Our Quality Manual turns 10 years old with ISO 9001!

Our Quality Manual based on the ISO 9001 standard will celebrate its 10th anniversary in 2023. Although it was initially structured on the basis of ISO 9001, in 2019 it incorporated the ISO 13485 standard for the healthcare technology sector and the ISO 17100 standard for translation services. Today we can say that we have a mature system that has been improved over the years and thanks to the audit reports.

What benefits brings to AbroadLink having a Quality Manual?

Although initially the motivation behind achieving the ISO certification were more related to the company's commercial and marketing strategy, the processes introduced at AbroadLink to get compliance with the ISO 9001 standard have taken root over the years, going from considering the standard itself as an administrative burden on operation to placing value on it as a real system for quality control and targeting customer satisfaction.

In this sense, the greatest value that compliance with the Quality Manual incorporated into the company's activity was the preparation and implementation of a customer satisfaction survey, which is a great indicator of the level of satisfaction. By incorporating the survey, we have been able to detect both an optimal level of satisfaction and incidents in projects that would probably have been hidden without this process.

Another key element that has evolved over the last 10 years is the creation of indicators to monitor quality-related processes. Key indicators include survey scores as well as supplier evaluations carried out for each translation project.

How has our QMS improved over the last 10 years?

The implementation of a quality management system requires the engagement and training of all actors in the company. Finally, an QMS is a tool that has to be used and refined. Among the improvements that have been made over the last few years based on the audit reports of the certifying bodies, we can highlight the following:

• Refinement of the scale of values for supplier evaluation;
• Creation of indicators more focused on quality rather than on economic aspects;
• Automatic generation of indicator reports directly from our management system;
• Level of training and engagement of the company's employees;
• Incorporation of industry-specific quality management standards: ISO 17100 for translation services and ISO 13485 for medical device manufacturers.

Integration of ISO 17100 and ISO 13485 standards

One of the most significant milestones during these 10 years was the incorporation in 2019 of two industry-specific standards that were fundamental to continue evolving as a company and to demonstrate our commitment to quality. Thus, in 2019 our Quality Manual was modified to adopt ISO 17100 for translation services and ISO 13485 for medical devices.

Adopting the ISO 17100 standard for translation services was a necessary step in the development of our business as a translation company. At the operational level, this was a step that had been foreseen from the outset, so the principles expressed in this standard had already been used in the creation of the Quality Manual, but it was from that moment that we were able to certify our clients the projects that followed the principles of this standard. Most important is the fact that the standard prescribes as mandatory a translation and revision process carried out by two different professionals.

In relation to ISO 13485, it was a natural step in reaffirming our commitment to a broad part of our customer portfolio dedicated to the manufacture of medical devices and in-vitro medical devices. The interpretation and implementation of this standard in our translation services implied stricter criteria than those foreseen in the ISO 17100 standard for the selection of providers. Those linguists are assigned to the most specialised projects in the medical field and with high risk classifications.