Wrocław, 5 August 2019 — Ryszard Jarża Translations, a language service provider specialised in translation, transcreation and localisation into Polish with a focus on life sciences and technical domains, was awarded the EN ISO 13485:2016 certificate for its quality management system by TÜV Nord Polska.
The EN ISO 13485:2016 standard was developed specifically for organisations in the medical devices sector, and the new certificate confirms Ryszard Jarża Translations’ unique competencies as a service provider for this highly regulated industry. As an ISO 13485-certified provider, Ryszard Jarża Translations joins the exclusive group of LSPs worldwide whose quality management practices are formally compliant with the strict requirements of the medical device standard.
Ryszard Jarża, the company’s founder, commented: ‘With almost 20 years in the market and in-house resources comprising biomedical engineers, biotechnologists and linguists specialised in the life sciences field, we wanted to validate our competencies and tune all the processes we have in place. The decision to apply for the ISO 13485 certificate was thus not a marketing exercise, but primarily a way to document, formalise and improve the way we actually work.’
Alongside the EN ISO 13485:2016 certification, the company is certified for compliance with the more generic EN ISO 9001:2015 standard. As Ryszard Jarża Translations has also held the EN ISO 17100 certificate for many years, the company has now become one of the few ‘triple certified’ language service providers.
Kamila Karkoszka, the company’s quality management representative, says: ‘In order to upgrade our quality processes and make them compliant with ISO 13485, we had to rethink our risk management practices. We now involve all our staff in the process of monitoring and reporting quality risks. We also had to validate our physical infrastructure very carefully, because when it comes to medical devices, shortcuts are completely unacceptable anywhere.’
About Ryszard Jarża Translations
Ryszard Jarża Translations, founded in 2000, is a language service provider offering translation, transcreation and localisation services into Polish. The company, employing in-house translators, revisers and subject matter experts, is able to handle most of its production internally. Ryszard Jarża Translations’ value proposition is of particular interest to importers of medical devices and CROs executing their projects in Poland.
The company’s customer base includes many direct, high-profile corporate
clients, as well as leading multi-language vendors. For more information,
please visit www.jarza.pl
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