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Verify that risks affecting QMS processes are identified and documented.
Are risks affecting QMS processes identified and documented?
15. Risk Management
15.1 Risk Identification
Risk Registers, Risk Assessment Reports
Ensure that identified risks are analyzed to determine their impact.
Are identified risks analyzed for their impact?
15.2 Risk Analysis
Risk Analysis Reports, Risk Matrices
Confirm that risk mitigation plans are
Are risk mitigation plans developed and implemented?
Risk Mitigation Plans, Implementation Records
15.3 Risk Mitigation
developed and implemented.
Verify that risks are monitored and reviewed regularly.
15.4 Monitoring and Review
Are risks monitored and reviewed regularly?
Risk Monitoring Records, Review Minutes
Ensure product safety requirements are defined and documented.
Are product safety requirements defined and documented?
16.1 Safety Requirements
16. Product Safety
Safety Requirement Documents, Safety Plans
Are safety controls implemented to mitigate identified risks?
Verify safety controls are implemented to mitigate identified risks.
Safety Control Records, Risk Assessment Reports
16.2 Safety Controls
Confirm that safety performance is monitored and reviewed.
16.3 Safety Performance Monitoring
Is safety performance monitored and reviewed?
Safety Performance Reports, Monitoring Records
Ensure environmental aspects are identified and documented.
Are environmental aspects identified and documented?
17.1 Environmental Aspects
Environmental Aspect Registers, Impact Assessments
17. Environmental Management
Verify that environmental controls are implemented to manage significant aspects.
Are environmental controls implemented to manage significant aspects?
17.2 Environmental Controls
Environmental Control Plans, Monitoring Records
Confirm compliance with relevant environmental regulations.
Is there compliance with relevant environmental regulations?
17.3 Compliance with Environmental Regulations
Compliance Records, Audit Reports
Ensure environmental performance is monitored and reviewed.
17.4 Environmental Performance Monitoring
Is environmental performance monitored and reviewed?
Environmental Performance Reports, Review Minutes
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