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ISO 9001:2008 Awareness 1 y QU  ALITY MANAGEMENT SYSTEM - REQUIREMENTS
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ISO 9001_2008 Awareness - General

Apr 10, 2018

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Page 1: ISO 9001_2008 Awareness - General

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ISO 9001:2008 Awareness

1

y QU ALITY MANAGEMENT SYSTEM - REQUIREMENTS

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 What is Quality?

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 What is Quality?

y FITNESS FOR  USE

y CONFORMANCE TO SPECIFICATIONS

y  VALUE FOR MONEY 

y

CONSISTENCY y OPPORTUNITY, OCCASION

y SNOB VALUE ,ELEGENCE, AESTHETICS

FOR REPEAT BU  YING MOST

IMP IS PROBABLY ..CONSISTENCY 

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 Wh y Quality?

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 Wh y Quality?

Customer have a choice today «

AB

C

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 Wh y Quality?

y Rising Customer Expectations

y

Increasing Competitiony Increasing penalties for Failure

y Loss of Business to Competitor

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 Wh y Quality?

Organization Needs Quality because ««««

y Our Customers demand it

y Our Future depends on it

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 Wh y Quality?

Customers want ««..

y Product or Service that is reliable

y Product or Service to meet their requirements

y  Value for money 

y No hassle

CUSTOMER DEMANDS QUALITY

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 Wh y Quality?

³ The only survivors at the end of two decades will be

companies with constancy of purpose for

Quality, Productivity & Service´

y Edward Deming

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QUALITY

DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILSREQUIREMENTS

QUALITY CONTROL

OPERATIONAL TECHNIQUES AND ACTIVITIES THAT ARE USED TO FULFILREQUIREMENT OF QUALITY

QUALITY ASSURANCE

ALL THOSE PLANNED AND SYSTEMATIC ACTIONS NECESSARY TO

PROVIDE ADEQUATE CONFIDENCE THAT OF PRODUCT OR SERVICE WILL

SATISFY THE GIVEN REQUIREMENT FOR QUALITY

QUALITY MANAGEMENT SYSTEM

SYSTEM TO ESTABLISH QUALITY POLICY & OBJECTIVES AND TO ACHIEVE

THOSE OBJECTIVES

Definitions

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TOP MANAGEMENT

MARKETING PURCHASE

LABORATORY

PRODUCTION

PROCESS CONTROL

TECH. SERVICE

DESPATCH

TRAINING

AUXILIARY

Definitions

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International Organization for Standardization

(ISO) created a series of quality

management standards called ISO 9000, to

address this need.

ISO 9000 Standards SeriesISO 9000 Standards Series

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PROCESS

INPUTS

FINAL PRODUCT OR

SERVICE

CONSISTENT

CONSISTENT

CONSISTENT

How  it W orks ?

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How  it W orks ?

MECHANISMEquipmentPeople

PROCESS

Planning &

Organisation

ProceduresSpecification

Training

Objectives

OUTPUT

Product

INPUT

Materials

Information

CONTROL

Consistent Input and a Consistent Process gives aConsistent output.

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y Economy -  Acquiring the inputs for an operation atthe lowest possible cost

(consistent with specified requirements for inputs)

y Efficiency - Producing the required quantity of outputs with the minimum quantity of inputs and resources.

(consistent with specified requirements for outputs)

y Effectiveness - Producing goods and services that

customers want

The Three ³E´s

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Interested

Parties

 CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENTSYSTEM

Clause 5

Clause 6 Clause 8

Clause 7

Service/Product 

realization

 Value adding activities

Information flow

Input Requirements

Output 

InterestedParties

Satisfaction

Service

Product 

Resource

Management 

Measurement,analysis andimprovement 

Management responsibility

ISO 9001 QMS ModelISO 9001 QMS Model

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Principles of QMSPrinciples of QMS

17

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Say   w hat  you do:

Document each step in your company's business process.

Do  w hat  you say: 

Ensure that all processes adhere to written procedures.Show   w hat  you have done:

Document evidence that your QMS meets ISORequirements & that the quality standard is being

implemented effectively.

 Verify: 

Conduct periodic internal audits to ensure continuedsuitability, compliance, and effectiveness of the QMS.

Underlying Principles of ISO 9001Underlying Principles of ISO 9001

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ISO 9001 QU ALITY MGMT SYSTEM

y What it IS

a way of life

definesQuality System requirements aimed at preventing

nonconformity at all stages, from design through to

servicing.

systematic µprocess¶ control of all activities affecting the

quality of th

e product satisfies company and customer needs

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ISO 9001 QU ALITY MGMT SYSTEM

y What it IS NOT

a µcoffee table¶ quality system

a cure for poor product design or manufacturing methods

a barrier to creativity or continuous improvement

an attempt to bury processes in paper

a µflavour of the month¶ initiative

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EXTERNAL BENEFITS OF ISO 9001

(Reported by 620 U.S. and Canadian registered companies)

y Higher perceived product quality 33.5%

y Improved customer satisfaction 26.6%

y Competitive advantage 21.5%

y Reduced customer quality audits 8.5%

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INTERNAL BENEFITS OF ISO 9001

(Reported by 620 U.S. and Canadian registered companies)

y Better documentation 32.4%

y Greater quality awareness 25.6%

y Positive µcultural change¶ 15.0%

y Increased operational efficiency/ productivity 9.0%

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OVERALL SCHEME 

ISO CREATES STANDARDS

 ACCREDITATION  BODIES e.g. UKAS   ADOPT THE STANDARDS 

 CERTIFYING  BODIES ( )

CHECK COMPLIANCE 

TO THE STANDARDS 

BVQI , LRQA , DNV , TUV , BSI etc.

CONSULTANCY FIRMS ( IRCA )

EXTERNAL SUPPORT FOR COMPLIANCE,

RISK MANAGEMENT AND SUSTAINABILITY 

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Any Questions?