Meet ISO standards
and stay compliant

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ISO compliance without the stress



ISO standards provide the globally recognised quality benchmarks for regulated companies.

Businesses focus the entire energy of their quality systems towards compliance, leaving no time for real quality improvement and turning audits into stressful nightmares.

And with quality contained in paper and spreadsheets, a fatal lapse in compliance remains a constant risk.



Qualio's fully integrated eQMS software makes ISO compliance natural, automatic and easy.

Workflows, audit trails and fully controlled records help you embed - and show off - the compliant processes you need without hours of admin.

Audits become routine, adherence becomes unshakeable - and you get the headspace you need to make quality your secret weapon.

How it works

ISO 9001

  • Holistic eQMS provides all the functionality needed for modern quality management, from document control to CAPA close-out
  • Single source of truth aligns your business around key ISO requirements, from proving management commitment to managing resources and instilling customer focus
  • Audit trails and incorruptible records make you 100% audit-ready, 100% of the time

ISO 13485

  • Assemble all the elements of a holistic medical device QMS, from design controls to training, in a single cloud-based system
  • Control all aspects of your device's lifecycle, from design to PMS
  • Pinpoint risks and drive digital workflows for a connected, right-first-time and patient-centric approach

ISO 14971

  • Build a configurable database of design control data, from risks and risk levels to test cases and results
  • Apply an ISO 14971 and FMEA risk management structure with configurable matrices, mitigation logs, associated V&V system data, and more
  • Pull device design and testing data straight from their source systems with instant API synchronization

ISO 15189

  • Give yourself the connected, cloud-powered quality system you need for a continuously improving medical laboratory
  • Align all laboratory staff with version-controlled SOPs, digital training records, standardized workflow-driven processes, and more
  • Unlock full visibility of quality issues - and the traceable, end-to-end accountability you need to fix them

ISO 17025

  • Make your testing lab a patient-centric operation by connecting your teams to a central quality repository of processes and documents
  • Ensure staff are properly trained and following the latest and greatest procedures
  • Demonstrate control and compliance to your auditors

ISO compliance resources


ISO 13485 toolkit

Learn how to tackle the medical device quality management standard with our bundle of helpful resources

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ISO 9001 toolkit

Become an expert on the core quality management standard: the baseline for all other ISO standards.

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Don't just take our word for it!

Hear from our many happy customers

"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"When I recommend Qualio, one of the first things I say is: you're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources.
That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
"I joined in November. I contacted Qualio 2 weeks later. We went live mid-December. We had all users working in the system by January. And we had our ISO 13485 certification by July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
"We’ve been able to show certain clients what we’ve accomplished with Qualio, and they were very impressed.

The VP of Quality for a client company said, "If I could build from the bottom up, I’d do it exactly the way you guys did it"."
Stephana P.
VP of Quality, Alphazyme
"There are other eQMS providers that are very well-established, but not particularly accessible to organizations that don't have the fundamental basics in place.

Qualio is not overly complicated. It gives us those foundational aspects of a quality system in a way that people can actually get behind."
Phil C.
Quality Manager, Bond Digital Health
"The perfect QMS system for a start-up. Everything, from validation to migration and training, was a positive experience."
Drew M.
Director of Quality, ECM Therapeutics
"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE. 

Qualio has given us one more staff member in a company where we throw nickels around like manhole covers!"
Mike T.
VP of IT & Information Security, xCures
“The cost of our Qualio licenses is insignificant compared to what we've saved by just improving our processes.”
Peter B.
Director of QA, Watchmaker Genomics
"The Qualio team made a big difference to our company by providing amazing help and guidance at a critical time in our QMS development."
Jackie L.
Managing Director, Auxilio Pharmaceuticals
"Set-up is easy and very user-friendly.  Qualio gets rid of the paperwork. Simple to use, affordable."
Rachel A.
Medical Outreach Specialist, eHealth Technologies
“We evaluated all players on the market and came up with Qualio as the best balance of price, capability, and quality of support.”
Jeffrey B.
CEO, FifthEye
“Once you understand how Qualio works, it's really easy to plan out processes and put them into place within the QMS.”
Sara V.
Quality Manager, Leaseir Technologies
"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"Any intelligent person would look at Qualio and say, "This is exactly what a cloud-based system should do". But when you actually see it in action, you still think it's pretty cool."
Andrew L.
CEO, ArcScan
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us reduce our workload and our paper trail."
Paul M.
CEO, Arann Healthcare
"Qualio+ fits right in to ensure a smooth transition to an eQMS. The team offered excellent advice every step of the way."
Chris S.
Quality Manager, CureMetrix
"The validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support and chat function."
Soni M.
QA/RA Director, NovoSource
"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
"Qualio has been great to work with. We implemented an entire QMS with them! Intuitive functionality, friendly staff."
Kim K.
Executive VP of Operations, VirTrial
"A big step up for our small company. Much easier than digging through a file repository manually!"
Matt S.
Senior Software Engineer, ArcScan
"Now that we’re electronic, we can grow to 500 or 1,000 employees.
Since we don’t need to grow the QA team as much, we can put more resources into employees who make us money, like scientists and manufacturing personnel."
Adolfo R.
Director of Information Systems & Data Compliance, IRISYS
"With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world."
Eric D.
Director of Quality Assurance, Expression Therapeutics
Qualio enabled us to seamlessly work through our ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.
David H.
CEO, Surfatek
The support Kelly and the team gave us at the beginning was great and we were really leveraging them to build out our QMS from scratch.

It was so streamlined, it was so efficient, they were super helpful and communicative.

That's exactly what we needed - and that's why we went with Qualio.
Heather U.
CEO, EvoEndo
"Qualio shows we're taking quality seriously and investing in quality improvement initiatives.

We plan to keep growing with Qualio, offering visibility, continuous improvement and knowledge management to our current and potential customers."
Edgar G.
Quality Assurance Specialist, The Dot

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