1. I 1 ISO 9000 Quality Management System ISO 9001:2000 1 What is ISO 9000 ? u Series of international standards for quality systems. u specify requirements for design & assessment of a management system. u Aim: ensure suppliers provide products and services that satisfy specified requirements

2. I 2 ISO 9000 Quality Management System ISO 9001:2000 2 u Specified requirements are specific, or of particular market, u ISO 9000 enable companies to provide products and services that satisfy customers. u ISO not product standard. NB : Products cannot meet ISO 9000, organizations can.

3. I 3 ISO 9000 Quality Management System ISO 9001:2000 3 Evolution of ISO 9000 1950s - QMS appeared, QC emerged after WW11 1959 - 1 st national std, MIL Q 9858 by US Dept. of Defence 1968 - NATOs – Allied Quality Assurance Publications, AQAP 1970 -UK Ministry of Def – 05 -08 (UK version of AQAP) 1972 - BSI BS 4891 (A guide to QA) 1979 - BSI published BS 5750 in 3 parts 1983 - Canada, Australia, US organization on quality 1984 - BSI rev. of 1979, encourage ISO embark on Intern. std 1985 - First drafts for public comments 1987- Final approval for publication 1994 - Revision 2000 - Revision (Published on 15.12.2000)

4. I 4 ISO 9000 Quality Management System ISO 9001:2000 4 ISO 9000 International Standards Series u ISO 9000: terms/vocabulary used in QMS u ISO 9001: specifies requirements for QMS u ISO 9004: improvement of performance u ISO 19011: guide auditing of QMS & EMS u Form a set of QMS standards facilitating national and international trade

5. I 5 ISO 9000 Quality Management System ISO 9001:2000 5 Quality concepts b ased on ISO 9000:2000 ( definitions and vocabulary) “Quality” “Degree to which a set of inherent characteristics fulfils requirements” Quality = customer satisfaction

6. I 6 ISO 9000 Quality Management System ISO 9001:2000 6 Grade “Category or rank given to different quality requirements for products, processes or systems having the same functional use” - “Differences in product or service performance, degrees of refinement = differences in grade. E.g.: 1 star, 2 star hotel

7. I 7 ISO 9000 Quality Management System ISO 9001:2000 7 Product Quality Characteristics u Taste u Appearance u Reliability u Size u Storability u Testability Service Quality Characteristics u Accessibility u Dependability u Efficiency u Reliability u Responsiveness u Effectiveness

8. I 8 ISO 9000 Quality Management System ISO 9001:2000 8 Quality Management “Coordinated activities to direct and control an organisation with regard to quality ” with regard to quality ”

9. I 9 ISO 9000 Quality Management System ISO 9001:2000 9 Quality Management Quality Assurance Quality Improvement Quality Control

10. I 10 ISO 9000 Quality Management System ISO 9001:2000 10 Quality Assurance “Part of quality management, focused on providing confidence that quality requirements will be fulfilled”

11. I 11 ISO 9000 Quality Management System ISO 9001:2000 11 Quality Control “Part of quality management, focused on f ulfilling quality requirements” Quality Improvement “ Part of quality management, focused on increasing the ability to fulfil the requirements”

12. I 12 ISO 9000 Quality Management System ISO 9001:2000 12 Process Approach ProcessActivities+Resources InputOutput Controls(e.g.procedure) ISO 9000 standard promotes adoption of process approach to enhance customer satisfaction and meeting customer needs

13. I 13 ISO 9000 Quality Management System ISO 9001:2000 13 Process Approach u Activity using resources and managed in order to enable the transformation of inputs into outputs = process. u Output of one process forms input to the next

14. I 14 ISO 9000 Quality Management System ISO 9001:2000 14 Processes interactions ProcessA ProcessDProcessB ProcessC InputOutputControls

15. I 15 ISO 9000 Quality Management System ISO 9001:2000 15 Process Approach Therefore, The application of a system of processes, and the identification and interactions of processes, and their management = process approach

16. I 16 ISO 9000 Quality Management System ISO 9001:2000 16 CUSTOMERSCUSTOMERS CUSTOMERSCUSTOMERS Management responsibility Resource management Measurement, analysis, & improvement Product realisation Continual Improvement of the Quality Management System RequirementsRequirements SatisfactionSatisfaction Input Output Model of a Process-based QMS

17. I 17 ISO 9000 Quality Management System ISO 9001:2000 17 Process-based QMS (explained)  Above model shows ALL requirements of this International Standard u Illustrates process linkages for clauses 4- 8 u Customers define requirements as inputs

18. I 18 ISO 9000 Quality Management System ISO 9001:2000 18 u Monitoring of customer satisfaction requires analyzing customers’ perception if the company has met requirements u Also PDCA methodology can be applied to all processes

19. I 19 ISO 9000 Quality Management System ISO 9001:2000 19 Plan Do Check Act PDCA Cycle Quality “ Achieving quality products not accidental.. PLAN”

20. I 20 ISO 9000 Quality Management System ISO 9001:2000 20 1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach 6. Factual approach to decision making 7. Continual improvement 8. Mutually beneficial supplier relationship Quality Management Principles

21. I 21 ISO 9000 Quality Management System ISO 9001:2000 21 Determine customer needs & expectations Requirements Customer satisfaction Principle1 : Customer Focus Organisations depend on customers

22. I 22 ISO 9000 Quality Management System ISO 9001:2000 22 Leaders establish unity of purpose, direction and internal environment in which people become which people become fully involved. fully involved. Principle 2:Leadership

23. I 23 ISO 9000 Quality Management System ISO 9001:2000 23 Principle 3: Involvement of people People are the essence of the organisation. People are the essence of the organisation. Their full involvement enables using their abilities to the benefit of the organisation. Their full involvement enables using their abilities to the benefit of the organisation.

24. I 24 ISO 9000 Quality Management System ISO 9001:2000 24 Principle 4: Process Approach A desired result is more efficiently achieved when resources and activities are managed as a process. as a process.

25. I 25 ISO 9000 Quality Management System ISO 9001:2000 25 Identifying, understanding and managing a system of interrelated processes for a given objective contributes to effectiveness and efficiency. Principle 5: System Approach

26. I 26 ISO 9000 Quality Management System ISO 9001:2000 26 Principle 6: Continual improvement Continual improvement is a permanent objective of the organisation

27. I 27 ISO 9000 Quality Management System ISO 9001:2000 27 Principle 7: Factual approach to Decision making Effective decisions are based on the logical and intuitive analysis of data and information. Months Sales in million Bar Graph of XYZ Sales 123 2 4 6

28. I 28 ISO 9000 Quality Management System ISO 9001:2000 28 Mutually beneficial relationship between organisation and its suppliers enhance the ability of both organisations to create value. Principle 8: Mutually Beneficial Supplier relationship

29. I 29 ISO 9000 Quality Management System ISO 9001:2000 29 Benefits of implementing ISO 9000 u Achieving customer satisfaction by preventing nonconformity at all stages u If right tasks carried out right first time, no waste, costs will be min. profit maximum u Profit = reducing error, remedial action and waste, saving time, resources and materials

30. I 30 ISO 9000 Quality Management System ISO 9001:2000 30 An effective QMS will: u Reduce fire fighting-by giving staff means to control their own operations u Right tasks are identified and specified that yield right results - by planning in advance u Provide a means for identifying and resolving problems and preventing their recurrence

31. I 31 ISO 9000 Quality Management System ISO 9001:2000 31 u Provide the means of enabling people perform right first time- by providing right resources, training etc u Provide objective evidence to demonstrate quality of your products and that your operations are under control – by having records

32. I 32 ISO 9000 Quality Management System ISO 9001:2000 32 1. Know current position 2. Set aims/objectives 3. Appoint MR 4. Define processes 5. Awareness training 6. Quality manual/ procedures 7. Implement practices 8. Internal audit training 9. Finalize manuals 10. Apply to CBs 11. Do internal audit 12. Management review 13. Do Pre-audit 14. Corrective action 15. Do Final audit 16. Corrective action 17. Cert. award & registration Steps to Certification