iso awareness self learn module 230209

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  • 8/8/2019 ISO Awareness Self Learn Module 230209

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    Issued by: K.K.Bijani Issue Date:23.02.2009

    ISO 9001

    AWARENESS MODULE

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    Contents

    What is Quality?

    Why ISO?

    What is ISO 9001 ?

    What is Quality Policy ?

    ISO 9001 Quality Management Standards

    8 Quality Management Principles

    The Process Approach

    Quality Management System- Requirements What does each Team Member MUST Know properly?

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    QUALITY

    DEGREE TO WHICH A SET OF INHERENT

    CHARACTERISTICS FULFILLS REQUIREMENTS

    QUALITY POLICY

    OVERALL INTENTIONS AND DIRECTION OF AN

    ORGANIZATION RELATED TO QUALITY, AS FORMALLYEXPRESSED BY TOP MANAGEMENT

    QUALITY OBJECTIVES

    SOMETHING SOUGHT OR AIMED FOR, RELATED TO QUALITY

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    TOP MANAGEMENT

    PERSON OR GROUP OF PEOPLE WHO DIRECT AND

    CONTROL AN ORGANIZATION, AT THE HIGHEST LEVEL

    QUALITY MANAGEMENT

    CO-ORDINATED ACTIVITIES TO DIRECT AND CONTROL

    AN ORGANIZATION WITH REGARD TO QUALITY

    CUSTOMER SATISFACTION

    CUSTOMERS PERCEPTION OF THE DEGREE TO WHICH

    THE CUSTOMERS REQUIREMENTS HAVE BEEN FULFILLED

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    WHY ISO?

    HOW DOES A CUSTOMER GET A CONFIDENCE THAT A

    COMPANY/SUPPLIER PROVIDING SERVICES WHICH

    CONSISTENTLY CONFORM TO ACCEPTABLE QUALITYLEVELS ?

    IF THE COMPANY/SUPPLIER HAS AN INTERNATIONALLYRECOGNISED QUALITY MANAGEMENT SYSTEM IN ITS

    PRODUCTION / SERVICING.

    THIS SYSTEM HAS BEEN CERTIFIED BY APPROVED

    CERTIFYING AGENCIES.

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    WHAT IS ISO?

    INTERNATIONAL ORGANISATION OF STANDARDS BASED AT

    GENEVA

    THIS ORGANISATION DRAWS UP STANDARDS IN VARIOUSASPECTS SO THAT IT CAN BE APPLIED UNIFORMLY AND

    THERE IS AN ACCEPTABILITY ACROSS VARIOUS

    COUNTRIES.

    QUALITY MANAGEMENT SYSTEM - ISO 9000 SERIES HAS

    BEEN DEVELOPED FOR ENSURING QUALITY CONSISTENCY

    IN DESIGN / PRODUCTION / SERVICING / INSTALLATION /INSPECTION / TESTING, SO THAT IT MEETS THE STATED

    QUALITY POLICY OF THE COMPANY.

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    What is ISO 9001?

    ISO9000 is the International Standard for Quality System.

    It tells the supplier and manufacturer what is required of a

    Quality- oriented system.

    It identifies the basic principles and specifies the

    procedures and criteria to ensure that all products /

    services meet the Customer Requirements.

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    KEY FEATURES OF ISO9001

    Standard Designed around : 8 Quality Management Principles.

    Process Model- Input, Process & Output.

    P-D-C-A Approach

    Flexibility in documentation- Only six mandatory

    documented procedures.

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    KEY FEATURES OF ISO9001(contd)

    Major Requirements

    Top Management commitment emphasis

    Continual Improvement

    Analysis of Data

    Customer Perception Monitoring

    Increased attention towards Human resources

    such as communication & work environment.

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    KEY FEATURES OF ISO9001(contd)

    Other Specific Requirements

    Statutory / Regulatory requirements.

    Periodic review of documents Employee Awareness & Training.

    Evaluation of Training Effectiveness.

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    8 Quality Management Principles

    Customer Focused Organization.

    Leadership

    Involvement of People.

    Process Approach.

    System Approach to Management.

    Continual Improvement

    Factual Approach to decision making.

    Mutually beneficial supplier relationship.

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    The Process Approach

    PROCESS

    (set of activities)

    INPUTS OUTPUTS

    (Including

    resources) (Result of a Process)

    Monitoring and Measurement

    Opportunities.

    (Before, During & After the Process)

    Effectiveness of a Process : Ability to achieve the planned results

    Efficiency of a Process : Results achieved in relation to

    resources used

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    Quality Management System- Requirements

    4. Quality Management System

    4.1 General requirements

    4.2 Documentation Requirements

    4.2.1 General

    4.2.2 * Quality Manual

    4.2.3 * Control of Documents

    4.2.4 * Control of records

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    Quality Management System- Requirements

    5. MANAGEMENT RESPONSIBILITY5.1 Management Commitment

    5.2 Customer Focus

    5.3 * Quality Policy

    5.4 Planning

    5.4.1 Quality Objectives

    5.4.2 Quality management systems planning

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    Quality Management System- Requirements

    5.5 Responsibility, authority and communication

    5.5.1 Responsibility and authority

    5.5.2 Management representative

    5.5.3 Internal Communication

    5.6 Management Review

    5.6.1 General

    5.6.2 Review Input

    5.6.3 Review Output

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    Quality Management System- Requirements

    6.0 Resource Management6.1 Provision of Resources

    6.2 Human Resources

    6.2.1 General

    6.2.2 Competence, awareness and training

    6.3 Infrastructure

    6.4 Work Environment

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    Quality Management System- Requirements

    7.0 Product Realization

    7.1 Planning of Product Realization

    7.2 Customer related processes

    7.2.1 Determination of requirements related to the

    product.

    7.2.2 Review of requirements related to the products

    7.2.3 Customer communication

    7.3 Design and development

    7.3.1 Design and development planning

    7.3.2 Design and development inputs

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    Quality Management System- Requirements

    7.3 Design and development

    7.3.1 Design and development planning

    7.3.2 Design and development inputs

    7.3.3 Design and developments outputs

    7.3.4 Design and developments review

    7.3.5 Design and developments verification

    7.3.6 Design and development validation7.3.7 Control of design and development changes

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    Quality Management System- Requirements

    7.4 Purchasing

    7.4.1 Purchasing Process

    7.4.2 Purchasing information7.4.3 Verification of purchased product

    7.5 Product and service provision

    7.5.1 Control of production and service provision7.5.2 Validation of processes for production and serviceprovision.

    7.5.3 Identification and traceability

    7.5.4 Customer property

    7.5.5 Preservation of Product

    7.6 Control of monitoring and measuring devices

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    Quality Management System- Requirements

    8.0 Measurement, Analysis and Improvement

    8.1 General

    8.2 Monitoring and measurements

    8.2.1 Customer Satisfaction

    8.2.2 * Internal Audits

    8.2.3 Monitoring and measurement of processes8.2.4 Monitoring and measurement of product

    8.3 Control of Non conforming products

    8.4 Analysis of data

    8.5 * Improvements

    8.5.1 Continual Improvements

    8.5.2 Corrective Action

    8.5.3 Preventive Action

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    What does each Team Member Must know properly?

    .. As a requirement of ISO 9001

    Quality Policy & Quality Objectives

    All Zonal/Regional/HO Heads must document the work Procedures & possess

    a Procedures Manual with latest updates.

    All personnel must understand their Job roles.

    All employees must undergo ISO 9001 awareness program.

    All HO/Location Heads & internal auditors must undergo Internal Auditors

    Training Course.

    All HO & Zonal/Regional Heads must maintain documentation of minutes of all

    meetings/audit reviews which should be retrievable in a reasonable time. All Process Owners must have clarity & understanding of their work procedures/

    flow chart.

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    THANK YOU