ISO 14971:2007 - update to risk management systems

The risk management process, as spelled out in ISO 14971:2007, 'will go a long way to prevent errors' in medical device design and manufacture, according to the Director of Quality Assurance for the US-based Lipid Science, Barrett Craner.

ISO 14971 is recognized as the international standard for risk management and is used by device manufacturers who need to conform to both the European Medical Device Directives and the Food and Drug Administration’s (FDA) quality system regulation. While the FDA does not require risk management, it does require risk evaluation and analysis, Craner noted.

ISO 14971:2007 replaces the original risk management standard, ISO 14971:2000, and a 2003 amendment.

Craner said there are few changes to the 2007 version, which include six new terms and definitions:

  • In vitro diagnostic medical device
  • Life cycle
  • Postproduction
  • Risk estimation
  • Top management
  • Use error
There is also a change in Section 4.3 of ISO 14971:2007 emphasizing the potential path of a hazard — from identification of the hazard to development of a hazardous situation and ultimately harm to the patient or user. The standard also adds a traceability requirement to the risk management report.