ISO 14971 - Risk Management in Medicine

Risk management processes can save lives

The countries in which Nordic Certification operates are well-versed in the field of medical technology and risk management. We now offer our customers certification for ISO 14971:2007.

As a manufacturer of medical devices, you are probably familiar with the term risk. The recent amendments to standards and regulations including ISO 13485:2003, European Medical Device Directive and the third edition of IEC 60601-1, require that a documented management system for risk management must be implemented to show that your product is designed and manufactured in a safe manner. This applies regardless of the probability of the risks and severity of these potential risks could be.

Risk management and documentation with ISO 14971

ISO 14971:2007 is a principled standard for medical device manufacturers which can be used to develop a management system for risk management. The standard requires the manufacturer to identify the hazards associated with their products, calculate and assess risks, and control and monitor risk management effectiveness. The requirements of the standard applies at all stages of the product life cycle, and results in reduced risks from potential hazards of the product.

How the company identifies its risks can be done according to several models such as FMEA analysis.

A number of standards and regulations for medical devices now refers to ISO 14971 in terms of risk management. A certification for ISO 14971 is no guarantee that these standards and regulations are followed but provides greater security, because it is a confirmation that your management system for risk management compliance. Risk management is now also available in several industry areas as food by HACCP "Hazard Analysis & Critical Control Points" is a tool for risk management in the food industry and its need to ensure food safety. It is a structured and proactive approach to optimize measures to provide consumers with safe food and automotive industries through FMEA (Failure Mode and Effect Analysis) and / or SPC (Statistics Process) to ensure good quality of various critical components.