How to pass an ISO 9001 audit with Qualio

ISO 9001 is an international standard that sets out the general criteria for a quality management system.

Organizations of all sizes and industries can use an ISO 9001-accredited quality management system to ensure their customers receive consistent, high-quality products and services every time.

To achieve certification, organizations need to meet the seven ISO 9001 quality management requirements:

  1. Customer focus
  2. Leadership
  3. Engagement and training of people
  4. Processes
  5. Continual improvement
  6. Decisions based on evidence
  7. Relationship management 

In 2021, Qualio received an external audit to achieve ISO 9001 certification, putting our own Qualio platform to the test. Here's what happened.

 

Qualio's ISO 9001 audit (using Qualio!)

 

The audit was a two-stage process, conducted virtually due to the COVID-19 pandemic. 

In the first stage, the Qualio team gathered all the documentation and procedures the auditor would need to complete the audit. In the second, the auditor had access to the system and reviewed all of Qualio’s documentation and procedures over the course of four days.

The Qualio team prepared by coupling an internal preparatory audit with a comprehensive gap assessment.

Preparation included management review meetings incorporating team members from quality, sales, marketing, operations, engineering and people ops. Documentation was gathered and CAPA plans executed to address any potential weaknesses.

When the audit began, the auditor asked for examples of how the Qualio team followed its own procedures to accomplish a certain task.

Since all of the information was already captured inside Qualio in a simple and intuitive manner, the auditor’s job was a piece of cake.

“We had zero errors! That’s because training is a big piece within Qualio. We made sure to utilize Qualio’s dashboard and created training videos to make sure all team members were properly trained on Qualio. All training records were organized and stored within the platform as well.”

- Kelly Stanton, Director of Quality, Qualio

 

The team used the Qualio platform to quickly and easily present evidence and documentation to the ISO 9001 auditor:

  • The Qualio Dashboard demonstrated how quality tasks were routed and distributed business-wide 
  • The integration of documents and training within Qualio demonstrated how staff could be quickly and easily trained on policies and procedures
  • Centralized digital training records allowed staff compliance and competence to be easily demonstrated

 

3 tips for passing your ISO 9001 audit

 

1. Use a purpose-built quality management system

 

Since the Qualio platform was used to prepare for the audit, it was much easier for the quality team to ensure every box was checked.

At the same time, it was straightforward and simple for the auditor to verify Qualio's internal processes and documentation.

If you’re still relying on a paper-based quality management system, prepare for a needlessly complex and drawn-out accreditation process.

 

2. Prepare to the max

 

“You can’t be over-prepared for an audit. There’s no such thing!”

- Meg Sinclair, Quality Specialist, Qualio

 

During Qualio’s internal audit, the team discovered multiple areas of improvement. Leaving enough time allowed the team to begin resolving and closing out these findings.

Not everything could be resolved in time, which brings us to...

 

3. Be upfront with your auditor

 

If your goal is passing an audit, you need to be upfront with your auditor and tell them where your open areas of improvement are.

The last thing you want is for the auditor to discover a non-conformance and ask you to explain it away.

 

“The more transparent you can be, the better off you are. The auditor will find the things you’re trying to hide.

We pointed out non-conformances and CAPAs and showed him the things we were working on and what we wanted to correct.”

- Kelly Stanton, Director of Quality, Qualio

 

Next steps

 

Want to see a leading ISO 9001 quality management software system in action?

Book a demo with us!