ISO certifications are already a strong indicator that a business has high quality standards. But if a translation agency is certified to a standard as comprehensive as ISO 13485 for medical devices, that shows they’ve gone even further: they’re specialists! Andrea Gutwein explains the everyday reality of quality management at an ISO 13485 certified translation agency.
As a translator who previously worked as a technical editor, how did you end up being responsible for quality management at a translation agency?
The boring reason is that I’m a perfectionist, and that’s ideal for working in quality management. I studied interpreting and translation in Madrid, and I also did a Master’s in translation in Geneva, and that all comes together for my job as a quality manager – by nature I care about quality, and I can apply my knowledge and expertise as a translator and technical editor every day. I handle all quality management issues at MEINRAD, whenever and wherever they occur.
MEINRAD is certified to the ISO 13485 medical device standard. Is that normal for a translation agency?
I wouldn’t say it was “normal”, as translation agencies don’t need to be ISO 13485 certified – we could still serve customers in the medical industry even without ISO 13485 certification. So this certification is something that makes us stand out from many other agencies.
ISO 13485 certification has nothing to do with translation per se. How does it apply to the work a translation agency does?
The operating instructions are considered part of the medical device – so if they contain errors, the whole product is defective. Even though ISO 13485 doesn’t explicitly mention translations, they are nonetheless part of the medical device and so fall under ISO 13485’s remit.
Choosing to get ISO 13485 certification says a lot about a translation agency’s priorities. It shows that MEINRAD has a clear focus on the medical sector and that we will go to great lengths to meet its requirements. And of course, we put quality first. Everyone here documents what needs to be documented, everyone knows where to find the information they need, and everyone is audited. So quality isn’t a sideline – it’s key to what we do. As a quality manager, it’s extremely rewarding to see that an awareness of quality is reflected in the company’s values and has been absorbed by all our staff, who are passionate about living up to our high standards.
Why did MEINRAD decide to get ISO 13485 certification?
Certification is reliable evidence that quality is the top priority for a business. MEINRAD has always set great store by high-quality service, with or without certification. But our CEO Eva Reiterer thought: “If we already work in accordance with these high standards, why not get official recognition from a certification body to prove it?” So MEINRAD decided to get ISO 13485 certification.
Is getting certification like this something you can do as a sideline to your everyday work?
[Laughs] No, absolutely not! There’s so much work involved at the start. Even though we already worked in accordance with stringent quality standards such as ISO 17100, we had to do a lot of preparation. The certification process starts by producing a huge, comprehensive handbook which documents all processes, forms, procedural instructions, validations and so on. Although we of course already had a quality management handbook for ISO 9001 and 17100, we expanded it into an all-round quality management system which helps us work much more effectively as a team across the various areas of our business. ISO 13485 is one of the most complex certifications to get, and anyone who has been a quality manager will know the amount of effort that goes into it. And it isn’t just a one-off thing: internal and external audits are carried out on a regular basis, and the QM system needs to be kept up to date at all times. We also set ourselves quality goals for each quarter in all areas of our business to ensure we continue to optimize our workflows. Once you decide to work in accordance with ISO 13485, quality management is a constant part of what you do – and that goes for every single department.
And what about your everyday work? What has ISO 13485 certification changed a) for clients b) for MEINRAD as a translation agency and c) for you as a quality manager?
- Clients benefit from knowing that they don’t have to carry out a mandatory supplier audit for us as their translation agency. ISO 13485 stipulates that all suppliers must be carefully selected and evaluated. If a translation partner doesn’t have its own quality management system that complies with ISO 13485, clients have to provide binding specifications for the procedures involved and carry out regular audits to ensure compliance. The only way for clients to avoid these audits is if the translation agency has an ISO 13485 quality management system and can produce the necessary documentation. So choosing an ISO 13485 certified translation partner will save clients a lot of work.
- The main consequence of getting certification is that you are required to adhere to strict quality standards at all times, and across all departments. This doesn’t just affect the translations themselves: it also applies to localization engineering, accounting, marketing and all other areas of the business. So awareness of the importance of high-quality service is an essential part of the work everyone at MEINRAD does. Everyone knows the promises we make to our clients, and they work hard so that we live up to them – providing high-quality service and unbeatable client support is our top priority.
- Personally, it means that I scrutinize everything even more closely, and I am constantly trying to identify where we need to optimize our workflows and how we can do that. Every day my focus is on fine-tuning processes and developing ways to fix and prevent any issues we may be having, and I try to pour my passion and commitment to quality into what we do as a business. And if my perfectionism proves infectious, all the better!
How does ISO 13485 relate to the MDR?
Fundamentally, they’re two different things: one is the EU’s Medical Device Regulation and the other is the international ISO certification. But if you look more closely, they have the same aim: high quality and comprehensive safety for users of medical devices.
What role does the FDA play in all this?
The FDA (Food and Drug Administration) is a federal agency of the United States Department of Health and Human Services. It regulates the safety and effectiveness of all drugs used in human and veterinary medicine, so as you can imagine, it has stringent quality standards. The main aim of the MDR is to enable free trade and commercial use of medical devices within the EU while ensuring that all products are safe to use and meet quality standards. In simple terms, businesses that value high quality and are prepared to invest time and money in it won’t have any problems getting FDA approval, complying with the MDR or securing ISO certification. Think of them as roadmaps for high-quality products.
Let’s move on to another issue: what do you think about the use of machine translation for medical technology?
From a quality management perspective, there’s a certification that focuses on this exact issue: ISO 18587. Agencies with that certification are experts in what machine translation can do and what it can’t, and most of all they know that what applies today could easily become obsolete by tomorrow.
Generally speaking, I don’t think there are any problems with using machine translation for medical technology. The medical sector produces a wide range of texts, after all, and machine translation is just as suitable for many of them as it is for other sectors such as software or mechanical engineering. Essentially, machine translation is suitable for use every day – provided it’s used correctly – and we’re constantly testing it. I don’t have any hesitation in recommending machine translation for medical technology, as long as the texts are suitable and the output is reviewed by qualified post-editors (a process called full post-editing). If all these requirements are met, machine translation can produce outstanding results for medical texts, like it does in other sectors. Just make sure your translation agency has obtained special dispensation from the machine translation provider first.
Main image: © MEINRAD
