i 1 iso 9000 quality management system iso 9001:2000 1 what is iso 9000 ? u series of international...

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

ISO 9001:2000 2I 2


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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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)

ISO 9001:2000 4I 4


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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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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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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Product Quality

Characteristics Taste Appearance Reliability Size Storability Testability

Service Quality Characteristics

Accessibility Dependability Efficiency Reliability Responsiveness Effectiveness

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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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Quality Management

Quality Assurance

Quality Improvement

Quality Control

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Quality Assurance

“Part of quality management, focused on providing confidence that quality requirements will be fulfilled”

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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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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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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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Processes interactionsProcesses interactions

ProcessProcessAA

ProcessProcessDD

ProcessProcessBB

ProcessProcessCC

InputInputOutputOutputControlsControls

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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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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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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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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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Plan

Do

Check

Act

PDCA Cycle

Quality

“Achieving quality products

not accidental..

PLAN”

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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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Determine customerneeds & expectations

Requirements

Customer satisfaction

Principle1 :Customer Focus

Organisations Organisations depend on depend on customerscustomers

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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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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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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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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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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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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

i 1 iso 9000 quality management system iso 9001:2000 1 what is iso 9000 ? u series of international...

Documents

quality management system

quality slide

qms u iso

quality systems

evolution of iso

different quality requirements

vocabulary quality degree

quality concepts b