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
"We looked a lot at how Qualio worked, its user interface, and the technology behind it. It was by far the freshest, most logical eQMS system out there."
Dmitry F.
Chief Technology Officer, ViQi
"I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
"Qualio’s become a verb here. When people need things, Qualio is the word that’s used."
Chris R.
QA Associate, AGADA Biosciences
"There are other eQMS providers that are very well-established, but not particularly accessible.

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 an 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
"I entered a world with Qualio where quality is no longer a hassle."
Fedora B.
Co-Head of Biopharma Corporate Finance, JMP Securities
“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
"Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"Qualio is far superior to other
systems I've worked with in the past.
The flexibility has been mind-boggling."
Michael H.
QA Director, TriMed
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"Document control took anywhere from 5 hours to 3 days. Now things get done in hours, even minutes. I can send training out in seconds now. Qualio has made my life 100% better!"
Angela P.
QA Manager, Akadeum Life Sciences
"Qualio helps me sleep better at night.
Having that structure for everyone to work within is essential for us to really succeed this year in getting onto the market and staying compliant."
Heather U.
CEO, EvoEndo
"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
"I feel 100% ready in our 510(k) and ISO 13485 preparations.
Qualio let us bring quality in-house in a way that will make us successful."
Hilary B.
VP of Regulatory & Quality, SimBioSys
"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
“We’re building a quality product. So we bought a tool that gives us a quality culture. Instead of pushing
quality to one department, Qualio breaks down that barrier.
Daniel A.
Chief Technology Officer, InVivo Bionics
"When you're using paper, you're not moving forward. You can't.
Now we're so streamlined, we're finally making progress. We're talking about bringing a new product into design controls right now.
I don't think that'd be possible if we didn't have Qualio."
Ami A.
Director of Ops & Quality Management, NeuFit
"I’ve never been more confident in my 27 years of being audited."
Lowell H.
Director of Quality Assurance, Restech

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