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Feb 01, 2021 Kelly Stanton

Qualio is Officially ISO 9001 Certified!

At Qualio, we’re all about helping life sciences, biotech, pharma, and medical device companies get products to market faster with our robust enterprise quality management software (eQMS) solution designed to make regulatory compliance a cinch.

In an effort to deliver more and more value to our customers, we’re happy to announce that our platform recently received ISO 9001 certification! 

What is ISO 9001 certification?

ISO 9001 is an international standard that recognizes when an organization is meeting specific requirements for a quality management system. 

When organizations achieve ISO 9001 certification, they demonstrate the ability to create high-quality products on a consistent basis, which makes it easier for them to expand into new markets. Since they’re operating more efficiently, there’s also less waste, more productivity, and higher margins. 

Simply put, ISO 9001 makes it easier to experience consistent outcomes through repeatable work processes.

How do you achieve ISO 9001 certification?

In order to receive certification, an organization must be able to pass an audit that demonstrates their commitment to the seven principles of ISO 9001:

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

 

At Qualio, we conducted our audits in December 2020 using Qualio for our internal and external ISO 9001 audit. Using Qualio, we were able to show the auditor our commitment to quality while testing our own product in a real-world scenario. 

We might be a bit biased, but we think that using a purpose-built eQMS like Qualio made it that much easier for us to achieve certification — and for the auditor to verify our processes and documentation.

What ISO 9001 means for Qualio

Our ISO 9001 certification — which lasts for three years — demonstrates our commitment to quality, transparency, and continuous improvement. 

Now, our customers can rest comfortably knowing that a third-party auditor agrees that we’re a trusted partner for QMS purposes. And they can also be assured that we are focused on doing everything we can to build a robust QMS solution that makes it easier for life science organizations like yours to achieve regulatory approval.

“I couldn’t be prouder of our team — and Director of Quality Kelly Stanton and Quality Specialist Meg Sinclair in particular — for their hard work on this impressive milestone,” explains Robert Fenton, founder and CEO of Qualio. “Qualio is committed to helping our customers succeed, which is why it was so important for us to highlight our ongoing commitment to quality and aim for this certification.”

For more information on what the ISO 9001 certification process was like for us, check out this case study. To learn more about the easiest way to build your processes on top of a proven eQMS that makes compliance that much easier to achieve while accelerating go-to-market strategies, request a demo of Qualio today.

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Published by Kelly Stanton February 1, 2021