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What is ISO 13485?ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. While it remains a stand-alone document, ISO 13485 is based on ISO 9001 with some additional clauses as well as the removal of some requirements. Read compare ISO 9001 & ISO 13485 ISO 13485 requires more attention to regulatory requirements and the exception of 9001’s requirement of continuous improvement. ISO 13485 only asks for the QMS to be implemented and maintained. For more information on ISO 13485 please see our tutorial: Basics of ISO 13485 which covers:
Comparing ISO 9001 to 13485 compares ISO 13485 to ISO 9001, and outlines their: To learn more about the Medical Device terminology, please view: ISO 13485 Definitions which covers the various classifications of medical devices across the globe. |
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