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ISO-9001: 2000 Awareness Training

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Title: ISO-9001: 2000 Awareness Training


1
ISO-9001 2000 Awareness Training
  • Presentation By Shashikant Gupta

2
ISO 90012000
3
CONTENTS
  • Course Objectives
  • What is ISO?
  • What is Quality?
  • Terms and definitions
  • Stake holders and their expectations
  • Quality Management principles
  • The software process
  • ISO 90002000 Family of Standards
  • ISO-90012000 Clauses
  • Guidelines for Self Assessment

4
COURSE OBJECTIVES
  • To provide an overview of ISO 9001 2000
    standards
  • To understand the elements that support the
    implementation of an ISO 90012000 Quality
    Management System

5
What is ISO?
  • The International Organization for
    Standardization (ISO) is a worldwide federation
    of national standards bodies from some 130
    countries, one from each country.
  • ISO is a non-governmental organization
    established in 1947. The mission of ISO is to
    promote the development of standardization and
    related activities in the world with a view to
    facilitating the international exchange of goods
    and services, and to developing cooperation in
    the spheres of intellectual, scientific,
    technological and economic activity

6
More about ISO
  • Worldwide Federation of National Standards Bodies
    (ISO Member Countries)
  • Preparation of International Standards carried
    out through
  • - ISO Technical Committees (TCs)
  • - Subcommittees (SCs)
  • - Working Groups (WGs).

7
More about ISO
  • ISO Collaborates closely with the International
    Electro-technical Commission (IEC) on all matters
    of Electro-technical Standardisation.
  • Committee Draft (CD) prepared by Technical
    Committees.
  • Draft International Standards (DIS) adopted by
    the Technical Committees are circulated to the
    Member Bodies for voting.
  • Publication as an International Standard requires
    approval by at least 75 of the Member Bodies
    casting a vote.
  • ISO 9000 Standards prepared by Technical
    Committee ISO / TC 176, Quality Management and
    Quality Assurance.
  • ISO 9001 prepared by Subcommittee SC2, Quality
    Systems.

8
Objectives of ISO 9000
  • A successful organisation should offer products
    that
  • - Meet a well defined need, use or purpose.
  • - Comply with applicable standards and
    specifications.
  • - Comply with requirements of society.
  • - Address environmental considerations.
  • - Are available at competitive prices.
  • - Satisfy customers expectations.
  • - Are provided at a cost which will yield a
    profit.

9
WHAT IS QUALITY?
  • The formal definition of quality as stated in ISO
    9000 2000 is -
  • Ability of a set of inherent characteristics of
    a product, system or process to fulfill
    requirements of customers and other interested
    parties.
  • Note The term quality may be used with
    adjectives such as poor, good or excellent.

10
TERMS AND DEFINITIONS
  • ORGANIZATIONGroup of people and facilities with
    an arrangement of responsibilities, authorities
    and relationships.

11
TERMS AND DEFINITIONS
  • REQUIREMENT
  • Need or expectation that is stated, generally
    implied or obligatory.
  • Notes
  • 1.Generally implied means it is custom or common
    practice for the organization, its customers, and
    other interested parties, that the need or
    expectation under consideration is implied.
  • 2.A qualifier can be used to denote a specific
    type of requirement, e.g. product requirement,
    quality system requirement, customer requirement.
  • 3.A specified requirement is one which is stated,
    for example, in a document.
  • 4.Requirements can be generated by different
    interested parties.

12
TERMS AND DEFINITIONS
  • PROCESSSet of interrelated or interacting
    activities which transforms inputs into outputs.
  • PRODUCTResult of activities or process.
  • Notes
  • A product may include service, hardware,
    processed materials, software or a combination
    thereof.
  • A product can be tangible (e.g. assemblies or
    processed materials) or intangible (e.g.,
    knowledge or concepts) or a combination thereof.

13
TERMS AND DEFINITIONS
  • TRACEABILITYAbility to trace the history,
    application or location of that which is under
    consideration.
  • Note When considering PRODUCT, traceability can
    relate to - origin of the material and parts-
    processing history- distribution and location of
    the product after delivery.

14
TERMS AND DEFINITIONS
  • PROCEDURESpecified way to carry out an activity
    or process.
  • Note A procedure when documented, becomes a
    documented procedure.
  • PROJECTUnique process, consisting of a set of
    coordinated and controlled activities with start
    and finish dates, undertaken to achieve an
    objective conforming to specific requirements,
    including the constraints of time, cost and
    resources.

15
TERMS AND DEFINITIONS
  • AUDITSystematic, independent and documented
    process for obtaining audit evidence and
    evaluating it objectively to determine the extent
    to which audit criteria are fulfilled.
  • REVIEWActivity undertaken to determine the
    suitability, adequacy and effectiveness of the
    subject matter to achieve established objective.

16
TERMS AND DEFINITIONS
  • CONFORMITY
  • Fulfillment of a requirement
  • NON-CONFORMITYNon-fulfillment of a requirement
  • DEFECTNon-fulfillment of a requirement related
    to an intended or specified use
  • CORRECTIONAction to eliminate a detected
    non-conformity.

17
TERMS AND DEFINITIONS
  • CORRECTIVE ACTIONAction to eliminate the cause
    of a detected non-conformity or other undesirable
    situation.
  • PREVENTIVE ACTIONAction to eliminate the cause
    of a potential non-conformity or other
    undesirable potential situation.(Preventive
    action is taken to prevent occurrence whereas
    corrective action is taken to prevent
    recurrence.)

18
TERMS AND DEFINITIONS
  • CUSTOMER SATISFACTION
  • Customers opinion of the degree to which a
    transaction has met the customers needs and
    expectations.
  • QUALITY MANAGEMENT SYSTEM
  • System to establish a quality policy and quality
    objectives and to achieve those objectives.

19
TERMS AND DEFINITIONS
  • QUALITY POLICY
  • Overall intentions and direction of an
    organization related to quality as formally
    expressed by Top Management.
  • Note 1 The quality policy should be consistent
    with the overall policy of the organization and
    should provide a framework for the settings of
    quality objectives.
  • Note 2 Quality Management principles of this
    International Standard may form a basis for the
    establishment of a quality policy.

20
TERMS AND DEFINITIONS
  • QUALITY OBJECTIVE
  • Something sought or aimed for, related to
    quality.
  • Note 1 Quality objectives should be based on
    organizations quality policy.
  • Note 2 Quality objectives are specified at
    different levels in the organization.
    At an operational level, quality
    objectives should be quantitative.
  • Note 3 Different terms are sometimes used for
    quality objectives, such as quality
    targets, quality aims or quality goals.

21
TERMS AND DEFINITIONS
  • TOP MANAGEMENT
  • Person or group of people who direct and control
    an organization at the highest level.

22
TERMS AND DEFINITIONS
  • QUALITY PLANNING
  • Part of quality management focused on setting
    quality objectives and specifying necessary
    operational processes and related resources to
    fulfill the quality objectives.
  • QUALITY IMPROVEMENT
  • Part of quality management, focused on
    increasing effectiveness and efficiency .

23
TERMS AND DEFINITIONS
  • QUALITY CONTROLOperational techniques and
    activities that are used to fulfil requirements
    for quality.
  • QUALITY ASSURANCEPlanned and systematic
    activities implemented within the quality system
    and demonstrated as needed to provide adequate
    confidence that an entity will fulfil given
    requirements for quality.

24
TERMS AND DEFINITIONS
  • EFFECTIVENESS
  • Measure of the extent to which planned
    activities are realized and planned results
    achieved.
  • EFFICIENCY
  • Relationship between the result achieved and the
    resources used.

25
TERMS AND DEFINITIONS
  • SUPPLIER Organisation that provides a product to
    the customer.
  • CUSTOMERRecipient of a product provided by the
    supplier.
  • Notes
  • Example Consumer, client, end-user, retailer,
    beneficiary or purchaser.
  • The customer can be either external or internal
    to the organisation.

26
TERMS AND DEFINITIONS
  • SUPPLIER CHAIN AS PER ISO 90012000
  • SUPPLIER
  • ORGANIZATION

  • CUSTOMER

27
STAKE HOLDERS AND THEIR EXPECTATIONS
28
QUALITY MANAGEMENT PRINCIPLES
  • Customer Focus
  • Leadership
  • Involvement of people
  • Process Approach
  • System Approach to Management
  • Continual improvement
  • Factual approach to decision making
  • Mutually beneficial supplier relationships

29
QUALITY MANAGEMENT PRINCIPLES
  • Customer Focus
  • -Understand current and future customer needs
  • -Meet customer requirements and strive to
    exceed customer expectations

30
QUALITY MANAGEMENT PRINCIPLES
  • Leadership
  • -Establish unity of purpose, direction, and the
    internal environment of the organization.
  • -Create the environment in which people can
    become fully involved in achieving the
    organizations objectives.

31
QUALITY MANAGEMENT PRINCIPLES
  • Involvement of people
  • -People at all levels are the essence of an
    organization and their full involvement enables
    their abilities to be used for the
    organizations benefit.

32
QUALITY MANAGEMENT PRINCIPLES
  • Process approach
  • -A desired result is achieved more
    efficiently when related resources and
    activities are managed as a process.
  • System approach to management
  • -Identifying, understanding and managing a
    system of interrelated processes for a given
    objective contributes to the effectiveness
    and efficiency of the organization.

33
QUALITY MANAGEMENT PRINCIPLES
  • Continual improvement
  • -A permanent objective of the organization is
    continual improvement.
  • Factual approach to decision making
  • -Effective decisions are based on the
    logical or intuitive analysis of data and
    information.

34
QUALITY MANAGEMENT PRINCIPLES
  • Mutually beneficial supplier relationships
  • -The ability of the organization and its
    suppliers to create value enhanced by mutually
    beneficial relationships.

35
THE SOFTWARE PROCESS
  • REQUESTS

SOFTWARE PROCESS
SOFTWARE PRODUCTS OR SERVICES
RESOURCES
PEOPLE HARDWARE SOFTWARE TIME EFFORT MONEY
QUALITY VALUES
FEEDBACK
CONTROL
36
TO ACHIEVE PROCESS CONTROL
  • Measurement is effected.
  • Comparison against a pre-set goal is made.
  • Any deviations are corrected by a feedback
    mechanism.

37
C U S T O M E R
C U S T O M E R
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT
SYSTEM
SAT I S FACT ION
MANAGEMENT RESPONSIBILITY
R E Q U I R E M E N T S
MEASUREMENT, ANALYSIS, IMPROVEMENT
RESOURCE MANAGEMENT
PRODUCT REALISATION
OUTPUT
INPUT
PRODUCT
MODEL OF THE PROCESS APPROACH
38
ISO 90002000 FAMILY OF STANDARDS
39
MODEL FOR QUALITY
  • ISO 9001 2000
  • QUALITY MANAGEMENT SYSTEMS
  • REQUIREMENTS

40
STANDARDS / GUIDELINES FORCERTIFICATION
  • ISO 9000 2000 - QMS Fundamentals Vocabulary
  • ISO 9001 2000 - QMS Requirements
  • ISO 9004 2000 - QMS Guidelines for
    PerformanceImprovement
  • ISO 9000 - 3 1997 - Guidelines for application
    of ISO to the development, supply, installation
    and maintenance of Computer Software
  • ISO 10005 1995 QM Guidelines for Quality
    Plans
  • ISO 10006 1997 QM Guidelines for Quality in
    Project Management

41
STANDARDS / GUIDELINES FORCERTIFICATION
  • ISO 10007 1995 QM Guidelines for
    Configuration Management
  • ISO 10013 1995 Guidelines for developing
    Quality Manuals / Documentation
  • ISO / IEC 12207 1995 Information Technology
    Software life cycle process
  • ISO / IEC 9126-1 2001 Software Engineering
    Product Quality
    (non-functional attributes)
  • ISO 19011 2000 Guidelines for Quality Systems
    Auditing

42
ISO 9001 2000QUALITY MANAGEMENT SYSTEMS -
CLAUSES
  • 4. Quality Management System
  • 4.1 General Requirements (For Software
    Development and Services)
  • 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

43
  • 5. Management Responsibility
  • 5.1 Management Commitment
  • 5.2 Customer Focus
  • 5.3 Quality Policy
  • 5.4 Planning
  • 5.4.1 Quality objectives
  • 5.4.2 Quality management system

44
  • 5. Management Responsibility
  • 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

45
  • 6.Resource Management
  • 6.1 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

46
  • 7. Product Realization
  • 7.1 Planning the Product Realization
  • 7.2 Customer Related Process
  • 7.2.1 Determination of Requirements
    related to the Product
  • 7.2.2 Review of Requirements related to the
    product
  • 7.2.3 Customer Communication

47
  • 7. Product Realization
  • 7.3 Design And Development
  • 7.3.1 Design And Development planning
  • 7.3.2 Design And Development inputs 7.3.3 Desig
    n And Development outputs
  • 7.3.4 Design And Development review
  • 7.3.5 Design And Development verification
  • 7.3.6 Design And Development validation
  • 7.3.7 Control of Design And Development
  • changes

48
  • 7. Product Realization
  • 7.4 Purchasing
  • 7.4.1 Purchasing Process
  • 7.4.2 Purchasing Information
  • 7.4.3 Verification of Purchased Product

49
  • 7. Product Realization
  • 7.5 Product and Service Provision
  • 7.5.1 Control of Service Provision
  • 7.5.2 Validation of Processes for
    production and service provision
  • 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

50
  • 8. Measurement, analysis and improvement
  • 8.1 General
  • 8.2 Monitoring and measurement
  • 8.2.1 Customer Satisfaction
  • 8.2.2 Internal Audit
  • 8.2.3 Monitoring and measurement of process
  • 8.2.4 Monitoring and measurement of product

51
  • 8. Measurement, analysis and improvement
  • 8.3 Control of non conforming product
  • 8.4 Analysis of data
  • 8.5 Improvement
  • 8.5.1 Continual Improvement
  • 8.5.2 Corrective Action
  • 8.5.3 Preventive Action

52
GUIDELINES FOR SELF - ASSESSMENT
  • Specific features of the ISO 9004
    self-assessment methodology are that it can
  • Be applied to the entire Quality Management
    System or to a part of the Quality Management
    System
  • Be applied to the entire organization or a part
    of the organization
  • Be completed in a short period of time with
    internal resources

53
GUIDELINES FOR SELF - ASSESSMENT
  • Be completed by a cross-section team or by one
    person in the organization, when supported by Top
    Management
  • Form the input to a more comprehensive Quality
    Management System self-assessment process
  • Identify and facilitate the prioritization of
    opportunities for improvement

54
GUIDELINES FOR SELF - ASSESSMENT
  • Facilitate the maturity of the Quality Management
    System towards world - class performance levels
  • Another advantage to the use of this methodology
    is that is can be regularly used to appraise the
    progress of improvement efforts

55
PERFORMANCE MATURITY LEVELS
56
PERFORMANCE MATURITY LEVELS
57
PROCESSMETHODOLOGY FOR IMPROVEMENT
  • Actions for continual improvement should consist
    of the following steps
  • Reason for improvement select an area for
    improvement and the reason for working on it.
  • Current situation Evaluate existing process
    efficiency. Collect and analyse data to discover
    what types of problems occur most often. Select a
    problem and set a target for improvement.

58
PROCESSMETHODOLOGY FOR IMPROVEMENT
  • Analysis Identify and verify the root causes of
    the problem.
  • Identification of possible solutions Explore
    alternatives and implement solutions that will
    eliminate the root causes of the problem and
    prevent them from recurring.

59
PROCESS METHODOLOGY FOR IMPROVEMENT
  • Evaluation of effects Confirm that the problem
    and its root causes have been decreased, the
    solution worked, and the target for improvement
    has been met.
  • Evaluation of efficiency of the process and
    effectiveness of the improvement action Review
    the improvement projects effectiveness and plan
    solutions to remaining problems and objectives
    for further improvement.

60
QUALITY SYSTEM DOCUMENT HIERARCHY
Describes the quality system in accordance with
the stated Quality Policy and objectives and the
applicable standard Describes the activities of
individual functional units needed to implement
the quality system elements in the
organization. Consists detailed
work documents
QUALITY MANUAL (LEVEL I)
QUALITY PROCEDURES (LEVEL II)
OTHER QUALITY DOCUMENTS (WORK INSTRUCTIONS,
STANDARDS, GUIDELINES, TEMPLATES, FORMS)
(LEVEL III)
61
DEMINGS PDCA CYCLE
  • WHERE YOU ARE
  • WHERE YOU WANT TO BE

Benchmark - Plan
Initial Approach
Plan
Revise Approach
Deployment - Impediments - Short Term -
Long Term
Improve Plan
Act
Do
Results
Check
62
Outcome of this awareness training
  • An overview of ISO-90012000 standards
  • Understanding Quality and its importance
  • Definitions of certain frequently used ISO
    terminologies
  • Knowledge about Quality Management Principles
  • How a Software Process works?
  • PDCA life cycle
  • Meaning of ISO-90012000 clauses and its
    application
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