1. Quality Management Systems Chapter 14
Kevin Siefert
Solomon Nathi
Harshavardhan Vennapusa

2. 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.

3. 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.

4. The Eight Principles: ISO 9000’s Basis
Customer Focus
Leadership
Involvement of People
Process Approach
Systems Approach to Management
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships

5. ISO 9000: 2000 Quality Management Systems – Fundamentals and Vocabulary
Defines fundamental terms and definitions used in the ISO family.

6. ISO 9001: 2000 Quality Management Systems Requirements
Standard to assess ability to achieve customer service.

7. ISO 9004: 2000 Quality Management Systems – Guidelines for Performance Improvements
Guidelines to a company for continual improvements of its quality-management system.

8. Application of ISO 9000 to Organizations
No organization is required to use ISO 9000, but some customers may insist on registration. ISO 9001: 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:

9. 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.

10. Deming Wheel: PDCA Cycle3.
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

11. ISO 9000 Quality Management System: Definition
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.

12. Quality Management System’s Documentation
A quality policy – This statement describes how the organization approaches quality.
The quality manual – This addresses each clause of the ISO 9001 standard. Also must demonstrate management responsibility for the operation of the quality system.
Quality objectives – The goals and the quality policy must be in agreement. Objectives are assigned to relevant functions and are supervised by to management.

13. Quality Management System’s 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.

14. 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 Organization’s 1994 Agreement on Technical Barriers to Trade.

15. ISO 9000 Registration Statistics
ISO 9000 is becoming what it claims to be, ‘the international standard for managing quality’
According to the ISO’s worldwide survey of ISO certificates, as per December 2008, “more than a million organizations in 179 countries had registered to ISO 9001”

16. 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

17. The top 10 countries for ISO 9001:2000 certificates
1. China ,107
2. Italy ,437
3. Japan ,375
4. Spain ,883
5. Germany ,568
6. United States ,820
7. India ,473
8. United kingdom ,409
9. France ,697
10.Netherlands ,003

18. 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 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.

19. 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.
harsha

20. 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.

21. Steps of registration:-
The organization that wants a conforming ISO QMS must go through the following steps,
Develop a quality manual.
Documentation.
Management’s commitment to QMS.
Customer requirements.
Hire an accredited registrar company.

22. 6. Registered or not, must conduct internal audits.
7. Periodic audits.
l7sdLtI&feature=related

23. 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.

24. 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

25. 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.

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

27. http://www.youtube.com/watch?v=GdUPyUlKrAQ&fe ature=related

28. 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.

29. 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.

30. 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.

31. Characteristics
ISO 9000
TQM
Customer Focus(internal & external)
Yes
yes
Obsession with Quality
Scientific approach to problem solving
Long term commitment
partial
Teamwork
Continual process and product improvement
Education & training intensive
Freedom through control
Unity of purpose
Employee involvement and empowerment

32. 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.

33. 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

34. ISO 9000 and TQM are not in competition:
Organizations can adopt to either of them or both ISO and TQM.
Both have worthwhile and similar aims.
Both support each other and are complementary.

35. 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.

36. 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

37. 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