Expert Advice Community

Guest

ISO 13485:2016/21 CFR 820 requirement question

  Quote
Guest
Guest user Created:   May 08, 2020 Last commented:   May 11, 2020

ISO 13485:2016/21 CFR 820 requirement question

Is it part of regulations to provide auditors with employee(s) signed job descriptions if asked?
 

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
Kristina Zvonar Brkić May 11, 2020

In the ISO 13485:2016, requirement 6.2 Human resources, it is stated that the organization must ensure that all employees are aware of the relevance and importance of their activities. The auditor will ask for the proof that employees are familiar with this. Usually, the best way to prove that manufacturer has fulfilled this requirement is to show the signed job description. However, if there is another way that manufacture can prove that employee knows exactly their activities and responsibilities covered in the job description, it can also be acceptable.

For more details regarding roles and responsibilities, please see in 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/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

May 08, 2020

May 11, 2020

Suggested Topics