qms (final)

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    1

    PRESENTED TO: SIR ALI ZUQARNAIN

    PRESENTED BY:

    SHEHR BANO YAWAR ALI (10585)

    MUHAMMAD SAAD AWAN (10302)

    QAMROSH ZAHEER (10443)

    SYED MUHAMMAD FAHAD (8165)

    M N GEMENT

    SYSTEM

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    What Is Quality?

    Degree to which a set of inherent characteristics

    fulfils requirements

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    Identify, understand and agree customer requirements

    Plan to achieve them

    Measure, monitor & control processes/activities

    Requires A System

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    Meeting Our Customers Requirements

    Doing Things Right the First Time; Freedom from Failure(Defects)

    Consistency (Reduction in Variation)

    Continuous Improvement

    Quality in Everything We Do

    4

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    A belief in the employees ability

    to solve problems

    A belief that people doing the

    work are best able to improve it

    A belief that everyone isresponsible for quality

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    MANAGEMENT SYSTEM

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    Management Support

    Mission Statement

    Proper Planning

    Customer and Bottom Line Focus

    Measurement

    Empowerment

    Teamwork/Effective Meetings

    Continuous Process Improvement

    Dedicated Resources

    ELEMENTS FOR

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    Quality Techniques & QMS Standards

    Quality

    Control

    Quality

    Assurance

    Quality

    Management

    (Detection) (Prevention) (Direction)

    BS 5750

    1979-1987ISO

    9001/2/3

    1987-2000 ISO 9001

    2000

    9

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    Why Document in

    Quality ManagementCommunication Tool

    Manage Change

    Aids consistency

    Record of Best Practice

    Enables Effective Audit

    ISO 9001 Pre-requisite

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    Documented Q.M.S.

    POLICY

    QUALITY

    MANUAL

    PROCEDURES

    LOCAL/WORK INSTRUCTIONS

    RECORDS / FORMS

    INTENT

    WHAT?

    PROOF

    HOW?

    WHY?

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    ISO 9001 - Q.M.S. Requirements

    ISO 9004 - Q.M.S. Guidelines on Performance Improvement

    ISO 9000 - Q.M.S. Fundamentals & Vocabulary

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    The Structure of Quality Standards

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    1. Customer Focus

    2. Leadership

    3. Involvement of People

    4. Process Approach

    5. System Approach to Management

    6. Continual Improvement

    7. Factual Approach to Decision Making

    8. Mutually Beneficial Supplier Relationships

    ISO 9001:2000

    Based on the 8 Quality Management Principles:

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    Continual improvement ofthe quality management system

    Requirements

    Satisfaction

    Customers Customers

    Resourcemanagement

    Measurement,analysis andimprovement

    ProductRealisation

    ManagementResponsibility

    Input Output

    Product

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    ISO9001defines what the organization does toensure that its products or services satisfy thecustomer's quality requirements and complywith any regulations applicable to those

    products or services.

    ISO 14000is primarily concerned with

    "environmental management". In plainlanguage, this means what the organizationdoes to minimize harmful effects on theenvironment caused by its activities.

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    ISO 14001 is an internationally recognised standard for environmental

    management system which can be applied by any organisation.

    It has much in common with ISO 9001, in particular the PLAN - DO -CHECK- ACT concept.

    As a minimum, ISO 14001 requires a commitment to legal compliance,continual improvement and pollution prevention.

    It involves the identification and assessment of all environmental aspectsand impacts in order to determine which are significant.

    These must then be managed so as to minimise harm to the environment.

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    ISO14001 - Environmental management system model

    for the international standard

    Environmental Policy

    Planning

    Environmental aspects

    Legal and other requirements

    Objectives and targets

    Environmental managementprogrammes

    Implementation and Operation

    Structure and responsibility

    Training, awareness and competence

    CommunicationEMS documentation

    Document control

    Operational control

    Emergency preparedness and response

    Checking and Corrective Action

    Monitoring and measurement

    Non-conformance and corrective

    and preventative action

    Records

    EMS audits

    Continual

    improvement

    Management Review

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    ISO 14001Fundamental requirements

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    From

    Motivation through fear and loyalty

    To

    Motivation through shared vision

    Attitude: Its their problem Ownership of every problem affectingthe customer

    Attitude: the way weve always done it Continuous improvement

    Decisions based on assumptions/ judgmentcalls

    Decisions based on data and facts

    Everything begins and ends withmanagement

    Everything begins and ends withcustomers

    Crisis management and recovery Doing it right the first time

    Choosing participative OR scientificmanagement

    Choosing scientific AND participativemanagement

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    Control

    &

    Improvement

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    Process set-up?

    Risks?

    Objectives of the process?

    Which contributes to the goals of theorganization?

    Resources and

    conditions?

    Results of the process?

    Measurement and steering?

    ?

    1

    2 3

    4

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    The ISO 9000:2000 series consists of 3 Primarystandards

    ISO 9000: QMS concepts and vocabulary

    ISO 9001: QMS requirements

    ISO 9004: QMS guidelines

    This is supported by an additional standard

    ISO 10011: QMS auditing guidelines

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    ISO 9001 specifies the requirements for a

    quality management system that may be

    used for internal application by

    organizations, certification, or contractual

    purposes.

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    ISO 9004 gives guidance on a wider

    range of objectives of a quality

    management system to improve the

    organisations overall performance.

    It is not a guideline for implementing

    ISO 9001 and is not intended for

    certification or contractual use.

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    ISO 9001:2008 is divided into 8 sections:

    the first 3 are introductory

    The requirements begin at section 4 and have the

    following headings: Quality management system

    Management responsibility

    Resource management Product realisation

    Measurement, analysis and improvement

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    QUALITY MANAGEMENT

    PRINCIPLES

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    Quality Management System

    The organisational structure, responsibilities,procedures, processes and resources

    for implementing quality management.

    ISO 9001:2000 Process model

    Customersatisfaction

    Customer Customer? Delivery of

    Services

    Management

    Resources Measurement

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    1. SCOPE

    Includes the design and construction of clean room, ventilation

    and air conditioning system, metal finishing system,

    environmental control system for automotive and otherindustrial or commercial applications. Exclusion Design and

    development validation.

    2. Normative References :

    - ISO 9000:2005- ISO 9001: 2008 QMS

    - ISO 9001:2000 QMS

    - ISO 9002:1994

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    3. Terms and Definition

    Definitions Terms used by an organization;Processes, interaction,

    improvement The focus is on looking at: What we do. Who we aredoing it for. Improving how we provide service.

    4. General requirements

    Documentation requirements Control of document Documents must

    show a control number, adoption and revision dates, in order toensure use of the most recent information. Control of records Each

    record must be controlled in order to ensure uniform quality.

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    4. General requirements

    - General Documents

    - Quality Manual

    - Control of Documents

    - Control of Records

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    5. Management Responsibility

    - Commitment

    - Focus

    - Policy

    - Objectives

    - PlanningThese correspond to the following

    principles: Customer focus

    Leadership

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    6. Resource Management

    - Provide quality resources

    - Provide quality personnel

    - Provide quality infrastructure- Provide quality environment

    This corresponds to the following principle: Involvement of People

    7. Product Realization

    Control of the following process realization, planning, customer, communication,

    product development, purchasing, function, operation, monitoring

    These correspond to: Get the facts before you decide Focus on customers Use aprocess approach Work with your suppliers

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    8. Measurement, Analysis and Improvement

    - Perform remedial processes Monitor and measure quality Control

    - nonconforming products

    - Analyze quality information

    - Make quality improvements

    This corresponds to: Get the facts before you decide Encourage continual

    improvement

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    International, expert consensus on state-of-the-art

    practices for quality and environnemental management. Common language for dealing with customers and

    suppliers worldwide in B2B.

    Increase efficiency and effectiveness.

    Model for continual improvement. Model for satisfying customers and other stakeholders.

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    Documented procedures required by this standard andthose needed by the organisation to control its

    processes.

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    ISO 9001 IS SIMPLY

    A SYSTEM FORCREATINGPAPERWORK!!!

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    The extent of the QMS documentation depends on the

    following:

    a) size and type of the organisation

    b) complexity and interaction of the processes

    c) competence of personnel

    Note: The documented procedu res may be in any

    form o r type of medium.

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    QMS documents shall be controlled.

    A do cumented p rocedure shall be

    establ ished:

    to approve documents prior to use

    to review/update & re-approve as

    necessary

    to identify changes and current revision

    status

    to ensure relevant versions are available

    to ensure legibility and identification

    to control documents of external origin to control obsolete documents

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    QMS records shall be maintained to provide evidence of

    conformance to requirements and effective QMS

    operation.

    A documented p rocedure shal l be establ ished for: Identification,

    storage

    retrieval

    protection

    retention time and

    disposition of records.

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    Determine team, set budget Internal auditor(s) training if using in-house resources Hire consulting firm if applicable Gap Assessment Implement requirements of standard to meet your business

    needs against the gap assessment Go-Live Hold Management Review Meeting Conduct Internal Audit Refine documentation

    Employee involvement training System adjustment Registration auditStage 1 System adjustment Registration auditStage 2

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    Submit application to registrar

    Stage 1: Assessment of readiness

    Stage 2: Assessment for registration audit

    Registration/certification awarded for 3 years

    Surveillance audits (at least annually)

    Recertification audit at the end of 3rdyear

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