ISO 9000

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