The general standard ISO 9001 sets out the criteria for a quality management system (QMS), and applies to all fields of activity. Companies acquire this certification to demonstrate their commitment and ability to provide, products and services that consistently meet the needs and expectations of their customers.
The ISO 17100 standard applies specifically to translation services and, in 2015, it replaced the European standard UNE-EN 15038. The provisions of this standard establish the competencies and qualifications that translators, revisers and other professionals working in this fields must have. It also establishes the basic principles of the framework for collaboration between organizations, providers, and customers in such a way as to ensure the optimum quality of both the product (translation) and the service, and the relationship between stakeholders.
The ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This standard relates to risk analysis and management for each translation project in such an important field as health, where a single error could have serious consequences for the user.
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