Robust ISO Standards for Quality Systems and Risk Management
Professional and reliable
As a pioneering leader in the language solutions industry, Merrill Brink has achieved success by focusing on business practices that build a foundation for excellence:
Robust ISO Standards for Quality Systems and Risk Management
Merrill Brink International is committed to quality and risk management. We are one of the few language service providers in the world to be certified to ISO 13485:2003 and ISO 9001:2000 and registered to ISO 14971:2007. Together, these standards provide assurance that the most stringent process and quality standards for translation are followed.
Our clients are increasingly being asked to audit their outsourced suppliers and the cost of this can be significant. These costs can be reduced or eliminated by collaborating with a language service provider that is certified and registered to quality and risk management standards such as ISO 9001:2000, ISO 13485:2003 and ISO 14971:2007.
Our quality and risk management systems have resulted in efficiencies that are used to process every translation project. These efficiencies can save our clients substantial time and money, as well as expedite their product’s time-to-market.
ISO 9001:2000 Certification
Merrill Brink’s quality management system is ISO 9001:2000 certified and we were the first language service company to achieve ISO certification in 1999.
ISO 9001:2000 is an internationally-recognized standard for establishing a business management system. ISO 9001:2000 is applicable to any manufacturing and service organization and provides a focus on system performance and ongoing improvement. Merrill Brink has maintained certification to this standard since 1999, proving that our quality system processes are defined, measurable, repeatable and constantly being inspected and refined.
ISO 14971:2007 Registration
Merrill Brink is one of the few language service providers in the world that is registered to ISO 14971:2007. This internationally-recognized standard ensures that all aspects of risk management are considered throughout the product lifecycle for medical devices. ISO 14971:2007 ensures that all hazards are identified, evaluated and controlled and also monitors the effectiveness of these controls. Merrill Brink has applied this standard to the translation and desktop publishing of technical documentation for our life sciences and medical clients.
ISO 13485:2003 Certification
Merrill Brink is one of the few language service providers in the world that is certified to ISO 13485:2003. ISO 13485 is an internationally-recognized quality systems standard that requires an organization to demonstrate its ability to comply with customer and regulatory requirements. ISO 13485:2003 is applicable to organizations that manufacture private label medical devices, in-vitro diagnostic medical devices, and medical components. Merrill Brink has successfully applied this standard to the translation and desktop publishing of technical documentation for our life sciences and medical clients.
Quality services and responsive service
Our mission to provide high-quality, professional language services to our clients is second to none. Equally important, we’re a reliable, financially stable, committed partner. Whatever the project, our clients know they can count on us for superlative results, year after year.
Have an immediate translation need or question? Contact us today at 800.688.4400 (US), 353-91-771171 (Europe) or translations@merrillbrink.com.