Overall, the standard is tailored to meet both the industry standards for medical device quality management, as well as, customer and regulatory requirements. It is designed to help organizations develop, establish, and maintain quality management systems that facilitate consistent and effective development, design, production, etc. ISO 13485 is derived from the ISO 9001 quality management standard, and modifies its process-based approach for the regulation of medical device manufacturing. ISO 13485 is an International Organization for Standardization (ISO) standard originally developed in the 1990’s, that consists of requirements for a Quality Management System (QMS) for designing and manufacturing medical devices.
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