A journey from ISO 9001 to ISO 17025 accreditation

Laboratory TestingBioLogiQ helped Endoval to prepare for the upgrade of their Quality Management System from ISO 9001 to ISO 17025 to demonstrate the competency of their laboratory testing to their cutomers. Their INAB accreditation audit should be taking place in the coming months. Daniel Parra, Endoval’s Managing Director describes how this went for them.

Why ISO 17025 accreditation?

“Endoval provides maintenance services for medical devices in hospitals and part of this service requires chemical and microbiological testing of waters taken from these. Endoval has been ISO 9001 certified for a number of years but we decided that ISO 17025 accreditation with its focus on laboratory management systems was critical to demonstrate the competency of our testing services. When we first looked at upgrading our management system we got quotes from a number of different service providers but we picked BioLogiQ as they offered a phased, project-based approach that would involve us intimately in its development. The alternative would have involved “experts” coming in, working full-time (with all the associated high costs) and developing a complete laboratory management system for us to follow. This might have been a faster route to accreditation but it didn’t appeal to me because as owner of the company I want to understand everything about it so that I have the information I need to make the right decisions. For this reason as far as I was concerned the BioLogiQ method seemed to be the best way forward.

Gap analysis

The first task we undertook was a gap analysis with Douglas highlighting the fact that we already had many of the elements in place that we needed for accreditation but an upgrade of documentation was required along with documented descriptions of activities which we as professionals took as a given. Mac delved into the technical side and identified gaps in our understanding of our instruments. ISO 17025 requires organisations to have detailed knowledge of the working of their instrumentation, including its limitations and suitability or otherwise for the work being carried out. As Mac explained many instrumentation users just follow manufacturers’ instructions, “press a button” and “get” the result without understanding what that result actually means and how accurate it is. At the end of the gap analysis clear tasks and timelines were set for us while Douglas took charge of the drafting of the Quality Manual.

Instrument failures

In the process of developing our ISO 17025-based system with BioLogiQ’s guidance we identified many issues which under the non-specialised ISO 9001 would have been acceptable or even completely un-noticed. The process of describing undocumented activities also highlighted gaps in our system which we could then address to ensure a consistent approach. A key technical job was to produce standard curves for our instruments and in fact as a result of this we identified that one of our new instruments, the most expensive in fact, showed significant deviations in its precision at the lower end of its measurement range, exactly where we needed to be measuring most accurately. We informed our supplier who once they realised that we were now “on the ball” couldn’t have been more helpful, replacing the instrument for a higher-grade one but for the same price as the original and ensuring that this had been “properly checked” before supplying it to us! We weren’t “button-pushers” any longer!

Business opportunities

We also sub-contract some of the chemical testing to an accredited, third-party contractor, a very expensive service which we wanted to look into to see if we could do it ourselves. BioLogiQ carried out an evaluation of suitable UV-Vis spectroscopes on the market in relation to their cost, specifications, servicing and follow-up suport etc. and identified a cost-effective, reliable instrument perfectly suited to our analytical needs. Using this we have been able to expand our range of in-house testing and validate the methodologies we require. In addition, we had identified that one of the parameters the third party were providing fluctuated widely in an unexpected manner and as part of the root-cause investigation we started to perform parallel testing which confirmed our concerns about its reliability. With BioLogiQ’s help and our new UV-Vis we developed and validated our own in-house method to correct this issue.

Similarly, adequate refrigeration is a key environmental parameter for much of our testing and as part of the equipment validation we identified variations in the performance of our fridges depending on the degreee of sample loading and the position it was placed in them. Once we had established this we were able to develop a new protocol to ensure adequate sampling refrigeration.

Internal audit

We steadily worked our way through our list of jobs and Douglas was always available to provide any assistance or explanations that we required where we had any doubts about what the standard was looking for, how it applied to our activities or what was the best way to do things. We had several sessions working through our draft Quality Manual in the context of ISO 17025 and our activities which enabled us both to perfect the Manual and to deepen our knowledge and understanding of the standard (we’re now on version twenty I think!).

A key step when we were ready was training in best practice for performing internal audits which we quickly put into effect as best we could. Douglas subsequently reviewed these and demonstrated to us how we could improve them with respect to ensuring a more root-cause, system basis for our findings so that our corrective and preventive actions would permanently resolve these.

Overall experience

As a result of this ISO 17025 process I and my staff have carried out further research and additional training and deepened our understanding of equipment and instrumentation validation and verification, conceived of innovative ideas for new services and are now fully confident in all aspects of our services. I don’t believe any of this would have been possible had I opted for the “external expert” approach which might have bought us the system “badge” but would never have given us the understanding and control that we now have in the development of OUR management system. It may have taken longer to get there but we are now fully “there” with a proactive management system process that regularly identifies opportunities for continual improvement. By the way it was more cost-effective as well!

Lastly, BioLogiQ were always flexible in relation to our “work commitments” so that they only came in when we were (relatively) free and able to concentrate on the work in hand. For us 17025 accreditation was critical for our continued business success and I would thoroughly recommend BioLogiQ’s services to anyone either looking for ISO 17025 accreditation or to revitalise an existing accreditation.”

This is Endoval‘s experience of ISO 17025 accreditation and how we helped them on their journey. What has been your experience of the process?  If you need to prepare for ISO 17025 accreditation, rejuvenate an existing system or need any laboratory training we can assist you. Book your place for one of our public or in-house ISO 17025 or GLP courses or call us on 087 9678 372 for your free initial consultation.

 

 

photo credit: Portable Screening Devices (1129) via photopin (license)

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