Understanding the Importance of ISO 14971 – Part 2

18 May 2011

On the April 18 blog, we took a closer look at what ISO 14971 does cover. Specifically, ISO 14971 outlines a clear process for manufacturers to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices. But what about those areas in which ISO 14971 does not cover?

ISO 14971 does not:

  • Apply to clinical decision making;
  • Specify acceptable risk levels; or
  • Require that the manufacturer have a quality management system in place. However, in Annex A, the standard states that "when a manufacturer employs a quality management system, the risk management process should be fully integrated into that system", as it extremely helpful in properly managing risks.

"The ISO 14971 standard does not specify acceptable risk levels. How could it? ISO standards' requirements are always generic," said Christine Forcier, Program Manager for the medical device sector at Intertek. "It is up to each organization to determine what is appropriate for each of their products and it requires top management involvement to do so. "

Understanding the benefits of ISO 14971 is crucial for medical device manufacturers. Do you have a question about ISO 14971?

To speak with an Intertek expert on this subject matter, please send an e-mail to us at askmedical@intertek.com.