At the end of this session the participants will be able

to:
1. Recognize the benefits of the Quality Management
System in Actual Nursing practice
2. Identify the elements to consider in setting up
Quality Management System
3. Analyze the seven (7) quality management principles
4. Apply the concept of Plan-Do-Check-Act as
methodology in managing the improvement in his/her
workplace
5. Apply the concepts of organizational knowledge,
process approach, and risk based thinking in planning
6. Understand ISO high level structure for Quality
Management System
 Quality is a perception that is based on an
individuals value system. It relies heavily
on the culture, life experiences and
expectations of\each individual.
Quality receives a new definition in each
interaction between an individual and an
item for which the term is evaluated. It is
one of those things that is very difficult
to define but anyone can recognize
know it when he/she see it.
 When an Organization or
individual generates outputs,
either as products or services,
and delivers those outputs to
other organizations or
individuals, then a quality
judgement can occur.
A well organized way of managing for quality
will function as follows:
An organization is established to provide
Value to customer
The value is provided to customers through
products and services
Quality management focuses management
systems on ensuring quality
The Management system will be a
comprehensive one.
This will result in improving brand value and
financial results.
 Quality Management in
healthcare begins with the
patient and should be fully
tuned to his/her needs.
As patients requirements and
expectations vary over time;
quality management has to keep
up with the changing needs and
demands.
In line with this, the following
means can go long way in
ensuring quality management in
healthcare;
The healthcare setting has to
identify goals for ensuring
quality management in health
care. Each department has to be
given measurable goals to reach
 Implementing quality standards
goes along way in ensuring that
quality management in health
care is imparted in the
Organization. Six Sigma, ISO
9001 and PDCA are some of the
popular standards and tools that
are used in the healthcare
industry.
 Hiring the right professionals
is another important step for
healthcare organizations that
are determined to implement
quality management in
healthcare.
 According to the Business Quality

Management System is a system by which and

organization aims to reduce and eventually

eliminate non-conformance to specifications,

standards, and customer expectations in the

most cost effective and efficient manner.

The benefits of a QMS will ensure that two
important requirements are met:
The customer requirements Confidence
in the ability of the organization to deliver
the desired products and service
consistently meeting their needs and
expectations/
The organizations requirements both
internally and externally, and at an
optimum cost with efficient use of the
available resources materials, human ,
technology and information.
 A QMS and organization to achieve
the goals and objectives set out in
its policy and strategy.
It provides consistency and
satisfaction in terms of methods,
materials, equipment etc. and
interacts with all activities of the
organization, beginning with the
identification of customer
requirements and ending with their
satisfaction, at every transaction
interface.
 Design
Build
Control
Deployment
Measurement
Review
Improvement
 Includes the structure of the
quality management system, the
process and its implementation.
Its design must be led by senior
managers to suit the needs of
the organization, and this is
ideally done using a framework
to lead the thinking
 Design of the QMS should come from
determining the organizations core progress
and well defined goals and strategies, and be
linked to the needs of one or more
stakeholders.
The process for designing and building the
QMS must also be clear, with the quality
function playing a key role, but involvement
and buy in to the system must also come
form all other functions.
 Deployment and implementation is best
achieved using process packages, where
each core process is broken down into
sub- processes, and described by a
combination of documentation,
education, training tools, systems and
metrics.
Electronic deployment via Intranets is
increasingly being used
 Control of the QMS will depend on the size
and complexity of the organization.
ISO is site- based system, and local audits
and reviews are essential even if these are
supplemented by central reviews.
Local control, where possible, is effective,
and good practice is found where key
stakeholders are documented within the
process and where the process owner is
allowed to control all of the process.
Ideally, process owners/operators are
involved in writing procedures.
 Measurement is carried out to
determined the effectiveness and
efficiency of each towards attaining its
objectives.
It should be include the contribution of
the QMS to the Organization s goals; this
could be achieved by measuring the
following;
Policy definition completeness
Coverage of business
 MEASUREMENT
Reflection of policies
Deployment
Usage
Whether staff find the QMS helpful
in their work
Speed of change of the QMS
Relevance of QMS architecture to
the job in hand
 Review of the effectiveness,
efficiency and capability of a QMS is
vital, and the outcome of these
reviews should be communicated to
all employees.
Reviewing and Monitoring should be
conducted whether or not
improvement activities have
achieved their expected outcomes.
 Improvement should follow as a
result of the review process, with
the aim of seeking internal best
practice.
It is part of the overall
improvement activities and an
integral part of managing change
within the organization
 Quality Management Principles ( QMP) are a
set of fundamentals beliefs, norms, rules and
values that are accepted as true and can be
used as a basis for quality management
The QMPs can be used as a foundation to
guide an organizations performance
improvement. They were developed and
updated by international experts of ISO,
which is responsible for developing and
maintaining ISOs quality management
standards.
 QMP 1 Customer focus
QMP 2 Leadership
QMP 3 Engagement of people
QMP 4 Process approach
QMP 5 Improvement
QMP 6 Evidence based decision Making
QMP 7 Relationship Management
 The primary focus of quality
Management is to meet
customer requirements and
to strive to exceed customer
expectations.
 Sustained success is achieved when and
organization attracts and retains the
confidence of customers and other interested
parties
Every aspect of customer interaction
provides and opportunity to create more
value for the customer
Understanding current and future needs of
customers and other interested parties
contributes to sustained success of the
organization.
 Increased customer Value
Increased customer Satisfaction
Improved Customer loyalty
Enhance repeat business
Enhance reputation of the
organization
Expanded customer based
Increase Revenue and market share
 Recognized direct and indirect customers as
those who receive value from the
organization
Understand customer current and future
needs and expectations
Link the organization's objectives to
customer needs and expectations
Communicate customer needs and
expectations throughout the organization
Plan, design, develop, produce, deliver and
support goods and services to meet customer
needs and expectations.
 Measure and monitor customer
satisfaction and take appropriate
actions.
Determined and take actions on
interested parties needs and
expectations that can affect
customer satisfactionn
Actively manage relationships with
the customer to achieve sustained
success.
 Leaders at all levels establish
unity of purpose and direction
and create conditions in which
people are engaged in achieving
the quality objectives.
 Creation of unity of purpose
and direction and
engagement of people are
enable an organization to
align its strategies, policies
and resources to achieve its
objectives.
 Increased effectives and efficiency in
meeting the organizations quality objectives
Better coordination of the organizations
process
Improved communication between levels and
functions of the organization
Development and improvement of the
capability of the organization and its people
to deliver desired results
 Communicate the organizations
mission, vision, strategy policies and
process throughout the organization
Create and sustain shared values,
fairness and ethical models for
behaviour at all levels of the
organization
Establish a culture of trust and
integrity
 Encourage an organization wide
commitment to quality
Ensure that leaders at all levels are
positive examples to people in
organization
Provide people with the required
resources, training and authority to act
with accountability
Inspire, encourage and recognize
peoples contribution
 Competent, empowered and
engaged people at all levels
throughout the organization are
essential to enhance its
capability to create and deliver
value
 To manage an organization
effectively and efficiently, it is
important to involve all people at all
levels and to respect them as
individuals. Recognition,
empowerment and enhancement of
competence facilitate the
engagement of people in achieving
the organizations quality objectives
 Improved understanding of the
organizations quality objectives by
people in the organization and
increase motivation to achieve
them.
Enhance involvement of people in
improvement activities.
Enhance personal development,
initiates and creativity
 Enhance people satisfaction
Enhance trust and collaboration
throughout the organization.
Increased attention to shared values
and culture throughout the
organization
 Communicate with people to promote
understanding of the importance of their
individual contribution
Promote collaboration throughout the
organization
Facilitate open discussion and sharing of
knowledge and experience.
Empower people to determined constraints
to performance and to take initiatives
without fear
 Recognized and acknowledge
peoples contribution, learning and
improvement.
Enable self evaluation of
performance against personal
objectives
Conducts surveys to assess peoples
satisfaction, communicate the
results, and take appropriate
actions.
 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
 The quality management
systems consist of interrelated
processes. Understanding how
results are produced by this
system enables an organization
to optimize the system and its
performance.
 Enhanced ability to focus effort on key
processes and opportunities for improvement
Consistent and predictable outcomes through
a system of aligned processes
Optimized performance through effective
process management, efficient use of
resources, and reduced cross- functional
barriers
Enabling the organization to provide
confidence to interested parties as to its
consistency, effectiveness and efficiency
 Defined objectives of the system and
processes necessary to achieve them
Establish authority, responsibility and
accountability for managing process
Understand the organizations capabilities
and determined resources constraints to
action
Determined process interdependence and
analyse the effect to modifications to
individual process on the system as a whole.
 Ensure the necessary information is
available to operate and improve the
processes and to monitor, analyze and
evaluate the performance of the overall
system.
Manage risks that can affect outputs of the
processes and overall outcomes of the
quality management system
Manage processes and their interrelations as
a system to achieve the organizations
quality objectives effectively and efficiently
 Successful
organization have
an ongoing focus on
improvement

Improvement is essential for
an organization to maintain
current levels of
performance, to react to
changes in its internal and
external conditions and to
create new opportunities
 Improved process performance,
organizational capabilities and customer
satisfaction.
Enhanced focus of root cause investigation
and determination, followed by prevention
and corrective actions
Enhanced ability to anticipate and react to
internal and external risks and opportunities
Enhanced consideration of both incremental
and breakthrough improvement
Improved use of learning for improvement
Enhanced drive for innovation
 Promote establishment of improvement at
all levels of the organization
Educate and train people at all levels on
how to apply basic tools and methodologies
to achieve improvement objectives
Ensure people are competent to successfully
promote and complete improvement projects
Develop and deploy processes to implement
improvement projects throughout the
organization
 Track, review and audit the
planning, implementation,
completion and results of
improvement projects.
Integrate improvement
consideration into the development
of new or modified goods, services
and processes.
Recognize and Acknowledge
improvement . 6 QMP Evidence
based
 DECISION
BASED ON THE
ANALAYSIS AND
EVALUATION OF DATA
AND INFORMATION ARE
MORE LIKELY TO
PRODUCE DESIRED
RESULTS
 Decision making can be a complex
process, and it always involves some
uncertainty. It often involves multiple
types and sources of inputs, as well as
their interpretation, which can be
subjective. It is important to understand
cause and effect relationships and
potential unintended consequences.
Facts, evidence and data analysis lead to
greater objectivity and confidence in
decision making.
 Improved decision making processes
Improved assessment of process
performance and ability to achieve
objectives
Improved operational effectiveness and
efficiency
Increased ability to review, challenge and
change opinions and decisions
Increased ability to demonstrate the
effectiveness of past decisions
 Determine, measure and monitor
key indicators to demonstrate the
organizations performance
Make all data needed available to
the relevant people
Ensure the data and information are
sufficiently, accurate reliable and
secure.
Ensure people are competent to
analyze and evaluate data as needed
 Make decisions and take actions
based on evidence, balanced
with experience and intuition.
Analyze and evaluate data and
information using suitable
methods
 For sustained success, and
organization management its
relationships with interested
parties, such as suppliers
 Determined relevant interested parties
(such as suppliers, partners, customers,
investors, employees, and society as a
whole) and their relationship with the
organization.
Determined and prioritize interested party
relationships that need to be managed
Established relationships that balance short
term gains with long term considerations
 Pool and share information, expertise and
resources with relevant interested parties.
Measure performance and provide
performance feedback to interested parties,
as appropriate, to enhance improvement
initiatives.
Establish collaborative development and
improvement activities with suppliers,
partners and other interested parties
Encouraged and recognize improvements and
achievements by suppliers and partners
 PDCA is a tool manage processes and
systems:
PLAN set the objectives of the system and
processes to deliver results
DO - - implement and control what was
planned
CHECK monitor and measure processes and
results against criteria and report results
ACT take action to improve the
performance of processes

PDCA enables an
organization to ensure that
its processes are adequately
resourced and managed, and
that opportunities for
improvement are determined
and acted on.
 Define the context of the organization
Define the scope, objectives and policies
Determine the process
Determine the sequence of processes
Define ownership and accountability
Define need for documented information
Define interface, risks and activities within
process
Define monitoring and measuring
requirements
 Implement
Define the resources needed
Verify the process against its
planned objectives
Improvement

The process Approach enables an

organization to plan its processes
and their interaction.
Examples of application to integrate into business
processes
In the organizations strategy
Into the corporate governance of the
organization
Within job descriptions
Into standard accountancy practices
Within the organizations business performance
systems
Could include department or employee
appraisals
In external organizational reporting
Examples of application to integrate into
business processes
Into its standard business risk management
process
In business planning
Product of service design
Procurement or purchasing processes
Engagement with interested parties
Its organizational compliance function
Into normal business communication
channels and processes
 Management Responsibility Leadership
Increased Leaders Requirements
Puts greater emphasis on leadership
engagement
Engaging rather than ensuring
- To be actively involved
- Removal of reference to management
representative
- QMS to be embedded into routine operation
Link to engagement of
people
Link to strategic direction
and integration to business
process
Standard Requirements Describe in;
5.1 Leadership and Commitment
5.1.1 General
5.1.2 Customer Focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibility and
Authorities
Risk based thinking is used throughout the
process approach to;
Decide how risk is addressed in establishing
processes and to
Prevent unintended outputs
Define extent of process planning and
controls needed based on risk
Improve effectiveness of QMS
Maintain and manage system that addresses
risk and meets objectives
 Risk based thinking enables and
organization to determine the
factors that could cause its
processes and its QMS to deviate
from planned results, to put
preventive controls to minimize
negative effects and to make
maximum use of appropriate as they
arise.
 Organizational Knowledge = knowledge
specific to the organization, generally gained
by experience. Information used and shared
to achieve organizations objectives.
Internal Sources, examples: Intellectual
property, lessons from experience, results of
improvements of processes or products or
service
External sources, examples: standards,
academe, conferences, knowledge from
customers of external providers
Requirements Introduced for the purpose of;
Safeguard from loss of knowledge
Turnover
Unshared information
Encourage the organization to acquire
knowledge
Learning from experience
Mentoring
Benchmarking
HIGH
LEVEL
STRUCTURE
 ISO 9001:2008
1. Scope
2. Normative References
3. Terms and definitions
4. Quality Management Systems
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis, and Improvement
 ISO 9001:2015
1. Scope
2. Normative Reference
3. Terms and Definition
4. Context of the Organization
5. Leadership
6. Planning for the quality management system
7. Support
8. Operation
9. Performance Evaluation
10.Improvement
1. Scope
2. Normative Reference
3. Terms and definition
4. Context of the Organization
5. Leadership
PLAN
6. Planning
7. Support
DO
8. Operation
9. Performance Evaluation CHECK

10. Improvement ACT

For Organization with:
Need to demonstrate its ability to
consistently provide products and services
that meet customer and applicable statutory
and regulatory requirements
Aims to enhance customer satisfaction
through effective application of system,
including processes for improvement and
assurance of conformity to customer and
applicable statutory and regulatory
requirements
 ISO 9001:2015 Quality
Management Systems
Fundamentals and
Vocabulary
 The terms and
definitions in ISO
9001:2015 apply
4.1 Understanding the Organization and its
context
Internal Issues
External Issues

4.2 Understanding the needs and expectations

of interested parties
Relevant to the Organization
Monitor and Review Information
4.3 Determining the scope of QMS
o Consider internal and external issues
o Consider requirements of relevant interested
parties
4.4 QMS and its processes
4.4.1 shall establish, implementing, maintain
and improve a QMS, including process needed
and their interactions, in accordance with
the Standard.
4.4.2 To the Extent Necessary
o Shall maintain documented information to
support the operation of its process
o Shall Retain documented information to
have confidence that the processes are being
carried out as planned
5.1 Leadeship and Commitment
Top Management shall Demonstrate leadership
and commitment with respect to QMS
Take accountability on effectiveness of QMS
Ensure that quality policy and objectives are
established for QMS and compatible with the
context and strategic direction of the
organization
Ensure integration into the organizations
business processes
Promote the use of process approach and risk
based thinking
Ensure resources for QMS are availbale
5.1 Leadersship and Commitment (cont)
o Communicate importance of effective QMS
o Ensure QMS achieves intended results
o Engage, direct, and support persons to
contribute to effective QMS
o Promote improvement
o Support other relevant management roles to
demonstrate their leadership as it applies to
other areas or responsibility
5.1.2 Customer Focus
Top Management to Ensure that:
Customer and applicable statutory and
regulatory requirements are determined,
understood and consistently met.
Risks and opportunities determined and
addressed
Focus on enhancing customer satisfaction
maintained
5.2 Policy
5.2.1 Establishing the quality policy
Appropriateness
Commitments
Framework for objectives

5.2.2 Communicating the quality Policy

Documented information
Communicated and Understood
Available to interested parties, as
appropriate
6.1 Actions to address risks and opportunities
6.1.1 When planning QMS, consider the risks in
4.1 and the requirement 4.2
6.1.2 The organization shall plan
Action to address risks and opportunities
How to integrate actions to QMS
How to evaluate the actions
5.3 Organizational roles, responsibilities and
authorities
Top Management assignments;
Ensuring QMS Conformity
Ensuring processes with intended outputs
Reporting performance of QMS
Ensuring promotion of customer focus
Ensuring integrity of QMS is maintained
6.1 Actions to address risks and opportunities

6.1.1 When planning QMS, consider the risks

in 4.1 and the requirement in 4.2

6.1.2 The organization shall plan:

Actions to address risks and opportunities
How to integrate actions to QMS
How to evaluate the actions
6.2 Quality Objectives and planning to achieve
them
6.2.1 Quality objectives at relevant
functions, levels and processes needed for
QMS
6.2.2 Determined needed resources

6.3 Planning of Changes

Changes carried out in a planned manner.
7.1 Resources
7.1.1 General

Consider capabilities and constraints on existing

internal resources
Consider needs from external providers

7.1.2 People

Determined and provide persons necessary for the

effective implement of QMS
7.1.3 Infrastructure
Building and associated facilities
Equipment Hardware and software
Transportation and resources
Information and communication technology

7.1.4 Environment for the operation of processes

A suitable environment can be a combination of
human and physical factors
Social
Psychological
Physical
7.1.5Monitoring and Measuring resources

7.1.5.1 General
Suitability for specific type of monitoring and
measurement
Maintained for continuing fitness

7.1.5.2 Measurement Traceability

Calibrated or verified
Identified
Safeguard from damage or deterioration
7.1.6 Organizational knowledge

Determine the knowledge necessary

Be maintained and made available to
the extent necessary
Changing needs and trends; Consider
current knowledge and determine how
to acquire any necessary additional
knowledge and updates
7.2 Competence
Determine necessary competence
Ensure personnel competence
Take actions to acquire
competence
Retain appropriate documented
information as evidence of
competence
7.3 Awareness
Awareness of personnel doing work under the
organizations control:

On Quality Policy
On relevant Quality Objectives
Contribution to the effectiveness of QMS, benefits of
improved performance
Implication of not conforming to QMS
7.4 Communication
Determined internal and external
communication relevant to QMS:

What?
When?
With Whom?
How?
Who Communicate?
7.5 Documented Information

7.5.1 General
Documented information required by the Standard
Documented information determined by organization
as necessary for effectiveness of QMS

7.5.2 Creating and Updating

Ensure appropriate identification,
format and media, review and approval
7.5.3 Control of documented information

7.5.3.1 Available and Adequately protected

7.5.3.2 Address
Distribution
Storage

Control

Retention And Disposition

Consider: External Origin, Unintended alterations,

Access
8.1 Operational Planning and Control

Determine requirements for products and services

Establish criteria for processes and acceptance
Determine resources
Implement control of processes
Determine, maintain and retain documented
information
:Ensure outsourced processes are controlled
8.2 Requirements for products and services

8.2.1 Customer communication

Product or service information

Handling enquiries, contacts, charges
Customer feedback, including complaints
Handling customer property
Contingency actions, when necessary
8.2.3.2 Retain documented information:

Results of review
Any new requirements

8.2.4 Changes to requirements for products

and services

Relevant documented information is amended

Relevant persons are made aware
8.3 Design and development of products and
services

8.3.1 General
Establish, implement and maintain a D&D processes
appropriate to ensure
Subsequent provision of products and services
8.3.2 D&D planning

Consider:
Nature, duration and complexity
Required process stages
Required Verification and validation
Responsibilities and authorities
Internal and External Resources
8.3.2 Planning cont.

Consider
Control Interfaces
Need for customer involvement
Requirement for subsequent provision
Level of control expected by customers and relevant
interested parties
Documented Information
8.3.3 D&D inputs
Consider:
Functional and performance requirements
Information from previous design
Statutory and regulatory Requirements
Standards or codes of practice
Potential consequences of failure
* Retain Documented information
8.3.4 D&D control
Ensure:
Results to be achieved are defined
Reviews conducted
Verification conducted
Validation Conducted
Necessary actions on problems determined
Documented Information Retained
8.3.5 D&D outputs
Ensure outputs:
Meet inputs
Adequate for subsequent processes for provision
Include reference monitoring and measurement
requirements
Specify Characteristics of products and services
*Retain Documented information
8.3.6 D&D Changes
Retained Documented Information
D&D Changes
Results of Reviews
Authorization of changes
Actions taken to prevent adverse impacts
8.4 Control of externally provided processes,
products and services
8.4.1 General
For Incorporation into core products or services
Provided directly to the customer on behalf of the
organization
Provided as a result of a decision of the organization
*evaluation, selection, monitoring of performance,
re-evaluation of external providers
8.4.2 Type and extent of Control
Externally provided processes remain in the
control of QMS
Define controls for external provider and those
for outputs
Consider: potential impact to organization,
effectiveness of controls
Determine verification
8.4.3 Information for external providers
Communicate:
Processes, products and services to be provided
Approval considerations
Competence of personnel
Interactions with organization
Control and monitoring of performance
Verification and validation activities
8.5 Production and service provision
8.5.1 Control of production and service
provision
Controlled conditions:
Availability of documented information on product
characteristics and results to be achieved
Suitable monitoring and measuring equipment
Monitoring and measuring activities
Appointment of competent persons
Validation and re-validation activities
Implementation of actions to prevent human error
Release, delivery and post-delivery activities
8.5.2 Identification and traceability
Identify the outputs

Identify the status of outputs

Retain documented information

to enable traceability
8.5.3 Property belonging to customer or
external providers
Exercise care:
Identify
Verify
Protect
Safeguard
Report when damaged or unsuitable
*Retain Documented information
8.5.4 Preservation
Can include:
Identification
Handling
Contamination control
Packaging
Storage
Transmission of transportation
Protection
8.5.5 Post Delivery Activities
Consider:
Statutory and Regulatory Requirements
Potential undesired Consequences
Nature, use and intended lifetime of products or
services
Customer requirements
Customer feedback
8.5.6 Control and Changes
Retained Documented Information:
Results of review
Person authorizing change
Necessary actions from the review

8.6 Release of products and services

Implement planned arrangements before
release of products and services, unless
Otherwise approved
8.7 Control of Nonconforming outputs
8.7.1 Use of none or more of the following
ways:
Correction
Segregation, containment, return or
suspension
Informing the customer
Obtaining authorization for acceptance under
concession
Conformity shall be verified when outputs
are corrected
8.7.2 Retain Documented information:

Describing the nonconformity

Describing the actions taken
Describing the concession obtained
Identifying the authority deciding the action
taken
9.1.1Monitoring, Measurement, Analysis and
Evaluation
9.1.1 General
What needs to be monitored and measured?
What methods?
When to be done?
When to be analyzed?
*Retained documented information
10.1 General

Determine and select opportunities for

improvement.
Include:
Improve products and services
Correct/prevent/reduce undesired effects
Improve performance of QMS
10.2 Nonconformity and corrective action
10.2.1 Shall:
React to the NC as applicable
Evaluate need to eliminate the cause(s)
Implement actions
Review effectiveness
Update risks and opportunities, if necessary
Make changes to QMS
10.2.2 Retained Documented Information:
Nature of NC and actions taken
Results of corrective action

10.3 Continual Improvement

Continually improve suitability, adequacy and
effectiveness of the QMS
Consider the results of analysis and evaluation
Consider the outputs from Management reviews
Thank you!