The document discusses risk management and opportunities according to ISO 9001:2015. It defines risk as an undesirable situation or circumstance with a likelihood of occurring and negative consequences, while opportunities are defined as having a positive effect to improve quality management systems and customer needs. It then provides a probability and impact guide for scoring risks, an evaluation criteria matrix for determining risk levels, and describes the type of control measures needed for different risk levels.

1. RISK MANAGEMENT
AND OPPORTUNITIES
ISO 9001 2015
27/10/2022

2. RISK MANAGEMENT AND OPPORTUNITIES
• Reference: MS ISO 9001:2015 Quality Management System (Sub-Clause 6.1
Action to Address Risk and Opportunities)
• Risk : As per ISO 9001 Standard, any undesirable situation or circumstance
that has both a likelihood of occurring and potentially negative
consequences.
• Opportunities : Positive effect to determine the new practices or ideas to
improve the Quality Management System and practices to improve the
performance and effectiveness of JBD’s and customer’s needs.

3. Risk and Opportunities
Probability and Impact Guide
Score Probability Example Score Impact Consequences
1 Rare No case so far 1 Negligible No effect on and not noticeable
by customer
2 Unlikely Once in several years 2 Marginal May require customer
notification but very minimal
effect on customer satisfaction
3 Possible Once a year 3 Moderate May concern customer but
issues easily resolved
4 Likely Seen several times a year 4 Critical Serious non-compliance may
results to customer complain
5 Almost certain Seen several times a
month
5 catastrophic Serious impact to customer and
may risk legal action

4. Risk and Opportunities
Evaluation Criteria
Impact
Probability Negligible Marginal Moderate Critical Catastrophic
Almost
certain
5 10 15 20 25
Likely 4 8 12 16 20
Possible 3 6 9 12 15
Unlikely 2 4 6 8 10
Rare 1 2 3 4 5

5. Level of Risk and Control Measure
Risk level Risk Index Score Type of Control measure
Significantly high &
intolerable
17 – 25 Generally unacceptable. Stringent monitoring of work
by HOD and MR.
Significant risks 12 – 16 Monitoring during work by HOD. Control measures in
place before work commence. Worker informed or
training given for identified risk.
Moderate risks 5 – 11 Preparation of Work Instruction to ensure limited non-
conformance.
Trivial 1 – 4 General monitoring by relevant personnel.

6. Risk and Opportunities Register - Example