Moravia has recently become one of the first companies to achieve the ISO 17100:2015 certification, via the company’s Life Sciences division. We sat down with Andrea Tosovska, Moravia’s project manager who managed the preparations for the certification as well as the audit, to find out about what lies behind this new standard, and how difficult it was to meet the standard’s requirements.
1. First off, why did Moravia Life Sciences decide to get certified to ISO 17100?
ISO 17100:2015 is a new standard, officially published on May 1, 2015, and while it has been in the making for some time, it is only now getting more attention from clients. There was actually no requirement from our life sciences customers to get certified to this standard and to build on our existing ISO 9001 and ISO 13485 certifications.
But as a company, we like to be pathfinders, and so we wanted to be among the first to apply the new standard and achieve certification. We wanted to have the hands-on experience with the new requirements early on and be able to guide and advise others. Another goal was to get our whole in-country life sciences partner base up to speed and compliant as soon as possible.
In general, we anticipate a relatively fast adoption from now on, especially since ISO 17100 is replacing the European standard EN 15038.
2. How much time did it take? What was the overall effort to comply and get certified?
It was relatively fast. It took us only a couple of months to get ready. The key activity was creation of a new Translation Services Manual to incorporate the ISO 17100 requirements, rather than updating our existing manual. But since the new standard builds heavily on EN 15038, to which we had been certified for years, this was relatively straightforward.
3. How did the existing EN 15038 actually help? What are the main differences with ISO 17100 from your perspective?
The core of both standards is identical. ISO 17100 includes more terminology and term definitions, which helps facilitate communication among everyone involved — linguists, clients, SMEs, etc. In general, there is a lot more responsibility on project managers and heavy emphasis is placed on their development. This necessitated additional training to improve some specific competences of our project managers. ISO 17100 covers the competences of other positions as well, but the real focus is on project managers. In this sense, while EN 15038 talks about LSPs being obliged to do something, in ISO it is specifically the responsibility of PMs.
ISO 17100 does not alter our general requirements for translators, nor the way we select and qualify them. Actually, our internal requirements are stricter than those defined in the standards, and have always included the requirement for their SME expertise, for instance. But we did use the new ISO standard to further improve our translation quality control process and the ongoing evaluation and development of translators.
This is all the more important since, in life sciences, we normally work with individual named translators who are known to end clients, so there is a full audit trail with their quality performance as well as training and new competences that they get over time. Importantly, there is now a wider range of requirements defined for linguists, not only translation and quality-related.
But, in general, getting certified to ISO 17100 was no stretch for us, and I assume it will be the same for any other organization that already possesses EN 15038 or ISO 9001 certification.
4. What were some of the major steps in getting ready for the certification?
As I mentioned, we created a new Translation Services Manual and included the new areas such as requirements for project managers. The amount of changes was not huge. But ISO 17100 does have a new structure, so this had to be reflected in the manual.
It’s worth mentioning that ISO 9001 got revised in 2015 as well, to respond to the latest trends, and the structure of ISO standards tends to get aligned; I see a general trend here. While the quality standard had been traditionally more suited and used by manufacturers, it is now better tuned to provision of services. For instance, there is no longer a requirement for a quality manual as we know it today. There is more focus on risk management, and more top management involvement in quality management.
5. Is there anything you recommend adding or improving in any future update of ISO 17100?
The existing standard EN 15038 was indirectly linked to ISO 9001, while ISO 17100 is not. A chapter related to quality management systems was dropped in ISO 17100, so that link is now broken. In my opinion, ISO 9001 is now effectively unnecessary in order to get certified to ISO 17100, but it does help.
We were thrilled that the auditor found no observations or non-conformances for Moravia during his audit, or as he put it, “Sadly I couldn’t find any non-conformances or observations, but there is always next year!”
Which is very true. So please watch this space for our future observations related to standards.
If you’ve implemented and got certified to ISO 17100, what was your experience?