ISO 13485

Medical Device Industry

ISO 13485

ISO 13485 is the globally acknowledged standard for quality management systems in the medical device industry. It identifies necessities for a quality management system where an organization requirements to demonstrate its ability to deliver medical devices, and that related services constantly meet client requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices.

It is important to note that the text of the worldwide standard ISO 13485:2003 is unchanged. Only the foreword and annexes in the European version have been revised. The revised standard will be available in the next few weeks.

EN ISO 13485, as the EU harmonized standard for medical device quality management systems, is an necessary tool allowing medical device manufacturers to prove indication of compliance to the European legislation.

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory necessities for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular necessities for medical devices such as risk analysis, sterile manufacturing and traceability. Organizations being certified to ISO 13485 cannot claim conformity to ISO 9001.

Benefits of ISO 13485

  • Tool to confirm your business’s continuity
  • Progresses efficiency
  • Tool to develop management activities
  • Increases risk management and reduces risks
  • Tool to involve staff through risk management
  • Signal of reliability for your stakeholders

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