ISO 13485, the passport to assured safety of medical devices

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@Shutterstock - Nednapa Sopasuntorn

@Shutterstock – Nednapa Sopasuntorn

Recently revised, international voluntary standard ISO 13485 is a certifiable standard. Certification is possible for organizations specializing in medical devices whose quality management system is deemed to conform to the standard or for organizations forming part of the supply chain. Examples of companies already holding the certification are Russian equipment supplier MSM Medimpex and French startup SLS France, commented on here by their respective representatives Quality Manager Oleg Levchenko and CEO Axel Dubois.

Why have you committed to this ISO 13485 certification approach?
Oleg Levchenko : The primary objective is to improve quality of production, essential in order to meet customer and statutory requirements. Prior to holding ISO 13485 certification, MSM Medimpex referred to ISO 9001, the general voluntary quality management system standard. But from 2012, and having developed our own medical device production, we decided to implement the principles of a standard specific to medical devices.
Axel Dubois : As a manufacturer, we have to be guided by economic imperatives and a business plan. But that doesn’t mean we forget that our end customers are patients. Safety is our priority. That is why, from the outset, we have developed production methods largely based on voluntary standard ISO 13485. In 2015 we took the plunge and today we are the only enterprise in our market segment to hold this certification.

What are the benefits?
Axel Dubois : Firstly, ISO 13485 gives credence to our venture, which is vital for a startup. Secondly, the standard requires us to adopt a continual improvement approach; this encourages us to question our practices so that we are always at the top of our game. Lastly, certification inspires confidence in our customers. In the field of dental prosthetics, our specialist area, quality and precision are essential. To sum up, it gives us assurances of safety, for the benefit of patients, due to controlled and properly managed processes.
Oleg Levchenko : With this management system, we will improve the quality of our products and provide satisfaction for our customers. The official certification gives us competitive advantages in the market since it is recognized proof of the quality of our production. In addition, the certification greatly facilitated our obtaining the licence to manufacture in Russia.

What has changed in practice for your company and your activities?
Oleg Levchenko : In particular we have changed how we manage measurement. If we detect a nonconformity in a measuring method, then products already measured must be checked again, more meticulously. This is a procedure we have put in place but which fortunately we have not yet had to use. Another example: communications with customers and statutory authorities are now more detailed and more closely monitored. These are on the whole adaptations of what we were already doing, helping us continually improve and strive for excellence.
Axel Dubois : We have also revised our processes as regards nonconformity. Previously, when a prosthesis did not conform we would manufacture it again. Now we have improved traceability and keep computerized records of all nonconformities, descriptions of them and their source. In this way we will be able to obtain statistics to help us identify the stages when problems appear, so that we can correct them and anticipate as regards the relevant investment to be made.

And internally, how has the approach been perceived?
Axel Dubois : We organized training sessions to raise awareness among existing employees and we ensure that all new recruits are aware of the importance of these issues, for our patients and for our business. This approach is fully understood and integrated by everyone. Our teams take pride in seeing the quality of their work rewarded. This quality label adds value for us all!


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