ISO 13485 – Medical devices – Quality management systems

ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. Borrowing the structure of ISO 9001, ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components.

Created by the International Organization for Standardization, ISO 13485 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact based decision-making and mutually beneficial supplier relationships. When fully adopted, these principles have been proven to enhance organizational performance.

The benefits of ISO 13485 Certification are:

  • Provides international recognition.

  • Enables your organization to become more cost-effective.

  • Improves internal communications, efficiency and resilience to change.

  • Improves product and process quality and provides a basis for meeting regulatory requirements.

  • Requires your organization to monitor and improve key business and customer satisfaction measures.

  • Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.

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