We live in an ever-changing world where we are forced to deal with uncertainty every day. But how an organization tackles that uncertainty can be a key predictor of its success.
Risk is a necessary part of doing business, and in a world where enormous amounts of data are being processed at increasingly rapid rates, identifying and mitigating risks is a challenge for any company. It is no exception for Bio-Medical in fact it is more than any other field since it stakes human life for its benefits and hence there is no wonder that many contracts and insurance agreements require solid evidence of good risk management practice.
ISO 31000 provides direction on how companies can integrate risk-based decision making into an organization’s governance, planning, management, reporting, policies, values and culture. It is an open, principles-based system, meaning it enables organizations to apply the principles in the standard to the organizational context.
ISO 31000 helps organizations develop a risk management strategy to effectively identify and mitigate risks, thereby enhancing the likelihood of achieving their objectives and increasing the protection of their assets. Its overarching goal is to develop a risk management culture where employees and stakeholders are aware of the importance of monitoring and managing risk.
Implementing ISO 31000 also helps organizations see both the positive opportunities and negative consequences associated with risk, and allows for more informed, and thus more effective, decision making, namely in the allocation of resources. What’s more, it can be an active component in improving an organization’s governance and, ultimately, its performance.
The risk management process involves the systematic application of policies, procedures and practices to the activities of communicating and consulting, establishing the context and assessing, treating, monitoring, reviewing, recording and reporting risk.
- Communication and consultation including ,
- Bring different areas of expertise together for each step of the RM process
- Ensure different views are considered when defining risk criteria and evaluating risks
- Provide sufficient information to facilitate risk oversight and decision-making
- Build a sense of inclusiveness and ownership among those affected by risk
- Scope, context, and criteria, including:
- Define the purpose and scope of risk management activities
- Identify the external and internal context for the organization
- Define risk criteria by specifying the acceptable amount and type of risk
- Define criteria to evaluate the significance of risk and to support decision-making
- Risk assessment, including:
- Risk identification to find, recognize and describe risks that might help or prevent the achievement of objectives and the variety of tangible or intangible consequences
- Risk analysis of the nature and characteristics of risk, including the level of risk, risk sources, consequences, likelihood, events, scenarios, controls, and their effectiveness
- Risk evaluation to support decisions by comparing the results of the risk analysis with the established risk criteria to determine the significance of risk
- Risk treatment, including:
- Select the most appropriate risk treatment option(s)
- Design risk treatment plans specifying how the treatment options will be implemented.
- Monitoring and review, including:
- Improve the quality and effectiveness of process design, implementation, and outcomes
- Monitor the RM process and its outcomes, with responsibilities clearly defined
- Plan, gather, and analyze information, recording results, and providing feedback
- Incorporate the results in performance management, measurement, and reporting activities
- Recording and reporting, including:
- Communicate risk management activities and outcomes across the organization
- Provide information for decision-making
- Improve risk management activities
- Provide risk information and interacting with stakeholders