The 2016 revised standard of ISO 13485:2003 is coming; ISO 13485 – the internationally recognized quality management systems standard for the medical device industry – has been updated after thirteen years. The final version of this standard was published on March 1st, 2016. Soon after, the harmonized version of the standard, EN ISO 13485:2016, was released. This international standard provides requirements for both medical device manufacturers and service providers with regards to quality management systems. There are several changes from the 2003 version of the ISO standard in the following areas:

  • Quality Management System (General and Documentation Requirements)
  • Management Responsibility (Management Review)
  • Resource Management (Human Resources, Infrastructure, and Work Environment)
  • Product Realization (Planning, Customer-related Processes, Design and Development, Purchasing, Production and Service Provision)
  • Measurement, Analysis and Improvement (Monitoring and Measurement, Control of Nonconforming Product, Analysis of Data, and Improvement)

Some of the key changes in the latest edition of ISO 13485 include:

  • Global alignment of regulatory requirements for quality management systems
  • Risk-based approach and decision making throughout the quality management system
  • Focus on supplier sourcing and selection criteria
  • Additional requirements for verification, validation, and other design activities
  • Validation requirements for software used in quality management systems
  • New sub-clauses added for Design and Development and Monitoring and Measurement
  • Design and Development Transfer
  • Design and Development Files
  • Complaint Handling
  • Reporting to Regulatory Authorities
  • Additional requirements for Corrective Action and Preventive Action to verify that corrective or preventive action does not have an adverse effect and corrective actions are implemented without undue delay
  • A Medical Device File is required for each medical device/medical device family to demonstrate conformity to the requirements of ISO 13485
  • The European Union incorporates a three-year grace period to give manufacturers time to adopt the new standard into their procedures and practices. The deadline for this standard’s full adoption into the quality system will be 2019. For a smooth and successful transition, it is recommended that manufacturers do not wait until the last minute to begin making the changes to their systems. It is important to note that all commercialized products (e.g., legacy products) must also meet the requirements of the new standard.