ISO 14971 Training

ISO 14971 establishes quality standards for medical device producers.

ISO 14971 is a standard established by the International Organization for Standardization (ISO) that outlines a process to help medical device manufacturers identify and mitigate any hazards associated with the production of medical devices. To do this effectively, manufacturers send selected personal to ISO 14971 training.

Identification

ISO 14971 training qualifies individuals to conduct ISO 14971 hazard identification and mitigation procedures. The training is generally for quality assurance, quality control or operations personnel of a company that manufactures medical devices.

Features

During training, individuals learn ISO 14971 regulatory and reporting standards and how to apply them. In addition, they learn how to identify hazards in the product or production process, how to modify the design or production process to meet ISO 14971 standards and how to control or monitor the effectiveness of those changes during the product lifecycle. Training providers offer training on-site, in workshops and online.

Considerations

Individuals considering 14971 training should also consider training or learning ISO 13485. ISO 13485 is a standard governing the quality management systems of organizations that provide medical devices. There are many overlapping uses; in fact, many ISO 14971 training institutions include ISO 13485 integration in their coursework.

References

• International Organization for Standardization: ISO 14971:2007
• Emergo Group: SO 14971:2009 Training for Medical Device Risk Management
• International Organization for Standardization: ISO 13485:2003

Resources

• British Standard Institute: ISO 14971 Risk Management Certification Program