The document outlines the implementation of risk management requirements in ISO 9001:2015, detailing responsibilities and processes for managing risks within a Quality Management System (QMS). Key clauses addressed include risk-based thinking, actions to address risks and opportunities, and the roles of senior management and process owners. Additional resources and templates related to ISO 9001:2015 are mentioned for further guidance.

1. © 2015 Centauri Business Group Inc. QPRC training@c-bg.comISO 9001:2015 – Risk Management Requirements Implementation
Risk Management
Requirements Implementation
in ISO 9001:2015 clauses

2. © 2015 Centauri Business Group Inc. QPRC training@c-bg.comISO 9001:2015 – Risk Management Requirements Implementation
Clauses of ISO
9001:2015
Object of Control
(what is managed)
Subject of Control
(who manages)
Regulatory document
(recommended)
01 General (0.1.c) Scope of the QMS Senior
Management
Not Provided
0.3.3 Risk- Based
Thinking
All QMS Processes Senior
Management
Quality Policy
4.4 QMS and its
Processes (4.4.1.f)
All QMS Processes Process Owners System QSP (which
regulates the performance
of QMS processes)
Risk Management Requirements Implementation

3. © 2015 Centauri Business Group Inc. QPRC training@c-bg.comISO 9001:2015 – Risk Management Requirements Implementation
Clauses of ISO
9001:2015
Object of Control
(what is managed)
Subject of Control
(who manages)
Regulatory document
(recommended)
6.1 Actions to
address risks and
opportunities
All QMS Processes Senior Management
+ Process Owners
New QSP ‘Actions to
address risks and
opportunities’
8.3.3 Design and
development inputs
(8.3.3.e)
‘Design and
Development’
Process
Owner of ‘Design
and Development’
Process
‘Actions to address risks
and opportunities’ QSP
Risk Management Requirements Implementation

4. © 2015 Centauri Business Group Inc. QPRC training@c-bg.comISO 9001:2015 – Risk Management Requirements Implementation
Clauses of ISO
9001:2015
Object of Control
(what is managed)
Subject of Control
(who manages)
Regulatory document
(recommended)
8.5.5 Post Delivery
Activity
(8.5.5.b)
Products in use ‘Design and
Development’
process owner
‘Design and
Development’ QSP
9.3 Management
Review (cl.9.3.2.e)
QMS Processes Senior Management
(Directors)
‘Management Review’
QSP
10.2 Nonconformity
and corrective action
Nonconformities Process owners ‘Corrective action’ QSP
Risk Management Requirements Implementation

5. © 2015 Centauri Business Group Inc. QPRC training@c-bg.comISO 9001:2015 – Risk Management Requirements Implementation
Related Products
ISO 9001:2015 Quality
Manual Template
Control of Documented
Information in ISO
9001:2015 Clauses
ISO 9001:2015 QMS
Transition Program
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Actions to Address Risks and Opportunities Procedure Preview
More ISO 9001:2015 Documents and Templates