i 1 iso 9000 quality management system iso 9001:2000 1 what is iso 9000 ? u series of international...
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ISO 9001:2000 1I 1
ISO 9000 Quality Management System
What is ISO 9000 ?
Series of international standards for quality systems. specify requirements for design &
assessment of a management system.
Aim: ensure suppliers provide products and services that satisfy specified requirements
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ISO 9000 Quality Management System
Specified requirements are specific, or of particular market,
ISO 9000 enable companies to provide products and services that satisfy customers.
ISO not product standard. NB: Products cannot meet ISO 9000,
organizations can.
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ISO 9000 Quality Management System
Evolution of ISO 9000 1950s - QMS appeared, QC emerged after WW111959 - 1st national std, MIL Q 9858 by US Dept. of
Defence1968 - NATOs – Allied Quality Assurance Publications,
AQAP1970 -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 quality1984 - BSI rev. of 1979, encourage ISO embark on Intern.
std1985 - First drafts for public comments1987- Final approval for publication1994 - Revision2000 - Revision (Published on 15.12.2000)
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ISO 9000 Quality Management System
ISO 9000 International Standards Series
ISO 9000: terms/vocabulary used in QMS ISO 9001: specifies requirements for QMS ISO 9004: improvement of performance ISO 19011: guide auditing of QMS & EMS
Form a set of QMS standards facilitating national and international trade
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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
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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
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ISO 9000 Quality Management System
Product Quality
Characteristics Taste Appearance Reliability Size Storability Testability
Service Quality Characteristics
Accessibility Dependability Efficiency Reliability Responsiveness Effectiveness
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ISO 9000 Quality Management System
Quality Management
““Coordinated activities to direct Coordinated activities to direct
and control an organisationand control an organisation
with regard to quality ”with regard to quality ”
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ISO 9000 Quality Management System
Quality Management
Quality Assurance
Quality Improvement
Quality Control
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ISO 9000 Quality Management System
Quality Assurance
“Part of quality management, focused on providing confidence that quality requirements will be fulfilled”
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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”
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ISO 9000 Quality Management System
Process ApproachProcess Approach
ProcessProcessActivitiesActivities
++ResourcesResources
InputInput OutputOutput
ControlsControls(e.g.procedure) (e.g.procedure)
ISO 9000 standard promotes adoption of process approach to enhance customer satisfaction and meeting customer needs
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ISO 9000 Quality Management System
Process Approach Activity using resources and
managed in order to enable the transformation of inputs into outputs = process.
Output of one process forms input to the next
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ISO 9000 Quality Management System
Processes interactionsProcesses interactions
ProcessProcessAA
ProcessProcessDD
ProcessProcessBB
ProcessProcessCC
InputInputOutputOutputControlsControls
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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
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ISO 9000 Quality Management System
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,
& improvement
ProductProduct
realisation
Continual Improvement of theQuality Management System
Requirements
Satisfaction
InputOutput
Model of a Process-based QMS
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ISO 9000 Quality Management System
Process-based QMS (explained)
Above model shows ALL requirements of this International Standard
Illustrates process linkages for clauses 4- 8
Customers define requirements as inputs
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ISO 9000 Quality Management System
Monitoring of customer satisfaction requires analyzing customers’ perception if the company has met requirements
Also PDCA methodology can be applied to all processes
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ISO 9000 Quality Management System
Plan
Do
Check
Act
PDCA Cycle
Quality
“Achieving quality products
not accidental..
PLAN”
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ISO 9000 Quality Management System
1. Customer focus2. Leadership3. Involvement of people4. Process approach5. System approach6. Factual approach to decision making7. Continual improvement8. Mutually beneficial supplier relationship
Quality Management PrinciplesQuality Management Principles
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ISO 9000 Quality Management System
Determine customerneeds & expectations
Requirements
Customer satisfaction
Principle1 :Customer Focus
Organisations Organisations depend on depend on customerscustomers
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ISO 9000 Quality Management System
Leaders establish unity of Leaders establish unity of purpose, direction and purpose, direction and internal environment ininternal environment in
which people becomewhich people become
fully involved.fully involved.
Principle 2:Leadership
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Principle 3: Involvement of people
• People are the essence People are the essence of the organisation.of the organisation.
• Their full involvement Their full involvement enables using their enables using their abilities to the benefit of abilities to the benefit of the organisation.the organisation.
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Principle 4: Process Approach
A desired result is more efficiently A desired result is more efficiently achieved when resources and achieved when resources and activities are managedactivities are managed
as a process.as a process.
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Identifying, understanding and Identifying, understanding and managing a system of managing a system of interrelated processes for a interrelated processes for a given objective contributes to given objective contributes to effectiveness and efficiency.effectiveness and efficiency.
Principle 5: System Approach
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ISO 9000 Quality Management System
Principle 6: Continual improvement
Continual improvement is a Continual improvement is a permanent objective of the permanent objective of the organisationorganisation
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ISO 9000 Quality Management System
Principle 7: Factual approach to Decision making
Effective decisions Effective decisions are based on the are based on the logical and logical and intuitive analysis intuitive analysis of data and of data and information.information.
Months
Sale
s in
million
Bar Graph of XYZ Sales
1 2 3
2
4
6
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Mutually beneficial relationship Mutually beneficial relationship between organisation and its between organisation and its suppliers enhance the ability of suppliers enhance the ability of both organisations to create both organisations to create value.value.
Principle 8: Mutually Beneficial Supplier relationship
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Benefits of implementing ISO 9000 Achieving customer satisfaction by
preventing nonconformity at all stages
If right tasks carried out right first time, no waste, costs will be min. profit maximum
Profit = reducing error, remedial action and waste, saving time, resources and materials
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ISO 9000 Quality Management System
An effective QMS will: Reduce fire fighting-by giving Reduce fire fighting-by giving
staff means to control their own staff means to control their own operationsoperations
Right tasks are identified and Right tasks are identified and specified that yield right results specified that yield right results - by planning in advance- by planning in advance
Provide a means for identifying Provide a means for identifying and resolving problems and and resolving problems and preventing their recurrencepreventing their recurrence
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ISO 9000 Quality Management System
Provide the means of Provide the means of enabling people perform right enabling people perform right first time- by providing right first time- by providing right resources, training etcresources, training etc
Provide objective evidence to Provide objective evidence to demonstrate quality of your demonstrate quality of your products and that your products and that your operations are under control – operations are under control – by having by having recordsrecords
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ISO 9000 Quality Management System
1.1. Know current positionKnow current position2.2. Set aims/objectivesSet aims/objectives3.3. Appoint MRAppoint MR4.4. Define processesDefine processes5.5. Awareness trainingAwareness training6.6. Quality manual/ Quality manual/
proceduresprocedures7.7. Implement practicesImplement practices8.8. Internal audit trainingInternal audit training9.9. Finalize manualsFinalize manuals
10. Apply to CBs 10. Apply to CBs 11. Do internal audit11. Do internal audit12. Management review 12. Management review 13. Do Pre-audit13. Do Pre-audit14. Corrective action14. Corrective action15. Do Final audit15. Do Final audit16. Corrective action16. Corrective action17. Cert. award & 17. Cert. award &
registrationregistration
Steps to Certification