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    CM-21 Rev No:01, Date: 01.10.2001 1

    ATOZ QUALITY MANAGEMENT

    PVT.LTD

    ISO 9001:2008Awareness

    WELCOME TO ALLWELCOME TO ALL

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    CM-21 Rev No:01, Date: 01.10.2001 2

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    Todays AgendaTodays Agenda

    Introduction to Quality Management System

    Evolution of Quality Management System Standards

    Process Approach towards QMS.

    Requirements of ISO 9001:2000.

    Benefits of implementing ISO 9000

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    CM-21 Rev No:01, Date: 01.10.2001 3

    Evolution of Quality Management System Standards.Evolution of Quality Management System Standards.

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    BS 5750BS 5750 Base Standard

    ISO 9000ISO 9000 Developed in 1987 by ISO body

    ISO 9000ISO 9000 Revised in 1994

    ISO 9000ISO 9000Revised in 2000

    These standards are

    developed by ISO

    ISO means Equal

    These standards are

    generic.

    Applicable all types of

    organizations

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    CM-21 Rev No:01, Date: 01.10.2001 4

    4.0 Quality Management System

    4.1 General Requirements

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    Identify Process Determine SequenceDetermine Method

    to Control

    Ensure ResourcesAvailable

    Measure, Monitor& Analysis

    CA/PA & CI

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    CM-21 Rev No:01, Date: 01.10.2001 5

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    4.0 Quality Management System Contd.

    4.2 Documentation Requirements

    Documented statements of Quality Policy & Objectives

    Document process as required

    Document in any form.

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    CM-21 Rev No:01, Date: 01.10.2001 6

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    4.0 Quality Management System Contd.

    4.2.2 Quality Manual

    Define Quality Policy

    Define Process within the organization

    Define interfaces between the processes identified

    Define Scope & Justification for Exclusions of requirements

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    CM-21 Rev No:01, Date: 01.10.2001 7

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2008 Awareness

    4.0 Quality Management System Contd.

    4.2.3 Control of Documents

    Approve documents for adequacy prior to issue

    Review and update as necessary

    Maintain Record of Change

    Update all documents

    Prevent unintended use of obsolete documents

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    CM-21 Rev No:01, Date: 01.10.2001 8

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    4.0 Quality Management System Contd.

    4.2.3 Control of Records

    Identify

    Legible

    Storage & Preservation

    Retain records to meet Customer & Legal requirements

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    CM-21 Rev No:01, Date: 01.10.2001 9

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    5.0 Management Responsibility Contd.

    CustomerCustomerFocusFocus

    LeadershipLeadership8

    Management

    Principals

    InvolvementInvolvementof peopleof people

    ProcessProcessApproachApproach

    SystemSystemapproach toapproach to

    managementmanagement

    ContinualContinualImprovemenImprovemen

    tt

    Mutual beneficialMutual beneficialsuppliersupplier

    relationshipsrelationships

    FactualFactualapproach toapproach to

    decisiondecisionmakingmaking

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    CM-21 Rev No:01, Date: 01.10.2001 10

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    5.0 Management Responsibility

    Define Quality Policy

    Appropriate to the purpose of organization

    provide framework for establishing and reviewingobjectives

    POLICYPOLICY

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    CM-21 Rev No:01, Date: 01.10.2001 11

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    5.0 Management Responsibility Contd.

    Define Quality Objectives

    S - Specific

    M - Measurable

    A - Attainable

    R - Realistic

    T - Time Bound

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    CM-21 Rev No:01, Date: 01.10.2001 12

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    5.0 Management Responsibility Contd.

    Define Responsibility & Authority

    Assign Responsibility for Quality

    Provide Authority to Stop Production in case of NC.

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    CM-21 Rev No:01, Date: 01.10.2001 13

    ATOZ QUALITY MANAGEMENTISO

    9001:2000 Awareness

    5.0 Management Responsibility Contd.

    Management Review to address

    PerformancePerformance of ofQualityQuality SystemSystem

    Cost of QualityCost of Quality

    Achievement ofAchievement of

    Quality PolicyQuality Policyand Objectiveand ObjectiveAll Elements ofAll Elements of

    Quality SystemQuality System

    CustomerCustomerSatisfactionSatisfaction

    Field Failure & ItsField Failure & Itsimpact on Safetyimpact on Safety

    & Environment& Environment

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    CM-21 Rev No:01, Date: 01.10.2001 14

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    6.0 Resource Management

    Assign Competent Personnel for work affecting Quality

    Define Competency Level for each Job.

    Provide training and evaluate effectiveness

    Designers to be skilled in applicable tools

    Define JobDefine Job

    SpecificationsSpecifications

    DOE, QFD,DOE, QFD,

    DFMEA, etc.DFMEA, etc.

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    CM-21 Rev No:01, Date: 01.10.2001 15

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    6.0 Resource Management Contd.

    Cleanliness of Premises Ensure Premises maintained in the

    state of orderliness.

    Maintain 5SMaintain 5S

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    CM-21 Rev No:01, Date: 01.10.2001 16

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    7.0 Product Realization Contd.

    Plan & identify the processes required for product realization

    nderstand customerUnderstand customer

    requirementsrequirementsDesign & DevelopmentDesign & Development Purchase & StorePurchase & Store

    ProductionProductionInspectionInspection

    DispatchD

    ispatch

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    CM-21 Rev No:01, Date: 01.10.2001 17

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    7.0 Product Realization Contd.

    Maintain confidentiality to customer contracted product.

    Process to manage the changes in the Product & Process

    Determine quality objectives and requirement of the product

    Establish processes, documents and provide resources specific

    to the product.

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    CM-21 Rev No:01, Date: 01.10.2001 18

    ATOZ QUALITY MANAGEMENTISO

    9001:2000 Awareness

    7.0 Product Realization Contd.

    Customer Related Process:-

    Customer designated Special Characteristics Compliance in

    terms of designation, control and monitoring

    Critical productCritical product

    characteristicscharacteristics

    Implement SPC/Implement SPC/

    PokeYokePokeYoke

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    CM-21 Rev No:01, Date: 01.10.2001 19

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    7.0 Product Realization Contd.

    Purchasing:-

    Purchase material used in product to comply with all Govt.

    Safety / Environmental Regulation

    Customer approved sources Purchase from customer approved

    source, if part of contract.

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    CM-21 Rev No:01, Date: 01.10.2001 20

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    7.0 Product Realization Contd.

    Incoming Product Quality Acceptance of incoming material

    can be based on following

    Receiving inspection Receipt and evaluation of Statistical data

    Part evaluation by external lab

    Any other method agreed with the customer.

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    CM-21 Rev No:01, Date: 01.10.2001 21

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    7.0 Product Realization Contd.

    Monitor supplier performance:-

    Delivered partDelivered part

    quality performancequality performanceincluding lineincluding linerejectionrejection

    DeliveryDeliveryperformanceperformance

    CustomerCustomercomplaints duecomplaints due

    to Suppliersto Supplierspartpart

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    CM-21 Rev No:01, Date: 01.10.2001 22

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    7.0 Product Realization Contd.

    Identification & Traceability

    Mandatory to identify the products at various stages of

    Product realization.

    Customer owned tooling Identify visually

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    CM-21 Rev No:01, Date: 01.10.2001 23

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    7.0 Product Realization Contd.

    Storage & Inventory

    Periodically assess the condition of the stock

    Use Inventory Management system to optimize inventorylevels.

    Use FIFO, where applicable.

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    CM-21 Rev No:01, Date: 01.10.2001 24

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    7.0 Product Realization Contd.

    Control of Monitoring and Measuring Devices.

    Calibrate all Measuring devices..

    CalibrationCalibration

    RecordsRecords

    As receivedAs received

    conditioncondition

    Gage revisionGage revision

    statusstatusStatement ofStatement of

    conformanceconformance

    Out ofOut of

    CalibrationCalibration

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    CM-21 Rev No:01, Date: 01.10.2001 25

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    8.0 Measurement, Analysis and Improvement

    Identify & Implement Statistical Techniques

    Impart basic Knowledge on Statistical tools to all employees

    Knowledge of Variation, Control, Stability & Capability.

    7 QC

    Tools

    SPC

    Charts

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    CM-21 Rev No:01, Date: 01.10.2001 26

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    8.0 Measurement, Analysis and Improvement

    Customer Satisfaction Measurement

    Field ReturnsField ReturnsDeliveredDeliveredpart Qualitypart Quality

    PerformancePerformance

    Customers

    DeliveryDelivery

    PerformancePerformance

    CustomerCustomer

    complaints /complaints /

    feedbackfeedback

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    CM-21 Rev No:01, Date: 01.10.2001 27

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    8.0 Measurement, Analysis and Improvement

    Internal Audits

    Internal Auditor Should be Qualified

    System AuditSystem Audit

    Internal Audits

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    CM-21 Rev No:01, Date: 01.10.2001 28

    ATOZ QUALITY MANAGEMENTISO

    9001:2000 Awareness

    8.0 Measurement, Analysis and Improvement

    Control of Nonconformance Product

    Nonconformance

    SuspectSuspect

    productproduct -- NCNC

    ReworkRework

    InstructionInstruction

    for R/wfor R/w

    InformInform

    customer ifcustomer if

    NC isNC is

    shippedshipped

    CustomerCustomer

    deviationdeviation--maintain recordmaintain record

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    CM-21 Rev No:01, Date: 01.10.2001 29

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    8.0 Measurement, Analysis and Improvement

    Analysis of Data

    Identify Key Quality & Organizational performance data

    Monitor the performance

    Timely reporting of the performance

    Monitor trends in performance .

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    CM-21 Rev No:01, Date: 01.10.2001 30

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    8.0 Measurement, Analysis and Improvement

    Improvement

    Define Process for Continual Improvement

    Focus on reduction of variation in product / processparameters.

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    CM-21 Rev No:01, Date: 01.10.2001 31

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    8.0 Measurement, Analysis and Improvement

    Corrective Actions

    To avoid recurrence of the non-conformance.

    Preventive Actions

    To avoid potential failures / non-conformance.

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    CM-21 Rev No:01, Date: 01.10.2001 32

    ATOZ QUALITY MANAGEMENT

    ISO 9001:2000 Awareness

    THANK YOUFOR FURTHER DETAILS PLEASE CONTACT

    MR.JIVAN KATHE(Lead Auditor for QMS/HOD)

    (9930141710)

    [email protected]