ISO Compliance Processes

Excel Translations is dedicated to the proposition that quality does not exist without rigorous systems — systems that are not merely effective, but are documented, measurable, and auditable. Our Quality Management System is uniquely designed to meet the requirements of ISO 9001:2008, ISO 13485:2003, ISO 14971:2007, EN 15038, and ASTM F 2575-06.

Tracking & Measurement

Unlike other translation companies, at Excel Translations we don’t just talk about quality, we measure quality. A key to our Quality Management System is careful tracking of defect and performance data. Within the framework of our ISO-certified translation processes, Excel Translations’ clients have the ability to raise non-conformances. Excel Translations monitors reported non-conformances per project, per client, and per document.

The Excel Translations team reviews quality data as part of its continuous improvement initiative. The data is also reviewed during periodic meetings between our clients’ project managers and Excel Translations, and clients have found the regular quality updates submitted by Excel Translations to be helpful in tracking their own improvement goals.

Control & Supervision

At the heart of our Quality Assurance Process is a double-check mechanism. Simply put, every action is double-checked by a second person, following defined procedures and authorization levels. Though deceptively simple, the logistics of organizing a double-check procedure are daunting.

For example, a ten-language project containing three documents may undergo seven actions. That totals 210 discreet tasks (10 x 3 x 7) to be performed and checked! Excel Translations’ process builds in a sophisticated infrastructure to organize this effort, ensure completion of each action, and collect data, thereby assuring that the final deliverable matches the expectation set forth in the initial project planning.

Compliance Translation Certification

Given the strict regulatory requirements and high quality standards that companies in compliance-intensive industries face on a regular basis, Excel Translations has developed its own translator testing, translator screening and translator certification / qualification program. This demanding system ensures that linguists:

• Are professional medical translators and editors, working in their natives languages;
• Possess significant experience in their field of specialization and are subject-matter experts;
• Pass a rigorous translation screening and translation testing process; and
• Receive feedback on the quality of their work on a continuing basis.