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Control of Risks & Opportunities
1 Control of Risks & Opportunities
1.1 Introduction & Purpose
The purpose of this procedure is to outline your organization’s the risk and opportunity management
framework and the activities within. The risk and opportunity management framework defines our current
risk management process, which includes; methodology, risk appetite, methods for training and reporting.
1.1.1 Process Activity Map
With what With who
QMS planning requirements Risk Manager
Customer Requirements Quality Manager
Organizational context Top management
Input Activity Output
Customer requirements Determination of risks and Process improvement
Statutory or legal opportunities relating to QMS improvement
requirements our organizational context Conforming processes
Areas of concern and the needs and Risk controls
Context of the expectations of interested Enhanced desirable effects
organization parties Integrated actions
Needs and expectation of Evaluation
interested parties New practices
How With what measure
Assessment process Level of compliance
Risk register Objectives met
SWOT/PESTLE analysis Risk analysis
Forms & reports Risk mitigation scores
1.1.2 References
Standard Title Description
BS EN ISO 9000:2015 Quality management systems Fundamentals and vocabulary
BS EN ISO 9001:2015 Quality management systems Requirements
BS EN ISO 9004:2000 Quality management systems Guidelines for performance improvements
BS EN ISO 19011:2011 Auditing management systems Guidelines for auditing
1.1.3 Terms & Definitions
Term ISO 9000:2015 Definition
Documented Information Information (3.8.2) Required to be Controlled and Maintained
Risk The effect (3.7.9) of Uncertainty
Objective Evidence Data (3.8.1) Supporting The Existence or Verity of Something
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