ISO 9001:2015

1. Understanding
RISK & OPPORTUNITY Analysis
ISO 9001:2015

2. Situation where something
is not prefect or some
information is unknown
Uncertainty
RISK Opportunity
Negative
Impact
Positive
Impact
• Avoid the Risk
• Eliminate the Risk
• Share the Risk
• Mitigate the Risk
• Retain the Risk by
informed decision
• Enhance the
Opportunity
• Adopting new
practices, new
products, new
markets
ISO 9001:2015
ANALYSIS
Clause 6. 1 Actions to Address Risk &
Opportunity

3. Clause 6: Planning
6.1 Actions to address risk and opportunity
6.1.1 Determine RISK &
OPPORTUNITY
Issues in Clause 4.1
Understanding the
Organization & its
context
 External (out side organization- legal,
technological, market, culture, regional,
social, national, international)
 Internal ( Inside organization- value,
knowledge, performance)
Requirement in Clause
4.2
Understanding the
needs & Expectation
of interested parties
 Interested parties that could affect
product / service
 Those relevant to QMS
 Customer, External Provider, Employee,
Shareholder & Stakeholders
Should
Cover
Should
Cover

4. • Action to Address the RISK & OPPORTUNITY
Clause 4.4 Quality Management System &
It’s processes
Clause 6: Planning
6.2 The Organization Shall plan
 Identify the processes & interactions
 Risk & Opportunity Analysis based on
processes involved
 Action must be proportionate to potential impact
 Effectiveness Evaluation

5.  Risk & Opportunity Analysis
 Action implemented
After implementation, Effectives
need to be Evaluated
Clause 9.1.3 Analysis &
Evaluation
Evaluation of Effectiveness of Action taken to
address RISK & OPPORTUNITY need to be
Reviewed
Clause 9.3.2
Management Review
Inputs