Quality Management System

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 Kevin Siefert
 Solomon Nathi
 Harshavardhan Vennapusa
A set of procedures and policies for international quality
certification of suppliers. ISO 9000 relates to QMS
by:

Improve customer satisfaction by fulfilling
customer requirements.

Achieve continual improvement of organizational
performance and competitiveness.
 Continually improve its processes, products,
and services.
 Comply with regulatory requirements.
The original objective of ISO 9000 was to ensure
that the product or services provided by
registered organizations were consistently fit
for their intended uses. Management
achieved this by featuring the following
principles.
1.
2.
3.
4.
5.
6.
7.
8.
Customer Focus
Leadership
Involvement of People
Process Approach
Systems Approach to Management
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships
 Defines fundamental terms and definitions used in the
ISO family.
 Standard to assess ability to achieve customer service.
 Guidelines to a company for continual improvements
of its quality-management system.
No organization is required to use ISO 9000, but some
customers may insist on registration. ISO 9001: 2000
sets the standards for Quality Management Systems
conformity, but not how to implement it. An
organization determines how to attain the
requirements and if seeking registration must hire an
accredited registrar firm to verify its conformance to
ISO 9001: 2000.
 Apply its QMS to its operations according to the




standard and exactly as the QMS states.
Continually assess the effectiveness of the QMS and
make changes to improve it.
Conduct periodic internal QMS audits.
Submit to external (third party) surveillance audits at
least annually by its registrar.
Submit to a new registration audit every third year by
registrar.
4. ACT
Institutionalize
Improvement;
continue cycle
1. Plan
Identify
problem and
develop plan for
improvement
3.
3. Study/Check
Assess plan; is it
working
2. Do
Implement plan on
a test basis
As stated in the ISO 9000: 2000’s guidelines a Quality
Management System is a management system to direct
and control an organization with regard to quality.
A quality policy – This statement describes how the
organization approaches quality.
2. The quality manual – This addresses each clause of
the ISO 9001 standard. Also must demonstrate
management responsibility for the operation of the
quality system.
3. Quality objectives – The goals and the quality policy
must be in agreement. Objectives are assigned to
relevant functions and are supervised by to
management.
1.
Quality Procedures – The procedures are a step by
step description of what the company is required to
meet the quality policy. Quality procedures can be
part of the quality manual or reference in the
manual.
5. Forms, records, ect. – These are the proof of activities
required for the firm and the auditors to remain
certified.
4.
 Once a organization aspires to be registered, they
hire a registrar firm. This is usually a private
company.
 These certification bodies are accredited by a
accreditation body.
 Another level of the ISO conformity assessment is
the Accreditation Forum composed of accreditation
bodies, industry representatives, and other
stakeholders.
 IFA is authorized from Article 6 of the World Trade
Organization’s 1994 Agreement on Technical
Barriers to Trade.
 ISO 9000 is becoming what it claims to be, ‘the
international standard for managing quality’
 According to the ISO’s worldwide survey of ISO 9001
certificates, as per December 2008, “more than a
million organizations in 179 countries had
registered to ISO 9001”
Registrat
ions
2002
2004
2005
2006
2007
2008
World
total
167,124
497,919
660,132
776,608
897,886
1,016,558
growth
122,736
330,795
162,213
116,476
121,258
118,692
149
154
161
170
179
No of
133
countries
1. China
2. Italy
3. Japan
4. Spain
5. Germany
6. United States
7. India
8. United kingdom
9. France
10.Netherlands
180,107
117,437
89,375
63,883
51,568
49,820
45,473
45,409
23,697
21,003
China – the growing industrial super power: The growth of ISO organizations in China ,compared
to the other countries with major economies like US,
UK, Germany, and Japan is quite larger.
 Chinese organizations hold nearly as many ISO 9001
certificates as those in the US, Germany and Japan.
 Clearly, it shows that ISO9001 is the model selected by
China to elevate the world’s perception of Chinese
goods.
Recognized by Service sector: few of years back ISO 9000 was widely considered to be
applicable only to manufacturing sector.
 But, eventually considering that any service can be
evaluated for suitability, effectiveness, performance
and quality the service sector recognized the benefits
of ISO 9000.
 Of the 121,258 new registrations in year 2006, 33%
of the organizations are from the service sector.
 ISO 9001’s generic requirements can apply to
organization in any industry or in economic
sector.
 The organization that wants a conforming ISO
9000 QMS must go through the following steps,
1.
2.
3.
4.
5.
Develop a quality manual.
Documentation.
Management’s commitment to QMS.
Customer requirements.
Hire an accredited registrar company.
6. Registered or not, must conduct internal audits.
7. Periodic audits.
 http://www.youtube.com/watch?v=KP1bAsjI6eI&NR=1
 http://www.youtube.com/watch?v=zzT-
l7sdLtI&feature=related
 Improved consistency of service and product
performance: Guidelines provided by the standards
establish a consistent approach to policy
documentation. Controls are set forth in the standards
in the areas of document control,
 Enhances customer responsiveness: ISO
registration assists a company in developing and
maintaining a competitive advantage over nonregistered competitors.
 Encourages continual improvement: The ISO
series standards ensure this, by providing not only
for the initial registration auditing, but on-going
surveillance audits
 Acceptance of the system as a standard for
ensuring quality in a global market
 Originally developed in response to the need to
harmonize dozens of national and international
quality standards existing throughout the world.
 A world wide federation of national standard
organizations from more than 158 nations, formed
Technical committee to develop ISO 9000.
 ISO 9000 includes American National Standards
institute(ANSI).
 The first version of ISO 9000 was released in year
1987.
 http://www.youtube.com/watch?v=GdUPyUlKrAQ&fe
ature=related
 ISO 9000 Are not interchangeable.
 ISO 000 is compatible with, and can be
viewed as subset of, TQM.
 ISO 9000 can improve operations in a
Traditional Environment.
 ISO 9000 and TQM are not in
competition.
 ISO is concerned with QMS for design,
development, purchasing, production,
installations and servicing of products and
services
 TQM is concerned with every aspect of the
organization which include support systems like
human resources, finance and marketing. TQM
also means that org is responsible for developing
the vision, establishing guiding principles and
setting a strategy and tactics in achieving the
vision.
 The degree to which the total organization is involved
 TQM requires involvement of all functions and levels
of org is involved.
 ISO 9000 does not require the QMS to include
functions and levels that play only indirect roles in the
management and execution of product or service.
Characteristics
ISO 9000
TQM
Customer Focus(internal & external) Yes
yes
Obsession with Quality
yes
Scientific approach to problem
solving
Yes
Yes
Long term commitment
partial
yes
Teamwork
yes
Continual process and product
improvement
Yes
Yes
Education & training intensive
Yes
Yes
Freedom through control
Yes
Unity of purpose
Yes
Yes
Employee involvement and
empowerment
partial
yes
 ISO 9000 and TQM are not quite the same. But ISO
can be viewed as a part of larger TQM environment.
 There are many organizations that have successfully
included ISO as part of a larger total quality effort and
it is simple to follow ISO 9000 for the organizations
that are already at some level of TQM.
 Traditional environment means an organizational
environment that has persisted in companies for
decades.
 Traditional org environment still operates according to
the “old way of doing things” rather than according to
principles of TQM
 Organizations can adopt to either of them or both ISO
9000 and TQM.
 Both have worthwhile and similar aims.
 Both support each other and are complementary.
 http://www.youtube.com/watch?v=leVtLumjW7w
 To improve operations by implementing a quality




management system.
To create or improve quality management system.
To improve product or service quality or the
consistency of quality.
To improve customer satisfaction.
To improve competitive posture.
 ISO 9000 and TQM working together
 MOVEMENT from ISO 9000 to TQM and Vice Versa
 ISO 9000 as an entry into TQM
ISO 9000 can give an organization a head
in implementing TQM
start
 Credibility of the Standard
 Updating ISO 9000
 The three FDIS (Final Draft International Standards)
which have been published are the following:
 ISO/FDIS 9000, Quality management systems -
Fundamentals and vocabulary
 ISO/FDIS 9001, Quality management systems Requirements
 ISO/FDIS 9004, Quality management systems Guidelines for performance improvements
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