Quality & ISO Certification
Quality & Compliance is Critical To Your Team,
It is Critical to Ours, Too.
Maintained, Measured, Reported & Proven
Measurably Better® Quality
ISO 9001:2015
This quality foundation requires a defined approach, a quality manual, standard documented processes, and a direction for continuous improvement.
ISO 13485:2016
(Ingenuiti Life Sciences)
Medical device, Pharmaceutical, and Clinical translation projects require the highest level of accuracy and consistency. The quality standards are congruent with those of our Life Sciences clients who need to demonstrate the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
ISO 17100:2015
(Ingenuiti Life Sciences)
This global standard 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.
Ingenuiti doesnโt take its quality management system for granted.
Achieving certification has its rewards, but demonstrated and measurable continuous improvement is the ultimate goal. In order to remain a critical partner to our clients, it is important that we participate in formal audits to identify and focus on areas most needing our attention.
Through rigorous internal process audits, client desk and on-site audits and formal regulatory and registrar audits, Ingenuiti remains in a continuous feedback loop, pushing our staff to achieve measurable enhancements across the board. Ingenuiti has a record of no “major non-conformities” in our client audits, and has often been recognized for our best practices.
We are passionate about supporting companies in their training and global communication efforts. Reach out today for a free consultation and we can determine if we are a good fit for your next project!