Understanding

RISK & OPPORTUNITY Analysis

ISO 9001:2015
 Uncertainty
Situation where something
Negative is not prefect or some Positive
Impact information is unknown Impact

ISO 9001:2015
RISK ANALYSIS Opportunity

• Avoid the Risk Clause 6. 1 Actions to Address Risk & • Enhance the
• Eliminate the Risk Opportunity Opportunity
• Share the Risk • Adopting new
• Mitigate the Risk practices, new
• Retain the Risk by products, new
informed decision markets
 Clause 6: Planning
6.1 Actions to address risk and opportunity
Understanding the
Issues in Clause 4.1 Organization & its
Should context
Cover
 External (out side organization- legal,
technological, market, culture, regional,
6.1.1 Determine RISK &
social, national, international)
OPPORTUNITY
 Internal ( Inside organization- value,
knowledge, performance)
Should
Cover Understanding the
Requirement in Clause
needs & Expectation
4.2
of interested parties
 Interested parties that could affect
product / service
 Those relevant to QMS
 Customer, External Provider, Employee,
Shareholder & Stakeholders
 Clause 6: Planning
6.2 The Organization Shall plan
• Action to Address the RISK & OPPORTUNITY
Clause 4.4 Quality Management System &
It’s processes  Identify the processes & interactions
 Risk & Opportunity Analysis based on
processes involved

 Action must be proportionate to potential impact

 Effectiveness Evaluation
  Risk & Opportunity Analysis
 Action implemented

After implementation, Effectives

Clause 9.1.3 Analysis &
need to be Evaluated Evaluation

Evaluation of Effectiveness of Action taken to

address RISK & OPPORTUNITY need to be
Clause 9.3.2
Reviewed Management Review
Inputs