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Risk management is the identification, evaluation, and prioritization of risks (defined in ISO 31000 as the effect of uncertainty on objectives) followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.. Risks can come from various sources including ... The Basel Committee's
Principles for the sound management of operational risk and the role of supervision describe eleven
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principles and generic guidelines on
risk management. ISO 31000:2009 can be used by any public, private or community enterprise, association, group or individual. GHTF Study Group 3 SG3/N15R8 Page 5 of 23
Risk Management Guidance
Risk management principles should be applied throughout the life cycle of medical devices and used to identify and address safety issues.
Risk management is about taking practical steps to protect people from real harm and suffering - not bureaucratic back covering. Taking a sensible approach to
risk management is about: ensuring that workers and the public are properly protected enabling innovation and learning not stifling them ...
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ISO 31000:2018,
Risk management – Guidelines, provides
principles, framework and a process for managing
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