First time being audited (ISO 9001), asking for advice

[Whiskey]

Hello Cove

I've posted a few questions on the forum before, but I'm still a relative newbie in quality management.
As in I've never held a job in nor studied Quality prior to being hired as a Quality Manager a few months ago.

We have a remote ISO 9001 re-certification audit and would like some last minute advice of what to expect, what I should have on hand, or maybe some stories you may have.

I've never been audited before, and while I have performed some internal audits this year, I'm not sure I'm doing it right.
I am good at organizing and looking up things so I at least know what's in our system.
Also, I did take a lead auditor course back in January so I'm not completely clueless, just definitely don't know what I'm facing.

Thank you all!

 

[Marc]

Thoughts:

 

[Whiskey]

Thoughts:

View attachment 27693

I feel like I need to print that out and post it in my office haha

 

[Marc]

I made that around 1996. I used to print them out with the company quality policy on the other side, laminate them and give one to every employee.

Simple and gave employees some confidence.

 

[Tagin]

We have a remote ISO 9001 re-certification audit and would like some last minute advice of what to expect, what I should have on hand, or maybe some stories you may have.

If you look at 9.2.2 on audits, it says at the end "NOTE See ISO 19011 for guidance"

ISO 19011 has a section A.16 Auditing virtual activities and locations. This discusses risks and recommended preparations for a virtual (remote) audit. I would suggest that you review this, and have some kind of document, risk register entry, etc. to show that you've considered these risks. Doesn't need to be elaborate - just a simple one-page doc that it shows you've thought this through.

How will you give a 'tour' of the facility to the auditor? Are you going to use a cellphone camera that is logged in as a meeting attendee? Have you tested this? Is background noise in your facility going to make it impossible to communicate with the auditor while in some locations? Do you have a charger handy due to battery drain?

Are you able to easily email/file transfer requested QMS docs to the auditor? Do you need to scan in paper docs during the audit that the auditor requests? How prepared are you for this?

 

[John Broomfield]

Remember it is not you that is being audited. But you are expected to know how your organization works as a system to determine and fulfill customer requirements.

...and how your organization improves continually. Any lack of confidence (backed by evidence) may cause the auditor to investigate further.

Make sure you have a copy of the audit plan and let your colleagues know when they’ll be expected explain (or show off) their particular part of the system.

Lastly, remember that the system is only partially documented to the extent necessary for effectiveness.

You are hoping the auditor reports examples of excellence and exposes any hidden weaknesses in your system.

 

[Mike S.]

Here is a thread on remote audits with a lotta good advice. Remote Audits for ISO 9001 (or any other standard)

 

[Randy]

After over 100 days of doing remote auditing last year and a couple weeks of it this year already the best advice I can give is maintain an even strain and your sense of humor. Honestly

• Make sure you have a good working internet connection. It is recommended that a minimum download speed of 2MB per second. If desired, you can check the speed of your internet connection in advance via Speedtest by Ookla - The Global Broadband Speed Test.
• Preferably use a headset. Using a laptop’s built-in microphone often results in a poor audio connection.
• Limit the background noise by setting the microphone to ‘mute’ when you’re not speaking. This is particularly important in a meeting or conversations with larger groups.
• Preferably, use a webcam to enable face-to-face engagement. However, if the audio quality is insufficient or faltering, it’s advisable to disable the webcam or video connection in order to improve your connection.
• Collect relevant documents and information prior to the interview. Based on the knowledge of your management system and previous experience with audits, you’ll be aware of the documents and information the auditor would like to review, as per the remote audit plan.
• Ensure clear communication during the interview. For example, clearly indicate what you are doing or going to do, for instance: ‘I’m going to log on to the application now, I’m trying to find the document on our network, I’m going to read your procedure now’.

Remote work can be more tiring and stressful than face-to-face and clarity of language is important both directions.

Good luck

 

[Whiskey]

If you look at 9.2.2 on audits, it says at the end "NOTE See ISO 19011 for guidance"

ISO 19011 has a section A.16 Auditing virtual activities and locations. This discusses risks and recommended preparations for a virtual (remote) audit. I would suggest that you review this, and have some kind of document, risk register entry, etc. to show that you've considered these risks. Doesn't need to be elaborate - just a simple one-page doc that it shows you've thought this through.

How will you give a 'tour' of the facility to the auditor? Are you going to use a cellphone camera that is logged in as a meeting attendee? Have you tested this? Is background noise in your facility going to make it impossible to communicate with the auditor while in some locations? Do you have a charger handy due to battery drain?

Are you able to easily email/file transfer requested QMS docs to the auditor? Do you need to scan in paper docs during the audit that the auditor requests? How prepared are you for this?

Thanks! I was able to check off most of your points, so that's definitely a confidence booster.

 

[Whiskey]

Lastly, remember that the system is only partially documented to the extent necessary for effectiveness.

Definitely a good thing to remember, thank you for the advice!