ISO 9001:2008

QUALITY MANAGEMENT
SYSTEM
 What is Quality ?

ISO 9001: 2008 defines Quality as:

“ degree to which a set of inherent characteristics fulfils

requirements”
 International Organization for
Standardization
(1) The International Organization for Standardization (ISO)
was founded in Geneva in 1947.

(2) The original purpose of the organization was to provide

standardization of technical specifications for products
traded in the international marketplace.

(3) The term "ISO" is a word derived from the Greek "isos,"
meaning "equal.”

(4) It was first developed in 1987 and revised in 1994 and

2000 and lastly in 2008.
 Reason for implementing ISO9001

1. Provides for work performance consistency

2. Enables the discovery of causes of poor performance

3. Stresses the process approach

4. Defines goals and objectives for quality

5. Provides benchmarks to measure improvements

 Reason for implementing ISO9001

1. Quality management requires customer focus and

continual improvement.

2. It provides for accountability within the system and

ensures that the most important functions are carried out.

3. It establishes a clear document system throughout the

organization, a common language across the organization
and common identifiers for customers.
Underlying Principles of ISO 9001
Say what you do:
Document each step in your business process.
Do what you say:
Ensure that all processes adhere to written procedures.
Show what you have done:
Document evidence that your QMS meets ISO Requirements &
that the quality standard is being implemented effectively.
Verify:
Conduct periodic internal audits to ensure continued
suitability, compliance, and effectiveness of the QMS.
 ISO 9001 – QMS Model
CONTINUAL
CONTINUALIMPROVEMENT
IMPROVEMENTOF
OFTHE
THEQUALITY
QUALITY
MANAGEMENT
MANAGEMENTSYSTEM
SYSTEM

Management Interested
responsibility Parties

Interested Clause 5

Parties Measurement,
Resource analysis and
Clause 6 Clause 8 improvement Satisfaction
Management

Clause 7
Input Service/Product Service Output
Requirements realization Product

Value adding activities

Information flow
PRINCIPLES OF
QMS
 Principles of QMS
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1. Customer Focus
Customer focus
•Organization depends customers
•Understand current & future customer needs.
•Meet / exceed customer expectations

Internal Customer:
Next Department

5.2 Always keep your

customer in the focus. Fulfil
his requirements and satisfy
his needs
 2. Leadership

Leadership
•Leaders establish purpose & direction of the organization
•Should create & maintain environment to achieve
organization’s objectives

Management
Commitment

5.3 Set up Quality Policy and

Objectives for uniform direction
5.4 Quality Planning to
achieves Objectives
5.6 Management Review
3. Involvement of People

Involvement of People
•People of all levels are essence of an organization
•Their full involvement for organization’s benefit

Team Work 6.2 Adequate Utilization of

competences of Human resources
4. Process Approach

Process approach
Desired results are achieved more efficiently when activities
and resources are managed as process

Resources

Input Process Output

Controls
4.1 Determine the Processes, Sequence,
interaction, Controls, Arrange resources &
Monitor & Measure effectiveness to
Continually improve upon.
5. System Approach

System approach
identifying, understanding and managing interrelated
processes as a system contributes to the organization’s
effectiveness and efficiency in achieving it’s objectives

Form small
systems

4.2.2 Describe the interaction between the

processes
6. Continual
Improvement
Continual improvements
Continual improvement of the organization’s overall performance
should be a permanent objective of the organization

Continual improvement
Recurring activity to increase the
ability to fulfil requirements and
enhance the satisfaction of interested
parties

8.5.1 Strive for continual

improvement through the use of the
quality policy, quality objectives,
audit results, analysis of data,
corrective and preventive actions
and management review.
7. Factual approach to
decision making
Factual approach to decision making
Effective decisions are based on the analysis of data and
information

Effective Decision Making

Supported by data analysis

8.4 Gather information, analyze the

Data to evaluate the effectiveness of
QMS. Decide on areas for continual
improvement
8. Mutually beneficial
supplier relationships
Mutually beneficial supplier relationships
•An organization & its suppliers are interdependent
•Mutually beneficial relationship enhances the ability of
both to create value

Good Purchase Practices

Vendor Development

7.4 Adopt good purchase practices. Supplier

evaluation and enforcing controls on them is
necessary for getting good material
Continual Improvement
Analyze existing Continual
systems Improvement
Yes
Identify the areas for improvement No Ok
Establish objectives for
improvement Measuring,
Verifying,
Searching for Solutions Analyzing,
to achieve objectives evaluating
the results
Evaluate Select the Implement
these best the selected
solutions solution solution
QMS Establishment

a) determining the needs and expectations of

customers and other interested parties;

b) establishing the quality policy and quality objectives

of the organization;

c) determining the processes and responsibilities

necessary to attain the quality objectives;

d) determining and providing the resources necessary

to attain the quality objectives;

e) establishing methods to measure the effectiveness

and efficiency of each process;
QMS Establishment

f) applying these measures to determine the

effectiveness and efficiency of each process;

g) determining means of preventing nonconformities

and eliminating their causes;

h) establishing and applying a process for continual

improvement of the quality management system.
TOTAL QUALITY
MANAGEMENT
 INTRODUCTION

 Total Quality Management is a management approach that

originated in the 1950’s and has steadily became more popular
since Coined by the US Naval Air Systems Command in early 1980s.
 Definition
 Holistic approach to long-term success that views continuous
improvement in all aspects of an organization as a journey and not as a
short-term destination.
 It aims to radically transform organization through progressive changes
in the attitudes, practices, structures, and systems.
 TQM transcends the 'product quality' approach, involves everyone in the
organization, and encompasses its every function administration,
communications, distribution, manufacturing, marketing, planning,
training, etc.
 Meanings
 understanding of the changing needs of the internal and external
customers, and stakeholders, and satisfying them in a cost
effective manner,

 instituting leadership in place of mere supervision so that every

individual performs in the best possible manner to improve quality
and productivity, thereby continually reducing total cost,

 eliminating barriers between people and departments so that they

work as teams to achieve common objectives.
 Meanings
 commitment and direct involvement of highest-level
executives in setting quality goals and policies, allocation
of resources, and monitoring of results.

 realization that transforming an organization means

fundamental changes in basic beliefs and practices and
that this transformation is everyone's job.

 building quality into products and practices right from the

beginning doing things right the first time, every time.
PRINCIPLES OF TQM

 Management commitment
 Employee Empowerment
 Fact Based Decision Making
 Continuous Improvement
 Customer Focus
CONCEPT OF CONTINUOUS
IMPROVEMENT BY TQM

There are three major mechanisms of prevention:

 Preventing mistakes from occurring
 Inspection at source or by next operation
 Stopping production / services until the process is
corrected
EIGHT ELEMENTS OF TQM

 Ethics
 Integrity
 Trust
 Training
 Teamwork
 Leadership
 Communication
 Recognition
KEY ELEMENTS

Recognition

Communication

Training, team work and

leadership

Ethics, Integrity and Trust

ETHICS

 Ethics is the discipline concerned

with good and bad in any situation.
Organizational ethics establish a
business code of ethics that outlines
guidelines that all employees are
to adhere to in the performance of
their work. Individual ethics include
personal rights or wrongs.
INTEGRITY
 Integrity implies honesty, morals,
values, fairness, and adherence to the
facts and sincerity. The characteristic
is what customers expect and
deserve to receive. People see the
opposite of integrity as duplicity.
 TQM will not work in an atmosphere
of duplicity.
TRUST

 Trust is a by-product of integrity

and ethical conduct. Without trust
the framework of TQM cannot be
built. Trust fosters full participation
of all members. It allows
empowerment that encourages
pride ownership and it encourages
commitment.
TRAINING
 Training that employees require are
 interpersonal skills,
 the ability to function within teams,
 problem solving,
 decision making,
 job management performance analysis and
 improvement business economics and technical skills.
 employees are trained so that they
can become effective employees
for the company.
TRAINING

 Training is very important for employees to be

highly productive.
 Supervisors are solely responsible for
 implementing TQM within their departments, and
 teaching their employees the philosophies of TQM
TEAMWORK
 QUALITY IMPROVEMENT TEAMS OR EXCELLENCE
TEAMS [ QITS ]

 PROBLEM SOLVING TEAMS [ PSTs ]

 NATURAL WORK TEAMS [ NWTs ]

LEADERSHIP

 It is possible the most important element in

TQM. It appears everywhere in organization.
 Leadership in TQM requires the manager to
provide an inspiring vision, make strategic
directions that are understood by all and to instill
values that guide subordinates .
COMMUNICATION

 DOWNWARD COMMUNICATION

 UPWARD COMMUNICATION

 SIDEWAYS COMMUNICATION
RECOGNITION

 Recognition is the last & final element in the entire

system. It should be provided for both suggestions
& achievements for teams as well as individuals.
Recognition comes in different ways, places & time
such as, ways- it can be by way of personal letter
from top management.
Implementation of TQM
1. Involvement of all, from worker to top executive
2. Management commitment must be evidently
demonstrative.
3. Document what you do (quality manual); then do
what you had documented (follow the quality
manual)
4. Effective strategic planning and information
management must be introduced.
5. Mission and Vision statement must be written and
displayed every-where. These must be the guiding
rules to all employees.
Implementation of TQM

6. People satisfaction should be the first priority. A satisfied person is

motivated to do work in a better way.
7. Identification of problem should be the way of life, so that problem-solving
may be undertaken as a route of continuous improvement. Use Ishikawa
diagram, Six sigma, quality circle, brain-storming, suggestion-box scheme,
etc. to identify and solve problemLong-term needs, rather than short-term
needs must be given more emphasis to derive major benefits.
8. All employees should be committed to adhere to systems and procedures so
that a quality culture is a regular affair.

10. Motivational scheme, regular training and educational scheme should be

regular affair to sustain interest in TQM endeavor.
5 Ways to Improve Processes

 Reduce Errors
 Meet or exceed expectations of Internal/external
customers
 Reduce Resources
 Make Process safer
 Make the process more satisfying to the person doing it.
ISO 9001 – TQM – Six Sigma

 TQM tries to improve quality by ensuring conformance

to internal requirements,
 ISO 9001 tries to improve quality ensuring conformance
to customer requirements.
 Six Sigma focuses on improving quality by reducing the
number of defects and errors.
QUESTIONS ???

FUTURE

PRESENT
 THE END
WHEN YOU MEASURE
YOU CAN MANAGE