Risk Management Professional

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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 certified to ISO 9001:2008, and also certified to ISO 27001:2005; registered to EN 15038:2006; certified to ISO 13485:2003, and registed 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.
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.

What is ISO 9001:2008
This international standard applies documented processes and procedures to assist in maintaining a Quality Management System. This standard is the basis for Merrill Brink’s Quality Management System and is intended to help us provide quality and conformity to meet our customer requirements on a consistent basis and to promote continual improvements. Merrill Brink conducts annual surveillance audits by an outside agency to ensure compliance.

What is ISO 13485:2003
ISO 13485 is based on ISO 9001 with a focus on the design, development, production and installation of medical devices and related services. This standard emphasizes “maintaining” effectiveness of processes, rather than the “continual improvement” that is stressed in ISO 9001. Requires more documentation, monitoring and measurement of data, risk management processes, stresses the need to “maintain effectiveness” of the system.

What is ISO 14971:2007
This international standard provides a process to ensure that all aspects of risk management are considered throughout the lifecycle of our translation service for medical devices. It complements the ISO 13485 standard described above. We must identify the hazards associated with our translation service to medical clients, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. The requirements of the standard apply at all stages of our service’s life cycle – from project initiation through post-production – with a goal to reduce risk in our medical translation product.

What is ISO 27001:2005
This international standard specifiies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving a documented Information Security Management System. It is designed to ensure the selection of security controls-such as entry cards, document shredding, password management and so on-that protect information assets in our company.

What is EN 15038:2006
This is a quality standard developed by the European Committee for Standardization (CEN) especially for the translation/localization industry in Europe. It addresses quality management and standards for the translation/project management process; technical resources, client/vendor relations, and requirements for selecting translation resources.

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.

About Merrill Brink:

Merrill Brink International (www.merrillbrink.com) is a leading provider of complete translation and language solutions for global companies and law firms, with special expertise in serving the legal, financial, life sciences, software, heavy machinery and corporate markets. A proven leader with more than 30 years of experience, Merrill Brink offers a wide range of language solutions including translation, localization, desktop publishing and globalization services.
For more information, please contact Merrill Brink, Tel: 800-688-4400; Email: [email protected]; Web: http://www.merrillbrink.com
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