ISO 13485, compliance with requirements includes compliance with regulatory requirements. Thus, for devices used in the United States to comply with ISO 13485, manufacturers must also comply with the QS Reg. standard. As a regulation, QS Reg. Is often more specific than ISO 13485, particularly in the areas of claims handling, labeling control and documentation. ISO 13485 is structured similarly to ISO 9001: 2000 and is actually 90% the same as the general standard for quality management systems..
ISO 13485 Medical Device - Quality Management System - Requirements for regulatory purposes is a standard of the International Organization for Standardization (ISO) first published in 1996; It represents the requirements of a complete quality management system for the design and manufacture of medical products.
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