Expert Advice Community

Guest

Auditing process

  Quote
Guest
Guest user Created:   May 24, 2021 Last commented:   May 26, 2021

Auditing process

I would like to ask few questions on iso 13485 internal auditing clause 8.4. I am required to audit a process within my company, this process is Control of Non Conforming product, the audit will be remote. My question is where do I start and what do I look at when auditing this process? What kind of questions do I ask and what evidence must I look at or request?

0 0

Assign topic to the user

Assign

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 26, 2021

First of all, you can start with checking the procedure, is there a procedure in place, who is responsible to carry out the procedure, to whom non-compliances products should be reported. Then you can check when the last time was reported non-conforming product and how it was resolved. Have any corrective actions been taken, what records are there about that? Review the evidence that the corrective action taken is effective.

For more detail on this topic, you can see the following articles:

You can see how we prepared the form for the non-conforming product so, maybe it will give you an idea about the additional questions:

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

May 24, 2021

May 26, 2021

Suggested Topics