IAS is providing the service of ISO Certification audits for various international standards. Out of these Standards, ISO 13485:2016 certification specifies the requirement of Quality Management System of Medical devices/equipments that consistently meet the Customer and applicable regulatory requirement. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device/equipment.
ISO 13485 is generally harmonized with ISO 9001 and the basic difference is that ISO 9001 requires Organization to demonstrate continual improvement whereas ISO 13485 requires an Organization to demonstrate the quality management system for medical devices is effectively implemented & maintained.
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