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    Introduction to

    ISO 9001:2008

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    Quality isFitness for purpose

    So, What is Quality?

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    Head Office situated in Geneva.

    Internationally Harmonized Standards

    are released by ISO. More than 200 countries have adopted

    ISO 9001 as their national standard.

    What is ISO?

    (1/2)

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    ISO 9000:2005 Quality Management

    Systems Fundamental and Vocabulary

    ISO 9001:2008 Quality Management

    Systems Requirements

    ISO 9004:2000 Quality Management

    Systems Guidelines for Performance

    ISO 9000 family

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    ISO 9001:2008 is an International

    Standard for Quality Management

    System Requirements

    Certifiable standard

    What is ISO 9001?

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    CustomerFocus

    Leadership

    Involvement

    of

    People

    System

    Approach to

    Management

    Process

    Approach

    ContinualImprovement

    Factual

    Approachto Decision

    Making

    MutualBeneficial

    Supplier

    Relationship

    Quality Management Principles

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    5.Management

    Responsibility

    7. Product

    Realization

    6. Resource

    Management

    C

    ustom

    er C

    ustom

    er

    Requirements ConsumptionProduct /

    Service

    Satisfaction

    Continual Improvement of

    the Quality Management System

    ISO 9001 : 2008 Process Model

    8. Measurement

    Analysis and

    Improvements

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    Four Pillars of a Quality Management System

    Management Support

    Procedures

    Internal Audit

    Corrective Action

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    ISO 9001 : 2008 Clauses and

    Sub Clauses

    5. MANAGEMENT RESPONSIBILITYo 5.6 MANAGEMENT REVIEW

    The Top management should conduct meetings at regular interval and review the

    performance in various angle

    Audit results, Customer Feedback, Process Performance and so on

    The result of meeting should recommend action in improvement, resource need etc.

    o 5.6.1 GENERALo 5.6.2 REVIEW INPUT

    Information on: results of audits, customer feedback, process performance and product

    conformity

    Status of preventive and corrective actions, follow up of actions from previous

    management reviews, changes that could affect the quality management system, and

    Recommendations for improvement.o 5.6.3 REVIEW OUTPUT

    Actions related to: improvement of the effectiveness of the quality management system

    and its processes, improvement of product related to customer requirements, and

    resource needs.

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    Activity that transforms input into output

    OutputActivityInput

    Control

    Resource

    What is a Process? (1/2)

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    Procedure

    Required

    ISO 9001 : 2008 Clauses and

    Sub Clauses

    o 8.2.2 INTERNAL AUDIT

    Organisation Should conduct internal audit

    At defined intervals Ensure unbiased audit

    Ensure effectiveness of the QMS

    Responsibility of Planning and Conducting

    Audit to be defined

    Corrective audit to the findings are to betaken without delay

    8. MEASUREMENT, ANALYSIS AND IMPROVEMENT(Contd)

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    Thank you

    13

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