Jan 28, 2021 Kelly Stanton

Using Qualio for ISO 9001 Audit and Certification

ISO 9001 is an international standard that sets out the criteria for a quality management system. Organizations of all sizes and in all industries can use ISO 9001 to ensure that customers get consistent, good-quality products and services with every transaction. Whereas ISO 9001 is a more general regulation, ISO 13845 builds upon it and focuses specifically on medical devices.

If you are a biotech, pharmaceuticals, medical device, contract research organization, or other life sciences organization that is facing an audit, Qualio can help. Qualio is the go-to for internal and external audits for FDA, ISO, and more.

To achieve ISO 9001 certification, organizations need to meet these 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 

Recently, Qualio conducted an external audit to achieve ISO 9001 certification, using the Qualio platform and test our own product for real-world usage.

What was the external audit like?

The audit was a two-stage process, conducted as an external virtual audit, due to the 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.

“Everything went really smoothly,” says Meg Sinclar, a Quality Specialist at Qualio.

In large part, that’s because the team conducted a gap assessment in its own internal audit ahead of the external audit. This preparation included management review meetings that included team members from Quality, Sales, Marketing, Operations, Engineering, and People Ops, getting all documentation in order, and opening CAPAs for gaps they identified, among other things.

“We were very transparent about what we had to work on,” Meg continues.

To read the full case study, please visit: Using Qualio for ISO 9001 Audit and Certification

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Published by Kelly Stanton January 28, 2021