Quality Management in

Healthcare
D.S.Nagesh
Part-I
 Standard

Time
Gap
 Performance vs. expectations
• Q = P/E
– Q = Quality
– P = Performance
– E = Expectations
Organisation is looking for…
Quality Management

Quality Management System

Quality System

Quality Assurances

Quality
Control
 What is a
Quality Management System?
• Quality Management System is a
combination of elements such as
– Management policies
– Objectives
– Organisational structure
– Documentation to perform & monitor
– Resources
Quality Management Systems - Types
Category Example System
Product Thermometer CE Mark
Organisation Hospital ISO9001 / NABH
Medical & Pham GMP/
Manufacturer ISO13485
Study Evaluation of GLP
Oxygenator
Test General lab ISO17025
Test Medical lab ISO 15189
 Advantages of having a
Quality Management System
• Confidence
– it has been done right
• Competence
– get the right answer
• Appropriateness
– fit for purpose
• Repeatability
– get the same answer twice
• Reproducibility
– others get same answer
 How?
• An established system through
documentation
• Irrespective of personalities (ideally)
 Accreditation
• From Le Comité Français
d’Accréditation (COFRAC) of France
• Logo only for accredited tests

No 1-1433
 Accreditation
• From National Accreditation Board for
Testing & Calibration Laboratories
(NABL)
• Logo for Calibration
 What is accreditation?
• Accreditation is the formal recognition
– For Technical Competence
• (In ISO9001 System it is certification)
 Needs?
• Maslow’s hierarchy of need
Maslow’s hierarchy of need
Need
Need Vs Want
 ISO
• International Organization for
Standardization
• "ISO", derived from the Greek isos,
meaning "equal“
• ISO, officially began operations on 23
February 1947, in Geneva, Switzerland
 ISO time line
ISO Technical committees ISO time line
ISO Members
Total Published Standards

500 19024 20000

450 18000
16455
400 16000
350 13025 14000
300 12000
250 224 10000
7778 193
187
200 172 163
8000
160 158
138
150 131 6000
4269
100 89
100 67 66 88 4000
44
50 26 29 1384 2000
173
0 0
1947 1950 1960 1970 1980 1990 2000 2006 2011
(end of year)
 ISI/BIS
• 1947
– Establishment of the Indian Standards Institution (ISI)
• under the Societies Registration Act 1860
• 1952
– Responsibility of certification marking under an Act of
Parliament
• 1987, April 1
– Bureau of Indian Standards (BIS)
• Act of Parliament 1986
– With adequate autonomy as well as flexibility to achieve
• harmonious development of the activities of standardisation
• certification marking
• and connected matters
 Generic Vs specific
• "Generic" means that the same standard
can be applied to any organization
– large or small
– whatever its product or service
– in any sector of activity
 Hierarchy of Quality

Specification
Product
Quality

QUALITY Organi-
Process sational
Quality Quality

Culture
Conformity
 Evolution of Quality
Inspection
• Check work after Quality Control
the event
• Identifying • Self-inspection
Quality Assurance
sources of • Quality planning
nonconformities and procedures TQM
• Develop Quality
• Take corrective • Use of basic
Systems
action statistics
• Use of quality • Teamwork
• Use of process • Employee
cost data
performance data involvement
• Quality planning
• Use of statistical • Process
process control management
• Involve non- • Performance
operation measurement
functions • Involve
•All functions
•Suppliers
•customers
 The change ….
Quality Element Then TQM
Definition Product oriented Customer oriented
Priorities Not Service & Cost Service & Cost
Decisions Short term Long-term
Emphasis Detection Prevention
Errors Operations System
Responsibility Quality control Everyone
Problem solving Managers Teams
Life-cycle cost,
Procurement Price
partnership
Plan, assign, control Delegate, coach,
Manager's Role
and enforce facilitate and mentor
 Dimensions of Quality
Dimensions Example
Performance
Additional
features
Conformance
Reliability
Durability
Service
Aesthetics
Reputation
PDCA Cycle

Plan Do

PDCA
Cycle

Act Check
Six sigma

Sigma Defects/
Level Million

6 3.4
5 233
4 6,210
3 66,807
2 308,537
1 690,000
DMAIC
ISO Family of QMS standards

ISO

ISO14000

ISO9001 ISO17025 ISO13485 ISO15189

(1987) (1999) (1996) (2003)
 The link

ISO9001 ISO14000
(Industry) (Environment)

ISO17025
(Test & Calib
Lab)
ISO13485
(Medical ISO15189
Manufacturer) (Clinical Lab)
 What is Quality?
• Degree to which a set of inherent
characteristics (distinguishing feature)
fulfils requirement (need or expectation
that is stated, generally implied or
obligatory)
- (ISO9000:2000)
 What is …
• Mission
• Vision
• Goal
• Objective
• Targets
• Core Values
• Policy
• Strategy
Basics
What changes and
what changes not

Basics
 Mission

Why we exist, why we do what we do

The purpose

Basics
 Vision

What we want to become

Basics
 Goal

Our intended destination

Basics
 Objectives

What we want to achieve – the

results

Basics
Objectives

SMART

Basics
 Objectives
• SMART
– Specific
– Measurable
– Achievable
– Realistic
– Time-phased

Basics
 Targets

What we aim to achieve

objectives

Basics
 Core values

What beliefs will guide our

behavior

Basics
 Policy

Rules that guide our actions and

decisions – the signposts en route

Basics
 Quality Policy & Objectives
We are committed to good
professional practice and high
quality service in testing and
calibration of medical devices,
materials and instruments with
continual improvement, aiming
at full customer satisfaction
and zero defect performance
by conforming to policies and
procedures of international
standards
To carry out testing of samples supplied by
the customer and provide reports meeting
the requirements of ISO/IEC 17025 and
acceptable to medical device regulatory
authorities of Europe and USA.
To carry out calibration of items supplied by
the customer and provide calibration reports
meeting the requirement of ISO/IEC 17025
To follow relevant Good Professional
Practices and Ethical Guidelines in all
activities including usage of animals in tests.
To achieve the continuous improvement by
regular review of the parameters like timely
delivery of test reports and calibration
certificates, methods of assuring quality of
results and corrective and preventive action
reporting.
To ensure customer satisfaction on the
testing and calibration services provided by
way of accuracy, confidentiality with 90% or
more timely delivery of reports and
complaints less than 5%.
 Strategy

How we are going to get there

Basics
 What is my ?
• Mission
• Vision
• Goal
• Objective
• Targets
• Core Values
• Policy
• Strategy
Basics
 The alignment
Person Vs Organisation

Basics
 Core purpose
• 3M
– To solve unsolved problems innovatively
• HP
– To make technical contributions for the advancement and welfare of humanity
• McKinsey & Company
– To help leading corporations and governments to be more successful
• Merck
– To preserve and improve human life
• Sony
– To experience the joy of advancing and applying technology for the benefit of
public
• Nike
– To experience
• Wal-Mart
– To give ordinary folk the chance to buy the same things as rich people
• Walt Disney
– To make people happy
 Core values
• Merck
– Corporate social responsibility
– Unequivocal excellence in all aspects of the
company
– Science-based innovation
– Honesty and integrity
– Profit, but profit from work that benefits
humanity
 Core values
• Sony

– Elevation of the Japanese culture and

national status
– Being a pioneer-not following others, doing
the impossible
– Encouraging individual ability and creativity
 Core values
• Walt Disney
– No cynicism
– Nurturing and promulgation of “wholesome
American Values”
– Creativity, dreams, and imagination
– Fanatical attention to consistency and detail
– Preservation and control on the Disney magic
 TATA Motors
• Mission • Vision
– To become a world – Best in the manner in
class automotive which we operate,
engineering and best in the product we
product development deliver, and best in our
centre, and enable value system and
Tata Motors to ethics
become a world class
automotive company
 Reliance Mutual fund
• Mission • Vision
– To create and nurture – To be a globally
a world-class, high respected wealth
performance creator with an
environment aimed at emphasis on customer
delighting our care and a culture of
customers good corporate
governance
How it attained? (5+1 M’s)

Man

Measurement, Analysis &

Continuous improvement
Milieu Machine
Quality
Management
System

Method Material
 Man (Personnel)
• Personnel with appropriate education,
training, experience and/or demonstrated
skills
• Job descriptions
• Authorization of personnel
• Training programs
 Material
• Purchase, reception, storage and handling
• Verification of purchased supplies
• Evaluation of suppliers of critical
consumables, supplies and services
 Measurement
• Customer satisfaction
• Internal audit
• Monitoring products
• Monitoring processes
 Assuring the Quality
of test and calibration results
• Regular use of certified reference materials
and/or internal quality control using secondary
reference materials
• Participation in inter-laboratory comparison or
proficiency-testing programs;
• Replicate tests using the same or different
methods
• Retesting of retained items
 Audit
• First party audit
• Second party audit
• Third party audit
• Internal audit
 Internal audits
• Periodic with a predetermined
schedule
• Fact finding mission and not a fault
finding mission
• Based on objective evidence and not
on subjective evidence
 Internal audits (Contd…)
• Adequacy audit
– Extend to which documented system
meet the requirements of the
standard
• Compliance audit
– Extend to which the documented
system is being practiced
 Control of records
• Identification, collection, indexing, access,
filing storage, maintenance and disposal of
quality and technical records
• Observations, data and calculations
– recorded at the time they are made and shall be
identifiable to the specific task
• Mistakes shall be
– crossed out, not erased, made illegible or deleted
– and the correct value entered alongside
 Continues improvement
Corrective & Preventive action
• Cause analysis
• Investigation to determine root
cause(s)
• Selection and implementation of
corrective and preventive actions
• Monitoring of corrective and preventive
actions