Changes to ISO 13485:2016

MedicalANSI has released a new edition of ISO 13485:2016, the standard for “Medical devices – Quality management systems – Requirements for regulatory purposes.” The revised standard can now be purchased from ANSI’s standards store. According to ANSI, the most significant changes pertain to added requirements:

  • document management
  • management review
  • human resources
  • infrastructure
  • work environment and contamination control
  • planning
  • record keeping
  • communication with regulatory authorities
  • consideration of many aspects of design and development
Source: ANSI blog

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