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IAS provides ISO Certification audit services for various international standards. Beyond these Standards, the ISO 13485:2016 certificate establishes the requirements of a Medical device/equipment Quality Management System that consistently meets Customer and applicable regulatory requirements. Such organizations may be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation or servicing of medical devices/equipment. ISO 13485 is generally aligned with ISO 9001 and the basic difference is that ISO 9001 requires Organizations to demonstrate continuous improvement whereas ISO 13485 requires Organizations to demonstrate a quality management system for medical devices that is implemented and maintained effectively.sertifikasi ISO 13485

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