We are all familiar with the multilingual instructional documents that come with many of the products we buy. These translations are usually ignored as we fumble through for the information we need at the moment. In the case of translation and localization for surgical devices, manufacturing machinery, and the software that accompanies them, having strict standards in place is very important due to the many nuances and subtleties each language has and only those who are fluent are familiar with. These standards ensure that the translation process follows a set of rigorous quality assurance procedures. These procedures need to be the cornerstone of all work carried out by a translations firm.  A medical translations firm should be ISO 9001 certified with the following key ISO 9001:2008 sections governing their quality assurance processes.

ISO 9001 Certificate


Sections of an ISO 9001 Certification

Section 5 deals with management responsibility.  A translation firm's vision, policies and strategic objectives need to be built around customer focus, process approach, and continual improvement.

Section 6 is all about Resource Management.  A translation firm allocates and directs its resources –personnel, infrastructure, information, partners, finances – for the operation and continuous improvement of its production process, as well as the full satisfaction of its customers.

Regarding Section7 -Product Realization, the quality Management system ensures the effective and efficient operation of linguistic and supportive processes, which provides it with the capability to satisfy its customers.

And finally, Section 8 — Measurement, Analysis & Improvement, the Measurement data from the execution of projects is important in making fact-based decisions. Here, a translation firm ensures the effective and efficient measurement, collection and validation of data to ensure its performance and the satisfaction of its customers.

Many companies are ISO 9001 certified these days; however, it is not the label alone that is important.  It is how a company has a documented Quality Management System designed to meet the requirements of ISO 9001:2008.  In addition, it is how that quality management system is applied and benefits their clients they serve.  A translation firm works with each client to make sure that their ISO 9001 certified process, among others, is appropriate to their requirements and internal processes, in many cases customizing process flows to a client's special needs.