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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
BS EN ISO 9000:2015
BS EN ISO 9001:2015
BS EN ISO 9004:2000
BS EN ISO 19011:2011
Title
Quality management systems
Quality management systems
Quality management systems
Auditing management systems
Description
Fundamentals and vocabulary
Requirements
Guidelines for performance improvements
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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