Let's talk about certification... Arnoud Loof

August 24, 2020

Arnoud Loof, ICT coordinator
Arnoud Loof, ICT coordinator

In this special edition of Let's Talk About Test, we talk to Arnoud Loof, ICT coordinator at Radboudumc. In this interview, he tells us how Testersuite got an important role in the ISO certification of the laboratory information system. Let's Talk About Certification!

"You know that ISO is going to take you to task".

Just a heads up: Who is Arnoud?

I am Arnoud Loof and I work in Laboratory Medicine at the Radboudumc. In our organisation we have four laboratories. Within one of these laboratories I have been team leader.

What is your role now?

There is a lot of talk about IT in laboratories. Patient diagnostics is about something. So it's not surprising that IT is very important there. Especially that it works well and continues to do so. We regularly ask ourselves 'what if that or that fails'. The impact on patients is very great when applications fail.

We then proposed to create a position for someone to make the link between the laboratories and IT. Eventually, I started doing this myself. It is mainly a coordinating role. I was also assigned the AVG part. It is now a broad function.

How do you handle this?

You map out processes by means of process diagrams. You look at how things run and which IT components play a role in this. If a problem needs to be tackled, we tackle it together with the IT service managers. Testersuite also plays a role in this.

For which certification process did you use Testersuite ?

That was NEN-EN-ISO 15189:2012. The CCKL used to issue certificates to laboratories for this. Nowadays, it is the ISO certification.

The certification process had a great impact when we replaced our laboratory information system GLIMS-8 with GLIMS-9. The new version had a completely different architecture. That meant a lot for all links with diagnostic equipment middleware and links with our Epic EPD. How are you going to arrange and secure this? You have to be able to show this to ISO.

What made you decide to use Testersuite for this route?

You know that ISO is going to put you through your paces. I had to be able to show how Glims-8 had been validated in the past. In some cases, this was not possible. It took me a lot of effort to demonstrate this.

For the new certification, things had to be documented again. Application managers were not used to documenting much.

Eventually I got to know Testersuite in our organisation through Sander Hassert.

"I was a little less popular for a while but now everyone sees the value in it..."

And so everyone got to work on it enthusiastically...

Now is Testersuite embraced by everyone. But in the beginning there was some resistance. People were not used to carrying out and recording tests via a tool.

When setting up Testersuite , you have to think carefully about how you are going to set things up. What terminology do you use and what conventions do you agree upon. There was some resistance in the beginning. Now everyone is happy we did it.

I can now retrieve things. Everything is archived in Testersuite . I was a little less popular for a while, but now everyone sees the value of it and everyone knows what Testersuite is.

What benefits did this bring?

A system can never be 100% tested. At most, you can get 95%. The question is whether that is enough to go live. If you want to convince the steering committee to go live, you need arguments. For example, before going live I was able to point out to the steering committee that 200 remaining defects were not blocking issues. That helped me enormously. After going live, we continued to work on defects .

ISO is also pleased with this evidence. They are impressed. Even after going live, we continue to test and record in Testersuite. Auditors regularly invite us to demonstrate things. That is now easy.

Are there functionalities specific to certification processes that you would like to see in Testersuite ?

In cooperation with external parties, it would be nice if screenshots could be exported as well as results. I can no longer imagine working without Testersuite . Testersuite is ideal for me as an audit trail. No idea how other hospitals do it without Testersuite.

What is your advice to other organisations facing a certification process?

Make sure you have clearly agreed on how to name things within Testersuite. This convention is very important for retrieving test results. How big do you make a test cycle. When do you use a chain test, when a record test and what is the naming convention. You must be able to find things easily for the ISO. Also for your successors in the future. This is very important for a certification process.

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