In addition to quality management standards (as established by ISO 9001 2000), ISO is concerned with establishing standards for risk management. The term "risk management" is more than just a buzzword in the medical device industry It is considered essential both by ISO and the FDA for ensuring the safety and reliability of medical devices. The significance of ISO 14971 Compliance is recognized internationally by manufacturers of all types.
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The above question-and-answer article about ISO 14971 was prepared by MasterControl Inc., the leading provider of quality management software solutions for companies in FDA and ISO environments. The QA article answers the following questions:
The FDA recognizes ISO 14971 as an acceptable risk management model and the European Union has made it mandatory. Even if manufacturers choose not to implement ISO 14971, they are still expected to conduct and document a risk management process.
ISO 14971 specifies a process for a manufacturer to use in order to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices. The process is used to estimate and evaluate associated risks, control these risks, and monitor the effectiveness of the controls. The requirements of ISO 14971 are applicable to all stages of the lifecycle of a medical device.
The recently revised standards for ISO 14791 compliance (ISO 14971 2007) provide questions medical device manufacturers can use in order to identify medical device characteristics that could have an impact on safety.
Among other things, the revisions to ISO 14971 provide examples of hazards, foreseeable sequences of events, and hazardous situations. This will undoubtedly entail stricter standards and make it more important than ever for manufacturers of medical devices to ensure that their methods for ISO 14971 compliance are up to the task of assuring compliance.
ISO 14971 Hazard means any potential source of harm to the patient or consumer. Risk refers to a combination of the severity of the harm and the probability of its occurrence. Risk control is the process of implementing protective measures for reducing risks or keeping them to a minimum.
Other related ISO 14971 standards you may be interested in that MasterControl can help with include, among others, standards related to ISO 9001 2000 (quality management standards), ISO 14000 (environmental standards), and, as noted previously, ISO 13485.
To learn more about risk management and ISO 14971 (or about any other ISO standard), please feel free to contact a MasterControl representative.