2414046-iso9000

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    Tahir Mehmood Younes, Frontier Cable Industries, Hattar

    Understanding ISO9000Understanding ISO9000

    Presented by

    Tahir Mehmood Younes

    GM Quality Assurance (FCI)

    ISO90

    00

    ISO9000

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    Foundation & familiarization

    ISO 9000:2000

    STANDARDSINTRODUCTION AND

    KEY LEARNING OBJECTIVESpdfMachinet

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    Discuss what you think the definition

    of Quality is. Give as many examples

    as you canpdfMachinet

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    Right First Time,

    All the time.

    Zero Defect

    Meet implied/MarketNeeds

    Conformance

    to specification

    Build RightCharacteristics

    ISO -Language of Quality System

    QUALITY- Degree to which a set of inherent characteristics

    fulfill REQUIREMENTS (9000:3.1.1)

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    Ability of a set of inherent characteristics of aproduct, system or process to fulfill requirements

    of customers and other interested parties.(ISO 9000:2000)

    Quality

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    What Customers buy?Customers do not buy goods and services;

    they want solutions of problems, andfulfillment of their needs & wants.

    A high standard of service at a low price is what allcustomers would like. If our competitors are able toprovide the same standard of service as us, but..at a lower price, or a higher standard at the same price,

    then we have a problem!!!then we have a problem!!!

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    ISO -Language of Quality System

    Quality Management

    - Coordinated activities to direct and control anorganization with regard to quality (9000:3.2.8)

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    QUALITY ASSURANCE

    ISO -Language of Quality System

    - Part of Quality management focused onproviding confidence that quality requirementswill be fulfilled (9000:3.2.11)

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    QUALITY CONTROL

    ISO -Language of Quality System

    - Part of Quality management focused onfulfilling quality requirements (9000:3.1.2)

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    QUALITY MANAGEMENT SYSTEM

    ISO -Language of Quality System

    Management System to Direct and Control anOrganization with Regard to Quality

    Procedure

    processes

    QCQA

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    Quality AssuranceQuality Assurance

    Quality Evaluation

    Checking to see that

    what should be happeningis happening and

    is it effective?

    Quality Management System

    Policies and procedures

    detailing how we do

    the work.

    Quality Control

    Checks performed

    as we do the work.

    Auditing !Auditing !

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    Services

    Hardware

    Software

    Processed

    Materials

    ISO -Language of Quality System

    PRODUCT

    THE RESULT OF ACTIVITIESOR PROCESSES

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    Foundation & Familiarization

    ISO 9000:2000 Quality

    Management Systemsan Overview

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    How to get StartedHow to get Started??

    Determine whether

    our organization wants

    to register to ISO 9001:2000

    Get a commitmentfrom the top

    management

    No

    End

    Yes

    We may need to engage

    external expertise!!

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    7

    Product/servicesProduct/servicesrealizationrealization

    OutputInput Product/Product/ServiceService

    CONTINUAL IMPROVEMENT OF THE

    QUALITY MANAGEMENT SYSTEM

    CU

    STOM

    ER

    Sat

    isfaction

    CU

    STOM

    ER

    Req

    uIremen

    Ts

    5

    86

    Resource

    ManagementResource

    Management

    Measurement,

    analysis &

    improvement

    Measurement,

    analysis &

    improvement

    Management

    ResponsibilityManagement

    Responsibility

    Quality Management Process Model

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    The Deming processThe Deming process

    Improvement CycleImprovement Cycle

    Establish

    Implementation

    Mechanisms

    Establish expectations

    Define ProcessFormalize

    improvement

    Corrective

    Action

    Compare

    Evaluate

    ACT PLAN

    DOCHECK

    Procedures

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    Evolution of ISO9000

    Babylon

    weig

    htsandm

    easures

    Guilds

    (Craf

    ts)

    IndustrialR

    evolu

    tion

    W

    orldW

    arI

    (MilitarySta

    ndard

    s)

    M

    assP

    roduction

    World

    WarII

    BS5

    750

    ISO

    900

    0

    3000

    B.C.

    1850sMiddleAges.

    1914 1939 1979 1987-19942000pdfM

    achinetrialv

    ersion

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    What is ISO 9000

    ISO 9000 stands -- International Organization

    for Standardization

    World Wide Federation -- 125 + Countries

    Identical in most respect -- European Standard, EN-

    29000 and the American

    standard, QS 9000pdfMachine

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    Four Primary Standards

    1. ISO9000: Quality Management Systems-

    Fundamentals and Vocabulary

    2. ISO9001: Quality Management Systems-Requirements

    3. ISO9004: Quality Management System Guideline

    for performance improvement

    4. ISO10011: Guidelines for Auditing QualitySystems (soon to be revised to ISO19011)

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    Tahir Mehmood Younes, Frontier Cable Industries, Hattar

    The ISO 9000:2000 is

    applicable to:

    SuppliersSuppliers

    Developers of the standardsDevelopers of the standards

    Customers.Customers.

    Consultants, university, and Institute.Consultants, university, and Institute.

    Auditors, regulatory , certification body,Auditors, regulatory , certification body,

    accreditation Body.accreditation Body. End users.End users.

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    Roles of ISO 9000:2000

    Is intended to replace ISO 8402:94 andIs intended to replace ISO 8402:94 and

    ISO 9000ISO 9000--1:94, clause 4 and 5.1:94, clause 4 and 5.

    Specifies quality management terminologySpecifies quality management terminology

    and their definition.and their definition.

    Provides fundamentals for QualityProvides fundamentals for Quality

    Management SystemsManagement Systems

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    Roles of ISO9001:2000

    ISO 9001:2000ISO 9001:2000-- The combination of ISO 9001The combination of ISO 9001--9003:949003:94

    series and the new requirements.series and the new requirements.

    ISO 9001:2000ISO 9001:2000 Presents the requirements for QualityPresents the requirements for Quality

    Management System.Management System.

    Being developed based on a process model usingBeing developed based on a process model using

    Quality Management Principals to move theQuality Management Principals to move the

    organization towards business excellence.organization towards business excellence.

    Emphasis on customer satisfaction.Emphasis on customer satisfaction.

    Consist of 8 clauses which contain all 20 requirementsConsist of 8 clauses which contain all 20 requirements

    in the old version of ISO 9001in the old version of ISO 9001

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    Roles of ISO9004:2000

    It is not a guideline for implementing ISO9001.It is not a guideline for implementing ISO9001.

    It is not intended for certification, regulatory orIt is not intended for certification, regulatory or

    contractual use.contractual use. Covers all aspect of a Quality ManagementCovers all aspect of a Quality Management

    system beyond the requirements of ISO 9001.system beyond the requirements of ISO 9001.

    Increase competitive advantage in the market.Increase competitive advantage in the market.

    Better respond to customer needs andBetter respond to customer needs andexpectationsexpectations..

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    Roles of ISO 9004:2000Roles of ISO 9004:2000

    Designed to address the need of all interestedparties to improve overall organizations quality

    performance.

    Use of the same Quality ManagementPrinciples but emphasis on satisfying the needsof other interested parties through sustainedcustomer satisfaction.

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    The Close Relationship

    ISO 9001-ISO 9004

    ISO 9004:QMSGuidelines

    Focus: Achieving business successand continual improvement of the

    performance of the organization tosustain customer satisfaction.

    ISO 9001:QMS Requirements

    Focus: Achieving conformance toestablished requirements and managing

    processes to provide confidence inproducts or service

    Degree of

    applying the

    quality

    management

    principles to

    management

    practices and

    its system

    Identified system of interrelated processes affecting the

    organizations objectives

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    Standard RelationshipISO Product Line

    ISO 9000 concepts

    and Definitions

    ISO 9004 Guidelines

    for performance

    improvement

    ISO 190011

    Tools and

    techniques

    ISO 9001 Quality

    Management

    Requirements

    Consistent

    Pair

    Vocabulary:

    replaces ISO 8402

    Principals of Quality

    Management

    Guides for Auditing

    and measurements etc

    ReplacesISO9001/2/3

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    ESSENCE OF ISO-9000

    You say what you are going to do (Write whatever you do)

    You do whatever you write

    You prove that you have done it

    It is not one of the things on our list.

    It is the way we do all the things on our list

    Finding of UK Govt.. Survey

    89 percent of ISO 9000

    registered companies reported

    greater operational efficiency,

    48 percent increased

    profitability, 76 percent

    improvement in marketing, 26

    percent reported increased

    export sales

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    ESSENCE OF ISO-9000

    Action to eliminate the cause of theAction to eliminate the cause of the

    potential nonconformity or otherpotential nonconformity or other

    undesirable potential situationundesirable potential situation

    Corrective ActionCorrective Action

    Action to eliminate the cause of aAction to eliminate the cause of adetected nonconformity or otherdetected nonconformity or other

    undesirable situationundesirable situation

    Preventive ActionPreventive Action

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    ESSENCE OF ISO-9000

    The organization shall continually improve theeffectiveness of QMS through use of :

    Quality Policy

    Quality Objectives

    Audit Results

    Analysis of Data

    Corrective and Preventive action

    Management Review

    Continuous ImprovementContinuous Improvement

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    3.BENCHMARKINGBest in industry, best innation, best in the world

    3.BENCHMARKINGBest in industry, best innation, best in the world

    2.Total Quality ManagementContinuous improvement, andInvolvement of every person

    2.Total Quality ManagementContinuous improvement, andInvolvement of every person

    1. ESTABLISH ISO 9000 SYSTEMS

    Basic Quality System infra-structure

    1. ESTABLISH ISO 9000 SYSTEMS

    Basic Quality System infra-structure

    CapableLead

    er-ship

    Journey Beyond ISO 9000

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    Total Quality Management

    Optimizing Seven Main Areas1

    Capable Leadership

    4

    Human ResourceDevelopment

    3

    Systems

    2

    Customer Driven

    7ResourceUtilization

    6

    Product control andImprovement

    5

    Process Control &Improvement

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    Step 3

    Step 4

    Step 5

    Step 6

    Step 7

    Step 8

    Step 9

    Step 2

    Registratio

    nFinalAssessment

    PreAssessment

    InternalQualityAudit

    Implementation of

    Documented QMSand ProgressmonitoringDocumentati

    on process

    Review ofCurrentQMS

    ManagementDecision &

    Commitment

    Setup/ Appointment of- Quality Council- MR-Task Team- Coordinators

    Road Map To ISO-9000 Registration

    Step 1

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    Benefits of ImplementationBenefits of ImplementationBetter Co-ordination

    Consistency in Processes

    Builds Data Base for the Company

    Increases Efficiency & EffectivenessReduces Costs

    Minimizes Defects & Rework

    Creates a Quality Culture

    Increases Customer Confidence/ Loyalty

    FOUNDATION FOR TOTAL QUALITY

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    Typical FailingsTypical Failings

    Emphasis on Adherence & not on Adequacy

    Just get the Certificate !

    Loss of Direction & Credibility

    Weak Internal Audit Programme

    Short term Corrective/ Preventive Actions

    Over Documentation

    PRODUCT QUALITY DOES NOT IMPROVE

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    Some Myths of ISO 9000Some Myths of ISO 9000 Once you've got ISO, you can only buy from ISOOnce you've got ISO, you can only buy from ISO

    certified companiescertified companies

    ISO is only for big companiesISO is only for big companies

    It produces lots of paperIt produces lots of paper It's only for manufacturersIt's only for manufacturers

    It is only for exportersIt is only for exporters

    It is conspiracy by JewsIt is conspiracy by Jews

    ISO will force us to adopt a specific level ofISO will force us to adopt a specific level ofqualityquality

    ISO certification involves highISO certification involves high costscosts

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    How to start ISO9001 implementation

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    Sequence of Activities

    in Implementing QMS

    Appreciation for Senior ManagersAppreciation for Senior Managers

    Formation of implementation team & understanding ofFormation of implementation team & understanding of

    requirements by key personnel.requirements by key personnel.

    Establishing quality policy & objectivesEstablishing quality policy & objectives

    Setting up documentation systemSetting up documentation system

    Writing quality Manual & PlansWriting quality Manual & Plans

    Writing quality procedures & instructionsWriting quality procedures & instructions

    Understanding quality audit systemUnderstanding quality audit system

    Setting up internal quality audit.Setting up internal quality audit.

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    Sequence of Activities

    in Implementing QMS (continued..)

    Performing internal Audit & reviewing noncompliance ofPerforming internal Audit & reviewing noncompliance of

    actual practice against documented.actual practice against documented.

    Taking corrective actions on nonTaking corrective actions on non--compliancescompliances

    Performing followPerforming follow--up audit reviewing new/recurring nonup audit reviewing new/recurring noncompliancescompliances

    Taking final corrective actionsTaking final corrective actions

    Ready for application/assessmentReady for application/assessment

    Note: For proper implementation makeImplementation Plan & Progress Work Flowdefining responsibility and duration required for

    each activity

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    There is a need for a good standard

    UP

    The need for conformity to

    international standards is

    glaringly obvious

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