Medicine relies on quality. Every medical performance, from a simple drug prescription to conducting the most complex surgeries, must be of the highest possible quality. How can you tell if those working in the field are capable of completing their tasks successfully? A first and important indicator is whether they possess an international quality standard.
Not long ago, our agency obtained the long-awaited ISO 13485 certification for medical devices. This certification represents our commitment to quality and safety, giving our clients confidence that our services meet the highest industry standards. What does ISO 13485 mean, and how does it benefit you as our partner and beneficiary of our translations?
The ISO 13485
ISO 13485 is an international standard specific to quality management systems in the medical devices industry. This standard sets the requirements for a quality management system that demonstrates our ability to provide translations for medical devices and similar services. The certificate was issued by TUV Austria for our agency this May.
Did you know that ISO 13485 is periodically updated to reflect the latest changes and innovations in the medical field? For example, the current version includes stricter requirements regarding risk management and compliance with international regulations.
The importance of ISO 13485 to our agency
For our team, obtaining the ISO 13485 certificate means improving and standardizing our internal processes to ensure the highest quality of translations we can offer. This involves increased attention to detail, more rigorous research, and constantly monitoring the services provided. In short, we make sure that every medical translation project is carried out with precision and in full compliance with the industry standards.
“We are both happy and proud to have obtained this certification, which attests to the high level at which our agency operates. A good quality management system has always been our priority, so now we have become very good friends, so to speak” – Antoaneta Flurchi, manager of the Medical Division at Swiss Solutions.
Why is the ISO certificate so important to our partners
For our partners, the ISO 13485 certification brings several clear benefits:
– It guarantees that our translations for medical devices are always accurate;
– It ensures that the translations comply with international regulations and are of the highest possible quality;
– It provides confidence and assurance that we work according to well-defined and controlled procedures, reducing the risk of errors at any step of the translation process.
According to a study conducted by the International Organization for Standardization, companies with ISO certification have a 20% higher customer satisfaction rate compared to those without one. This is largely due to improved processes and increased attention to customer needs. Ultimately, this is what matters most, more than any piece of paper or certificate.
Our previous ISO certifications
In addition to ISO 13485, our translation agency is certified with other global standards, such as ISO 9001 for quality management and ISO 17100 for translation services. These certifications reflect our ongoing commitment to providing high-quality services for every translation, as well as continually improving the processes we use on a day-to-day basis.
We are proud to have received the ISO 13485 certification, and determined to continue offering top-quality medical translation services, while adhering to these international standards. If you are ready to revolutionize medicine with one of your products or services and need translations, send us an email and we’ll take it from there.
