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My ISO9001 Journey

Back in 2018 when Nancy and Stuart had founded IVDeology, I was working as a lab technician in IVD manufacturing, where I had been for 14 years. In May 2019 I took the step to join Nancy and Stuart to help build and grow IVDeology. It was a no brainer as I knew there would be so many opportunities to learn and grow with the company and make a difference in the world of diagnostics.

At the start we knew we wanted to setup a QMS. We were all from lab environments so had lived and breathed in the ISO 13485 world. We knew by having a certified QMS it would help define and control our processes and give our clients confidence in our commitment to customer satisfaction and continuous improvement. For our business we decided ISO 9001:2015 was the most appropriate standard for our needs. 

My role as Operations and Quality systems Co-ordinator was to setup up and maintain our QMS. This was a great challenge as I had only ever worked within a QMS and had not been involved in the day to day running or setting up of one.

We tried using our current Microsoft system, but we really struggled with some of the document control features we wanted, and it just seemed to be really clunky. 

Then one of our customers introduced us to Cognidox. Cognidox is an electronic document management system but also so much more. After the demo we realised it ticked all the boxes we required from an EQMS. 

So we signed up for a trial and got to work creating the documents we needed for our company and to be compliant to ISO 9001:2015.

We created all the procedures, policies and forms and got through our stage 1 audit and once we were fully using the system got through stage 2 to gain certification in Jan 2021. 

That was a huge achievement and milestone for the team and I.

I am even more proud of this achievement as you may remember January 2021 we went into lockdown a second lockdown, and we had another period of home-schooling our then 5-year-old. Let’s just say this was a tough time, but I feel I came out of it stronger, and with more confidence to face future challenges. 

Though it wasn’t the end of the story of course, as with all QMS’s we are continually reviewing, updating, and improving our documents to evolve with the company. 

We lived with the documents and started to learn what worked and didn’t work for us within the scope of the standard. 

As a result, our documents are now much more streamlined as we’ve gone for a simplified process flow approach, as we’ve found these to be much more effective for our company. Cognidox were there to listen to our queries, our wants and needs, and make it work for us. It wasn’t a one size fits all which some EQMS can be.

We have a really robust process for CAPA, change control and staff training. It’s tailored to fit our quality and operational needs.

We have got through 2 successful surveillance audits, and we look forward to our recertification audit in December this year.

I have learned so much from this journey:

  • oRealising the perfect procedure or document doesn’t exist, they should always be evolving, the simpler the better and always designed with the user in mind. 
  • oDon’t over complicate things, as you can end up getting tied up in knots. 
  • oAn electronic document management system is so important for document control, training, and report functions (making management so much easier). 
  • oIt is a huge challenge, but with the right support ,hard work and knowledge it results in a huge achievement. 

Our team all have years of experience not only building quality management systems but living in them too, this helps us to understand the requirements for the people using the system to guarantee it works for the individual company.

If you require any Quality management system support or advice please get in touch, our highly experienced team are ready to help. 

We also partner with Cognidox, so if you feel you want to go from paper based to EQMS, please reach out and we can put you in touch with the team.