;   Medical Translation Insight: Goodbye EN 15038, hello ISO 17000 - ForeignExchange Translations

Goodbye EN 15038, hello ISO 17000

Goodbye EN 15038, hello ISO 17000 (medical translation)
Medical translation companies' quality systems are typically certified to ISO 9001 (or other industry specific ISO standards such as 13485, 14971). However, there has been an absence of translation-specific ISO standards. EN 15038 was published in 2006, and has been widely accepted by translation companies, in an effort to fill this gap. Now ISO 17100 is scheduled for release in late 2014 or early 2015, and it is intended to act as the international version of EN 15038 and replace the old standard.

There are some differences between EN 15038 and ISO 17100 but they are fairly minor. For anyone certified to EN 15038, the migration to the new standard should be seamless. Medical translation providers will have three years to migrate to the new ISO 17100, if they are already certified to the EN 15038 standard. This will allow time for registered bodies to prepare to complete audits against the new standard.

It's important to note there are more extensive differences with the U.S. standard ASTM F2575, which could present challenges to those not already certified to EN 15038. Also, the other ISO standard in the translation realm to be aware of is ISO/TS 11669, which was released in 2012. ISO 11669 is a technical specification (not a full standard) and standardizes the description of translation projects. Its intent is to provide buyers and suppliers with a framework in which to define quality requirements and to effectively manage translation assignments.

Importantly, actual translation quality is not defined in EN 15038, ISO 17100, or ISO/TS 11669. Medical translation providers will need to continue to find other sources to define their target translation quality levels. Some options include SAE J2450 (specific to the automotive industry), ForeignExchange's METRiQ (specific to the medical device and pharmaceutical industries), or even the old LISA QA model.

For more information on translation quality measurements, check out our new book The Definitive Guide to Measured Translation Quality.

ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.


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