Quality Assurance Processes
Excel Translations has established, documented, and maintains Quality Assurance Processes to ensure a quality program that supports its efforts to provide customers with quality products and services. Excel Translations' quality strategy is based on the following principles:
- Excel maintains a documented Quality Management System designed to meet the requirements of ISO 9001:2008, ISO 13485:2003, ISO 14971:2007, EN 15038, and ASTM F 2575-06. It is through the implementation of this Quality System that Excel Translations' Quality Policy commitments are realized.
- Through the use of documented and repeatable processes, quality plans, corrective and preventative actions, internal audits and effective management reviews, Excel Translations strives to provide the necessary tools and skills for its employees to continuously make improvements in the quality and consistency of products and services.
Quality System Documents
- The procedures and documents that make up the Quality Management System are defined and described in Excel Translations Quality Manual.
- These documents collectively define a Quality System that complies with ISO 9001:2008, ISO 13485:2003, ISO 14971:2007, EN 15038, and ASTM F 2575-06 and identifies the methodology for implementing the company's quality policy commitments.
Quality System Implementation
- All Excel Translations personnel who manage, perform, and verify work that affects quality are responsible for implementing the company's quality system.
- Implementation of the quality system is assessed regularly by way of internal and external audits and management review.
- Excel Translations' requirements for quality are met by documenting specific procedures, practices, tasks and activities for all production and production-supporting processes. Implementation of and adherence to these documents guarantee quality products and services. The quality documentation includes meeting contractual requirements, understanding and meeting customer needs with emphasis on problem prevention.
- Changes to the quality system are made as needed. Written quality and audit plans are prepared for these changes, which will be consistent with all other requirements of the company's quality management system.
We work with each client to ensure that our ISO processes are appropriate to their requirements and internal processes, in many cases customizing process flows to a client's special needs.