement in the ISO 13485:2016 how you are supposed to do it. The requirement 5.5.1 Responsibility and authority stated that top management shall ensure that responsibilities and authorities are defined, documented, and communicated within the organization. It is totally up to you how you will do it.
For more information on defining roles and responsibilities within an ISO 13485-based QMS, please see the following article:
- How to define roles and responsibilities within an ISO 13485-based QMS https://advisera.com/13485academy/blog/2017/11/16/how-to-define-roles-and-responsibilities-within-an-iso-13485-based-qms/
For more information fulfilling management responsibilities in ISO 13485:2016, please see the following article:
- How to fulfill management responsibilities in ISO 13485:2016 https://advisera.com/13485academy/knowledgebase/how-to-fulfill-management-responsibilities-in-iso-13485/
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Nov 06, 2020