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Setting new standards – ISO 13485:2016

As a business that manufactures medical devices, dentisan has a host of legalities that we must follow in order to be compliant with specific regulatory bodies. One of the most important of these is ISO 13485 that specifies requirements for a quality management system where an organisation, regardless of its size and type, needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

In 2016 this standard was significantly updated to ISO 13485:2016. This wasn’t just a minor update, it was a complete revamp of the previous 2012 version and the work involved in updating dentisan’s systems to be fully in line with the new standard was significant. There is a three-year running in period that the regulatory bodies give you to get your systems in order but if we failed to comply in that time we would lose our certification and would no longer be able to sell our medical devices to anyone else – it was that simple and that important.

We certainly had our work cut out. Members of staff most closely involved with the changes attended ISO training courses and we all had in-house training here at dentisan. These were run by a notified body who gave interpretation and significance to the new standard so everyone in the business would understand what the differences were and what it would mean to our procedures.

Being a full revision of the standard meant that several more procedures had to be written and more proof was needed to show we were following said procedures in the correct way. One of the most significant changes was a new section on software relating to the manufacture of medical devices that wasn’t even in ISO 13485:2012, so there was a lot of work to ensure our systems were up-to-date.

We also had to undertake something called a Gap Analysis Audit as we went along with the changes. This was to assess what was currently in place against the new set of requirements and look for any gaps in between that still needed to be attended to.

The final stage was a Transition Audit where the auditor came in to check that all our systems were up to the new standard. I’m delighted to say that thanks to everyone’s hard work we passed our Transition Audit first time and without a hitch – and with a year to spare! Even the auditor was impressed…

ISO 13485:2016 is not so much about changing what we do here at dentisan, it’s about making sure our procedures are fully documented and recorded as proof to an external body. The new standard is a lot more specific than before and we have to demonstrate we are doing everything in the right way. This can only be a good thing in the long run and our customers know that because we have reached the standard of ISO 13485:2016 we operate to a high quality level so they can be assured that the medical devices we produce have been robustly made and tested.

Laura Yates is a Research and Development Chemist at dentisan.