More Related Content More from Operational Excellence Consulting (20) ISO 9001:2015 (Quality Management System) Poster1. Customer
Focus
Leadership
Engagement
of People
Process
ApproachImprovement
Evidence-
based
Decision
Making
Relationship
Management
CUSTOMER FOCUS
The primary focus of quality
management is to meet customer
requirements and to strive to
exceed customer expectations.
LEADERSHIP
Leaders at all levels establish
unity of purpose and direction
and create conditions in which
people are engaged in
achieving the organization’s
quality objectives.
EVIDENCE-BASED
DECISION MAKING
Decisions based on
the analysis and
evaluation of data
and information are
more likely to
produce desired
results.
RELATIONSHIP
MANAGEMENT
For sustained success, an
organization manages its
relationships with
interested parties, such as
suppliers.
QUALITY
MANAGEMENT
PRINCIPLES
PROCESS APPROACH
Consistent and predictable results are
achieved more effectively and efficiently
when activities are understood and
managed as interrelated processes that
function as a coherent system.
IMPROVEMENT
Successful
organizations have
an ongoing focus
on improvement.
ENGAGEMENT OF
PEOPLE
Competent, empowered
and engaged people at all
levels throughout the
organization are essential
to enhance its capability
to create and deliver
value.
The Seven Quality Management Principles The Plan-Do-Check-Act (PDCA) Process
Drives the Quality Management System
Organization and
its context (4)
Customer
Requirements
Customer
Satisfaction
Products
and services
Results of
the QMS
Needs and expectations
of relevant interested
parties (4)
Leadership
(5)
Performance
evaluation
(9)
Support &
Operation
(7,8)
Planning
(6)
Improvement
(10)
Plan Do
CheckAct
PLAN DO CHECK ACT
4. Context of the
organization
5. Leadership 6. Planning 7. Support 8. Operation 9. Performance
evaluation
10. Improvement
4.1 Understanding
the organization
and its context
5.1 Leadership
and commitment
6.1 Actions to
address risks and
opportunities
7.1 Resources 8.1 Operational
planning and
control
9.1 Monitoring,
measurement,
analysis and
evaluation
10.1 General
4.2 Understanding
the needs and
expectations of
interested parties
5.2 Policy 6.2 Quality
objectives and
planning to
achieve them
7.2 Competence 8.2 Requirements
for products and
services
9.2 Internal audit 10.2
Nonconformity and
corrective action
4.3 Determining
the scope of the
QMS
5.3 Organizational
roles,
responsibilities and
authorities
6.3 Planning of
changes
7.3 Awareness 8.3 Design and
development of
products and
services
9.3 Management
review
10.3 Continual
improvement
4.4 QMS and its
processes
7.4
Communication
8.4 Control of
externally provided
processes,
products and
services
7.5 Documented
information
8.5 Production and
service provision
8.6 Release of
products and
services
8.7 Control of
nonconforming
outputs
Implement the processes
of the QMS
Establish objectives,
programs and processes
necessary to deliver results
in accordance with the
organization’s QMS policy
Monitor and measure
activities and processes
with regard to the QMS
policy and objectives, and
report the results
Take actions to
continually improve the
QMS performance to
achieve the intended
outcomes
Plan
Do
Act
Check
The ISO 9001 Approach is Based on the PDCA Cycle ISO 9001:2015 Key Clause Structure (4-10)
ISO 9001:2015
Quality Management
System (QMS)
© Operational Excellence Consulting. All rights reserved. Source: Based on ISO, 2015.
2. Customer
Focus
Leadership
Engagement
of People
Process
ApproachImprovement
Evidence-
based
Decision
Making
Relationship
Management
CUSTOMER FOCUS
The primary focus of quality
management is to meet customer
requirements and to strive to
exceed customer expectations.
LEADERSHIP
Leaders at all levels establish
unity of purpose and direction
and create conditions in which
people are engaged in
achieving the organization’s
quality objectives.
EVIDENCE-BASED
DECISION MAKING
Decisions based on
the analysis and
evaluation of data
and information are
more likely to
produce desired
results.
RELATIONSHIP
MANAGEMENT
For sustained success, an
organization manages its
relationships with
interested parties, such as
suppliers.
QUALITY
MANAGEMENT
PRINCIPLES
PROCESS APPROACH
Consistent and predictable results are
achieved more effectively and efficiently
when activities are understood and
managed as interrelated processes that
function as a coherent system.
IMPROVEMENT
Successful
organizations have
an ongoing focus
on improvement.
ENGAGEMENT OF
PEOPLE
Competent, empowered
and engaged people at all
levels throughout the
organization are essential
to enhance its capability
to create and deliver
value.
The Seven Quality Management Principles The Plan-Do-Check-Act (PDCA) Process
Drives the Quality Management System
Organization and
its context (4)
Customer
Requirements
Customer
Satisfaction
Products
and services
Results of
the QMS
Needs and expectations
of relevant interested
parties (4)
Leadership
(5)
Performance
evaluation
(9)
Support &
Operation
(7,8)
Planning
(6)
Improvement
(10)
Plan Do
CheckAct
PLAN DO CHECK ACT
4. Context of the
organization
5. Leadership 6. Planning 7. Support 8. Operation 9. Performance
evaluation
10. Improvement
4.1 Understanding
the organization
and its context
5.1 Leadership
and commitment
6.1 Actions to
address risks and
opportunities
7.1 Resources 8.1 Operational
planning and
control
9.1 Monitoring,
measurement,
analysis and
evaluation
10.1 General
4.2 Understanding
the needs and
expectations of
interested parties
5.2 Policy 6.2 Quality
objectives and
planning to
achieve them
7.2 Competence 8.2 Requirements
for products and
services
9.2 Internal audit 10.2
Nonconformity and
corrective action
4.3 Determining
the scope of the
QMS
5.3 Organizational
roles,
responsibilities and
authorities
6.3 Planning of
changes
7.3 Awareness 8.3 Design and
development of
products and
services
9.3 Management
review
10.3 Continual
improvement
4.4 QMS and its
processes
7.4
Communication
8.4 Control of
externally provided
processes,
products and
services
7.5 Documented
information
8.5 Production and
service provision
8.6 Release of
products and
services
8.7 Control of
nonconforming
outputs
Implement the processes
of the QMS
Establish objectives,
programs and processes
necessary to deliver results
in accordance with the
organization’s QMS policy
Monitor and measure
activities and processes
with regard to the QMS
policy and objectives, and
report the results
Take actions to
continually improve the
QMS performance to
achieve the intended
outcomes
Plan
Do
Act
Check
The ISO 9001 Approach is Based on the PDCA Cycle ISO 9001:2015 Key Clause Structure (4-10)
ISO 9001:2015
Quality Management
System (QMS)
© Operational Excellence Consulting. All rights reserved. Source: Based on ISO, 2015.
3. © Operational Excellence Consulting. All rights reserved. 3
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