AbroadLink Translations adds the ISO 13485 and ISO 17100 certifications to ISO 9001

Our quality system based on ISO 9001 was five years old last November, so it was a good time to continue moving towards a deeper quality management and audit of our processes. Since the end of last year, our quality manual contains the procedures that have enabled us to successfully overcome the audits of the ISO 13485 and ISO 17100 certifications.

Why a Medical Device Quality Standard in a Translation Company?

The ISO 13485 standard deals with the quality management of medical devices. In its nature and origin is a standard intended for manufacturers of medical devices. Why then is a translation company like AbroadLink Translations certified in this standard? At AbroadLink we are convinced that translations of medical devices carry a potential risk to people's health. It seemed a natural step in our development as a company to go one step further to assure our clients of our commitment to medical and healthcare translation.  The audit of translation management processes in this key area, which directly or indirectly affects all of us, is a sign of this commitment.

Among the different aspects included in this standard, translation is also included, recognising this quality system the vital importance that translations can have in the particular case of medical devices and the need for medical device manufacturers to specify a procedure for managing their translation requirements.

As a translation company, the vast majority of the procedures required by the ISO 13485 standard are not applicable to us, but the procedure that describes our translation process when we translate for clients who manufacture medical devices. With this standard, AbroadLink Translations has had the opportunity to define a specific procedure, which is particularly demanding with the verification of the veracity of the translators' CVs, their professional references and their specialisation within the medical field.

What Is So Special About The ISO 17100 Standard For Translation Services?

Most of our clients are unaware of the ISO 17100 standard for translation services. As its name already indicates, it is an exclusive standard for translation services and is currently the most demanding standard in relation to translation. It is a 2016 standard, although its history goes back to the ISO 15038 standard on translation services, which officially replaces. The ISO 17100 standard represents a slight improvement over the replaced ISO 15038, developed by translation professionals and released in 2006. The ISO 17100 standard clearly details how a translation should be managed: from the record system to be kept, the minimum requirements to be imposed on translation professionals (e.g. translators and proofreaders) as well as the quality process to be carried out. 

A particularly important element that details the standard and is a condition for a translation to bear this seal of quality is that all translations must be proofread by a second translator who acts as proofreader and certifies the quality of the translation by re-reading the source text and the translation to verify that there are no omissions in the translation or errors of meaning, grammar, spelling, formatting and that the conventions of the target language are followed as well as the specifications of the project.
It is not in vain that it is becoming more and more common for tenders for translation services from national and international organizations and institutions to require compliance with this standard in their specifications.

In the international translation market, many translation companies offer their clients translation jobs without a revision. This is explained by the fact that an ISO 17100-compliant translation costs between 30 and 40% more, which leads many companies to opt for a translation-only process in order to meet their translation budget. 

The adaptation of our quality manual to the ISO 17100 standard has been relatively straightforward. During the implementation of the ISO 9001 standard in AbroadLink Translationjs, the old ISO 15038 standard on translation services was taken as a reference.

From TUV Rheiland To Bureau Veritas

Another of the changes incorporated by the renewal of the ISO 9001 standard is that we decided to change the certifying entity after 4 years. This change does not really have to do with the certification process itself, but rather with the assessment that AbroadLink's marketing team has made of the trademarks of the different certifying bodies, opting for the French certifying body Bureau Veritas in this new certification stage that opens with the incorporation of the ISO 13485 and ISO 17100 certifications.