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ISO 13485 Medical devices

Quality Management Systems – Requirements for regulatory purposes

The basis of this standard is provided by the common requirements for quality management systems established by the ISO 9001 standard.

However, the ISO 13485 standard includes a number of additional specific requirements for organisations producing medical products, including:

  • Requirements for stages of monitoring, design and process control (including monitoring of the production environment), special processes, traceability, validation, sterilisation processes, records
  • Risk management
  • Need for documented procedures for the design and development of medical devices
  • Additional requirements for product purity and control of pollution
  • Special requirements for sterile medical products
  • Hygiene requirements for personnel, equipment and facilities
  • Additional requirements for the feedback system aimed at early prevention of quality problems

The purpose of the standard is:

  • implementation of a quality management system that focuses on the development and design of, production processes for, and use of medical devices and related services
  • demonstration to all stakeholders of the ability to produce medical products and provide related services that meet customer expectations and established requirements
  • assessment of the organisation’s ability to ensure customer satisfaction and compliance of the products with established requirements
  • certification of the quality management system in accordance with the requirements of the standard

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