Discussion Topic List

Hello - Was the company's procedure reviewed to determine if it is documented what an operator is supposed to do ...

I would recommend using a validated Excel form to enter the data. The Excel sheet can be formatted to include the ...

Thanks Ladies for your input! Much appreciated!




Hello. I work at the Thomas Jefferson National Accelerator Facility in Newport News, Virginia. We have a small ...

Hi Jacob! Welcome to the community. I think we can all associate with your comment of “wearing many hats". We ...


First, what did you answer when the auditor asked you why you hadn't audited sub-processes? I thought ...

1. Sit down with the process ...


Matthew, your pose a good question. I dislike the feedback from your auditor a lot. For several reasons. If we go to ...

Well articulated! Yes Risk based approach is the best way forward. We should not be doing internal audits for audit ...

You can’t audit your own work. You will have to train a second auditor for that.

Hi Matthew, it looks like you are getting some traction on your post (I'm thinking in December members were doing ...

Thank you for sharing such an important message about recertification.

At my last job where I worked for a company that designed and built jet engine test systems, we would have 3 ...

I'm curious about 8.5.6 which is for production changes.

"The organization shall review and control changes for production or service provision, ...

The way I approach Change control - be it process of document related, I established a Change Control Form ...

Hello Betty,
I'm one of the instructors for our ISO 9001:2015 Requirements from A to Z classes. We have an ...