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ISO 31000. ISO 31000 is a family of international standards relating to risk management codified by the International Organization for Standardization. [1] The standard is intended to provide a consistent vocabulary and methodology for assessing and managing risk, resolving the historic ambiguities and differences in the ways risk are described.
Enterprise risk management (ERM) in business includes the methods and processes used by organizations to manage risks and seize opportunities related to the achievement of their objectives. ERM provides a framework for risk management, which typically involves identifying particular events or circumstances relevant to the organization's ...
The European version of the risk management standard was updated in 2009 and again in 2012 to refer to the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) revision in 2007, as well as the In Vitro Medical Device Directive (IVDD). The requirements of EN 14971:2012 are nearly identical to ISO 14971:2007.
The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. [1] ISO 9000 deals with the fundamentals and ...
The Risk Management Framework (RMF) is a United States federal government guideline, standard, and process for managing risk to help secure information systems (computers and networks), developed by the National Institute of Standards and Technology (NIST). The RMF provides a structured process that integrates information security, privacy, and ...
Governance, risk management, and compliance are three related facets that aim to assure an organization reliably achieves objectives, addresses uncertainty and acts with integrity. [6] Governance is the combination of processes established and executed by the directors (or the board of directors) that are reflected in the organization's ...
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