ISO 9000 Quality Management System What is ISO

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

ISO 9000 Quality Management System 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. I ISO 9001: 2000 2

ISO 9000 Quality Management System Evolution of ISO 9000 1950 s - QMS appeared, QC emerged after WW 11 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) I ISO 9001: 2000 3

ISO 9000 Quality Management System 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 an I ISO 9001: 2000 4

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

ISO 9000 Quality Management System 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 I ISO 9001: 2000 6

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

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

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

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

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

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

ISO 9000 Quality Management System 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 I ISO 9001: 2000 13

ISO 9000 Quality Management System Processes interactions Process A Process C Process B Process D Input Output Controls I ISO 9001: 2000 14

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

ISO 9000 Quality Management System Model of a Process-based QMS Continual Improvement of the Quality Management System C U S T O M E R S R e q u i r e m e n t s Management responsibility Resource management Input Measurement, analysis, & improvement Product realisation C U S T O M E R S Product Output I ISO 9001: 2000 16 S a t i s f a c t i o n

ISO 9000 Quality Management System 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 I ISO 9001: 2000 17

ISO 9000 Quality Management System 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 I ISO 9001: 2000 18

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

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

ISO 9000 Quality Management System Principle 1 : Customer Focus Determine customer needs & expectations Organisations depend on customers Requirements Customer satisfaction I ISO 9001: 2000 21

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

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

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

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

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

ISO 9000 Quality Management System Principle 7: Factual approach to Decision making 6 Sales in million Effective decisions are based on the logical and intuitive analysis of data and information. Bar Graph of XYZ Sales 4 2 1 2 3 Months I ISO 9001: 2000 27

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

ISO 9000 Quality Management System 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 I ISO 9001: 2000 29

ISO 9000 Quality Management System 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 I ISO 9001: 2000 30

ISO 9000 Quality Management System 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 I ISO 9001: 2000 31

ISO 9000 Quality Management System Steps to Certification 1. 2. 3. 4. 5. 6. 7. 8. 9. Know current position Set aims/objectives Appoint MR Define processes Awareness training Quality manual/ procedures Implement practices Internal audit training 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 I ISO 9001: 2000 32