ISO13485 certified translation vendor standards and Localization

ISO Standards in Translation

I was recently contacted by one of my clients who informed me that he was approached by a competitor of mine taunting the benefits of ISO13485 translation certification. This vendor stated that “Our Notified Body-endorsed risk management methods can help you eliminate the effort and expense of overseas distributor review”. They also proceeded to inform my client that they are “the only ISO13485 certified translation vendor in the entire world!”

I can understand how a company tries to create a differentiator to win business. But I cannot see how developing a quality management system, policy or document can dismiss the client’s expert input on the translation without lowering the product’s final quality.

So I spent some time while on vacation reviewing write-ups on the ISO13485 standard and the article that our competitor forwarded to our client, which was authored by the president of their company.

In my research I could not find anything specific in the standard regarding the translation and localization industry or any recommendations on eliminating in-country client input. The standard is mainly targeting medical device manufacturers and their suppliers (typically manufacturers also).

When someone says “Our Notified Body-endorsed risk management methods can help you eliminate the effort and expense of overseas distributor review”, it is obvious to me that they have no clue to the complexity of the work localization vendors and their clients do and the value of in-country feedback. In Control Theory, the first thing we learn is the importance of a feedback loop and how without it a system becomes unstable.

The author of the submitted article himself admitted that “certification to ISO 13485 is not necessarily a guarantee of competence”. His main emphasis in the article is on parity and risk management.

Furthermore, if the standard is so important for translation, how come only one translation company in the world (which sold out to another company in 2005) has adopted it and no one else did? A few weeks ago I attended the Association of Language Companies conference and it seems that they are pushing for a different industry standard: ASTM F2575-06, which specifically addresses translation quality and standards.

At GlobalVision our translators amass significant amount of knowledge about our clients’ products and their in-country reviewers’ requirements that no standard or process can replace. We constantly depend on our client’s in-country’s experts input to improve our quality and better meet our clients’ needs.

Standards still have their purpose. Companies that require vendors to comply with standards are out there and the vendors that service them will diligently comply to win their business. But for a vendor to impose a standard on a client was until now unheard of! How desperate can a translation company be?