Our ISO 13485 quality standard celebrates its second birthday

Last November, AbroadLink Translations passed the follow-up audits with Bureau Veritas for ISO 13485, ISO 9001 and ISO 17100.

Our management system based on the ISO 13485 standard is a mature system that is eight years old this year, although in the spirit of the standard it is constantly evolving in search of improvements to the system. In this regard, a significant improvement over the past eight years has been the introduction of indicators that have allowed us to improve the system's sensitivity to the management quality.

The first ISO 13485 and ISO 17100 implementation audits at AbroadLink Translations took place in November 2018. One of the most relevant improvements that the auditors have made to our ISO 13485 standard in the last two audits has been the need to receive the academic accreditations that justify the classification of a translator as ISO 13485, i.e. that the translator meets the requirements set out in our quality manual for ISO 13485.

This measure is intended to ensure the accuracy of the information contained in the translator's curriculum vitae. Although the standard does not specify that this is necessary, the spirit of the standard emphasises the control of suppliers by standard holders.

The implementation of the ISO 13485 standard at AbroadLink goes beyond the requirements of the standard to provide correct and reliable translations. Through this standard, AbroadLink Translations makes a commitment to its clients to only use translators with training and specialisation in the field of medical translation.

In this sense, when we issue a translation under ISO 13485, the translators we use are specialised in medical translation, which is accredited by having specific training in medical translation (for example, having studied for a master's degree in medical translation) or having studied medicine, physiotherapy, nursing or veterinary medicine with experience in translation.