Chapter 10: Quality Management

System

TOTAL QUALITY
MANAGEMENT
BY
DR. ASIF MAHMOOD
[email protected]
Institute of Business & Management

University of Engineering and Technology,

Lahore

MANAGEMENT SYSTEM
Management

system

means
what
the
organization does to manage its processes, or
activities in order that its products or services meet
the organization's objectives
E.g.
satisfying
the
customer's
quality
requirements, complying to regulations, meeting
environmental objectives, etc.
The ISO 9001 and ISO 14001 management
system standards now make these successful
practices available for all organizations.

QUALITY MANAGEMENT SYSTEM

It is the organizational structure,

responsibilities, procedures and resources
for ensuring the quality of a product or
service

STANDARD

An agreement developed by several parties

with the intent that all parties comply

SIGNIFICANCE OF STANDARDS
Encapsulation
of
best
practiceavoids
repetition of past mistakes.
They are a framework for quality assurance
processes - they involve checking compliance to
standards.
They provide continuity - new staff can understand
the organisation by understanding the standards
that are used.
De jure Vs de facto
Wars of Standards (DC/AC, Betamax/VHS, Blue ray
Disc/HD DVD)

ISO

Standards

WHAT IS ISO?
International Organization for Standardization

ISOHISTORY
1906 - International Electro-technical
Commission
1926 - International Federation of the National
Standardizing Associations (ISA)
1946 London - delegates from 25 countries
decided to create a new international
organization "the object of which would be to
facilitate the international coordination and
unification of industrial standards
1947 - ISO began to officially function
1951 - The first ISO standard was published

"Standard reference temperature for industrial length

measurement".

ISO ORGANIZATION
General
Assembly
Policy
Development
Committees

Council

Technical
Management Board
Technical Advisory
Groups
Technical Committees
Technical Committees
Technical Committees
Technical Committees

ISO KEY FACTS

ISO = International Organization for Standardization

Based in Geneva, Switzerland

Made up of over 100 National Standards Bodies (NSBs)

Almost 20,000 standards in the ISO portfolio

All standards are based on INTERNATIONAL CONSENSUS

ISO standards are usually developed by its Technical

Committees (TCs) and Sub-committees (SCs)
ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001

ISO 9001:2015 is being developed by a specific SC2

Working Group (WG24)

WG24 is composed of international experts nominated by their NSB or

from formal liaison member to ISO (typically industry associations)

WG23 is responsible for Communications and Product Support

ISO MOST POPULAR STANDARDS

SERIES

ISO
9000
ISO
14000

A set of standards governing

documentation of a quality program.

A set of international standards for assessing a

companys environmental performance.

ISO MOST POPULAR STANDARDS

SERIES
ISO 9001 and ISO 14001 are among ISO's most well
known standards ever
They are implemented by more than a million
organizations in some 175 countries
ISO 9001 and ISO 14001 are generic standards
Generic means that the same standards can be
applied:

any organization, large or small, whatever its

product or service,
in any sector of activity, and whether it is a business
enterprise, a public administration, or a government
department.
to

PROCESSES, NOT PRODUCTS

Both ISO 9001 and ISO 14001 concern the way an
organization goes about its work.
They are not product standards.
They are not service standards.
They are process standards.
They can be used by product manufacturers
and service providers.

PROCESSES, NOT PRODUCTS

(CONT.)

Processes affect final products or services.

ISO 9001 gives the requirements for what the
organization must do to manage processes
affecting quality of its products and services.
ISO 14001 gives the requirements for what the
organization must do to manage processes
affecting the impact of its activities on the
environment.

ISO
9000

A set of standards governing

documentation of a quality program.

QUALITY MANAGEMENT PRINCIPLES

The revised ISO 9000:2000 series of standards are

based on 8 Quality Management principles.

The Principles are derived from collective experiences of

the ISO/TC/176 members.

The eight quality management principles are defined in

both the: - ISO 9000:2000:- (QMS Fundamentals and
vocabulary) and ISO 9004:2000:- (QMS:-Guidelines for
performance improvement) standards

ISO 9000 AND QUALITY

MANAGEMENT (QM)

ISO standards based on the following

QM principles:
1.
2.
3.
4.
5.
6.
7.
8.

Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships

Real Life

What QS/ISO 9000 Means To You

You MUST:

Know Your Job Duties

Know What Training Your Job Requires

Be Able To Tell About How You Were Trained

Know What Documentation Involves YOU!

Know How To Find Out What The Latest Version Is

Know What The Documentation Says

Know How The Documentation Applies To You!

Know What The INTENT of the Documentation

WHY IS ISO 9000 IMPORTANT?

European Union directive

ISO 9000 certification required by suppliers of

Regulated Products

health, safety, and the environment

EC

(European Committee) has strict corporate

liability legislation protecting consumers

Globalization impact

ISO 9000 SERIES

There are 5 Standards in the basic ISO 9000

series: conformance models or guides.
A conformance model is a Standard to
which the organisation must conform in order
to be certified.
A guide is a set of recommendations
concerning the establishment of an effective
quality system in order to be certified in one of
the conformance models.

ISO 9000 SERIES

ISO
ISO 9000
9000

Guides
Guides

ISO
ISO9000
9000
ISO
ISO9004
9004

Conformance
Conformance
Models
Models

ISO
ISO9001
9001
ISO
ISO9002
9002
ISO
ISO9003
9003

GUIDES

ISO 9000

Guidelines

for selection and use of the standards on

quality management, quality system elements, and
quality assurance.

ISO 9004

Guidelines

for sustained quality management and

quality system elements.

CONFORMANCE MODELS

ISO 9001
Quality

assurance
in
design/development
(customization),
production,
installation,
and
servicingwas for companies and organizations whose
activities included the creation of new products.

ISO 9002
Quality

assurance in production, installation, and

servicing without covering the creation of new
products.

ISO 9003
Quality

assurance in final inspection and test

covering only the final inspection of finished product,
with no concern for how the product was produced.

EVOLUTION OF QUALITY
MANAGEMENT SYSTEM ISO 9001:2008
1987

First Published ISO 9001, 9002 & 9003

1994

First revision ISO 9001, 9002 & 9003

2000

Second revision - ISO 9001 (9001, 9002 and

2008

Third revision ISO 9001

9003 were merged into 9001)

ISO 9001:2008

It is the only standard in the series of the ISO 9000

that
specifies

the requirements of a quality management

system
can be used for certification

ISO 9001:2008 did not introduce additional

requirements, and nor did it change the intent of the
ISO 9001:2000 standard.
ISO 9001:2008 was developed in order to:

Introduce clarifications to the existing requirements of

ISO 9001:2000 and
Introduce changes that are intended to improve
compatibility with ISO 14001:2004, Environmental
Management Systems.

ISO 9001:2015
A change is coming

Reasons For The Changes

Decrease the emphasis on Documentation
Increase the emphasis on Achieving Value for the
Organization and its customers
Increase emphasis on Risk Management to achieve
objectives

DOCUMENTING PROCEDURES

DOCUMENTING PROCEDURES

Say what you do

Do what you say
And where necessary

Show what you did

CERTIFICATION

CERTIFICATION AND
REGISTRATION
Certification is known in some countries as
registration.
It means that an independent, external body has
audited an organization's management system and
verified that it conforms to the requirements
specified in the standard (ISO 9001 or ISO 14001).
Some customers require suppliers to be ISO 9000
certified although the need for flexibility here is
increasingly recognised.
ISO does not carry out certification and does not
issue or approve certificates.
ISO develops standards and guides to encourage
good practice in accreditation and certification.

CERTIFICATION NOT A
REQUIREMENT
Certification is not a requirement of ISO
9001 or ISO 14001.
The organization can implement and benefit from
an ISO 9001 or ISO 14001 system without having
it certified.
The organization can implement them for the
internal benefits without spending money on a
certification program.

WHAT IS CERTIFIED?

Your quality system must conform to the standard

from ISO 9000 Standard series that your organisation
selects.
It is the quality system that becomes certified
(registered) during the certification process.

ISO 9000 REGISTRATION PROCESS

When an organization feels that its quality system is

good enough, it may ask an accredited registrar or other
third party audit team for pre-assessment.
The final audit begins with a review of the company's
quality manual, which the accredited registrar or third
party audit team typically uses as its guide. The audit
team checks if the documented quality system meets the
requirement of ISO 9000.
When the registrar is satisfied with the favorable
recommendation of the audit team, it grants registration
and issues a registration document to the company.

QUALITY SYSTEM AUDIT

An investigation of the intent and the

implementation of selected aspects of the quality
system of an organization.

QUALITY SYSTEM AUDITING

Quality certificates are issued after conducting quality
auditing in a systematic manner.
Auditing procedure is aimed at checking if the practices
followed conforms with the quality manual or not.
Types of Quality Audit
Quality auditing is done both by internal and
external bodies.
Based on the type of auditor, it is classified as:

First party audit

Second party audit
Third party audit

First Party Audit

o
Conducted by the organization on its own system
o
Conducted by its own personnel
o
Identifies non-conformities in the system
o
Suggests corrective actions
o
Effectiveness of quality management system is ascertained.
Second Party Audit
o
Conducted by purchaser on the supplier of goods
o
Conducted to assess the suppliers ability to provide quality
goods or services
o
It is not a comprehensive audit, as the purchaser will be
only interested in areas of his purchase not on the company
as a whole
o
By this the purchaser comes to know about the weak areas
of his supplier
o
This will be helpful in framing surveillance audit procedure

Third party audit

o

Conducted by person(s)/ agency who are neither

suppliers nor purchasers and who are totally
independent and have no vested interest in the outcome
of the audit
Usually conducted by the certifying agency or a
statutory body
Quality certificate can be issued only after third party
audit is done
It assures customers of the compliances of the quality
requirements

ACCREDITATION
Accreditation is like certification of the
certification body.
It means the formal approval by a specialized body an accreditation body - that a certification body is
competent to carry out ISO 9001:2008 or ISO
14001:2004 certification in specified business sectors.
Certificates issued by accredited certification bodies and known as accredited certificates - may be
perceived on the market as having increased
credibility.
ISO does not accredit, approve or control the
certification bodies.