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ISO 9000
By
Dr.A.Nithya
UNIT - 5
QUALITY SYSTEMS
ISO
Not acronym – Greek word called
isos means equal
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
ISO involves quality system
• How – method/process
• Who – responsibilities/authorities
• When – records/eveidence
• Where – identification/traceability
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.
• ISO does not lend its name to advertisements
and not registration business.
• But create and publish international standard
facilities.
• International exchange of G&S
ISO 9000
• Business dealings
• Product
• Material process
• Quality management
• Customer satisfaction
ISO 14000
• Environmental management requirements
• Control pollution
• Minimize effect
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
Kept ready for ISO 9000 std
• Technical report
• Handbook
• Web based document on quality management
/ assurance
Responsible for developing ISO 9000
std
• Technical and sub committee
• expert
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)
• 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)
• 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
Elements
• Management responsibility
• Quality systems
• Contract review
• Design control
• Documentation
• Purchasing
• Purchaser or customer supplied product
• Product identification/traceability
• Process control
• Inspection & testing
• 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
Implementation of QS
• Top mgt. commitment
• Appoint expert
• Create awareness
• Form team
• Training
• Time schedule
• Select element owners
• Review the present system
• Write the documents
• Install the new system
• Internal audit
• Management review
• Pre assessment
• Award of ISO 9000 certificate
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
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.
Types of audit
• First party – internal audit
• Second party – another organization (on
supplier by customer)
• Third party – by independent organization (on
supplier for accreditation)
Objectives
• Determine conformity & non – conformity
• Meet requirement
• Meet objectives
• Evaluate one’s own org. quality
• Recognize by third party
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

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ISO 9000

  • 3. ISO Not acronym – Greek word called isos means equal
  • 4. 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
  • 5. ISO involves quality system • How – method/process • Who – responsibilities/authorities • When – records/eveidence • Where – identification/traceability
  • 6. 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.
  • 7. • ISO does not lend its name to advertisements and not registration business. • But create and publish international standard facilities. • International exchange of G&S
  • 8. ISO 9000 • Business dealings • Product • Material process • Quality management • Customer satisfaction
  • 9. ISO 14000 • Environmental management requirements • Control pollution • Minimize effect
  • 10. 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
  • 11. Kept ready for ISO 9000 std • Technical report • Handbook • Web based document on quality management / assurance
  • 12. Responsible for developing ISO 9000 std • Technical and sub committee • expert
  • 13. 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)
  • 14. • 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)
  • 15. • 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
  • 16. Elements • Management responsibility • Quality systems • Contract review • Design control • Documentation • Purchasing • Purchaser or customer supplied product • Product identification/traceability • Process control • Inspection & testing
  • 17. • 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
  • 18. Implementation of QS • Top mgt. commitment • Appoint expert • Create awareness • Form team • Training • Time schedule • Select element owners • Review the present system
  • 19. • Write the documents • Install the new system • Internal audit • Management review • Pre assessment • Award of ISO 9000 certificate
  • 20. 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
  • 21. 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.
  • 22. Types of audit • First party – internal audit • Second party – another organization (on supplier by customer) • Third party – by independent organization (on supplier for accreditation)
  • 23. Objectives • Determine conformity & non – conformity • Meet requirement • Meet objectives • Evaluate one’s own org. quality • Recognize by third party
  • 24. 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