ISO 13485:2016 - Medical Devices - Quality Management System

ISO 13485 is an international standard by ISO (the International organization for Standardization) for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. 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 and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The benefits for ISO 13485 Certification are

  • Endorse Organization commitment on Quality Management by effective quality management system to provide medical devices and related services.
  • Continual Improvement
  • Increased customer confidence, the community, employees and the Authorities
  • International Recognition of Certification improve organisation image and reputation
  • Advantage over business competitors


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