How To Make it ISO/IEC 17025 Audit for Small Laboratories?

Author : isoaudit checklist | Published On : 16 Dec 2023

To prepare an ISO 17025 Audit is always a challenging task. It takes time and effort from staff when you are in a small laboratory. Where whole processes are more challenging. When "all hands-on deck" isn't all that many pairs of hands, it's clear that being a smaller lab offers a different problem than having a larger lab.

There is a Small Lab Case Study:

Michelle Robertson discussed how she prepared her tiny lab for ISO/IEC 17025 audits in another recent webinar. Michelle had a big assignment when she began her role as the Quality Assurance Officer at the Guadalupe-Blanco River Authority (GBRA). GBRA's documents included over 700 hard copies and over 260 bench sheets - a massive amount by any measure. However, you read it correctly: these records were still document-based, making retrieval difficult and time-consuming.

Handling these documents was challenging due to their disorganized structure, which was managed through a mix of shared drives, manuals, binders, an obsolete electronic archive system, and two overflowing filing cabinets situated separately. This state of disarray was far from optimal for audit readiness.

Michelle had to deal with challenges caused by personnel turnover, which added to the disorganized document management system. Due to a lack of people, information flow and tracking degraded. To make matters worse, updates to the Standard Operating Procedures (SOPs) were not being made on time, producing extra difficulties for the workforce. There were also various issues with equipment and software.

What are the Important Aspects of Achieving Audit Readiness?

There are a few important elements for which you must have robust, efficient processes in place to be audit-ready. As a tiny lab, you will require:

A method of storing documents in one location while also making them easily retrievable. Having them in a filing area is OK, but if finding specific documents is a time-consuming effort in and of itself, you will be diverted from more vital lab chores.
Have solid mechanisms in place for managing proficiency testing and lab training. Monitor staff training progress and performance.
Establish and implement effective processes for SOPs, CARs, workflows, and all other processes. Having all partners in your quality system follow the same processes will greatly improve.
Establish protocols for managing personnel changes. This should complement your efforts to develop comprehensive proficiency testing and lab training, but it is also critical to have similarly well-established processes for bringing new starting up to speed - or existing personnel up to speed in a new capacity - as rapidly as feasible.
A method of keeping ISO 17025 Documents up to date and approved by the appropriate parties. The ability to track adjustments, get them signed off on, and have them conveniently available are all hallmarks of audit-ready.
Create methods for dealing with complaints and feedback. There are few better ways to understand what works and what doesn't for your lab, and such feedback might be critical for avoiding non-conformances during your next audit.
Create automated workflows for critical procedures. By introducing automated workflows, you can be extra certain that important procedures, such as equipment calibration and testing, are being carried out precisely and effectively. Know exactly what activities must be taken and when they must be taken.
Conduct internal audits. Internal auditing is critical for maintaining quality. To understand more, attend our webinar on critical internal auditing skills.

The Outcomes of Putting the Suggestions Above into Action:

If you implement the procedures outlined above, we know from Michelle at GBRA and many of our other customers that:
You will have more consistency in the face of employee turnover.
Greater staff accountability for the entire quality system, particularly the papers contained within it
There will be no "uncontrolled" documents floating about, and there will be no (or substantially decreased) publication errors when submitting modifications or new documents.
Documents are easily retrievable, reducing time and making audit preparation easier.
Fewer errors and blunders as processes govern essential equipment testing
Error rates are also significantly lower in all other sectors, and personnel bear responsibility and accountability.

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