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ISO 9001:2015 Quality Management System Auditor - Actions To Address Risks and Opportunities

The document discusses determining and addressing risks and opportunities as required by ISO 9001:2015. It notes that risks and opportunities must be considered in the context of interested parties and that managing risks can prevent nonconforming outputs and enhance customer satisfaction. Various risk assessment techniques are described such as SWOT analysis, FMEA, and matrix analysis. Common risks include those related to human resources, markets, infrastructure, finances, and legal compliance. Actions to address risks include avoiding, eliminating, accepting, sharing, or taking no action on a risk. An auditor would check for a formal risk management process and documented assessments or conduct interviews if documentation is lacking.

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45 views

ISO 9001:2015 Quality Management System Auditor - Actions To Address Risks and Opportunities

The document discusses determining and addressing risks and opportunities as required by ISO 9001:2015. It notes that risks and opportunities must be considered in the context of interested parties and that managing risks can prevent nonconforming outputs and enhance customer satisfaction. Various risk assessment techniques are described such as SWOT analysis, FMEA, and matrix analysis. Common risks include those related to human resources, markets, infrastructure, finances, and legal compliance. Actions to address risks include avoiding, eliminating, accepting, sharing, or taking no action on a risk. An auditor would check for a formal risk management process and documented assessments or conduct interviews if documentation is lacking.

Uploaded by

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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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ISO 9001:2015 Quality Management System Auditor

- Actions to address risks and opportunities -

Requirement
Determine risks and opportunities and plan actions to address them

Why?
To prevent nonconforming outputs & find opportunities to enhance customer
satisfaction or achieve quality objectives

What to take into consideration?


CONTEXT + INTERESTED PARTIES
ISO 9001:2015 Quality Management System Auditor
- Actions to address risks and opportunities -
“Managing risks will not ensure success but a lack of
risk management leads usually to failure”

Risk is associated with uncertainty

Positive Negative

Risk management - understanding the uncertainty elements


and to act in order to affect this uncertainty
ISO 9001:2015 Quality Management System Auditor
- Actions to address risks and opportunities -

Techniques:

SWOT analysis (Strength, Weaknesses, Opportunities and Threats),


PESTLE (Political, Economical, Social, Technological, Legal, Environmental)
FMEA (Failure Mode and Effects Analysis)
HACCP (Hazard Analysis and Critical Control Points).
Matrix of consequences and probabilities
What if techniques.
Brainstorming.

ISO 31000 family – risk management


IEC 31010 – risk assessment
ISO 9001:2015 Quality Management System Auditor
- Actions to address risks and opportunities -

RISKS AND OPPORTUNTIES ARE SPECIFIC TO EVERY ORGANIZATION

Risks:
HR related risks
Market related risks
Infrastructure related risks
Financial risks
Legal compliance related risks

Opportunities:
adopting new technologies,
going on new markets,
launching new products,
establishing partnerships
ISO 9001:2015 Quality Management System Auditor
- Actions to address risks and opportunities -

Possible actions:

Avoid the risk

Eliminate the risk

Take the risk

Share the risk

Take no action
ISO 9001:2015 Quality Management System Auditor
- Actions to address risks and opportunities -

AUDITING

Clarify if there is a formal documented risk management process


(possible for other reasons – ex. legal)
Then documented information is available (ex. risk assessment)

In case formal documented information on risk management is


not maintained:
- Interviews with top management and personnel
- Use of other documented information – management
programs, management reviews, strategy plans, etc

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