Tackling an ISO 17025 Audit as a Small Lab

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Anyone who’s ever prepared for an ISO 17025 audit knows that they can be both difficult and time consuming. ISO/IEC audits can be even more difficult today when some organizations are pushed to complete their audits remotely.

When Michelle Robertson first started as the Quality Assurance Officer at the Guadalupe-Blanco River Authority (GBRA), she had her work cut out for her. GBRA had over 700 hard copy documents and over 260 bench sheets – a lot for anyone to handle! The way these documents were organized was the hardest part about managing them . The documents were managed through a combination of shared drives, manuals, binders, and an archaic electronic archive system. They also had a couple of overflowing file cabinets that weren’t even in the same location. In terms of being ready for an audit, this was not a good situation.

On top of a chaotic document management system, Michelle had to deal with the side-effects of personnel turnover. They were short-staffed so there was no continuity in flow of information and tracking. Additionally, the SOP updates were not completed in a timely manner for the staff to use, and they had multiple issues with equipment and software.

When describing what her team was looking for in order to improve, Michelle described seven key items:
A computer-based Quality Management System they could use without having programming expertise;
Pre-configured template solutions for SOPs, CARs, workflows and other processes for rapid deployment of the system;
A way to keep all documents in one place;
Have improved document retrieval and traceability for staff;
More efficient internal/external audit assessments;
A way to keep document up-to-date and track revisions to help with audit readiness;
And something to help reduce publication errors.

The Bottom Line
Michelle wanted something beyond a quality document system. Michelle and her team needed a Quality Management System (QMS).

They implemented Qualtrax in May 2018 and they were fully up and running by October 2019. The full team was trained and audit ready by then as well.

As Michelle mentions in her presentation, there was so much that she gained by implementing an eQMS at her water lab: She was able to focus on the lab’s quality efficiently, automate essential processes, reduce the lab’s error rates, and she was able to create a great sense of responsibility and accountability on her team.

In this webinar full of great tips and insight, Michelle takes us through all of the ways she course corrected and got GBRA back on track. They went from a manual document control system to a complete, automated QMS, they’ve simplified information retrieval and have it available for anyone in the field, they created workflows, generated reports and gained an efficient, user-friendly system.

After Michelle’s presentation, Karen Arrivillaga takes us on a tour of the Qualtrax system and speaks to all of the ways an eQMS can help your organization innovate and thrive in today’s environment.

If you’re preparing your organization to meet increasing compliance pressure, like ISO 17025 or TNI, you won’t want to miss this webinar!