What Is ISO 14971?
ISO 14971 refers to a set of international standards guiding manufacturers on how to identify, size and contain the hazards associated with medical devices. ISO 14971:2007 represents the latest version of the guidelines and includes in vitro diagnostic devices. These standards were developed by the International Organization for Standardization (ISO), headquartered in Geneva, Switzerland. The Food and Drug Administration (FDA) endorses ISO 14971 as an acceptable risk management model for the United States. The European Union made these standards mandatory.
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History
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The International Organization for Standardization started working in 1947. Its mission focused on harmonizing guidelines between countries and providing a framework supporting interoperability. To achieve this objective, ISO welcomed nations to join the efforts and invited them to fill one seat per country for each technical committee tasked with drafting some standards. More than sixty years later, ISO gathers the participation of 160 nations. Since its founding days, ISO has issued in excess of 18,000 international standards. ISO 14971 represents one of the latest works from this organization.
Framework
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ISO 14971 aims at helping manufacturers launch safe medical devices into the market place. Companies producing devices hold full accountability for understanding the risks that their product may present to patients under all possible foreseeable conditions. Furthermore, their responsibility extends to evaluating how their solution may interact with other devices. ISO 14971 certification indicates to business partners and the medical industry that the company performs appropriate risk management and places patient's safety on the forefront.
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Hazard Identification
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ISO 14971 recommends investigating any possible harm that may affect the patient from using the medical device. Several assessment tools listed in the annex of the guidelines show possible approaches to identify the risks. ISO 14971 encourages weighing each risk for its severity and probability of happening. The standards provide clear ranges and definitions to categorize the risks and rank them.
Risk Management
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In a second phase, manufacturers must develop mitigation strategies to lower the chances of a hazard happening or diminish its impact on the patient. This may require some redesign of the product or tightening of the manufacturing processes. Although not all risks can be eliminated, residual risks must go through an acceptance process and be communicated to the physicians and patients.
Documentation
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ISO 14971 calls for a formal plan that describes the objectives of the company with managing risks, the resources that are deployed to implement the objectives, and the training given to the staff to mitigate the risks. Possible deviations in the company processes need to be analyzed and process documentation reviewed and upgraded to eliminate possible room for interpretation. Documentation must also indicate which parameters are monitored to detect the onset of a defect. Reason for accepting residual risks must be documented.
Commitment
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ISO 14971 places responsibility for proper risk management on all levels of the organization. Upper management demonstrates its commitment through allocation of staff and training and by setting risk management goals within its corporate objectives. Each employee in their daily activities is empowered to identify areas with increased risk and trigger the request for investigation and corrective measure.
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- Photo Credit A medical tool - stethoscope on a open book image by Paul Hill from Fotolia.com
