Training Iso 9001 Final

Embed Size (px)

Citation preview

  • 8/2/2019 Training Iso 9001 Final

    1/66

    WELCOME TO

    AWARENESS TRAINING PROGRAMME

    ISO 9001: 2000

    Quality Management System

  • 8/2/2019 Training Iso 9001 Final

    2/66

    Development of ISO 9001 Standard

    AQAP (1969)

    BS 5750 (1979)

    MILQ-9858A (1963)

    ISO9001 (1987)

    ISO9001 (1994)

    ISO9001 (2000)

    ISO9001 (2008)

  • 8/2/2019 Training Iso 9001 Final

    3/66

    ISO

    INTERNATIONAL ORGANISATION

    FOR STANDARDIZATION (I S O)

    BASED IN GENEVA, SWITZERLAND

    STARTED OPERATIONS IN 1947.

    MORE THAN 140 NATIONAL BODIESINCLUDING INDIA ARE MEMBERS

    MORE THAN 130 COUNTRIES HAVEADOPTED THIS STANDARD.

  • 8/2/2019 Training Iso 9001 Final

    4/66

    WHY ISO ?

    ISO CERTIFICATION IS IDENTIFIED AS A :

    BEST IN CLASS INITIATIVE IN STRATEGIC

    BUSINESS PLAN

    -- MONITOR , ANALYZE AND IMPROVE PERFORMANCE AND

    CONFORMANCE

    -- PREVENT AND REDUCE PROBLEMS (NON CONFORMANCES)

    -- OPERATIONAL EFFICIENCY THORUGH PROCESSCONSISTENCY.

    COMITTMENT TO CONTINUAL IMPROVEMENT

    -- QUALITY ,COST , DELIVERY, CUSTOMER SERVICE ETC,

    TO DISTINGUISH FROM ITS COMPETITOR

    LEADING TO .NEW BUSINESS , BETTER EFFICIENCY(SAFE , RELIABLE ,

    ECONOMIC ,QUICKER) , IMPROVED RELATIONS WITH

    EMPLOYEES , CUSTOMERS , SUPPLIERS , STAKEHOLDERS & REGULATORS.

  • 8/2/2019 Training Iso 9001 Final

    5/66

  • 8/2/2019 Training Iso 9001 Final

    6/66

  • 8/2/2019 Training Iso 9001 Final

    7/66

  • 8/2/2019 Training Iso 9001 Final

    8/66Innovation: A way To Remain Ahead

    Road to ISO Certification

    Start

    ISO

    Cert

    ISO

    Cert

    3 yrs?

    Decision

    for ISO Cet.

    INTRO.

    ISO STD to

    MGMT

    SELECT

    MR

    INTERNAL

    AWARENESS

    MR

    TRG

    DOC.

    CONTROL

    MAKE

    SOPTRG.

    EMPLOYEES

    DOC.

    MANUAL

    Q.POLICY

    GAP

    ANALYSIS.

    INT.AUDITOR

    TRAINING

    PERFORM

    INTERNAL

    AUDIT

    MGMT

    REVIEWPRE-

    ASSESSMENT

    REGIST.

    AUDIT

    RE-

    REGIST.

    SURV.

    AUDIT 3 YrsCycle

    MGMT

    REVIEW

    PERFORM

    INTERNAL

    AUDIT

    Yes

    No

  • 8/2/2019 Training Iso 9001 Final

    9/66

    The ISO Model

    Continual Improvement of the QMS

    ResourceManagement

    Measurement,Analysis,

    Improvement

    ManagementResponsibility

    ProductRealization Product

    Inputs Outputs

  • 8/2/2019 Training Iso 9001 Final

    10/66

    PDCA Cycle

    2. DO

    Try plan ona test basis

    1. PLAN

    Identify im-provements anddevelop plan

    3. CHECK

    Evaluate planto see if it

    works

    4. ACT

    Permanentlyimplement

    improvements

  • 8/2/2019 Training Iso 9001 Final

    11/66

    Analysis of Data

    Customer

    RequirementsStatutory

    Requirements

    Defect Rate &

    Customer Returns

    QMS Control

    Purchasing

    Organizational

    Results

    Customer

    SatisfactionStatutory

    Compliance

    QMS Metrices

    Insp.& Testing

    Supplier

    Performance

    OrganizationalObjectives

  • 8/2/2019 Training Iso 9001 Final

    12/66

  • 8/2/2019 Training Iso 9001 Final

    13/66

  • 8/2/2019 Training Iso 9001 Final

    14/66

  • 8/2/2019 Training Iso 9001 Final

    15/66

  • 8/2/2019 Training Iso 9001 Final

    16/66

    QMS MODEL O ll

  • 8/2/2019 Training Iso 9001 Final

    17/66

    ONIDAmay cause envyMIRC ELECTRONICS LTD

    QMS MODEL Overall

    QMSCertfy.

    Body

    Senior

    MgmtHR

    QAAudits for

    Compliances

    Reviews &

    Evaluates

    Certifies

    Mfg

    Sales /

    Mktg

    Customer

    ServiceFinance

    Finance

    Accounts

    Taxation

    Personnel

    Admin

    HR

    After

    Sales

    ServiceSales Marketing

    Logistics

    Prod. PurchasePlanning Maintenance

    Stores

    R &D

    Design Developmen

  • 8/2/2019 Training Iso 9001 Final

    18/66

    Typical Product Life Cycle

    Marketing&FinalizingContract

    DesigningProcurement

    Process/Planning

    Identifying

    Inspection &Testing

    Servicing

    Handling,Storage,Packing &Delivery

    Corrective/PreventiveAction

    Nonconforming

    Material Control

    Mark Teststatus

    ManagementResp & QSystem

    Documents

    Control of

    Equipments

    InternalAuditing/

    Training

    Statistics

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

  • 8/2/2019 Training Iso 9001 Final

    19/66

    The vast majority of ISO standards are highly specific to a particular

    product, material, or process. However, the standards that have earned

    the ISO 9000 and ISO 14000 families a worldwide reputation areknown as Generic Management System Standards".

    "Generic"means that the same standards can be applied:

    -to any organization, large or small

    - including whether its "product" is actually a service,

    - in any sector of activity,

    whether it is a business enterprise,a public administration,

    or a government department

    Innovation: A way To Remain Ahead

    ISO 9000 / ISO 14000 FAMILY

  • 8/2/2019 Training Iso 9001 Final

    20/66

    Management system" refers to theorganization's structure for managing its

    processes - or activities - that transform

    inputs of resources into a product orservice which meet the organization's

    objectives,

    Innovation: A way To Remain Ahead

    ISO 9000 / ISO 14000 FAMILY

  • 8/2/2019 Training Iso 9001 Final

    21/66

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    ISO FAMILY OF STANDARDS

    ISO 9001 : 2000 -- Fundamentals & Vocabulary

    ISO 9001 -- Requirements

    ISO 9004 -- Guidelines for PerformanceImprovements

  • 8/2/2019 Training Iso 9001 Final

    22/66

    ISO 9004 2000 SCOPE

  • 8/2/2019 Training Iso 9001 Final

    23/66

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    ISO 9004 : 2000 SCOPE

    Provides guidelines and recommendationsBeyond the requirements of ISO 9001:2000& is Published together as ISO 9004: 2000

    Making them Consistent Pair .

    C ti l I t

  • 8/2/2019 Training Iso 9001 Final

    24/66

    Evaluate & Select

    Solution

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    Continual Improvement

    Analyze &

    EvaluateData

    Establish

    Objectives

    Search for solutionsTo achieve the

    Objective

    Implement theSelected Solution

    Monitor ,Analyze &Evaluate Results

    Formalize the

    ChangesProcess

    WHAT IS QUALITY ?

  • 8/2/2019 Training Iso 9001 Final

    25/66

    QUALITY ISCONFORMANCE TO REQUIREMENTS

    RIGHT FIRST TIME

    ON TIME

    EVERY TIME

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    WHAT IS QUALITY ?

    CUSTOMER SATISFACTION

    COST OF POOR PERFORMANCE REPEAT BUSINESS

    INCREASED PROFITABILITY

    WHY QUALITY ?

  • 8/2/2019 Training Iso 9001 Final

    26/66

    MISCONCEPTIONS OF QUALITY

    QUALITY MEANS LUXURY

    QUALITY PROBLEMS ARE CAUSED BYOPERATORS

    QUALITY LEADS TO HIGHER COST

    QUALITY PROBLEMS BELONG TO THE

    QUALITY / INSPECTION DEPARTMENT HIGHER QUALITY MEANS LESSER OUTPUT

    FEAR OF INCREASED PAPER WORK

    FEAR OF NEED FOR MORE MANPOWER

    VERY RIGID AND CUMBERSOME

    QUALITY & PRODUCTIVITY CANNOT GOBESIDE

    ITNA TO CHALTA HAI CONCEPTISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    TERMINOLOGY

  • 8/2/2019 Training Iso 9001 Final

    27/66

    TERMINOLOGY

    PRODUCT : RESULT OF A PROCESS.

    NOTE: FOUR GENERIC CATEGORIES:

    HARDWARE

    SOFTWARE

    SERVICES

    PROCESSED MATERIALS

    MAY ALSO BE A COMBINATION OF GENERICCATEGORIES.

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    TERMINOLOGY

  • 8/2/2019 Training Iso 9001 Final

    28/66

    PROCESS:

    A SET OF INTERRELATED OR INTERACTINGACTIVITIES WHICH TRANSFORMS INPUTSINTO OUTPUTS.

    QUALITY:

    QUALITY IS A DEGREE TO WHICH A SET OFINHERENT CHARACTERISTICS FULFILSREQUIREMENTS.

    QUALITY CONTROL:

    PART OF QUALITY MANAGEMENT FOCUSSEDON FULFILLING QUALITY REQUIREMENTS.

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    TERMINOLOGY

    TERMINOLOGY

  • 8/2/2019 Training Iso 9001 Final

    29/66

    QUALITY ASSURANCE:

    PART OF QUALITY MANAGEMENT FOCUSSEDON PROVIDING CONFIDENCE THAT QUALITYREQUIREMENTS WILL BE FULFILLED.

    QUALITY MANAGEMENT SYSTEM:

    A MANAGEMENT SYSTEM TO DIRECT ANDCONTROL AN ORGANISATION WITH REGARDTO QUALITY.

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    TERMINOLOGY

    DEFECT:

    NON FULFILLMENT OF REQUIREMENT RELATEDTO AN INTENDED OR SPECIFIED USE.

    TERMINOLOGY

  • 8/2/2019 Training Iso 9001 Final

    30/66

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    TERMINOLOGY

    QUALITY POLICY:Overall intentions and direction of an organization

    related to quality as formally expressed by topmanagement.

    QUALITY OBJECTIVE :Something sought, or aimed for, related to quality.

    CONTINUAL IMPROVEMENT :RECURRING ACTIVITY TO INCREASE THE ABILITY TOFULFILL REQUIREMENTS

    TERMINOLOGY

  • 8/2/2019 Training Iso 9001 Final

    31/66

    NON CONFORMITY:NON FULFILLMENT OF A REUIREMENT.

    CORRECTION :ACTION TO ELIMINATE NON CONFORMITY

    CORECTIVE ACTION :ACTION TO ELIMINATE THE CAUSE OF A DETECTED

    NON CONFORMITY OR OTHER UNDESIRABLESITUATION

    PREVENTIVE ACTION :

    ACTION TO ELIMINATE THE CAUSE OF A POTENTIAL

    NON CONFORMITY OR OTHER UNDESIRABLEPOTENTIAL SITUATION

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    TERMINOLOGY

    TERMINOLOGY

  • 8/2/2019 Training Iso 9001 Final

    32/66

    DOCUMENTINFORMATION AND ITS SUPPORTING MEDIUM.

    RECORD:DOCUMENT STATING RESULTS ACHIEVED

    OR PROVIDING EVIDENCE OF ACTIVITIES PERFORMED

    OBJECTIVE EVIDENCEDATA SUPPORTING THE EXISTENCE OR VERIFYINGSOMETHING

    VALIDATION:

    CONFORMATION THROUGH THE PROVISION OFOBJECTIVE EVIDENCE THAT THE REQUIREMENTS FOR

    A SPECIFIC INTENDED USE OF APPLICATION HAVE

    BEEN FULFILLED.

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    TERMINOLOGY

    DOCUMENTS

  • 8/2/2019 Training Iso 9001 Final

    33/66

    Innovation: A way To Remain Ahead

    DOCUMENTS

    What is a Document

    a Procedure, WI, quality Manual.

    Input to Quality System.

    Can be revised

    Controlled document

    Responsibility of controller to ensureupdation as and when there is a revision

    Need to have Issue stamp.

    DOCUMENT STRUCTURE ISO 9001 : 2000

  • 8/2/2019 Training Iso 9001 Final

    34/66

    Innovation: A way To Remain Ahead

    DOCUMENT STRUCTURE ISO 9001 : 2000

    LEVEL - I

    LEVEL - II

    LEVEL - III

    LEVEL - IV

    LEVEL - V

    ManualProcedures

    Work Instructions

    External Documents Documents

    Records

    DOCUMENT FLOW ISO 9001 : 2000

  • 8/2/2019 Training Iso 9001 Final

    35/66

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    Updation of Master Listof Documents Obsoletein Intranet

    Document Preparation

    Document Approval

    Document submissionby dept to MR.

    Updation of DocumentChange History Record& Master List ofDocuments

    Note : The above flow is applicable for

    1.Level 1: Manual

    2.Level 2 : Procedures )3.Level 3 : Work Instructions

    4.Level 4 : Formats

    Disposal of Old(Obsolete Doc.)

    MaintainIssuanceRecords

    Document Issuance byMR.

    DOCUMENT FLOW ISO 9001 : 2000

    RECORDS

  • 8/2/2019 Training Iso 9001 Final

    36/66

    Innovation: A way To Remain Ahead

    RECORDS

    What is a Record

    Unfilled Format is a document butFilled Format is a Record

    Shows compliance to QMS Documents

    Out put of quality system

    e.g Test report, training report, production report Can not be revised

    What is data

    Test parameters.

    E.g test result in the check sheets/soft copy in PC

    RECORDS

  • 8/2/2019 Training Iso 9001 Final

    37/66

    Innovation: A way To Remain Ahead

    Records should have

    -- Identification-- Storage

    -- Retrieval

    -- Retention (Time Interval)

    -- Disposal-- Indexing

    Records should be

    -- Legible

    -- Identifiable

    -- Traceable

    RECORDS

    PROCESS MODEL APPROACH

  • 8/2/2019 Training Iso 9001 Final

    38/66

    PROCESS MODEL APPROACH

    THE APPLICATION OF A SYSTEM OF PROCESSES WITH INAN ORGANISATION, TOGETHER WITH THE

    IDENTIFICATION AND INTERACTIONS OF THESEPROCESSES, AND THEIR MANAGEMENT.

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    Understand

    Markets &

    Customers

    Develop

    Vision &

    Strategy

    Design

    Products &

    Services

    Market

    &

    Sell

    Produce

    Products /

    Services

    Customer

    Service

    Typical Process Flow

    ISO1994 version & ISO 2000 version Comparisons

  • 8/2/2019 Training Iso 9001 Final

    39/66

    APC case study

    sno Parameter ISO9000: ISO 9001: Remarks

    94 version 2000

    1 Mandatory 20 6 6 mandatory Procedures

    Procedures

    2 Clauses 20 8 All 20 Clauses Merged with

    Eight clauses

    3 Focus What we have wrote, Follow

    & write what we are following

    More Focus on documentation Less focus on documentation

    4 Internal audit More Focus on system follow

    5 Management Only Internal audit review Internal Audit Review EMR/QMR,

    Review Processes rejections & actions,

    Customer feedback & actions, any change

    All departments involvement6 Approach Generalised Continual improvement & how systematicallyTQM/QC/ Inovation scheme /

    ( Other than Normal corrective actions) Six sigma,Control charts required

    Training focus & results

    7 corrective Just Activity verification Corrective & Preventive actions details

    & Preventive Records & results of actions should have

    Actions Positive Trends if any abnormality.

    In Trends then some constructive action plan

    ISO 2000 for continual improvement rather then only documentation

    Record of corrective & preventive

    actions (Quality Record)

    ISO1994 version & ISO 2000 version Comparisons

    More Focus On Results, Corrective actions

    action against normality.

    Not only for the sake of document

    but to highlight the week points

    Continual improvement through

    Innovations

    Follow what ever we have written & Results are

    more Important.

    More Focus on corrective & PreventiveActivities

    What is New in ISO 9001 : 2000 ?

  • 8/2/2019 Training Iso 9001 Final

    40/66

    What is New in ISO 9001 : 2000 ?

    CLAUSE STRUCTURE & TERMINOLOGY

    COMMON SYSTEM PRINCIPLES WITH EMS. 9001 & 9004 CLAUSE COMPATABILITY

    GENERIC REQUIREMENT FOR ALL

    INDUSTRIES . 9004 TAKES IT BEYOND ISO 9001

    PROCESS APPROACH

    VISIBLE TOP MANAGEMENT INVOLVEMENT

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    What is New in ISO 9001 : 2000 ?

  • 8/2/2019 Training Iso 9001 Final

    41/66

    What is New in ISO 9001 : 2000 ?

    PLANNING OF PRODUCT REALIZATION

    EFFECTIVENESS OF TRAINING . FEWER DOCUMENTED PROCEDURES.

    CUSTOMER SATISFACTION .

    MONITORING , MEASURIMENT OFPROCESSES & PRODUCTS

    CONTINUAL IMPROVEMENT

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    EIGHT MANAGEMENT PRINCIPLES

  • 8/2/2019 Training Iso 9001 Final

    42/66

    CUSTOMER FOCUSLEADERSHIPINVOLVEMENT OF PEOPLEPROCESS APPROACHSYSTEM APPROACH TO MANAGEMENTCONTINUAL IMPROVEMENTFACTUAL IMPROVEMENT TO DECISION MAKINGMUTULALLY BENEFICAL SUPPLIER RELATIONSHIP

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    EIGHT MANAGEMENT PRINCIPLES

    EIGHT MANAGEMENT PRINCIPLES

  • 8/2/2019 Training Iso 9001 Final

    43/66

    1.CUSTOMERFOCUS

    ORGANIZATIONS DEPEND ON THEIR CUSTOMERS& THEREFORE SHOULD UNDERSTAND CURRENTAND FUTURE CUSTOMERS NEEDS, SHOULD MEETCUSTOMER REQUIREMENTS AND STRIVE TOEXCEED CUSTOMER EXPECTATIONS.

    2.LEADERSHIP

    LEADERS ESTABLISH UNITY OF PURPOSE ANDDIRECTION OF THE ORGANIZATION. THEY

    SHOULD CREATE AND MAINTAIN THE INTERNALENVIRONMENT IN WHICH PEOPLE CAN BECOMEFULLY INVOLVED IN ACHIEVING THEORGANISATIONS OBJECTIVES.

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    EIGHT MANAGEMENT PRINCIPLES

    EIGHT MANAGEMENT PRINCIPLES

  • 8/2/2019 Training Iso 9001 Final

    44/66

    3. INVOLVEMENT OF PEOPLE

    PEOPLE AT ALL LEVELS ARE THE ESSENCE OF ANORGANIZATION AND THEIR FULLINVOLVEMENT ENABLES THEIR ABILITIES TO

    BE USED FOR THE ORGANISATIONS BENEFIT.4.PROCESS APPROACH

    A DESIRED RESULT IS ACHIEVED MORE

    EFFICIENTLY WHEN ACTIVITIES AND RELATEDRESOURCES ARE MANAGED AS A PROCESS.

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    EIGHT MANAGEMENT PRINCIPLES

    EIGHT MANAGEMENT PRINCIPLES

  • 8/2/2019 Training Iso 9001 Final

    45/66

    5. SYSTEM APPROACH TO MANAGEMENT

    IDENTIFYING, UNDERSTANDING AND MANAGINGINTERRELATED PROCESSES AS A SYSTEMCONTRIBUTES TO THE ORGANIZATIONSEFFECTIVENESS AND EFFICIENCY IN ACHIEVING ITS

    OBJECTIVES.

    6. CONTINUAL IMPROVEMENT

    CONTINUAL IMPROVEMENT OF THE

    ORGANISATIONS OVERALL PERFORMANCE SHOULDBE A PERMANENT OBJECTIVE OF THEORGANISATION.

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    EIGHT MANAGEMENT PRINCIPLES

    EIGHT MANAGEMENT PRINCIPLES

  • 8/2/2019 Training Iso 9001 Final

    46/66

    7. FACTUAL APPROACH TO DECISION MAKING

    EFFECTIVE DECISIONS ARE BASED ON THEANALYSIS OF DATA AND INFORMATION.

    8. MUTUALLY BENEFICIAL SUPPLIERRELATIONSHIPS

    AN ORGANISATION AND ITS SUPPLIERS ARE

    INTERDEPENDENT AND A MUTUALLYBENEFICIAL RELATIONSHIP ENHANCES THE

    ABILITY OF BOTH TO CREATE VALUE.

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    EIGHT MANAGEMENT PRINCIPLES

    QUALITY SYSTEM ELEMENTS- ISO 9001:2000

  • 8/2/2019 Training Iso 9001 Final

    47/66

    QUALITY SYSTEM ELEMENTS ISO 9001:2000

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    ISO 9001 : 2000

    4.0. Quality Management System

    5.0.Management Responsibility

    6.0.Resource Management

    7.0.Product Realization

    8.0.Measurement Analysis & Improvement

    1.0. Scope

    2.0. Normative Reference

    3.0. Terms and Definitions

    QUALITY SYSTEM ELEMENTS- ISO 9001:2000

  • 8/2/2019 Training Iso 9001 Final

    48/66

    Q

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    4.1.General Requirement

    4.0. Quality Management System

    4.2.Documentation.Requirement

    5.0.Management Responsibility

    5.1.Management Commitment

    5.2.Customer Focus

    5.3.Quality Policy

    5.4.Planning

    4.2.1.General Requirement

    4.2.2. Quality Manual4.2.3 Control of Documents

    4.2.4. Control of Records

    5.4.1.Quality Objectives

    5.4.2 Quality ManagementSystem Planning

    QUALITY SYSTEM ELEMENTS- ISO 9001:2000

  • 8/2/2019 Training Iso 9001 Final

    49/66

    Q

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    5.0.Management Responsibility

    5.5. Responsibility ,Authority &Communication

    5.6.Management Review

    5.5.1.Responsibility & Authority

    5.5.2. Management Representative

    5.5.3 Internal Communication

    5.6.1. General

    5.6.3 Review Output

    5.6.2 Review Input

    QUALITY SYSTEM ELEMENTS- ISO 9001:2000

  • 8/2/2019 Training Iso 9001 Final

    50/66

    Q

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    6.0.Resource Management

    6.1.Provision of Resources

    6.2.Human Resources

    6.3.Infrastructure

    6.4.Work Environment

    6.2.1. General

    6.2.2. Competency , Awareness& Training

    QUALITY SYSTEM ELEMENTS- ISO 9001:2000

  • 8/2/2019 Training Iso 9001 Final

    51/66

    Q

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    7.0.Product Realization

    7.1.Planning of ProductRealization

    7.2.Customer RelatedProcess

    7.3.Design & Development

    7.4.Purchasing

    7.6.Control of Monitoring &

    Measuring Devices

    7.5 Production & ServiceProvision

    7.2.1.Customer Related Processes

    7.2.2. Determination of

    Requirements related to Product

    7.2.3 Review of Requirements

    7.3.1.Design and Development

    7.3.2. Design and Development

    Inputs

    7.3.3 Design & Dev.Ouputs

    7.3.4 Design & Dev.Review

    7.3.5 Design & Dev. Verification

    7.3.6 Design & Dev.Validation

    QUALITY SYSTEM ELEMENTS- ISO 9001:2000

  • 8/2/2019 Training Iso 9001 Final

    52/66

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    7.0.Product Realization

    7.4.Purchasing

    7.6.Control of Monitoring &

    Measuring Devices

    7.5 Production & Service

    Provision

    7.4.1.Purchasing Processes

    7.4.2. Purchasing Information

    7.4.3 Verification of PurchasedProduct

    7.5.1. Control of Production &Service Provision

    7.5.2. Validation of Processes forProduct & Service Provision

    7.5.3 Identification & Traceability

    7.5.4 Customer Property

    7.5.5 Preservation of Product

    QUALITY SYSTEM ELEMENTS- ISO 9001:2000

  • 8/2/2019 Training Iso 9001 Final

    53/66

    Q

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    8.0.Measurement Analysis&Improvement

    8.1. General

    8.2. Monitoring &Measurement

    8.3. Control of NonConforming Product

    8.4. Analysis of Data

    8.5. Improvement

    8.5.1 Continual Improvement

    8.5.2 Corrective Action

    8.5.3 Preventive Action

    8.2.1.Customer Satisfaction

    8.2.2.Internal Audit

    8.2.3 Monitoring and Measurementof Process

    8.2.4 Monitoring and Measurementof Product

    QUALITY POLICY-MIRC ELECTRONICS

  • 8/2/2019 Training Iso 9001 Final

    54/66

    QUALITY POLICY-MIRC ELECTRONICS

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    Quality Policy

    We are committed to qualityAnd

    Strive for continuous improvementthrough

    innovation and human development

    to give the customerbetter value for money

    always

    Re- affirmed ( G. L. MIRCHANDANI )19. 07. 2001 CHAIRMAN & MANAGING

    DIRECTOR

    QUALITY OBJECTIVES-MIRC ELECTRONICS

  • 8/2/2019 Training Iso 9001 Final

    55/66

    QUALITY OBJECTIVES MIRC ELECTRONICS

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    1.The product shall be designed and developed to meet thecustomers quality requirements including safety and reliability.

    2.Material supply & delivery shall be in line with stated specificationwith continuous efforts to improve cost of procurement andreducing inventory level.

    3.There shall be strict adherence to specifications duringmanufacturing and inspection with emphasis on statistical defectanalysis and pre vention in order to continuously improveoperational efficiency in the areas of cost of manufacturing , qualityand capacity utilization .

    4.The sales and distribution network and logistics shall be organizedsuch that there is easy and timely availability of the products to thecustomer while reducing working capital deployment in FG inventoryand debtor.

    QUALITY OBJECTIVES-MIRC ELECTRONICS

  • 8/2/2019 Training Iso 9001 Final

    56/66

    QUALITY OBJECTIVES MIRC ELECTRONICS

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    5.There shall be constant endeavor to increasecustomer satisfaction by reducing field failure

    rate continuously and by providing timely andefficient after sales service.

    6.Feed back continuously obtained from customers ,

    both internal and external, shall be used forimprovement of product, services and internalprocesses.

    7.Employees shall be deployed with right competence whichshall be continuously upgraded with training to improve

    overall performance.

    PROCEDURES REQUIRED BY ISO 9001:2000

  • 8/2/2019 Training Iso 9001 Final

    57/66

    Q

    PROCEDURE FOR CONTROL OF DOCUMENTS (CL. 4.2.3)

    PROCEDURE FOR CONTROL OF RECORDS (CL. 4.2.4)PROCEDURE FOR INTERNAL AUDITS (CL. 8.2.2)

    PROCEDURE FOR CONTROL OF NONCONFORMING

    PRODUCT (CL. 8.3)

    PROCEDURE FOR CORRECTIVE ACTION (CL. 8.5.2)

    PROCEDURE FOR PREVENTIVE ACTION (CL. 8.5.3)

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    SUPPORTING DOCUMENTS REQUIRED

  • 8/2/2019 Training Iso 9001 Final

    58/66

    SUPPORTING DOCUMENTS REQUIREDBY ISO 9001:2000

    a) PROCEDURES (THOUGH NOT SPECIFICALLYCALLED FOR)

    b) WORK INSTRUCTIONS, STANDARDOPERATING PROCEDURES (SOPS)

    c) FORMS, CHECKLISTS, GUIDELINES

    d) WORKSHOP MANUALS

    e) SERVICE LEVEL AGREEMENTS

    f) DRAWINGSg) FLOW CHARTS, PROCESS MAPS

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    CODIFICATION DOCUMENTS ISO 9001 2000

  • 8/2/2019 Training Iso 9001 Final

    59/66

    CODIFICATION DOCUMENTS ISO 9001:2000

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    C. Codification

    Level - I 6 digitalphanumeric code

    QMS-MIRC

    Level - II 6 digit

    alphanumeric code

    GP / XX / XX

    Gen. Proce./ Dept. Code /Sr.no

    Level - III 7 digitalphanumeric code

    WI / XX / XXXWork Instruction / Dept. code /Sr No.

    Level - IV 10 digit

    alphanumeric codeXX / XXX / A / YY / MM

    Dept.code/Sr.no/ Rev status/Year & month of issue

    DEPARTMENT CODING

  • 8/2/2019 Training Iso 9001 Final

    60/66

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    DEPT. CODE DEPT. CODE

    R&D

    PURCHASE

    EXPORTS

    P & A

    MKTG. & SALES

    SERVICE

    FINANCE

    CALIBRATION

    AUTO INSERTION

    PRODUCTION

    HRD

    RD

    PR

    EX

    PA

    MK

    SC

    FN

    CL

    AI

    PRD

    HR

    CKD

    SKD

    ENGINEERING

    QC/QA

    STORES

    PLANNING

    MAINTENANCE

    ACCOUNTS

    MANAGEMENTREPRESENTATIVE

    ENGINEERING

    CD

    SD

    EN

    QA

    ST

    PN

    MN

    AC

    MR

    ENGG

    Why Quality Management System?

  • 8/2/2019 Training Iso 9001 Final

    61/66

    y Q y g y

    Reduction of Rejection

    Facilitate continuous Improvement

    Identification of existing and potential problems inproduct, process and system

    Root Cause Analysis

    Product Liability & Market Acceptance

    Better Work Place and Innovative cultureatmosphere

    Cross Functional cooperation

    Productivity High,Lead time reduction

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    Why Quality Management System?

  • 8/2/2019 Training Iso 9001 Final

    62/66

    What do I do?

    How do I do?

    Am I able to do it?

    How well it hasbeen done?

    Can I affect it?

    Do I want to do it?

    Can I Prove job hasbeen doneproperly?

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    y Q y g y

    Specs, Drg, Pur requisitions,

    Contracts

    Procedures, Instructions,

    experience, qualification,

    Training

    Resources, Material, Eqpt, info,

    Experience, attributes

    Measurement and comparison

    Feedback, Involvement, C/S

    MotivationRecords, certification, Audits

    Need to Look for.

  • 8/2/2019 Training Iso 9001 Final

    63/66

    Need to Look for. Quality Policy & Objectives Documented, understood,

    implemented and maintained.

    Responsibility, Authority and interrelation of personnel. Work Instruction, Test Engineering Procedures, Flow charts

    Training .

    Have been trained on the job you are performing

    If we are well competent for present Job if no Skill Up

    Example : During Joining Class room trainings, On the Job Trainings Or any

    additional training received

    Identification & Traciability .

    Parts stored in the area is identified with appropriate part no.

    Component storage is as per Min./Max system

    Rejected material is stored in Red bin and designated area

    Rejected material is Identified with appropriate markings

    Failed Product or PCB is stored with Test Failure slip

    Material handling through tracibility

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    Need to Look for.

  • 8/2/2019 Training Iso 9001 Final

    64/66

    7S & Mind Innovation- Shop floor neat &clean-no unwanted material near our places

    -Clear Gangways-Clear identification-Visual factory-positive attitude

    -First accept problem ,Analyze &then come back

    -we are part of problem or part of solution .

    Measurements in data-Data integrity

    -Data collection mechanism

    Corrective & Preventive actions- Foolproof actions &systems in place

    Team spirit & system follow

    ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT

    QUALITY MANUAL

  • 8/2/2019 Training Iso 9001 Final

    65/66

    Q

    PURPOSE

    TO PROVIDE AN ADEQUATE DESCRIPTION OF THEQUALITY MANAGEMENT SYSTEM

    SERVE AS A PERMANENT REFERENCE IN THEIMPLEMENTATION & MAINTENANCE OF THE

    SYSTEM. THE REQUIREMENTS AND CONTENTS OF THE

    QUALITY SYSTEM TO BE STRUCTURED TO ITSRELEVANT STANDARD AND DEFINED IN THEQUALITY MANUAL.

    USES OF QUALITY MANNUAL

  • 8/2/2019 Training Iso 9001 Final

    66/66

    Q

    EFFECTIVE IMPLEMENTATION OF THE QUALITY

    SYSTEM

    COMMUNICATION OF THE COMPANYS QUALITYPOLICY, STANDARDS OR REQUIREMENTS

    PROVIDING IMPROVED CONTROL OF PRACTICES

    AND FACILITATING MANAGEMENT OF ACTIVITIES

    PROVIDING A BASIS FOR AUDITING

    PROVIDING FOR CONTINUITY OF QUALITY SYSTEM,ITS REQUIREMENTS AND METHODS DURING

    CHANGING CIRCUMSTANCES