Risk Management Requirements Implementation in ISO 9001:2015 clauses
ISO 9001:2015 – Risk Management Requirements Implementation
© 2015 Centauri Business Group Inc. QPRC
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Risk Management Requirements Implementation
Clauses of ISO 9001:2015 01 General (0.1.c)
Object of Control (what is managed) Scope of the QMS
Subject of Control (who manages) Senior
Regulatory document (recommended) Not Provided
Management 0.3.3 Risk- Based
All QMS Processes
Thinking 4.4 QMS and its
Senior
Quality Policy
Management All QMS Processes
Processes (4.4.1.f)
Process Owners
System QSP (which regulates the performance
of QMS processes)
ISO 9001:2015 – Risk Management Requirements Implementation
© 2015 Centauri Business Group Inc. QPRC
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Risk Management Requirements Implementation
Clauses of ISO 9001:2015 6.1 Actions to
Object of Control (what is managed) All QMS Processes
address risks and
Subject of Control (who manages)
Regulatory document (recommended)
Senior Management
New QSP ‘Actions to
+ Process Owners
address risks and opportunities’
opportunities 8.3.3 Design and
‘Design and
Owner of ‘Design
‘Actions to address risks
development inputs
Development’
and Development’
and opportunities’ QSP
(8.3.3.e)
Process
Process
ISO 9001:2015 – Risk Management Requirements Implementation
© 2015 Centauri Business Group Inc. QPRC
[email protected]
Risk Management Requirements Implementation
Clauses of ISO 9001:2015
Object of Control (what is managed)
Subject of Control (who manages)
Regulatory document (recommended)
‘Design and
‘Design and
Activity
Development’
Development’ QSP
(8.5.5.b)
process owner
8.5.5 Post Delivery
9.3 Management
Products in use
QMS Processes
Review (cl.9.3.2.e) 10.2 Nonconformity
Nonconformities
Senior Management
‘Management Review’
(Directors)
QSP
Process owners
‘Corrective action’ QSP
and corrective action
ISO 9001:2015 – Risk Management Requirements Implementation
© 2015 Centauri Business Group Inc. QPRC
[email protected]
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ISO 9001:2015 – Risk Management Requirements Implementation
© 2015 Centauri Business Group Inc. QPRC
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