QA Standards for ISO 14971

by itsbusiness AG

ISO standard ISO 14971 is used for the application of risk management to medical devices. This standard was developed specifically for manufacturers of medical devices on the basis of established principles of risk management that have evolved over many years.

The requirements contained in this document provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.

For more information on lifecycle risk management, see the Johner Institute article life-cycle-risk-management

Risk Management Process

Risk Management Plan

  • Scope of the planned risk management activities
  • Assignment of responsibilities and authorities
  • Review of risk management activities
  • Criteria for risk acceptability
  • Method to evaluate the overall residual risk
  • Activities for verification
  • Collection and review of relevant production and post-production information

Risk Management File

  • The records of all risk management activities

Risk Analysis

  • Each hazard identified shall be analysed.

Risk Evaluation

For each identified hazardous situation, the manufacturer shall evaluate the estimated risks and determine if the risk is acceptable or not, using the criteria for risk acceptability defined in the risk management plan.

Risk Control

Following the results of the risk evaluation, the control methods for the unacceptable risks must be planned and implemented by the manufacturers.

Evaluation of Overall Residual Risk

The overall residual risk is evaluated by qualified people in relation to the benefits of the intended use of the medical device.

Risk Management Review

The risk management review shall be performed after implementation and verification of all risk control measures but prior to commercial release of the medical device.

Production and Post-Production Activities

The manufacturer shall establish, document and maintain a system to actively collect and review information relevant to the medical device in the production and post-production phases.

With our experienced consultants, including staff who have developed and tested safety critical software, itsbusiness supports you in the development of robust software quality assurance, carries out an assessment together with you for a TARGET/ACTUAL analysis, and submits an action plan as well as for the implementation. Within the scope of the implementation, we support you in the implementation of the action plan and ensure the achievement of the objectives.


If you have questions or need more information, please contact:

Andrew Connell
QA Consultant, itsbusiness AG
+41 31 370 32 05​

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