Navigating Virtual ISO 9001 Audits: A Guide for Success

Preparing for ISO 9001 audits in a virtual world (1)For those who need ISO 9001:2015 certification, virtual audits are currently taking the place of face to face inspections.  While ISO has allowed remote auditing for several years, for obvious reasons the format has been stress-tested as never before during the pandemic crisis.  And it seems their popularity with auditors and auditees looks set to increase their prevalence in the future.

There is official guidance from ISO here on how these final external audits should be conducted. But, we’ve been looking at the experiences of external auditors and audited companies over the last year and have put together a short guide about what to expect from the process.

What you need to know about remote ISO 9001 audits

1 It’s the same but different

Auditors are saying the content and structure of these audits remain exactly the same as those that are conducted face to face - with certain exceptions made where physical inspections are absolutely required and can be deferred. The major difference, obviously, is that all your interactions are going to be virtual. And inevitably, while many are seeing upsides from not having to host physical meetings, this is where auditors and auditees have found their principal challenges lie.

2. Sort your tech out

Well before the day of the audit, the auditor should agree with you the best software to conduct your video conference on,  Most auditors will be able to accommodate your preference, whether it is GoToMeeting, Google Hangouts, Zoom or Skype.  Many auditors are letting audits go ahead using just conference calling, but their preference is video and screen sharing.  If you are going to use software you’re not familiar with, it’s worth checking it out before the day to be absolutely sure you know how it works.  It’s also definitely worth having a test call with your auditor to make sure everything is going to work the way it should.

3. Know the drill - tell your people

The structure of the audit will remain the same, with the opening and closing meetings bookending the process.  The ‘responsible person’ will need to be available throughout all of the audit process, with the key personnel and members of the leadership team required to call in at relevant points.  You should ensure that everyone in the organisation has the right log-ins and passwords to join the video conference, and knows how to do so.

4. Ready for your close up?

If you need to conduct a virtual tour of your facility, then do the right technical preparation.  Auditors are open to you conducting these on mobile or webcam, but make sure whoever is operating the camera has practised. The auditor may want to ask questions and you will need to answer them, so make sure the sound is turned up and that you are not obscuring the microphone on the device as the tour progresses.

5.Take care

Take lots of breaks.  This is a common theme in the reports that are coming in from auditors and auditees. An audit can be stressful at the best of times, schedule in breaks from screen time and be mindful of the needs of other participants.

5. Detailed plans help companies prepare for an unfamiliar process

A minimum of two weeks before the audit you should receive contact from your assessor to agree the logistics for the audit, the audit plan and timescales, plus the personnel, records and evidence required.  Don’t be afraid to ask for more detail if necessary. With a dispersed team you may need to do more exact scheduling for calls with your team to answer auditors questions. There’s no opportunity to walk across to someone’s desk, so make sure you’ve booked your interview slots in advance,

6. Auditors will be flexible and understanding

External auditing bodies are allowing screen sharing, photographs, emails, links to Dropbox and other platforms - and whatever methods may be necessary to share your documentation and demonstrate you have a compliant Quality Management System.  Clearly, though, those using paper systems are going to have their work cut out scanning documents and preparing them for a virtual inspection.  There have even been reports of companies holding up documents to the screen to show their auditor.  Auditors are being understanding about the necessity to do this kind of thing, but it’s inevitably going to slow down the inspection and make it more stressful for you.

7. Think through your plan for sharing documentation

The auditor will request documentation before the meeting and will definitely request to view more documents during the meeting.  If you don’t have a dedicated eQMS decide how you will share those documents - by screen sharing - or sending links via email to file locations. You will need to give auditors relevant log ins and passwords (in suitably secure format) and ensure permissions are controlled during the inspections and revoked afterwards.  Preparation and planning are absolutely essential here, you need to know exactly how you will demonstrate evidence of a compliant Quality Management System - in an entirely virtual way.

8. Have a rehearsal. 

Make sure you have tested all the tech, tools, links, log ins and passwords that you can, in advance.  A dry run will quickly show you gaps and omissions in your intended response methods.

Virtual audits are here to stay - are you ready for them?

This interesting article by an ISO auditor writing in Quality Magazine reflects on the challenges and opportunities offered by virtual auditing.

The feedback emerging from the industry is very positive and it is likely that, in the future, more of these inspections will move on line, where it is practical. 

But for many SMEs this has been a wake up call to sort out their tech and ensure they have the flexible, digital tools to securely manage the sharing of quality documentation as part of a virtual audit.

Those using dedicated eQMS with intuitive navigation tools already have an advantage over those using improvised SharePoint, DropBox or Google Drive solutions.  An eQMS with the right kind graphical interface, will give you the confidence to share the platform with an inspector and know that they will be to use its tools to retrieve the answers and the documents they need.  Even if they are sitting in an office hundreds of miles away from you.


Tags: ISO 9001:2015

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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