TOTAL QUALITY MANAGEMENT-UNIT V QUALITY SYSTEMS

1. ISO
Not acronym – Greek word called
isos means equal

2. International organization for
standardization
• Established in 1942 in Geneva, Switzerland
• It is an association of national standard bodies
of more than 150 countries.
• It is a specialized agency.
• Aim of ISO is create coordination and
unification of international standards.
• It employs – technical committee, sub
committee, working group

3. ISO involves quality system
• How – method/process
• Who – responsibilities/authorities
• When – records/eveidence
• Where – identification/traceability

4. Quality Systems
• System is well understood/ effective
• Product/service actually do satisfy customer
• Emphasis is placed on problem-prevention
rather than problem detection after
concurrence.

5. QS
• ISO does not lend its name to advertisements
and not registration business.
• But create and publish international standard
facilities.
• International exchange of G&S

6. ISO 9000
• Business dealings
• Product
• Material process
• Quality management
• Customer satisfaction

7. ISO 14000
• Environmental management requirements
• Control pollution
• Minimize effect

8. objectives
• Consistent dissemination of information
• Improve employee involvement
• Improve house keeping
• Improve decision making
• Improve customer satisfaction
• Improve safe working
• Reduce customer complaints
• Reduced inspection efforts
• Reduce quality cost
• Global market
• Control operation
• Standardized organization

9. Kept ready for ISO 9000 std
• Technical report
• Handbook
• Web based document on quality management
/ assurance

10. Responsible for developing ISO 9000
std
• Technical and sub committee
• expert

11. Classifications
• ISO 8402:1986 – vocabulary – gives the
definition of various terms (such as quality,
reliability, grade, inspection)
• ISO 9001: 1987 – Design, Development,
Production, Installation and Servicing (gives
model right from designing to customer
service such as: TV, cooler, pump fitters,
fridge, laptop)

12. Classifications
• ISO 9002: 1987 – production to installation ex:
road construction, bridge, dam and civil
structure
• ISO 9003:1987 – final inspection and testing –
after manufacturing ex: all consumer items,
petroleum, FMCG
• ISO 9004 : 1987 – guidelines for QM (quality
culture)

13. Classifications
• ISO 10011 – 1990 – guidelines for auditing QS
• ISO 10011 – 1991- role of
auditors/responsibilities/executing /reporting
• ISO 10011-1992 – evaluating/ qualification
• ISO 10011 1993 – establishment of audit
function

14. Elements
• Management responsibility
• Quality systems
• Contract review
• Design control
• Documentation
• Purchasing
• Purchaser or customer supplied product
• Product identification/traceability
• Process control
• Inspection & testing

15. Elements
• IMTE – inspection, measuring & test equipment
• Inspection and test status
• Control of non conforming products review
• Correction and preventive action
• Handling, storage, packaging, preservation and delivery
• Control of quality records
• Internal quality audit
• Training
• Servicing
• Statistical techniques

16. Implementation of QS
• Top mgt. commitment
• Appoint expert
• Create awareness
• Form team
• Training
• Time schedule
• Select element owners
• Review the present system

17. Implementation of QS
• Write the documents
• Install the new system
• Internal audit
• Management review
• Pre assessment
• Award of ISO 9000 certificate

18. Documentation of QS
• It is evidence or for reference
• Benefits are – clarity, systematic, consistency,
involvement
• Required document – policy / manual – rules and
regulation (what)
• Procedure – methods (who when where)
• Work instructions – manufacturing process (how)
• Records / formats - forms

19. Auditing
• It is carried out to see if QS is effective
• Features – who – auditor well versed and
qualified
• What – product, process, system, service
• How – information gathering activity not
police kind of activity
• Where – internal and external purpose.

20. Types of audit
• First party – internal audit
• Second party – another organization (on
supplier by customer)
• Third party – by independent organization (on
supplier for accreditation)

21. Objectives
• Determine conformity & non – conformity
• Meet requirement
• Meet objectives
• Evaluate one’s own org. quality
• Recognize by third party

22. Stages
• Audit planning – schedule, appoint auditor,
notification to auditee, prepare checklist (list
of questions to be asked in audit)
• Audit performance – meeting, inspection
• Audit reporting – summary of findings,
corrective action requirement
• Audit follow up – time period

23. ISO 14000
• After success of ISO 9000 another std for EM
came in 1992 i.e ISO 14000
• It covers – Env. Mgt, Systems
• Env. Auditing
• Env. Performance evaluation
• Life cycle assessment
• Env. Aspects in product std.

24. Why ISO 14000
• To encourage cleaner, safer, healthier world
for all
• To compete
• To start in other countries
• To make the customer to think that they
safeguard the people
• Own practices to be free pollution country –
to be uniform ISO 14000 developed.

25. ISO 14000 series
• Organization Evaluation standard
• ISO 14001 – EMS Specification – Elements to
get registration certificate
• ISO 14004 – EMS Guidelines Principles –
• ISO 14010 – EA Principles – Int/Ext Auditing
• ISO 14011 – Guidelines EA – plan
• ISO 14012 – EA Qualification – personal
attributes and skills

26. ISO 14000 series
• ISO 14031 – EPA Guidelines – monitoring and
measurings
• Product Evaluation Standard
• ISO 14064 – Env Aspects in product standard –
develop product standard
• ISO 14020:2000 – label and declaration – envl.
Basic principles for all environmental labeling
– goal used in label

27. ISO 14000 series
• ISO 14021 – L & D (terms and conditions) –
accurate, verifiable not deceptive
• ISO 14022 – L &D – symbol
• ISO 14023 – L & D – guidelines
• ISO 14024 – L & D – labeling or seal
• ISO 14040 – LCA – application and limitation -
principles
• ISO 14041 - LCA - review - goal
• ISO 14042 – LCA – impact
• ISO LCA - improvement

28. Terminology
• Environment –flora and fauna
• Envl aspect – water wastage, air emission
• Envl. Impact – negative or positive
• Envl. Objective – org. policy to safe & control
the env.
• Envl. Target – in no: or % of objectives like
reduce 2% -3% carbon

29. Requirement of ISO 14000
• General requirement
• Environmental policy
• Environmental Aspects
• Legal aspects
• Objectives and target
• Environmental management programme
• Structure and responsibilty
• Training, awareness and competency
• Communication

30. Requirement of ISO 14000
• EMS document
• Document control
• Operation control
• Emergency preparaedness and response
• Monitor and measurement
• Non – conformance
• Records
• EMS audit
• Mgt. review

31. Concept of ISO 14000
Environmental Policy
Cont. Imp.
Mgt. Rev
Implement
ation and
operation
Checking & corrective action
Planning

32. Benefits
• Global - no trade barrier
• Organizational – customer, employee, investor

33. TS 16949
• Automotive Industry
• It is an technical specification aiming to the
development of a quality management system
that provides for continual improvement
emphasizing defects prevention & the
reduction in variation and waste in the supply
chain.
• It is based on ISO 9001 published in Mar 2002
as TS 16949

34. Type of standard
• ISO 9000 & ISO 14000 industry – QM & EMS
• AS 9100 – Aerospace Industry
• TL 9000 – Tele Communication Industry
• TS 16949 – Automotive Industry

35. • Prepared by International Automotive task
force and the technical committee
• Chrysler (quality Assurance Manual)
• Ford Motor (QS std)
• GM (Target for excellence)

36. • TS 16949 applies to the design/development
production and installation and servicing of
automotive related products.
• Validity for 3 years

37. Content of specification
• QMS – General requirement, control of
documents
• Responsibility of the management
• Management resource
• Product realization (production)
• Measurement, Analysis and Improvement
• Customer requirement

38. process
• Business oriented process
• Customer oriented process

39. Application
• Supply chain automotive Industry
• Validity 3 years – IATF certified auditor
• Recertification for another 3 years
• OEM – original equipment manufacturing

40. Document required
• QS 9000 – QS requirement
• APQP – Advanced Product Quality Planning
• FMEA
• PPAP – Production Part Approved Process
• QSA – Quality System Assessment
• SPC -
• MSA – Measurement System Analysis

41. Quality awards
• Australian Business Excellence Awards
• China Quality Award
• Dubai Government Excellence Award
• Dutch Quality Assessment (Netherlands)
• Egypt Government Excellence Award
• Indonesian Quality Award

42. Quality Award
• Iran National Quality Award
• King Abdulaziz Quality Award (Saudi Arabia)
• Korean National Quality Management Award
(South Korea)
• Prime Minister Quality Award (Pakistan)
• Rajiv Gandhi National Quality Award (India)
• Singapore Business Excellence Awards