Definition
ISO 13485 is an international standard specifying requirements for quality management systems used by organisations involved with medical devices.
Human Explanation
It defines management-system requirements for organisations that design, manufacture or support medical devices.
Why it Matters
It supports consistent quality and the fulfilment of applicable customer and regulatory requirements.
Conceptual Boundary
ISO 13485 does not prescribe every technical process or guarantee that a product is safe. It defines requirements for the quality management system.
Practical Perspective
Validation, Risk Management and controlled Documentation must be integrated into the organisation's applicable quality processes.
Related Concepts
Official Source
ISO 13485:2016 — Medical devices — Quality management systems