ISO 9000

1. ISO 9000
By
Dr.A.Nithya

2. UNIT - 5
QUALITY SYSTEMS

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