Kevin%20Siefert

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Quality Management SystemsChapter 14

• Kevin Siefert
• Solomon Nathi
• Harshavardhan Vennapusa

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ISO 9000 The International Standard for Quality
Management Systems - Objective

• 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.

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ISO 9000 The International Standard for Quality
Management Systems - Objective Cont.

• 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.

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The Eight PrinciplesISO 9000s Basis

1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. Systems Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships

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ISO 9000 2000 Quality Management Systems
Fundamentals and Vocabulary

• Defines fundamental terms and definitions used in
  the ISO family.

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ISO 9001 2000Quality Management Systems
Requirements

• Standard to assess ability to achieve customer
  service.

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ISO 9004 2000Quality Management Systems
Guidelines for Performance Improvements

• Guidelines to a company for continual
  improvements of its quality-management system.

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Application of ISO 9000 to Organizations

• 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.

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Application of ISO 9000 to Organizations Once
Registered

• 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.

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Deming Wheel PDCA Cycle
3.
4. ACT Institutionalize Improvement continue
cycle
1. Plan Identify problem and develop plan for
improvement
3. Study/Check Assess plan is it working
2. Do Implement plan on a test basis
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ISO 9000 Quality Management System Definition

• As stated in the ISO 9000 2000s guidelines a
  Quality Management System is a management system
  to direct and control an organization with regard
  to quality.

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Quality Management Systems Documentation

1. 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.

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Quality Management Systems Documentation Cont.

• 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.
• Forms, records, ect. These are the proof of
  activities required for the firm and the auditors
  to remain certified.

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Authority for Certification or Registration

• 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 Organizations 1994 Agreement on Technical
  Barriers to Trade.

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ISO 9000 Registration Statistics

• ISO 9000 is becoming what it claims to be, the
  international standard for managing quality
• According to the ISOs worldwide survey of ISO
  9001 certificates, as per December 2008, more
  than a million organizations in 179 countries had
  registered to ISO 9001

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ISO 9000 registration worldwide
Registrations 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
No of countries 133 149 154 161 170 179
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The top 10 countries for ISO 90012000
certificates

• 1. China 180,107
• 2. Italy 117,437
• 3. Japan 89,375
• 4. Spain 63,883
• 5. Germany 51,568
• 6. United States 49,820
• 7. India 45,473
• 8. United kingdom 45,409
• 9. France 23,697
• 10.Netherlands 21,003

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• 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 worlds
  perception of Chinese goods.

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• 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.

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• Of the 121,258 new registrations in year 2006,
  33 of the organizations are from the service
  sector.
• ISO 9001s generic requirements can apply to
  organization in any industry or in economic
  sector.

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Steps of registration-

• The organization that wants a conforming ISO 9000
  QMS must go through the following steps,
• Develop a quality manual.
• Documentation.
• Managements commitment to QMS.
• Customer requirements.
• Hire an accredited registrar company.

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• 6. Registered or not, must conduct internal
  audits.
• 7. Periodic audits.
• http//www.youtube.com/watch?vKP1bAsjI6eINR1
• http//www.youtube.com/watch?vzzT-l7sdLtIfeature
  related

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Benefits of ISO 9000

• 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
  non-registered competitors.

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• 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

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The origins of ISO 9000

• 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.

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• ISO 9000 includes American National Standards
  institute(ANSI).
• The first version of ISO 9000 was released in
  year 1987.

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• http//www.youtube.com/watch?vGdUPyUlKrAQfeature
  related

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Comparative Scope of ISO 9000 and TQM

• 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.

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ISO 9000 and TQM Are not interchangeable.

• 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.

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Primary difference between ISO 9000 and TQM

• 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.

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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
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ISO 9000 is compatible with and can be viewed as
a subset of TQM

• 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.

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ISO 9000 can improve Operations in a traditional
environment

• 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

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ISO 9000 and TQM are not in competition

• 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?vleVtLumjW7w

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Management motivation for Registration to ISO 9001

• 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.

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• 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 start
  in implementing TQM

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Future of ISO 9000

• 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