Quality Management System (Institutional Level)

Quality Management System
(Institutional Level)
Reynaldo O. Joson, MD, MHA, MHPEd, MSc Surg
Lecture
Effective Nursing Service Administration Training
(Clinical Administration and Business Management Skills)
ManilaMed, May 10, 2017

Institutional Level – hospital or medical center wide
vs
Unit Level – department or section level
such as Medical Departments, Nursing Departments,
Allied Medical Departments, Finance Department, and
other Support Departments

(Institutional and Unit Levels)
[ALIGNED and INTEGRATED]
Hospital QMS
Unit 1 QMSUnit 4 QMS

(Institutional and Unit Levels)
[ALIGNED and INTEGRATED]
Hospital QMS
Vision,
Mission,
Core Values
Quality
Policy
Specific Quality
Objectives
Specific Quality
Objectives
Specific Quality
Objectives
Specific Quality
Objectives

Outline of Talk
>Concepts, Definitions, and Meanings
• Quality / Quality and Safe Patient Care
• Quality Management System / Total Quality Management System
>Importance of QMS in a Hospital
>QMS Standards and Accreditation
• ISO 9001 / PhilHealth Benchbook / Joint Commission International
/ Accreditation Canada International / others
>QMS Principles
>Process Approach to QMS (Inputs / Throughputs / Outputs)
>ROJoson’s Personal Recommendations on QMS
>Patient Experience (Video)

Concepts, Definitions, and Meanings
Quality
Quality and Safe Patient Care
Total Quality Management System

Quality
Quality – poor, good, excellent
• Medical care
• Nursing care
• Radiology services
• Housekeeping services
• Billing services
• SERVICE – any type of service in the hospital
What is quality?

What is quality?

What is quality?
A subjective term for which each person has his or her own
definition.

What is Quality?
• different concepts, definitions, and meanings depending on context
and perceptions
In technical usage, quality can have two meanings:
• characteristics of a product or service that bear on
its ability to satisfy stated or implied needs
• a product or service free of deficiencies
American Society for Quality (ASQ)

What is Quality?
and perceptions
• Quality is the degree to which health services for
individuals and populations increase the likelihood of
desired health outcomes and are consistent with current
professional knowledge. (Institute of Medicine)
• Key attributes of high quality healthcare systems, as
defined by the Institute of Medicine (U.S.) include safety,
timeliness, effectiveness, efficiency, equity and patient
centeredness.

What is Quality?
and perceptions
• Quality in health care is the degree to which its processes
and results meet or exceed the needs and desires of the
people it serves. (Joint Commission International)
• Quality is “the degree of excellence; the extent to which an
organization meets clients needs and exceeds their
expectations”. (Accreditation Canada International)

What is Quality?
and perceptions
PhilHealth Benchbook
• timely, safe, patient-centered and effective (patient care)

What is Quality?
• different concepts, definitions, and meanings depending on
context and perceptions
• Quality means degree to which a set of inherent
characteristics of an object fulfills requirements
(ISO).
• Degree to which services fulfill the requirements of
customers.

What is Quality?
and perceptions
General generic concepts:
• Quality means meeting the customer's requirements.
• Doing the right thing right at the right time and every time.
(Right thing = customer requirements)

What is Quality?
and perceptions
Specific concepts in patient care setting:
• Timely, safe, patient-centered, effective, efficient (patient
care)
LEADING TO
• Patient satisfaction
• Patient experience

What is Quality?
• different concepts, definitions, and meanings depending on context and
perceptions
Patient Satisfaction vs Patient Experience
Patient Satisfaction:
Satisfaction is about whether a patient’s expectations about a
health encounter were met.
Patient Experience:
“The sum of all interactions, shaped by and organization's
culture, that influence patient perceptions across the
continuum of care.”
The Beryl Institute

Patient Experience
The patient's cumulative evaluation
of the journey they have with you,
starting when they first need you
and based on their clinical and
emotional interactions, which are
shaped.
Patient Experience Journal

Patient Experience
Patient experience encompasses the
range of interactions that patients have
with the health care system, including
their care from health plans, and from
doctors, nurses, and staff in hospitals,
physician practices, and other health
care facilities.
Agency for Healthcare Research and
Quality

Patient Experience
As an integral component of health care
quality, patient experience includes several
aspects of health care delivery that patients
value highly when they seek and receive
care, such as getting timely appointments,
easy access to information, and good
communication with health care providers.
Agency for Healthcare Research and
Quality

Patient Satisfaction vs Experience
Patient Experience
(More than satisfaction / delight)
Satisfaction is about whether a patient’s
expectations about a health encounter were
met.
Two people who receive the exact same care,
but who have different expectations for how
that care is supposed to be delivered, can give
different satisfaction ratings because of their
different expectations.

Patient Satisfaction vs Experience
Patient Experience
(More than satisfaction / delight)
To assess patient experience, one must
find out from patients whether
something that should happen in a
health care setting (such as clear
communication with a provider)
actually happened or how often it
happened.

Recent Emphasis on Patient Safety
• Is there a difference between quality and safe
patient care?
• Should the quality and safety goals be independent
of each other?

Quality in health care is the degree to which its processes
people it serves.
Patient safety, as defined by the World Health Organization,
is the prevention of errors and adverse effects to patients
that are associated with health care.

Quality and safety are inextricably linked.
Quality in health care is the degree to which its processes
people it serves.
Those needs and desires include safety.

Safety is within the quality dimension.
It is recommended for the safety goals to be extracted from
the quality goals for emphasis reason.
However, the ultimate goals should still be an alignment and
integration of quality and safety in patient care.

Patient safety emerges as a central aim of quality.
Patient safety is often considered a component of
quality, thus, practices to improve patient safety
improve the overall quality of care.
The ultimate goals are quality of care and patient
safety.

PhilHealth Benchbook
•timely, safe, patient-centered and effective
(patient care)

What is Quality Management System?
• Management System with regard to quality
• Financial Management System  Finance
• Environment Management System  Environment

What is management system?
• set of interrelated or interacting elements of
an organization to establish policies and objectives
and processes to achieve certain objectives.
• elements include organization’s structure, roles and
responsibilities, planning, operation, policies,
practices, rules, beliefs, objectives and processes to
achieve certain objectives.

What is Quality Management System?
• organizational structure, processes, procedures and
resources needed to implement, maintain and
continually improve the management of quality
(American Society for Quality)

What is Quality Management System? (ISO)
• management system with regard to quality
• include establishing quality policies and quality
objectives
• processes to achieve these quality objectives through
• quality planning
• quality assurance
• quality control
• quality improvement

Quality planning
• focused on setting quality objectives and specifying
necessary operational processes and related resources
to achieve the quality objectives
Quality assurance
• focused on providing confidence that quality
requirements will be fulfilled
Quality control
• focused on fulfilling quality requirements
Quality improvement
• focused on increasing the ability to fulfil quality
requirements

What is Total Quality Management System?
• organization-wide efforts to install and make
permanent a climate to continuously improve its
ability to deliver quality products and services
• all members of an organization participate in
improving processes, products, services, and the
culture in which they work
Management approach to long–term success
through customer satisfaction!

What is Total Quality Management System?
COMPREHENSIVE

ISO 9001:2015 Quality Management System

ISO 9001:2015 Quality Management System
Organization
and its
Context
Products and
Services
Improvement
Leadership
Support
and
Operations
Performance
Evaluation
Planning
Customer
Requirements
Customer
Satisfaction
Plan Do
Act Check
Needs and
Expectations
of Relevant
Interested
Parties
Results of
QMS

PhilHealth Benchbook 2nd Edition
A. PATIENT CENTERED STANDARDS
1. PATIENT RIGHTS AND ORGANIZATIONAL ETHICS
2. ACCESS TO HEALTHCARE
3. INPATIENT ADMISSION AND OUTPATIENT REGISTRATION
4. ASSESSMENT OF PATIENTS
5. CARE PLANNING CARE DELIVERY
6. MEDICATION MANAGEMENT
7. SURGICAL AND ANESTHESIA CARE
B. FACILITY FOCUSED STANDARDS
8. LEADERSHIP AND MANAGEMENT
9. HUMAN RESOURCE MANAGEMENT
10. INFORMATION MANAGEMENT
11. SAFE PRACTICE AND ENVIRONMENT
12. INFECTION CONTROL
13. IMPROVING PERFORMANCE

QMS = TQMS
ORGANIZATION-WIDE EFFORT
• QM Office – QM Representative / Officer (Coordinator /
Education Function)
• Not the only one responsible for the QMS / TQMS of the
hospital!
• All units must have a QMS.
• All units must have a QM Officer.
• All units’ QMS must be aligned and integrated into the hospital
QMS Framework.
• ALL UNITS MUST BE CONTRIBUTING TO THE TQMS OF THE
HOSPITAL!

Hospital Quality and Safety Management System
Documented Information
Organizational
Context
Performance
Excellence
Improvement
Leadership
Support
Clients
Workforce
Operations
IT
EvaluationPlanning
Client
Requirements
Organizational
Vision
Client
Engagement
Plan Do
Act Check
Legal
Requirements

UNIT Quality and Safety Management System
Documented Information
Organizational
Context
Performance
Excellence
Improvement
Leadership
Support
Clients
Workforce
Operations
IT
EvaluationPlanning
Client
Requirements
Organizational
Vision
Client
Engagement
Plan Do
Act Check
Legal
Requirements

Manual of
Governance
and Operations
Manual of Quality and Safety Management
System
Management Systems
Guided by and
compliant with
established
standards

Quality and Safety Management System
Hospital-wide  Unit (ALIGNMENT AND INTEGRATION)
• Quality and Safety Management System
• Organizational Context Management System
• Organizational Vision Management System
• Legal Requirements Management System
• Client Requirements Management System
• Leadership Management System
• Planning Management System
• Support Management System

Hospital-wide  Unit
(ALIGNMENT AND INTEGRATION)
• Clients Management System
• Workforce Management System
• Operations Management System
• IT Management System
• Evaluation Management System
• Improvement Management System
• Documented Information
Management System
• Client Engagement Management
System
• Performance Excellence
Management System

ALIGNMENT AND INTEGRATION OF ALL MANAGEMENT
SYSTEMS!
Leadership Management System
• BOD Leadership Management System
• CEO Leadership Management System
• SMT Leadership Management System
• Directors Leadership Management System
Client Engagement Management System
• Community Engagement Management System
• Patient Engagement Management System
• Physician Engagement Management System
• HMO and Company Engagement Management System

Importance
of
Quality Management
System

Importance of Quality Management System
>Improve performance and increase customer
satisfaction with the hospital’s services leading
to
•quality and safe services
•financially viable and sustainable hospital
>Competitive with other hospitals

• Promote development of an effective and
efficient organization (hospital and all its units)
• Improve its overall performance

Advantages of QMS (ISO 9001:2015):
• Ability to consistently provide services that meet
customer and applicable statutory and regulatory
requirements
• Facilitating opportunities to enhance customer
satisfaction
• Addressing risks and opportunities associated with
its context and objectives
• Ability to demonstrate conformity to specified
quality management requirements

Quality Management
System Standards and
Accreditation

Quality Management System Standards
and Accreditation
In a hospital setting in the Philippines, as
of 2017,
the following local and international
documented sets of standards should
guide all hospitals in achieving a high level
of quality and performance:

and Accreditation
•ISO 9001:2015 (Quality Management System)
•PhilHealth Benchbook
•Joint Commission International /
Accreditation Canada International / National
Accreditation Board for Hospitals and
Healthcare Providers
•Philippine Quality Award

and Accreditation
Accreditation Standards URLs
PhilHealth Benchbook https://www.philhealth.gov.ph/partners/provi
ders/benchbook
Joint Commission International (JCI)
Accreditation International (ACI)
National Accreditation Board for
Hospitals and Healthcare Providers
(NABH)
http://www.jointcommissioninternational.org
/
http://www.internationalaccreditation.ca/en/
home.aspx
http://www.nabh.co/
Philippine Quality Award http://www.pqa.org.ph
http://www.dti.gov.ph/dti/index.php?p=492
http://www.nist.gov/baldrige/publications/hc
_criteria.cfm
ISO (International Organization for
Standardization)
http://www.iso.org/iso/home.html

and Accreditation
ISO / PQA PhilHealth Benchbook / JCI /
ACI / NABH
Origin manufacturing
industry
hospital industry
Language manufacturing health care
Product and
Service
easily defined, tangible
item
(can be used by
hospitals)
clinical aspects of health care
not easily defined, not readily
tangible

and Accreditation
Accreditation Standards Advantages
Philippine Quality Award Designed to help provide organizations with an
integrated approach to organizational
performance that results in
-Delivery of ever-improving value to
customers and stakeholders, contributing
to organizational sustainability
-Improvement of overall organizational
effectiveness and capabilities
-Organizational and personal learning
Standardization)
ISO 9001: Quality Management
System
Designed to help organizations ensure that
they meet the needs of customers and other
stakeholders while meeting statutory and
regulatory requirements related to the product.

Quality Management System Standards and Accreditation
PQA Criteria for Performance
Excellence
ISO 9001:2015
1. Leadership
2. Strategic Planning
3. Customer Focus
4. Measurement, Analysis, and
Knowledge Management
5. Workforce Focus
6. Operations Focus
7. Results
4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance Evaluation
10 Improvement

and Accreditation
Accreditation Standards Advantages
PhilHealth Benchbook Designed to encourage Philippine
hospitals improve on their quality
management system and to improve
quality and safe patient care
Joint Commission
International (JCI)
Accreditation International
(ACI)
National Accreditation Board
for Hospitals and Healthcare
Providers (NABH)
Designed to improve quality and safe
patient care
Designed to assess and improve
organization performance based on
internationally agreed standards and
stimulating continuous improvement to
achieve optimum outcomes on
healthcare

Accreditation
Canada
International
Joint Commission International National Accreditation Board
for Hospitals
 Individual Client
/ Patient Care
Groups (14)
 Information
Management
 Human
Resources
Development
and
Management
 Environmental
Management
 Leadership and
Partnerships
Patient-centered Standards
•Access to Care and Continuity of Care
•Patient and Family Rights
•Assessment of Patients
•Care of Patients
•Anesthesia and Surgical Care
•Medication Management and Use
•Patient and Family Education
Health Care Organization Management
Standards
•Quality Improvement and Patient Safety
•Prevention and Control of Infections
•Governance, Leadership, and Direction
•Facility Management and Safety
•Staff Qualifications and Education
•Management of Communication and
Information
• Access and Planning of
Services
• Customer Rights and
Education
• Care of Customers
• Management of
Medication, Consumables
and Equipment (including
Instruments)
• Infection Control
• Continual Quality
Improvement
• Responsibilities of
Management
• Facility Management and
Safety
• Human Resource
Management
• Information Management
System

PhilHealth Benchbook Joint Commission International
PATIENT CENTERED STANDARDS
1. Patient Rights and Organizational Ethics
2. Access to Healthcare
3. Inpatient Admission and Outpatient
Registration
4. Assessment of Patients
5. Care Planning and Care Delivery
6. Medication Management
7. Surgical and Anesthesia Care
FACILITY FOCUSED STANDARDS
8. Leadership and Management
9. Human resource Management
10. Information Management
11. Safe Practice and Environment
12. Infection Control
13. Improving Performance
PATIENT-CENTERED STANDARDS
•Access to Care and Continuity of Care
•Patient and Family Rights
•Assessment of Patients
•Care of Patients
•Anesthesia and Surgical Care
•Medication Management and Use
•Patient and Family Education
HEALTH CARE ORGANIZATION MANAGEMEHT
STANDARDS
•Quality Improvement and Patient Safety
•Prevention and Control of Infections
•Governance, Leadership, and Direction
•Facility Management and Safety
•Staff Qualifications and Education
•Management of Communication and
Information

PhilHealth Benchbook PhilHealth Benchbook (2ND Ed)
• Patient Rights and
Organizational Ethics
• Patient Care
• Leadership and
Management
• Human Resource
Management
• Information Management
• Safe Practice and
Environment
• Performance Improvement
PATIENT CENTERED STANDARDS
1. Patient Rights and Organizational Ethics
2. Access to Healthcare
3. Inpatient Admission and Outpatient Registration
4. Assessment of Patients
5. Care Planning and Care Delivery
6. Medication Management
7. Surgical and Anesthesia Care
FACILITY FOCUSED STANDARDS
8. Leadership and Management
9. Human resource Management
10. Information Management
11. Safe Practice and Environment
12. Infection Control
13. Improving Performance

Accreditation as a Strategy / Tool for
Hospital Quality Service Improvement

Processes by which a hospital voluntarily applies for
recognition or attestation of compliance to certain set of
standards by a third-party
What is Hospital Accreditation?
Accredited / Accreditation
Certified / Certification
Awarded / Award
Compliance
Demonstration of
competency /
consistency
Products
Processes
Systems
Persons

Accreditation as a Strategy / Tool for Hospital Quality
Service Improvement
A hospital seeking accreditation from an accrediting body is
done on a voluntary basis.
The hospital has the freedom to choose the set of standards
it wants to be assessed or evaluated on by an accrediting
body.
It also has the liberty to choose the accrediting body to do
the assessment or evaluation.

Accreditation, Certification and Award
Hospital
Set
Standards
Criteria
Indicators
Satisfactory
degree of compliance /
achievement
Certification AwardAccreditation
Third-party
Assessor
/ Auditor
Philippine
Quality Award
ISO 9001
ISO 14000
PhilHealth
Benchbook
JCI
ACI
NABH
Levels

Service Improvement
Hospital accreditation almost always entails fees:
• fee for the survey or assessment
• fee for the certificate
How much the fees are is dependent on the accrediting
body.

and Accreditation
Accreditation Standards Accreditation Fees (Assessment
and Certification)
As of 2017 (may change anytime)
PhilHealth Benchbook PhP 10T
JCI
ACI
NABH
JCI – PhP 14 M
ACI – PhP 8 M
NABH – PhP 3 M
Philippine Quality Award PhP 30T – small organizations
PhP 50T – medium to big
organizations
Standardization)
PhP 300T

Service Improvement
There are a lot of benefits that can be derived from hospital
accreditation.
Some can be considered as major benefits and some, as
minor benefits.
Some can be considered as primary benefits and others, as
off-shoots of the primary, or secondary.
These benefits are translatable to goals and objectives of
having a hospital accreditation.

Service Improvement
The overarching major primary benefit or
goal is to
promote the business development
program of the hospital so as to make it
viable and sustainable.

Service Improvement
The secondary benefits or objectives can and should be
the following:
To use the accreditation project as an assessment tool
on hospital performance as well as a change
management tool.
To identify and institute areas of improvement towards
excellence with the help of the hospital accreditation project.
To educate the staff on performance excellence with the help
of the hospital accreditation project.

Service Improvement
The secondary benefits or objectives can and should be
the following:
To increase the hospital’s credibility and to demonstrate
its accountability to the community using an attained
hospital accreditation.
To enhance the hospital reputation so as to attract more
clients utilizing its services.
To increase its leverage with the potential partners and
collaborators in the health care industry using the attained
hospital accreditation.

Service Improvement
• Stimulate continuous improvement in service and
patient care processes and outcomes.
• Improve management of health care services
particularly on patient safety.
• Provide staff education on better or best practices.

Service Improvement
• Increase efficiency / reduce cost.
• Improve organization performance.
• Promote recognition for excellence.
• Strengthen public and community confidence.

Service Improvement
Use it as change agent!
• Know & fulfill requirements of quality! (with assessment –
internal and external)
• Educate staff on quality!
• Motivate staff on quality!

Hospital Accreditation:
Does it Matter?
It depends on your need and situation!
Need - to participate in National Health Insurance
Program and get benefits – go for PhilHealth
Accreditation!
Need - to participate in medical tourism program and
get benefits –international accreditation (JCI / ACI /
NBAH)
Need – to satisfy requirement of corporate accounts –
go for accreditation!
Need – to satisfy expectations of the community – go for
accreditation!

Does it Matter?
Situation – to be with the trend of having an international
accreditation (not to be left out – strong community
expectation) – go for accreditation!
Situation – want to fast-track improvement of quality and
safety of operations and services with accreditation – go
for accreditation (assessment, training, improvement,
evaluation)!

Does it Matter?
NO need; NO situation
Be COMPLIANT with the standards and criteria without
going for formal accreditation!
(examples: ISO, JCI/ACI/NABH, PQA)
(self-directed learning and improvement!)

What are the recommended processes in going for hospital
accreditation?
Starting point:
Top management decides to have a Hospital Accreditation
Project
• To promote the business development program of the
hospital so as to make it viable and sustainable.
• To use it as a change agent to fast-track quality
improvement.

accreditation?
Top management creates a Steering Team / Committee for
Hospital Accreditation Project with clear functions and authority.
Membership of Steering Team / Committee
Senior Management Representative if not the Hospital
Director
Chair (with competency in hospital accreditation and
leadership)
Cross-sectoral or multisectoral membership with
representatives from key functional areas in the hospital,
such as the following:
(Note: the senior management team members may
constitute the Steering Team / Committee.)

accreditation?
Cross-sectoral or multisectoral membership with representatives
from key functional areas in the hospital, such as the following:
(Note: the senior management team members may constitute the
Steering Team / Committee.)
Medical service sector
Nursing service sector
Ancillary medical service sector
Administrative or support service sector
Human resource development sector
Business development sector
Finance sector
Secretariat

accreditation?
Steering Team formulates a master plan for Hospital
Accreditation Project.
Steering Team decides on set of standards to be assessed or
evaluated on by an accrediting body.
Steering Team seeks commitment for support and
collaboration from top, senior, middle, and lower
management on Hospital Accreditation Project.

accreditation?
Contents of master plan for Hospital Accreditation Project
• Goals and objectives of accreditation project (include
short- and long-term goals and objectives)
• Selection, prioritization, and integration of the
accreditation standards
• Selection of the accrediting bodies
• Expected outputs (short- and long-term)
• Expected impact (short- and long-term)
• ………..

accreditation?
Contents of master plan for Hospital Accreditation Project
• ..........
• Timelines (short- and long-term)
• Strategies and action plans to achieve expected outputs
and impacts (short- and long-term)
• Budget (short- and long-term)
• Monitoring and oversight plan
• Evaluation plan (short- and long-term)

Quality Management
System
PRINCIPLES

“Quality management
principles” are a set of
fundamental beliefs, norms,
rules and values that are
accepted as true and can be
used as a basis for quality
management.

QMS Principles (ISO)
• Customer focus
• Leadership
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management

QMS Principles
Customer Focus
Statement
• The primary focus of quality management is to meet
customer requirements and to strive to exceed customer
expectations.
Rationale
• Sustained success is achieved when an organization
attracts and retains the confidence of customers and other
interested parties. Every aspect of customer interaction
provides an 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.

QMS Principles
Customer Focus
Key benefits
• Increased customer value
• Increased customer satisfaction
• Improved customer loyalty
• Enhanced repeat business
• Enhanced reputation of the organization
• Expanded customer base
• Increased revenue and market share

QMS Principles
Leadership
Statement
• 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.
Rationale
• Creation of unity of purpose and direction and
engagement of people enable an organization to
align its strategies, policies, processes and
resources to achieve its objectives.

QMS Principles
Leadership
Key Benefits
• Increased effectiveness and efficiency in meeting
the organization’s quality objectives
• Better coordination of the organization’s processes
• 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

QMS Principles
Engagement of People
Statement
• Competent, empowered and engaged people at all
levels throughout the organization are essential to
enhance its capability to create and deliver value.
Rationale
• 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 organization’s quality objectives.

QMS Principles
Engagement of People
Key Benefits
• Improved understanding of the organization’s quality
objectives by people in the organization and increased
motivation to achieve them
• Enhanced involvement of people in improvement activities
• Enhanced personal development, initiatives and creativity
• Enhanced people satisfaction
• Enhanced trust and collaboration throughout the
organization
• Increased attention to shared values and culture
throughout the organization

QMS Principles
Process Approach
Statement
• 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.
Rationale
• The quality management system consists of
interrelated processes. Understanding how results
are produced by this system enables an
organization to optimize the system and its
performance.

QMS Principles
Process Approach
Key Benefits
• 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

QMS Principles
Improvement
Statement
• Successful organizations have an ongoing focus on
improvement.
Rationale
• 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.

QMS Principles
Improvement
Key Benefits
• Improved process performance, organizational capabilities
and customer satisfaction
• Enhanced focus on 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

QMS Principles
Evidence-based Decision Making
Statement
• Decisions based on the analysis and evaluation of data and
information are more likely to produce desired results.
Rationale
• 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.

QMS Principles
Evidence-based Decision Making
Key Benefits
• 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

QMS Principles
Relationship Management
Statement
• For sustained success, an organization manages its
relationships with interested parties, such as suppliers.
Rationale
• Interested parties influence the performance of an
organization. Sustained success is more likely to be
achieved when the organization manages relationships
with all of its interested parties to optimize their impact on
its performance. Relationship management with its
supplier and partner networks is of particular importance.

QMS Principles
Relationship Management
Key Benefits
• Enhanced performance of the organization and its
interested parties through responding to the opportunities
and constraints related to each interested party
• Common understanding of goals and values among
interested parties
• Increased capability to create value for interested parties
by sharing resources and competence and managing quality-
related risks
• A well-managed supply chain that provides a stable flow
of goods and services

Process Approach to
Quality Management
System

Process Approach to QMS
• All organizations normally use processes to achieve
their objectives.
• A process is a set of interrelated or interacting
activities that use inputs to deliver an intended
result, which consist of tangible inputs and outputs
e.g. materials, components or equipment or
intangible outputs e.g. data, information or
knowledge.

• Process approach involves systematic definition
and management of processes and their
interactions so as to achieve the intended results in
accordance with the quality policy and strategic
direction of the organization.
• 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.

ISO 9001:2008 Process Approach

ISO 9001:2015 Process Approach

(Whole System – Hospital and Units)

(Specific Service)

ISO 9001:2015 Quality Management System Process Approach
Organization
and its
Context
Products and
Services
Improvement
Leadership
Support
and
Operations
Performance
Evaluation
Planning
Customer
Requirements
Customer
Satisfaction
Plan Do
Act Check
Needs and
Expectations
of Relevant
Interested
Parties
Results of
QMS

PDCA
PDCA is a tool that can be used to manage processes and systems.
PDCA stands for:
• P Plan: set the objectives of the system and processes to deliver
results (“What to do” and “how to do it”)
• D Do: implement and control what was planned
• C Check: monitor and measure processes and results against
policies, objectives and requirements and report results
• A Act: take actions to improve the performance of processes
PDCA operates as a cycle of continual improvement, with risk‐based
thinking at each stage.

ROJoson’s Personal
Recommendations on
Quality Management
System Development

Personal Recommendations on QMS
Development
• Use ISO 9001:2015 and PhilHealth Benchbook as
guides and checklists (as a priority).
• Go for PhilHealth Benchbook accreditation.
• May go for ISO 9001:2015 certification if needed.
• Start with the ISO 9001:2015 QMS Framework.
Modify it to suit your hospital setting, e.g., to
include “safety.”

ISO 9001:2015 Quality Management System Framework
Organization
and its
Context
Products and
Services
Improvement
Leadership
Support
and
Operations
Performance
Evaluation
Planning
Customer
Requirements
Customer
Satisfaction
Plan Do
Act Check
Needs and
Expectations
of Relevant
Interested
Parties
Results of
QMS

-Quality and
Safe Health
Care Services
-Cost-efficient
/ Value-based
Services
-Maximal
Utilization of
Services
Patient
Experience

Development
• Formulate and decide on the quality and safety
policy.
• Use the policy as a guide to formulate quality
objectives.

Quality and Safety Policy
To continuously provide quality and safe health care services,
products, facility and environment to all our stakeholders
(communities, families, patients, workforce and partners).
This policy shall be realized through:
• Understanding the expectations of our stakeholders on quality and
safe health care services, products, facility and environment;
• Complying with all statutory and regulatory requirements;
• Designing effective and efficient quality and safe management
systems
• Providing adequate resources and highly competent staff to support
the implementation of the management system;
• Regularly evaluating and reviewing the results of implementation of
the management system;
• Continually improving the management system with innovations.

Development
• Your Manual of Governance and Operations should
be equivalent to the Manual on Quality and Safety
Management System. One, hospital wide and one,
specific for the unit. (NO more separate Quality
Manual vs Manual of Governance and Operations)
• The unit Manual of Governance and Operations or
Manual on Quality and Safety Management System
should be aligned and integrated into that of the
hospital.

Quality Management System (Institutional Level)

Development
• Develop hospital wide management systems for
each box in the QSMS framework to serve as a
guide for the unit management systems for
alignment and integration purposes.

Development
• In the management systems, both hospital and unit
wide, make use of the standards of ISO and
PhilHealth as guides and comply.

ISO 9001:2015 Quality Management System Standards
4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance Evaluation
10 Improvement

Development
• In all the departments, you can use this
Department Design and Development Framework
as a guide.
• Develop a Department Manual of Governance and
Operations or Manual of QSMS that contains all the
information and the needed processes in each of
the boxes.

Development
• Make the goals as uniform as possible for all units
and aligned to hospital goals like so:
• Client engagement (patient experience)
• Performance excellence
• Quality and safe health care services
• Cost-efficient / value-based services
• Maximal utilization of services

Development
• After you are done with the Manual of Governance
and Operations or Manual of QSMS (hospital-wide
and units),
•Deploy and educate staff
•Implement
•Check
•Improve

Development
When you are audited, the auditors will
• Examine documents and records (make sure they
are available) – priority = Manual of Governance
and Operations or Manual of QSMS
• Interview and observe on the service processes,
whether they are being implemented properly (use
of tracer methodology)
• Look at the results of the implementation and
improvement plans

Tracer Methodology
Individual Patient Tracers
• An individual tracer follows the actual experience
of an individual who received care, treatment, or
services in a health care organization.

Tracer Methodology
Individual Patient Tracers
• Individual (patient) tracer activity usually includes
observing care, treatment, or services and associated
processes; reviewing open or closed medical records
related to the care recipient’s care, treatment, or services
and other processes, as well as examining other
documents; and interviewing staff as well as care
recipients and their families.

Development
Lastly,
QMS = TQMS
Quality Management System = Quality and Safety
Management System
Manual of Governance and Operations = Manual of
Aim for Patient Experience!!!
(show video)

Patient Relations Management
Patient Experience
Goal – Patient Engagement
Continuum of Care – from 1st second to last second of contact with patients
All staff involved – regardless of rank / department / specialty
- Courteous – respectful
- Friendly – caring – compassionately assistive – giving information; manual help;
advices
- Ensuing quality and safe care in each point of care; by self; by others

Thank you
for
your kind
attention!

Quality Management System (Institutional Level)

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