The document provides an introduction to quality management systems and ISO 9000. It discusses that ISO 9000 establishes requirements for quality management systems to ensure customer satisfaction and continual improvement. It outlines the key principles of a quality management system such as customer focus, leadership, process approach and continual improvement. Organizations can get certified through independent audits to assure customers that their quality management system meets the ISO 9000 requirements. The summary is: 1. ISO 9000 establishes requirements for quality management systems and certification ensures systems meet requirements. 2. Quality management systems are based on principles like customer focus, leadership and continual improvement. 3. Organizations can get certified through independent audits to assure customers of meeting ISO 9000 standards

1. INTRODUCTION OF QUALITY MANAGEMENT
LECTURER: DR. DADANG SURJASA
Dian Hermawan
122140038
Rheyn Lusiana S.
122140125
Muh. Rizal Anshori
122140135

2. 2
A management system describes the set of procedures an
organization needs to follow in order to meet its objectives.
In some small organizations, there may not be an official system,
just "our way of doing things", that is mostly kept in the heads
of the staff.
But the larger the organization, the more likely that procedures
need to be recorded to ensure everyone is clear on who does
what. This process of systemizing how things are done is known
as a management system.
What is a management system
Picture: http://cloudtweaks.com/2014/01/improving-product-quality-
through-the-cloud/

3. 3
ISO 9000 is a family of standards and
guidelines related to the Quality Management
System (QMS). It sets the requirements for the
assurance of quality and for management`s
involvement .
Picture: http://defymed.com/defymed-certified-iso-134852003-
and-iso-90012008-for-its-quality-management-system/

4. 4
So . . . Is ISO 9000 applicable ?
 When an organization demonstrates conformity to ISO 9001 to an independent (3rd party) registrar
firm, the registrar can certify (or register) the organization. Registration provides assurance to
customers worldwide that products or services from the organization can be expected to
consistently meet customer requirements.
 To maintain its registration, the organization must constantly strive to ensure that the QMS
continues to function effectively and that it is continually improved. That is done through consistent
and rigorous application of the QMS and a system of formal, documented internal audits in
interaction with the organization`s top management, interspersed with periodic independent audits
by the registrar firm. Registration may be lost if the registrar`s audits determine that the
organization is no conforming to the requirements of its registered QMS.

5. 5
The ISO 9000 QMS is based on eight principles from total
quality management :
1. Costumer Focus. Understand the customer`s needs, meet
the customer`s requirements, and strive to exceed the
customer`s expectation.
2. Leadership. Establish unity of purpose and organizational
direction and provide an environment that promotes
employee involvement and achievement of objectives.
3. Involvement of People. Take advantage of fully involved
employees, using all their abilities for the benefit of the
organization.
4. Process Approach. Recognize that things accomplished
are the results of process and that processes along with
related activities and resources must be managed.
Picture: www.meted.ucar.edu

6. 6
5. System Approach to Management. The multiple
interrelated processes that contribute to the
organization`s effectiveness are system and should be
managed as a system
6. Continual Improvement. Continual improvement should
be a permanent objective applied to the organization and
to its people, process, systems and products.
7. Factual Approach to Decision Making. Decisions must
be based on the analysis of accurate, relevant, and reliable
data and information.
8. Mutually Beneficial Supplier Relationship. Both the
organization and supplier benefiting from one another`s
resources and knowledge results in value for all.
Picture: http://www.ronniekaufmancoaching.com/executive-business-
coaching.html

7. 7
 Plan. Establish objectives and develop the plans
to achieve them.
 Do. Put the plans into action.
 Check. Measure the results of the action; that
is, is the planned action working, or were the
objectives met?
 Act (or Adjust). Learn from the results of the
third (check) step, make any necessary changes
to the plans, and repeat the cycle
Plan
DoCheck
Act

8. 8
The original aim of ISO 9000 was to ensure that the
product or services provided by registered organizations
were consistenly fit for their intended purpose. The ISO
9000 raised the standard`s aim to a new level. Customer
focus and continual improvement, along with the other
six quality management principles that have been
incorporated into the standard, are intended to make
registered organizations more competitive. This is
essensially the same objective as that of total quality
management
Picture:
http://pubs.acs.org/subscribe/archive/tcaw/09/i11/html/11regs.html

9. 9
The ISO 9001 lays down the requirements for what an organization`s QMS must do, does not dictate how
the QMS should do it in any particular organization. The organization determines that for itself and, if
seeking registration, employs an accredited registrar firm to verify its conformance to ISO 9001.
The organization, once registered, must :
 Apply to 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 (3rd party) surveillance audits at least annually by its registrar.
 Submit to a new registration audit every third year by a registrar.

10. 10
Quality Management System (QMS) is composed of all the organization`s policies, procedures, plans,
resources, processes, and delineation of responsibility and authority, all deriberately aimed at achieving
product or service quality levels consistent with customer satisfaction and the organization`s objectives.
When the policies, procedures, plans, and so forth are taken together, they define how the organization
works and how quality is managed.
The QMS will include this documentation:
1. A Quality Policy. This statement describes how the organization approaches quality.
2. The Quality Manual. This must address each clause of the ISO 9001 standard. It will also typically
include an organization chart, or some such device, illustrating management responsibility for-

11. 11
operating the quality system. Quality procedures may be part of this manual, or they may be
referenced.
3. Quality Objectives. These are the goals related to quality and must be in harmony with the
quality policy. Quality objectives are assigned to the relevant organizational functions and levels
and are tracked by top management.
4. Quality Procedures. These describe step by step what the company does to meet the quality
policy. As a minimum, there will be a procedure for each of the ISO 9001 clauses outlining
requirements. There may also be procedures for any processes that can impact quality.
5. Form, Record, and so on. These provide proof of activities for the firm and for the auditors

12. 12

13. TickIT, by the United
Kingdom’s Board of Trade
specifically for the information
technology industry.
Picture: http://cesfl.com/
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14. Picture:
http://gerstarted.blogspot.com/2012/11/sejarah-
singkat-william-edward-boeing.html
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15. Picture: http://pharmatips.doyouknow.in/Jobs/Pharma-
Packaging/Mumbai/Executive-Packaging-Development-
Jobs-In-Pharma-Industry.aspx
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16. Picture: www.eltronis.com
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17. Picture: www.iconshut.com
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18. Picture: www.rumahkeluargaindonesia.com
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19. Picture: www.corken.com 19

20. The organization’s top management must ensure that customers requirements are determined and met
The Organization must secure, top management’s commitment t the QMS and continual improvement.
Document procedures that describe how the various processes for design, production, continual
improvement and so on, will be operated. This must include procedures for management reviews and audits
Develop a quality manual that describes how the organization will assure the quality of its products or
services
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…….

21. Once registered, the outside registrar will make periodic audits for the same purpose. These audits must be passed
to retain registration
Whether register or not, the organization must conduct its own internal audits to ensure that the systems, processes
and procedures are working effectively
If registering, the organization must hire and accredited registrar company to examine its system, processes,
procedures, quality manual, records, and related items. If everything is in order and if the registrar is satisfied that
the organization is effectively using the QMS, registration will be granted. Otherwise, the register will inform the
organization of the areas requiring work, and another audit will be schedule.
21
…….

22. The benefits of ISO can be
reviewed from 2 different
perspectives:
1. Organizational Benefits
2. Customer Benefits
22

23. ISO 9000
&
TQM
ISO 9000 & TQM
are not
interchangeable ISO 9000 is
compatible with,
and can be viewed
as a subset of, TQM
ISO 9000 is
frequently
implemented in a
non-TQM
environment
ISO 9000 can
improve
operations in a
traditional
environment
ISO 9000 may be
redundant in a
mature TQM
environment
ISO 9000 & TQM
are not in
competition
23

24. Characteristics ISO 9000 TQM
Customer focus (internal and external) √ √
Obsession with quality √
Scientific approach to problem solving √ √
Long term commitment partial √
Teamwork √
Continual process and product improvement √ √
Education and training intensive √ √
Freedom through control √
Unity of purpose √ √
Employee involvement and empowerment partial √
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25. TQM and ISO 9000 are not the same thing.
Its coming from different perspectives.
ISO 9000 can become a part of a larger TQM
environment.
It’s easy for organizations that are in some
level of TQM maturity to implement ISO
9000.
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Picture: http://iso22000resourcecenter.blogspot.com/2015/01/understanding-
total-quality-management.html

26.  TQM is compatible with and may help the
organization on facilitating ISO 9000
implementation.
 TQM is not a prerequisite/precondition for ISO 9000.
TQM Solutions knows that total quality management means
you not only have a mountain of documentation, but that you
organize that mountain.
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Picture: http://blog.atmel.com/2014/12/12/ir-reflow-oven-for-your-
prototype-pcbs/

27.  In traditional environment: people work
based on “Old way of doing things” rather
than according to TQM principles.
 If ISO 9000 approached inappropriately and
for wrong reasons, it can:
 Become nothing more than marketing
purpose.
 Develop more problems more than
before it.
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Picture: http://michelbaudin.com/2014/05/09/making-time-for-improvement/

28.  In a mature TQM environment (as like Toyota),
all ISO 9000 criteria may already in place.
 The only reason for registration under ISO 9000
would be for marketing purpose.
 What is the marketing purpose? To let potential
customer know that their products or services
satisfy the international standard.
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Picture: http://www.toyota-forklifts.co.uk/EN/News/Toyota-
knowledgebase/Pages/TPS_One.aspx

29.  Organizations can adopt TQM or ISO 9000, or
both. Both have worthwhile and similar aims.
 Both ISO 9000 and TQM are not only
compatible but they also actually support each
other and are complementary.
 There are good reasons for using both in a
single management system.`
29

30. Obtaining Marketing Advantages
Inappropriate
Motives
To improve operations by implementing
a QMS.
To create or improve a QMS that will be
organized by customers worldwide
To improve product and service quality
To improve customer satisfaction
To improve competitive posture
To conform the requirements of one or
more major customers
Appropriate
Motives
*) ideally, management will adopt ISO
9000 as a way to make real
improvements in the company’s
operations, serve its customers in a
more responsible way, and, as a result,
be more successful.
30

31.  ISO 9000 and TQM are different in scope and were
developed from different perspectives, but now have
similar requirements and objectives.
 TQM requires everything required by ISO 9000
registration, but no corresponding international
certification. ISO 9000 registration is necessary as a way to
satisfy the demands of its customers.
 ISO has international certification, but it needs the larger
TQM implementation to become or stay competitive. ISO
is properly seen as a subset of total quality.
Picture taken from: presentation file of Lilis Solehati Yuniasih, SE, M.Si
Resources: http://slideplayer.info/slide/2585767/#
31

32.  For TQM organizations which their processes has already been documented and under control, should
find it relatively easy to prepare for ISO 9000. In the other way, traditional organization that has
successfully registered under ISO 9001 should decide to implement total quality.
 Major Issue with ISO 9001 are:
Management Commitment Focus on Customer
Requirement and Satisfaction
Documenting Processes and
Procedures
32

33.  Registration to the ISO 9001 standard could become a good
strategy to begin the total quality journey.
 For an organization that is attempting to adopt total quality
and that would also benefit from ISO 9000, our 20-step
implementation process should be considered.
 However, not all the TQM implementation steps required
and should be done by ISO 9000.
 In summary, the organization that is already involved in ISO
9000 should see itself as having a head start on the larger
TQM implementation.
Picture: http://e-jspm.com/jpcom/wp-content/uploads/no39pdf/3-7.pdf 33

34. Credibility of ISO 9000???? Why?
It has become diluted because
there has been insufficient
oversight of the registrars
How to
solve?
ISO & IEC issued a new
standard ISO/IEC 17021:2006
How it
work?
Registrar conformity will be
verified by the accrediting
bodies.
34presented by Dian

35. Source: http://www.icmci.org/?page=17673085
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36. ISO 9000: 1987
• Contained three
models for QMS:
• ISO 9001: 1987
• ISO 9002: 1987
• ISO 9003: 1987
• Required mountains of
paperwork as evidence
of compliance with
documented
procedures.
ISO 9000: 1994
• Begin to move toward
process improvement
by emphasizing
preventive actions
rather than just
checking the final
product.
ISO 9001: 2000
• Combined ISO 9001,
9002, and 9003 into
one document that is
ISO 9001.
• Makes process
management its
centerpiece.
• Requires active
involvement of an
organization’s
executives.
• The application of
performance metrics.
ISO 9001: 2008
• The quality policy must be a formal
statement from upper management
• Quality policy must be understood &
used by all levels,
• All personnel must have measurable
work objectives,
• The quality system is audited
regularly,
• Decisions are based on recorded
data,
• Records allow problems to be traced
to their source,
• A comprehensive system for
communicating with customers
• Product development must have
planned stages,
• Organizational performance must be
regularly reviewed, and
• The organization must have
documented procedures for dealing
with non-conformances.

37. ISO 9001: 2015 (DIS version)
• Clause Structural Changes. The ISO 9001: 2015 is planned to be 10 clauses from current 8 clauses in ISO
9001: 2008.
• Clauses Reshuffle. In the ISO 9001: 2015 version, almost all clauses changed; more detail, more obvious, and
grouped according to relevant clause theme.
• Risk Management Approach. This was done with a reason to form Competitiveness and Sustainable
Systems.
• Unification of term “Document and Quality Records”. Both term will be merged into “Documented
Information”.
• Exclusion Clause. There are 2 clauses in ISO 9001: 2015 which can be excluded: (1) Clause 7.1.4 regarding the
measuring instrument, and Clause 8 about Operational.
• New Clause, Concepts and Principles. …from various sources

38. The contents of ISO 9001 are now as follows:
 Foreword
 Introduction
 Requirements
Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and Definitions
Section 4: Quality Management System
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Product Realization
Section 8: Measurement, Analysis, and Improvement
38