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Risk Management

Requirements Implementation
in ISO 9001:2015 clauses

ISO 9001:2015 Risk Management Requirements Implementation

2015 Centauri Business Group Inc. QPRC training@c-bg.com

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 training@c-bg.com

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 training@c-bg.com

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 training@c-bg.com

Questions? Comments? training@c-bg.com

Purchase

Actions to Address Risks and Opportunities Procedure

Preview

Related Products

ISO 9001:2015 Quality


Manual Template

Control of Documented
Information in ISO
9001:2015 Clauses

ISO 9001:2015 QMS


Transition Program

More ISO 9001:2015 Documents and Templates

ISO 9001:2015 Risk Management Requirements Implementation

2015 Centauri Business Group Inc. QPRC training@c-bg.com

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