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ISO 13485

Definition

ISO 13485 — Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485 is an international quality management system standard specifically developed for the medical device industry. It specifies requirements for a quality management system that enables organizations to consistently meet customer requirements and applicable medical device regulatory requirements.[1]

The standard emphasizes regulatory compliance, risk management, process control, validation, documentation and product traceability in the medical device sector. ISO describes it as an internationally recognized quality management system standard for medical device design and manufacturing.[1]

Why does it matter?

ISO 13485 is one of the most important quality management system standards in the international medical device supply chain.

For medical device buyers, it helps establish whether a manufacturer has quality management capabilities specifically designed for medical device production and regulatory requirements, beyond a general manufacturing quality management system.

References

  1. [1]International Organization for Standardization (ISO), ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes.

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