Guest
What are minimum personal/roles for the new company per ISO 13485?
What are minimum personal/roles for the new company per ISO 13485?
Assign topic to the user
Expert
Verlene Law
Dec 10, 2018
Answer:
At the minimum, there should be a competent or appointed leader who has some understanding about the 13485 Standard and the company's Quality Management System. This person is also the Management Representative.
Please refer to below link for more information:
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/
Comment as guest or Sign in
Dec 10, 2018
Dec 10, 2018
Dec 10, 2018