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ISO 13485:2016 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. It is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.
ISO 9001 is the most widely adopted Quality Management System (QMS) standard. It is used by organisations worldwide to demonstrate that the products and services offered by them meet the customer and regulatory requirements. To support organisations in demonstrating their compliance towards this important standard, TÜV SÜD offers ISO 9001 Quality Management System (QMS) Certification along with a range of training programs.
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