ISO 9000 AND TOTAL QUALITY MANAGEMENT: THE RELATIONSHIP

ISO 9000 AND TOTAL QUALITY:

THE RELATIONSHIP

INTRODUCTION OF QUALITY MANAGEMENTLECTURER: DR. DADANG SURJASA

Presented by:Dian

Hermawan122140038

Rheyn Lusiana S.122140125

Muh. Rizal Anshori

122140135

Magister Management Executive ClassUniversity of Trisakti

ISO 9000 : THE INTERNATIONAL STANDARD FOR QUALITY MANAGEMENT SYSTEM

Management System Definition

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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/

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ISO 9000 : The International Standard for Quality Management System

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/

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ISO 9001 Certification

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.

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The Eight Principle : ISO 9000`s Basis

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

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The Eight Principle : ISO 9000`s Basis… (Cont.)

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

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Plan – Do – Check – Act : ISO 9000`s Operating Principle

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

ISO 9000`S OBJECTIVES

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Aims of ISO 9000

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

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HOW ISO 9000 IS APPLIED TO ORGANIZATION

How ISO 9000 is Applied to Organization

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.

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THE ISO 9000 QUALITY MANAGEMENT SYSTEM: A DEFINITION

Definition of ISO 9000 Quality Management System

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-

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THE ISO 9000 QUALITY MANAGEMENT SYSTEM: A DEFINITION

Definition of ISO 9000 Quality Management System…(Cont.)

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

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AUTHORITY FOR CERTIFICATION/ REGISTRATION

Authority For Certification/Registration

International Accreditation Forum

(Assesses Accreditation Bodies)

Accreditation Body

(Accredits Certification Bodies)

Certification Body(Registers Organizations)

Organization Seeking Registration

TickIT, by the United Kingdom’s Board of Trade specifically for the information technology industry.

ISO 9001 & INDUSTRY-SPECIFIC APPLICATIONS

TickIT – Information Technology Industry

Picture: http://cesfl.com/

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AS 9000 – Aerospace Industry

Picture: http://gerstarted.blogspot.com/2012/11/sejarah-singkat-william-edward-boeing.html


PS 9000 – Pharmaceutical Packaging Materials Industry

Picture: http://pharmatips.doyouknow.in/Jobs/Pharma-Packaging/Mumbai/Executive-Packaging-Development-Jobs-In-Pharma-Industry.aspx

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ISO/TS 16949 – Automotive Industry

Picture: www.eltronis.com

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TL 9000 – Telecommunication Industry

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ISO 13485 – Medical Industry

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ISO/TS 29001 – Petroleum, Petrochemical and Natural Gas Industry

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ORGANIZATIONAL REGISTRATION TO ISO 9001

Organizational Registration to ISO 9001

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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ORGANIZATIONAL REGISTRATION TO ISO 9001

Organizational Registration to ISO 9001…(Cont.)

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.

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THE BENEFITS OF ISO 9000The Benefits of ISO 9000

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

Benefits2. Customer Benefits

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Comparative Scope of ISO 9000 & TQM

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

environmentISO 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

COMPARATIVE SCOPE OF ISO 9000 & TQM

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ISO 9000 & TQM are (Related but) not Interchangeable

Characteristics ISO 9000 TQMCustomer 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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ISO 9000 is Compatible with, and Can Be Viewed as a Subset of, TQM

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.


Picture: http://iso22000resourcecenter.blogspot.com/2015/01/understanding-total-quality-management.html

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ISO 9000 is Frequently Implemented in a Non-TQM Environment

TQM is compatible with and may help the

organization on facilitating ISO 9000

implementation.

BUT 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.


Picture: http://blog.atmel.com/2014/12/12/ir-reflow-oven-for-your-prototype-pcbs/

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ISO 9000 Can Improve Operations in a Traditional Environment

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.


Picture: http://michelbaudin.com/2014/05/09/making-time-for-improvement/

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ISO 9000 May Be Redundant in a Mature TQM Environment

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.


Picture: http://www.toyota-forklifts.co.uk/EN/News/Toyota-knowledgebase/Pages/TPS_One.aspx

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ISO 9000 & TQM are Not in Competition

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.`

TQM

ISO


Management Motivation for Registration to ISO 9001

Obtaining Marketing Advantages

Inappropriate

MotivesTo improve operations by implementing a QMS.To create or improve a QMS that will be organized by customers worldwideTo improve product and service quality

To improve customer satisfaction

To improve competitive postureTo conform the requirements of one or more major customers

AppropriateMotives

*) 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.

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MANAGEMENT MOTIVATION FOR REGISTRATION TO ISO 9000

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ISO 9000 & TQM WORKING TOGETHER

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.SiResources: http://slideplayer.info/slide/2585767/#


Movement from ISO 9000 to TQM and Vice Versa

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


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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

ISO 9000 as an entry into Total Quality Management

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Credibility of the Standard THE FUTURE OF ISO 9000

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.

presented by Dian

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ISO 9000: VERSIONS/UPDATES


Source: http://www.icmci.org/?page=17673085


ISO 9000: VERSIONS/UPDATESISO 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.


ISO 9000: VERSIONS/UPDATES…(Cont)

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.

Just Sharin

g

…from various sources

ISO 9001: THE CONTENTS

The contents of ISO 9001 are now as follows: Foreword Introduction Requirements

Section 1: ScopeSection 2: Normative ReferenceSection 3: Terms and DefinitionsSection 4: Quality Management SystemSection 5: Management ResponsibilitySection 6: Resource ManagementSection 7: Product RealizationSection 8: Measurement, Analysis, and Improvement

ISO 9001: The Contents

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THANK YOU

ISO 9000 AND TOTAL QUALITY MANAGEMENT: THE RELATIONSHIP

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