This document discusses risk and opportunity analysis according to ISO 9001:2015. It defines risk as uncertainty that can have a negative impact, while opportunity can have a positive impact. It outlines the clauses in ISO 9001:2015 that address determining risks and opportunities based on understanding the organization's context, interested parties' needs and expectations, and quality management system processes. Actions to address risks and opportunities must be planned, implemented, and evaluated for effectiveness.

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