"Explore the ISO 9001:2015 Process Risk Analysis Matrix, a strategic workflow to identify, evaluate, mitigate, control and monitor risks in your QMS."
1
Identify the processes within the scope of the ISO 9001:2015 QMS
2
Define the purpose, inputs, outputs, sequence and interaction of these processes
3
Determine the risks and opportunities in relation to the QMS objectives
4
Carry out process risk analysis
5
Formulate a risk evaluation criteria
6
Evaluate the identified risks based on the set criteria
7
Approval: Risk Evaluation
8
Create mitigation plans for the risks that meet the company's risk acceptance criteria
9
Document the process of risk analysis, identification, evaluation and mitigation
10
Establish risk monitoring and control procedures
11
Carry out a risk re-evaluation after implementing control measures
12
Approval: Control Measures Result
13
Identify the need for changes in risk management based on the results of monitoring and reviews
14
Implement necessary changes in the QMS
15
Review the effectiveness of the QMS in achieving its objectives
16
Approval: QMS Review
17
Document any changes brought in the process
18
Communicate the changes to the concerned staff
19
Conduct an internal audit to ensure adherence to the QMS and ISO 9001:2015 Standard
20
Approval: Internal Audit
Identify the processes within the scope of the ISO 9001:2015 QMS
In this task, you will identify the processes that fall within the scope of the ISO 9001:2015 Quality Management System (QMS). The identification of these processes is crucial for establishing an effective QMS. This task will help you understand the different areas of your organization that need to be considered for the QMS.
Define the purpose, inputs, outputs, sequence and interaction of these processes
In this task, you will define the purpose, inputs, outputs, sequence, and interaction of the processes identified in the previous task. This information is essential for understanding how each process contributes to the overall QMS and how they interact with each other. It will help you establish a clear understanding of the organization's operations and how they align with the ISO 9001:2015 standard.
Determine the risks and opportunities in relation to the QMS objectives
In this task, you will determine the risks and opportunities associated with the QMS objectives. By identifying potential risks and opportunities, you can develop strategies to mitigate risks and capitalize on opportunities. This task will help you assess the current state of the QMS and identify areas for improvement.
Carry out process risk analysis
In this task, you will perform a process risk analysis to assess the potential risks associated with each process. By conducting a thorough analysis, you can identify areas of vulnerability and develop appropriate risk mitigation strategies. This task will help you enhance the effectiveness of your QMS by proactively addressing potential risks.
Formulate a risk evaluation criteria
In this task, you will create a risk evaluation criteria to assess the severity and likelihood of identified risks. The risk evaluation criteria will help you prioritize risks and allocate appropriate resources for mitigation. This task will ensure a standardized approach to risk evaluation across the organization.
Evaluate the identified risks based on the set criteria
In this task, you will evaluate the identified risks based on the risk evaluation criteria formulated in the previous task. By assessing the severity and likelihood of each risk, you can determine the level of priority and develop appropriate mitigation plans. This task will help you focus on the most critical risks and allocate resources accordingly.
1
Critical
2
High
3
Medium
4
Low
Approval: Risk Evaluation
Will be submitted for approval:
Carry out process risk analysis
Will be submitted
Formulate a risk evaluation criteria
Will be submitted
Evaluate the identified risks based on the set criteria
Will be submitted
Create mitigation plans for the risks that meet the company's risk acceptance criteria
In this task, you will develop mitigation plans for the risks that meet the company's risk acceptance criteria. The mitigation plans should outline specific actions to reduce the impact and likelihood of identified risks. This task will help you proactively address risks and minimize their potential negative consequences.
Document the process of risk analysis, identification, evaluation and mitigation
In this task, you will document the process of risk analysis, identification, evaluation, and mitigation for future reference. The documentation should provide a clear overview of the steps taken and the decisions made during the risk management process. This task will ensure transparency and facilitate continuous improvement within the QMS.
Establish risk monitoring and control procedures
In this task, you will establish risk monitoring and control procedures to ensure that the identified risks are effectively managed and mitigated. The procedures should outline the responsibilities, frequency, and methods for monitoring and controlling risks. This task will help you maintain an ongoing risk management process within the QMS.
Carry out a risk re-evaluation after implementing control measures
In this task, you will conduct a risk re-evaluation after implementing control measures to assess their effectiveness. By re-evaluating the risks, you can determine if further actions are required to reduce their impact. This task will help you ensure the continuous improvement of risk management within the QMS.
1
Yes
2
No
Approval: Control Measures Result
Will be submitted for approval:
Create mitigation plans for the risks that meet the company's risk acceptance criteria
Will be submitted
Identify the need for changes in risk management based on the results of monitoring and reviews
In this task, you will identify the need for changes in risk management based on the results of ongoing monitoring and reviews. By analyzing the performance of the risk management process, you can identify areas for improvement and implement necessary changes. This task will help you ensure the effectiveness and efficiency of risk management within the QMS.
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Process documentation
2
Training and awareness
3
Risk assessment criteria
4
Mitigation plans
Implement necessary changes in the QMS
In this task, you will implement the necessary changes in the QMS based on the identified areas for improvement in risk management. The changes may include updating process documentation, providing additional training, revising risk assessment criteria, or modifying mitigation plans. This task will help you enhance the overall effectiveness of the QMS.
Review the effectiveness of the QMS in achieving its objectives
In this task, you will review the effectiveness of the QMS in achieving its objectives. By evaluating the performance of the QMS, you can assess its conformity to the ISO 9001:2015 standard and identify areas for further improvement. This task will help you ensure the continuous improvement of the QMS.
1
Highly conforming
2
Partially conforming
3
Non-conforming
Approval: QMS Review
Will be submitted for approval:
Review the effectiveness of the QMS in achieving its objectives
Will be submitted
Document any changes brought in the process
In this task, you will document any changes made to the QMS as a result of the review process. The documentation should include details of the changes made, the reasons for the changes, and the expected impact on the QMS and its objectives. This task will ensure proper documentation of all modifications to the QMS.
Communicate the changes to the concerned staff
In this task, you will communicate the changes made to the QMS to the relevant staff members. Effective communication is essential for ensuring that everyone is aware of the changes and understands their roles and responsibilities. This task will help you facilitate a smooth transition and promote a culture of continuous improvement within the organization.
Conduct an internal audit to ensure adherence to the QMS and ISO 9001:2015 Standard
In this task, you will conduct an internal audit to evaluate the organization's adherence to the QMS and ISO 9001:2015 standard. The internal audit should assess the effectiveness of the QMS, identify non-conformities, and propose corrective actions. This task will help you ensure compliance with the QMS and continuous improvement.
Approval: Internal Audit
Will be submitted for approval:
Conduct an internal audit to ensure adherence to the QMS and ISO 9001:2015 Standard
