Expert Advice Community

Guest

About Management Representative

  Quote
Guest
Guest user Created:   Oct 04, 2018 Last commented:   Oct 12, 2018

About Management Representative

Can there be 2 management representative for an organization?
0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law Oct 04, 2018

Answer:

There is no requirement that states in ISO 13485 on the number of management representative for an organization.
A Management Representative should be someone who is knowledgeable, trained and have experience in dealing with the Quality Management System of the company as well as familiar with the Standard applied.

You can also refer to the below link on:
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/

Quote
0 0
Guest
jjpei Oct 12, 2018

Is it mandatory to create a management review SOP if the quality manual mention about the management review process already?

Quote
0 0
Expert
Verlene Law Oct 17, 2018

The Standard requires a documented procedure for the Management Review. It will be recommended to supplement the Management Review procedure with a SOP if the procedure stated in the Quality Manual is brief.

For more information, please refer to :
How to Perform Management Review According to ISO 13485
https://advisera.com/13485academy/blog/2017/11/09/how-to-perform-management-review-according-to-iso-13485/
Procedure for Management Review
https://advisera.com/13485academy/documentation/procedure-for-management-review-iso-13485-2016/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Oct 04, 2018

Oct 17, 2018