ISO 13485

ISO 13485

ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.

Specific requirements include:

  • The promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
  • Controls in the work environment to ensure product safety
  • Focus on risk management activities and design control activities during product development
  • Specific requirements for inspection and traceability for implantable devices
  • Specific requirements for documentation and validation of processes for sterile medical devices
  • Specific requirements for verification of the effectiveness of corrective and preventive actions