Should You Require ISO 13485 for Your Medical Translation Company?
If you work in the medical device or healthcare industries, you may be required to translate content, such as user documentation, user interface and software, research documents and marketing materials, in order to sell your products in international markets. Each country has its own translation requirements and regulations are always changing and evolving, which makes it tricky to manage. Even in the European Union, there isn’t one standard – that’s why it’s important to partner with a translation company that specializes in medical translations.
The ISO 13485:2016 Standard
ISO has a standard, ISO 13485:2016, that defines the requirements for a quality management system (QMS) for those companies that are in the medical device industry. ISO 13485 outlines obligations for manufacturers to monitor and control their own internal processes and also their outsourced processes that affect their product quality. This is where translation and localization companies come in. If a medical device manufacturer outsources their translation process, the manufacturer must be accountable for their supplier.
Is it required for a company who provides outsourced services, such as a translation company, to have the ISO 13485 certification? Obtaining the certification is voluntary for these types of outsourced services. However, many medical device companies and / or markets may require it. In addition, it’s important to note that each branch of the translation company must be certified so be sure to understand what this means for your business needs. Even if you don’t have specific requirements, it’s still a good idea to work with a medical translation company that has the certification, and we’ll briefly describe why in this blog post.
A Commitment to Clients in the Medical and Healthcare Industries
If a translation company is going to apply to obtain the ISO 13485 certification, it shows the level of commitment a company has to serving the medical and healthcare markets. If a translation company doesn’t have the certification, chances are that they don’t work with one of the big medical companies since most of them do require it from their suppliers. Since obtaining the certification is voluntary, it should make clients feel secure and confident that the company is committed to the medical industry’s quality standards.
Companies Must Have Thorough Quality Processes
A quality management system refers to the planning, processes, resources and documents to achieve your quality objectives. A QMS can improve processes, reduce waste, lower costs, optimize resources and more. A translation supplier with the certification should have a solid understanding of clients’ quality needs and be able to implement the requirements since the quality foundation is already in place. To obtain the ISO certification, and to recertify, you must have good management and quality practices. This is the case to obtain any ISO certification, but it’s even more stringent with the ISO 13485 certification.
Infrastructure Is in Place to Create High-Quality Medical Translations
A translation company with the ISO 13485 certification should have a solid infrastructure in place. At Net-Translators, we have a network of professional, human translators living in our clients’ target countries in order to deliver the highest-quality translations. Since the medical industry has so much specific terminology, it’s critical to have translators who are experienced in the medical industry.
Translation Tools and Technologies Make Processes More Efficient
One of the benefits of having a QMS is that it makes processes more efficient, and translation tools help make that possible. Here at Net-Translators, we use internal tools such as a glossary management tool to manage all the specific terminology in the medical industry and a translation memory to manage all the content. We also have automated QA verification tools that we use on the translated content to verify terminology and validate content per established rules.
Other Certifications that a Medical Translation Company Should Have
In addition to ISO 13485, it’s beneficial for a medical translation company to have the following two ISO certifications:
ISO 9001:2015 is an internationally recognized standard that specifies requirements for a quality management standard. It’s intended for any type and size of business.
ISO 17100:2015 is designed for translation providers. It provides requirements for things like processes, resources and other things necessary to provide high-quality translations.
If you’re a company from the healthcare or medical device industry, your vendor will have all three of these certifications because it shows their commitment to high-quality translations, solid internal processes and expertise in the medical industry.
Conclusion
Having the ISO 13485 certification provides clients with the confidence that the language service provider is committed to the medical and healthcare industries as well as high-quality translations.
Net-Translators specializes in localization services for the medical device and healthcare industries. Our reputation for thoroughness and quality, the three ISO certifications and extensive experience working with medical industry leaders make us unique in our ability to deliver language services of the highest quality.
For additional information, I invite you to reach out to the office nearest you and to follow our Medical Translation and Localization LinkedIn Showcase page.
