When it comes to compliance, OmniLingua understands the challenges our clients face.
Our core principles are built on quality and continuous improvement—as evidenced by our successfully meeting the requirements of the following independent certifications since 2009. OmniLingua has been certified by, and continues to be audited by, TÜV SÜD America.
Read more about our past audit results demonstrating our strong commitment to compliance.
ISO 9001:2015 Quality Management Systems
This quality foundation requires a defined approach,
a quality
manual, standard documented processes,
and a direction for continuous
improvement. This aligns very closely with OmniLingua’s
focus on performance
achievement
and less on prescribed methods of operation.
ISO 13485:2016 Medical Devices Quality Management System
Medical device, Pharmaceutical and Clinical translation projects
require the highest level of accuracy and consistency. OmniLingua’s quality
standards and manuals are congruent with those of our Life Sciences clients who
need to demonstrate ability to provide medical devices and related services
that consistently
meet customer and regulatory requirements.
ISO 17100:2015 Translation Services
This is a new global standard, which as of November 2015 supersedes the European standard EN 15038. It outlines the requirements for the core processes and resources necessary for the delivery of a quality translation service that meets client specifications, industry codes and best-practice guides or legislation.
FDA-Related Compliance
With nearly 75% of our clients in the Life Sciences industry, OmniLingua is committed to compliance with 21 CFR Part 11, where appropriate, in order to ensure patient data confidentiality.
Export Compliance – ITAR
Abiding by domestic and international regulations on behalf of our Manufacturing and Defense clients is of utmost importance. For example, OmniLingua is registered with the Department of State and is authorized through licensing to engage in the business of manufacturing and exporting products, services or data which are regulated under the Arms Export Control Act (AECA) and International Traffic in Arms Regulations (ITAR).
