Expert Advice Community

Guest

What are minimum personal/roles for the new company per ISO 13485?

  Quote
Guest
Guest user Created:   Dec 10, 2018 Last commented:   Dec 10, 2018

What are minimum personal/roles for the new company per ISO 13485?

What are minimum personal/roles for the new company per ISO 13485?
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 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/
Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Dec 10, 2018

Dec 10, 2018

Suggested Topics

Guest Created:   Jan 12, 2023 ISO 13485 & EU MDR
Replies: 1
0 0

Preventive action

Guest Created:   Jan 11, 2023 ISO 13485 & EU MDR
Replies: 1
0 1

Purchase (vendors) scorecards