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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 ...
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.
Risk management involves consideration of the following components: Risks to patients : compliance with statutory regulations can help to minimise risks to patients. In addition, patient risks can be minimised by ensuring that systems are regularly reviewed and questioned – for example, by critical event audit and learning from complaints.
As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system." The subsequent validation or verification of computer systems targets only the "GxP critical" requirements of computer systems. Evidence (e.g. screen ...
As a professional role, a risk manager [8] will "oversee the organization's comprehensive insurance and risk management program, assessing and identifying risks that could impede the reputation, safety, security, or financial success of the organization", and then develop plans to minimize and / or mitigate any negative (financial) outcomes.
The International Organization for Standardization (ISO) and its ISO 37301:2021 (which deprecates ISO 19600:2014) standard is one of the primary international standards for how businesses handle regulatory compliance, providing a reminder of how compliance and risk should operate together, as "colleagues" sharing a common framework with some nuances to account for their differences.
IPSG.1 Identify Patients Correctly; IPSG.2 Improve Effective Communication; IPSG.3 Improve the Safety of High-Alert Medications; IPSG.4 Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery
Deliberate risk management is used at routine periods through the implementation of a project or process. Examples include quality assurance, on-the-job training, safety briefs, performance reviews, and safety checks. Time Critical Time critical risk management is used during operational exercises or execution of tasks.