First off the bat, what is a QMS or Quality Management System?  

Quality Management is not a new concept and has been used in multiple industries as a way of building efficiencies into a way of working.  

The International Standardization Organisation was established in 1926, and are a global group of experts who decided upon a uniform way of how best to perform something, for example developing a product that is going to be sold to people. Having this standardised approach facilitates a level playing field within trade and ensure consistency. In terms of medical devices, ISO 13485 was created in 1996 and is a specific set of requirements for the medical and IVD sector.  

What does it involve? 

Documenting processes that your company is going to follow which are in line with the requirements of the standard, ISO 13485, and providing evidence that those involved are following them. Once this is in place, you will have an external accredited auditing body to come in and assess what you have in place. All being well they will pass you and you can say that you are certified to this standard. Good news all round!  

Why do I need it? 

In many ways having a QMS in place formalises the day-to-day workings of a company and ensures that all employees are following the same process. This in turn increases efficiency within the business and ultimately customer satisfaction.  

In addition, putting a medical device on the market be it in the UK, EU, or US and beyond, has its compliance requirements, and working to ISO 13485 is pretty much a given requirement. Coupled with the FDA looking to align its own requirements with 13485, it’s looking increasingly likely that compliance to this standard is non-negotiable.  

So what’s the fuss? Why do I need an “expert”? 

One of the outputs of following ISO 13485 is to increase business efficiency and customer satisfaction, however, the two are not mutually exclusive. A company can implement a behemoth of a QMS which is bloated and unfit for purpose, resulting in employees having no idea what process to follow or form it fill in. This can lead to wasted company time and customers annoyed as there is not a seamless interface between them and the product, they wish to purchase.  

By getting someone with experience to lend a hand is not a waste of money. They will be aware of the nuances of the standards, what is important to the company, and most importantly can help minimise the time between implementing the standard and getting the company certified.  

If your company is looking to get certified to ISO 13485 do get in touch, to see how we can support your journey.