I 1 ISO 9000 Quality Management System ISO 9001: 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

I 2 ISO 9000 Quality Management System ISO 9001: 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 3 ISO 9000 Quality Management System ISO 9001: Evolution of ISO s - QMS appeared, QC emerged after WW st national std, MIL Q 9858 by US Dept. of Defence NATOs – Allied Quality Assurance Publications, AQAP UK Ministry of Def – (UK version of AQAP) BSI BS 4891 (A guide to QA) BSI published BS 5750 in 3 parts Canada, Australia, US organization on quality BSI rev. of 1979, encourage ISO embark on Intern. std First drafts for public comments Final approval for publication Revision Revision (Published on )

I 4 ISO 9000 Quality Management System ISO 9001: 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

I 5 ISO 9000 Quality Management System ISO 9001: 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

I 6 ISO 9000 Quality Management System ISO 9001: 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 7 ISO 9000 Quality Management System ISO 9001: 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

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

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

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

I 11 ISO 9000 Quality Management System ISO 9001: 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”

I 12 ISO 9000 Quality Management System ISO 9001: 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

I 13 ISO 9000 Quality Management System ISO 9001: 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 14 ISO 9000 Quality Management System ISO 9001: Processes interactions ProcessA ProcessDProcessB ProcessC InputOutputControls

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

I 16 ISO 9000 Quality Management System ISO 9001: 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

I 17 ISO 9000 Quality Management System ISO 9001: 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 18 ISO 9000 Quality Management System ISO 9001: 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 19 ISO 9000 Quality Management System ISO 9001: Plan Do Check Act PDCA Cycle Quality “ Achieving quality products not accidental.. PLAN”

I 20 ISO 9000 Quality Management System ISO 9001: 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

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

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

I 23 ISO 9000 Quality Management System ISO 9001: 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.

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

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

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

I 27 ISO 9000 Quality Management System ISO 9001: 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

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

I 29 ISO 9000 Quality Management System ISO 9001: 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 30 ISO 9000 Quality Management System ISO 9001: 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 31 ISO 9000 Quality Management System ISO 9001: 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 32 ISO 9000 Quality Management System ISO 9001: 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