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					FICCI
FICCI                                               CE



        Application of process approach
              for implementing
                ISO 9000:2000




                                   Competitive Edge
                                 Management Consultants
FICCI
FICCI                                                          CE

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FICCI
FICCI                                           CE

        Index


           1. Evolution of ISO 9000:2000

           2. Quality Management Principles -
              The foundation of ISO 9000:2000

           3. Adoption of process approach

           4. Key requirements

           5. Documentation

           6. Auditing of quality System

           7. Establishment of QMS
FICCI
FICCI                                     CE




                    Section-1
        Evolution of ISO-9000 Standards
FICCI
FICCI                                                                                    CE

                   Evolution of ISO-9000 Standards




        ISO-9000 series of standards were first published by International
        Organization for Standardization (ISO) in 1987. Within a few years, these
        standards caught the imagination of the industry world-over. Even though
        these standards were developed for manufacturing industries, seeing its
        success, service industries also started using these standards by adopting the
        requirements of the standard to suit their businesses.
FICCI
FICCI                                                                 CE

                   First Revision of ISO-9000
                           Standard




        As per rules of ISO, all standards are to be reviewed every
        5 years. First revision of standard took place in 1994.
        However, because of inadequate experience in usage of
        these standards, 1994 revision of the standard was limited
        in character. Basic structure of the standards was retained
        and the revision was mainly aimed to bring greater clarity
        in requirements for ease of implementation
FICCI
FICCI                                                                     CE


                  Need for Second Revision




        ISO-9000 standards have been         used by hundreds of
        thousands of companies of different types and sizes during last
        decade. During its usage certain major inadequacies have been
        observed which are shown in subsequent slides.
FICCI
FICCI                                                                              CE


                         Need for Second Revision


        A The structure of ISO 9001:1994 is heavily oriented towards
          manufacturing sector, making it difficult for application to service
          sector and other types of organizations.

        B    It was a stand alone document without any relationship with current
            quality management practices and business operations, causing
            confusion and conflict with existing quality control practices.
        C Although there was a higher level standard in the shape of ISO-9004,
          there was no alignment between the two standards due to which ISO-
          9004 standard was largely ignored by the companies.
FICCI
FICCI                                                                                 CE




        D There was over emphasis on documentation which have been specified
          for almost all requirements making it a bureaucratic system.

        E Customer relationship management has been given inadequate
          attention limited to contract review. Due to this customers of most of
          certified companies have not felt significant change after certification.

        F Basically it has been a consistency standard at the existing level of
          quality. Need for continuous quality improvement has not been
          incorporated. This necessitated adoption of other quality improvement
          methodologies causing diffusion of quality management efforts.
FICCI
FICCI                                                                          CE




        G Compliance to the standard required various activities by
          different departments, but need for a proper vertical and
          horizontal communication system for proper coordination was
          not                                               addressed.

        H There were three certifiable standards in the form of ISO-9001,
          ISO-9002 and ISO-9003. For some businesses particularly in
          services sector it was difficult to determine which standard would
          apply. ISO-9003 was literally ignored because it was focussed
          only to inspection and test, the concept which has become
          obsolete in the light of new quality philosophy.

        I   Although standard called for establishment of a documented
            quality system, its deployment in different areas and its
            effectiveness, but no basis was provided against which
            effectiveness of quality system could be assessed.
FICCI
FICCI                                                                    CE

              Major Changes in the new Standard




        ISO-9000-2000 marks a complete departure from earlier
        standard.It has been developed abinitio in the light of
        experiences gained during its application for over ten years
        and taking into account needs of users of the standards and
        other stake holders. Major changes in different aspects of the
        standard are explained in the following slides
FICCI
FICCI                                                                           CE
                    Concept and Structure


        This standard is based on eight universally accepted quality
        management principles which is synthesis of the philosophy of
        quality gurus. These 8 quality management principles have been
        defined in ISO-9000-2000, which serves as the framework of new set
        of standards on quality management.
        It has a totally new structure which no longer uses the 20 element
        structure of earlier standard. It follows a process approach which is
        closer to way most businesses operates. It has five operative clauses
        viz.,

        -   Quality Management System
        -   Management Responsibility
        -   Resource management
        -   Product Realization, and
        -   Measurement, Analysis and Improvement
FICCI
FICCI                                                                       CE

                    Application to Organizations




        There is only one requirement standard ISO-9001-2000, in
        stead of ISO-9001, ISO-9002 and ISO-9003 in the 1994
        version. Since all requirements may not apply to different
        organizations, the new standard permits exclusion of some
        requirements which have to be justified to the satisfaction of
        certification bodies. This provision enables it to cope with wide
        spectrum of organizations and activities.
FICCI
FICCI                                                                       CE



               Compatibility to other Standards

        • As compared to ISO-9001 and ISO-9004 of 1994 version, the
          new standards form a consistent pair of standards following the
          common structure. ISO-9001 standard aims to provide quality
          assurance of the product to enhance customer satisfaction
          whereas ISO-9004 standard has a broader perspective of quality
          management to give guidance for improved performance of the
          whole organization.

        • ISO-9000-2000 standards also have greater compatibility with
          ISO-14000 Environmental Management Standards thus
          facilitating implementation of these two standards which may be
          used in one organization.
FICCI
FICCI                                                   CE


          Customer Relationship




        ‘Customer satisfaction’ is recognized as the
        main driving force for any organization.
        Therefore, the new standard lays greater
        stress on interaction between the
        organization and the customers, before,
        during and after delivery of product/service.
        This interaction helps to clearly understand
        customer requirements and monitor
        information about customer satisfaction as a
        measure of system performance.
FICCI
FICCI                                                                               CE

                              Documentation




        One of the major complaints against the previous standard was that it
        required extensive documentation. The new standard has significantly
        reduced mandatory documented procedures. It has given greater
        flexibility to the organization to determine the documented procedures
        and instructions based on the nature of activities, level of training and
        established work practices.
FICCI
FICCI                                                                                   CE

                         Role of Top Management




        Top management has a crucial role in proper implementation of the quality
        system. The new standard emphasizes the role of top management which
        includes its commitment to development and effective implementation of
        quality management system. In addition to defining policy and quality
        objectives, it needs to identify, provide and manage resources for
        implementing quality system. It also needs to give consideration to legal and
        regulatory requirements of the products and establishment of measurable
        objectives to relevant functions and monitoring the extent of their
        achievement which would indicate the effectiveness of quality management
        system.
FICCI
FICCI                                                                                 CE

                        Internal Communications




        Good internal communication channels is essential for dissemination of
        information about quality policy, objectives and performance. The new
        standard requires management to define and implement an effective process
        for communication for implementation of quality system. There should be two
        way communication which should encourage feedback from people in the
        organization to directly involve them in achievement of quality objectives
        thereby ensuring effectiveness of quality management system.
FICCI
FICCI                                                                                     CE

                         Continuous Improvement




        The new standard is not content at eliminating non conformities in the
        products by corrective and preventive actions. It requires the organizations to
        continually improve the effectiveness of the quality system by having a
        concrete plan for measurement, analysis and improvement processes. In this
        respect ISO-9004-2000 goes still further. It requires that organization should
        create a culture which involves people actively seeking opportunities for
        improvement of performance in processes, activities and products. To facilitate
        this ISO-9004 also incorporates guidelines for self assessment and
        methodology of continual improvement.
FICCI
FICCI                                               CE


                      Section -2
          Quality Management Principles

        The Foundation of ISO 9000:2000 Standards
FICCI
FICCI                                                                CE




        1987 and 1994 versions of ISO 9000 standards did not
        have any theoretical basis. These were essentially adopted
        from US. MIL standards used during world war II for
        approval of suppliers by US defence forces and
        subsequently work done on these by British standards
        institute. Now for the first time an attempt has been made
        to provide a sound theoretical basis by alignment with
        quality management concepts developed in USA, Europe
        & Japan during last 50 years. These are explained in the
        subsequent slides.
FICCI
FICCI                                                                  CE




               Evolution of Quality Management
                          Philosophy

        Demands of First World War increased use of mass
        production technology. Requirement of reliable equipment
        and timely supply for the Armed Forces made quality an
        important issue. Concept of formal quality control was first
        developed by W A Shewhart in his famous book
        “Economic Control of Quality of Manufactured Product”.

        Subsequently other quality Gurus developed this concept
        further.
FICCI
FICCI                                                                 CE

                               Deming



        Demings’ philosophy of quality management is contained
        in his universal 14 points for management.

        Deming originated PDCA cycle. He came out with the new
        “climate” (organizational culture) which primarily consists
        of joy in work, innovation and cooperation.

        He referred to this new climate as win-win as opposed to I
        win : You lose.
FICCI
FICCI                                                                 CE



                                Juran
                                                   Planning
   Juran developed the idea of
   quality trilogy: quality planning,
   quality improvement and quality
   control. He concentrates not only
   on the end customer, but identifies
   other external and internal
   customers. According to him,
   quality is “Fitness of use”. Juran
   advocates 10 step approach to                              Improvement
                                         Control
   quality              improvement.
FICCI
FICCI                                                                      CE


                                  Crosby




        Crosby is known for his concepts of “Do it right first time” and
        “zero defects”. He defines quality as conformance to
        requirements which the company itself has established for its
        products based directly on customer needs. He emphasizes
        prevention management in every area. Crosby has suggested his
        own 14 step programme for quality improvement.
FICCI
FICCI                                                             CE


                     Variety of Concepts




        Since various quality gurus have propounded their own
        concepts and ideas on quality, there is an element of
        confusion in the minds of managers and quality
        professionals as to which quality methodology should be
        adopted in their organizations.
FICCI
FICCI                                                                  CE

            Universally acceptable Principles




        To resolve this problem International Organization for
        Standardization (ISO) has defined 8 universally acceptable
        principles to serve as basis for the new standard of quality
        management system ISO 9000:2000.
FICCI
FICCI                                                     CE

             Quality management Principles



        1.   Customer focused Organization
        2.   Leadership
        3.   Involvement of people
        4.   Process orientation
        5.   System approach to management
        6.   Continuous Improvement
        7.   Factual approach to decision making
        8.   Mutually beneficial supplier relationships
FICCI
FICCI                                                         CE

                Quality Management Principle No.1
                       Customer Focus

        Organizations depend on their customers and
        therefore should understand current and future
        customer needs, should meet customer requirements
        and strive to exceed customer expectations.

        Application of this principle is reflected in ISO
        9001:2000    clauses   5.2,   7.2.3    and    8.2.1
FICCI
FICCI                                                            CE


                          Customer Focus...


          Application of this principle involves :
        • Researching and understanding customer needs and
          expectations.
        • Ensuring that the objectives of the organization are
          linked to customer needs and expectations.
        • Communicating customer needs and expectations
          throughout the organization.
FICCI
FICCI                                                               CE


                       Customer Focus...




        • Measuring customer satisfaction and acting on the
          results
        • Systematically managing customer relationships.
          Ensuring a balanced approach between satisfying
          customers and other interested parties (such as owners,
          employees, suppliers, financiers, local communities and
          society as a whole)
FICCI
FICCI                                                                              CE
                    Quality Management Principle No.2
                                Leadership




        Leaders establish unity of purpose and direction of the organization.
        They should create and maintain the internal environment in which
        people can become fully involved in achieving the organization’s
        objectives.

        This principle is reflected in ISO 9001:2001 clauses 5.3, 5.4, 5.5, 6.1,
        6.2
FICCI
FICCI                                                                   CE

                            Leadership...




          Application of this principle involves:
        • Considering the needs of all interested parties including
          customers, owners, employees, suppliers, financiers, local
          communities and society as a whole.
        • Establishing a clear vision of the organization’s future.
          Setting challenging goals and targets.
        • Creating and sustaining shared values, fairness and ethical
          role models at all levels of the organization.
FICCI
FICCI                                                                  CE

                             Leadership...




        • Establishing trust and eliminating fear.
        • Providing people with the required resources, training and
          freedom to act with responsibility and accountability.
        • Inspiring, encouraging and recognizing people’s
          contributions.
FICCI
FICCI                                                                  CE
                  Quality Management Principle No.3
                       Involvement of people




   People at all levels are essence of an organization and their full
   involvement enables their abilities to be used for the organization’s
   benefit.

   This principle is reflected in ISO 9001:2000 clauses 5.3(d) and 6.2.
FICCI
FICCI                                                                 CE

                      Involvement of people...




          Application of this principle involves:
        • People understanding the importance of their contribution
          and role in the organization.
        • People identifying constraints to their performance.
        • People accepting ownership of processes and problems and
          their responsibility for solving them.
FICCI
FICCI                                                                  CE

                      Involvement of people...




        • People evaluating their performance against their personal
          goals and objectives.
        • People actively seeking opportunities to enhance their
          competence, knowledge and experience.
        • People freely sharing knowledge and experience.
        • People openly discussing problems and issues.
FICCI
FICCI                                                                CE
                   Quality Management Principle No.4
                          Process Approach




        A desired result is achieved more efficiently when
        activities and related resources are managed as a process.

        This principle is reflected in almost all clauses of ISO
        9001
FICCI
FICCI                                                                    CE

                         Process Approach...




          Application of this principle involves:

        • Systematically defining the activities necessary to obtain a
          desired result.
        • Establishing clear responsibility and accountability for
          managing key activities.
        • Analysing and measuring of the capability of key
          activities.
FICCI
FICCI                                                                   CE

                         Process Approach...




        • Identifying the interfaces of key activities within and
          between the functions of the organization.
        • Focusing on the factors - such as resources, methods, and
          materials - that will improve key activities of the
          organization.
        • Evaluating risks, consequences and impacts of activities on
          customers, suppliers and other interested parties.
FICCI
FICCI                                                                  CE
                    Quality Management Principle No.5
                  System approach to management




        Identifying, understanding and managing inter-related
        processes as a system contributes to the organization’s
        effectiveness and efficiency in achieving its objectives.

        This principle is reflected in ISO 9001:2000clauses 4.1& 4.2
FICCI
FICCI                                                           CE


             System approach to management...




          Application of this principle involves:
        • Structuring a system to achieve the organization’s
          objectives in the most effective and efficient way.
        • Understanding the inter-dependencies between the
          processes of the system.
        • Structured approaches that harmonize and integrate
          processes.
FICCI
FICCI                                                                                 CE


                System approach to management...




  •     Proving a better understanding of the roles and responsibilities necessary for
        achieving common objectives and thereby reducing cross-functional barriers.
  •     Understanding organizational capabilities and establishing resource constraints
        prior to action.
  •     Targeting and defining how specific activities within a system should operate.
  •     Continually improving the system through measurement and evaluation.
FICCI
FICCI                                                         CE
                  Quality Management Principle No.6
                     Continual Improvement




        Continual improvement of the organization’s overall
        performance should be a permanent objective of the
        organization.

        This principle is reflected in ISO 9001 clause 8.5.
FICCI
FICCI                                                                  CE

                   Continual Improvement...




          Application of this principle involves:
        • Employing a consistent organization-wide approach to
          continual improvement of the organization’s performance.
        • Providing people with training in the methods and tools of
          continual improvement.
FICCI
FICCI                                                               CE

                  Continual Improvement...




        • Making continual improvement of products, processes and
          systems an objective for every individual in the
          organization.
        • Establishing goals to guide, and measures to track,
          continual improvement.
        • Recognizing and acknowledging improvements.
FICCI
FICCI                                                           CE

                     Quality Management Principle No.7
                 Factual approach to decision making




        Effective decisions are based on the analysis of data
        and information.

        This principle is reflected in ISO 9001:2000 clauses
        5.4.1, 5.6.2, 7.3 and 8.4
FICCI
FICCI                                                             CE




             Factual approach to decision making



            Application of this principle involves:
        •   Ensuring that data and information are sufficiently
            accurate and reliable.
        •   Making data accessible to those who need it.
        •   Analyzing data and information using valid methods.
        •   Making decisions and taking action based on actual
            analysis, balanced with experience and intuition
FICCI
FICCI                                                         CE
                  Quality Management Principle No.8
                    Mutually beneficial supplier
                       relationships




        An organization and its suppliers are inter-
        dependent and a mutually beneficial relationship
        enhances the ability of both to create value.
        This principle is reflected in ISO 9001:2000 clause
        7.4
FICCI
FICCI                                                                  CE

             Mutually beneficial supplier relationships




            Application of this principle involves:
        •   Establishing relationships that balance short-term gains
            with long-term considerations.
        •   Pooling of expertise and resources with partners.
        •   Identifying and selecting key suppliers.
        •   Clear and open communication.
FICCI
FICCI                                                               CE



         Mutually beneficial supplier relationships




        • Sharing information and future plans.
        • Establishing joint development and improvement
          activities.
        • Inspiring, encouraging and recognizing improvements and
          achievements by suppliers.
FICCI
FICCI                                CE




               Section -3
           Process Approach to
        Quality Management Systems
FICCI
FICCI                                                                  CE
        Process Approach to Quality Management Systems




        New ISO-9000:2000 standards promote the adoption of a
        ‘process approach’ when developing, implementing and
        improving quality management system (QMS). Process
        approach and its application in quality management system is
        explained in the following slides:
FICCI
FICCI                                                                                     CE

                             What is a Process?




        “Any activity, or set of activities, that uses resources to transform inputs to
        outputs can be considered as a process.”
   •    Outputs from one process are typically inputs into other processes
   •    Overall aim is to add value by planning and controlling processes
FICCI
FICCI                                                                                 CE

                       What is a process approach?




        Any organization would have many processes depending upon complexity
        of its business and nature of its activities. To function effectively
        organizations have to identify and manage numerous interrelated and
        interacting processes. Often the output from one process will directly form
        the input into the next process. The systematic identification and
        management of the processes employed within an organization and
        particularly the interactions between such processes is referred to as the
        “Processes Approach”.
FICCI
FICCI                                                                              CE

                   What is a process approach….




        At the heart of quality management system are the product realization
        processes which add value. In addition to these processes, which
        transform inputs to outputs, they need auxiliary processes to facilitate
        efficient performance of activities or operations.
        This integrated process approach is schematically shown in figure 1.
FICCI
FICCI                                                                                          CE
                                           Figure 1
                 Schematic Representation of Process Approach


                            Top Management Process


                                                                          outputs
Customers/Inte
rested parties
                   inputs
                                    A        B        C                             Customers/Inte
                                                                                    rested parties
                                  REALISATION PROCESSES




                               Support Processes

   •Top management processes include, for example, planning, allocation of resources,
   management review, etc.
   •Realization processes include, for example, customer related processes, design and
   development, product realization, etc.
   •Support processes include, for example, training, maintenance, etc.
FICCI
FICCI                                                                           CE


        Management control through process approach


        Process approach enables effective control over the individual
        processes within the system of processes as well as their combination
        and interaction.
        When used within a quality management system such an approach
        emphasizes the importance of:
        a. Understanding and meeting requirements.
        b. The need to consider processes in terms of added value.
        c. Obtaining results of process performance and effectiveness and
        d. Continual improvement of processes based on objective
        measurement.
        The model of process based quality management system is shown in
        figure 2 on the next slide.
FICCI
FICCI                                                                   CE
                            Figure 2
   Complete Model of Process based Quality Management System

              Continual Improvement of the quality
                      management system

        R                                                           S
        E                                                           A
        Q                    Management
                                                                    T
  C                          responsibility                     C
        U                                                           I
  U                                                             U
        I                                                           S
  S                                                             S
        R                                                           F
  T              Resource
                                              Measurement,      T
        E                                      analysis &           A
  O             management                                      O
        M                                     improvement
                                                                    C
  M                                                             M
        E                                                           T
  E                                                             E
        N                                                           I
  R                            Product                          R
        T                    realization              Product       O
        S                                                           N
FICCI
FICCI                                                                  CE




         Process based Quality Management System



        The model of process based quality management systems
        illustrates the process linkages presented in clauses 4-8 of
        ISO 9001: 2000. The interrelationship of these clauses is
        explained in the following slides.
FICCI
FICCI                                                                                             CE

                          Customer Driven
                             Continual Improvement of the quality management system




               R                                                                              S
               E                               Management                                     A
               Q                                                                              T
           C                                   responsibility                             C
               U                                                                              I
           U                                                                              U
               I                                                                              S
           S                                                                              S
               R                                                       Measurement,           F
           T                Resource                                                      T
               E                                                        analysis &            A
           O               management                                                     O
               M                                                       improvement            C
           M                                                                              M
               E                                                                              T
           E                                                                              E
               N                                                                              I
           R                                                                              R
               T                                Product                                       O
               S                               realization                      Product       N




        The model assumes that quality starts and ends with the customer, as
        such it is customer driven. In the diagram customer is shown on both
        left and right. Generally it will be the same customer, but on occasions
        it could be different one. The system starts with understanding
        customers requirements which become input to the quality system.
        Delivery of product or service to the customer is the output of the
        quality system.The model gives importance to obtaining information
        on customer feedback shown by dotted arrows on the right.
FICCI
FICCI                                                                                             CE
                         Product Realization
                             Continual Improvement of the quality management system




               R                                                                              S
               E                               Management
                                                                                              A
               Q                               responsibility
           C                                                                              C   T
               U                                                                              I
           U                                                                              U
               I                                                                              S
           S                                                                              S
               R                                                       Measurement,           F
           T                Resource                                                      T
               E                                                        analysis &            A
           O               management                                                     O
               M                                                                              C
           M                                                           improvement        M
               E                                                                              T
           E                                                                              E
               N                                                                              I
           R                                                                              R
               T                                                                              O
               S                                Product
                                               realization                      Product       N




        The input in the form of customer requirements is fed into product or
        service planning the first process in the series of product realization
        processes. This box contains various activities which your
        organization needs to do to make your product or service. After
        transformation by various processes the final product or service is
        realized which is delivered as output to the customer
FICCI
FICCI                                                                                          CE

             Measurement, analysis and improvement
                          Continual Improvement of the quality management system




             R                                                                             S
             E                              Management
                                                                                           A
             Q                              responsibility
         C                                                                             C   T
             U                                                                             I
         U                                                                             U
             I                                                                             S
         S                                                                             S
             R                                                      Measurement,           F
         T               Resource                                                      T
             E                                                       analysis &            A
         O              management                                                     O
             M                                                                             C
         M                                                          improvement        M
             E                                                                             T
         E                                                                             E
             N                                                                             I
         R                                                                             R
             T                                                                             O
             S                               Product
                                            realization                      Product       N




        The next box covers activities such as measurement of various
        parameters in different processes with reference to the specified
        standards and generates data about deviations. These measurements
        not only include internal measurements, but also external inputs like
        field failures, customer feedback, etc. This data is required to be
        analyzed to determine corrective and preventive measures as well as
        improvements in the processes or products.
FICCI
FICCI                                                                                          CE
                 Management Responsibility
                          Continual Improvement of the quality management system




             R                                                                             S
             E                              Management
                                                                                           A
             Q                              responsibility
         C                                                                             C   T
             U                                                                             I
         U                                                                             U
             I                                                                             S
         S                                                                             S
             R                                                      Measurement,           F
         T               Resource                                                      T
             E                                                       analysis &            A
         O              management                                                     O
             M                                                                             C
         M                                                          improvement        M
             E                                                                             T
         E                                                                             E
             N                                                                             I
         R                                                                             R
             T                                                                             O
             S                               Product
                                            realization                      Product       N




        The results of analysis and customer feedback information is passed
        on to the management to take appropriate decisions for overall
        improvement      of    organizations   performance.    Management
        responsibility also covers defining of quality policy, setting of
        measurable objectives and necessary planning and documentation of
        standard instructions for important processes for guidance of
        concerned people.
FICCI
FICCI                                                                                         CE

                    Resource Management
                         Continual Improvement of the quality management system




            R                                                                             S
            E                              Management
                                                                                          A
            Q                              responsibility
        C                                                                             C   T
            U                                                                             I
        U                                                                             U
            I                                                                             S
        S                                                                             S
            R                                                      Measurement,           F
        T               Resource                                                      T
            E                                                       analysis &            A
        O              management                                                     O
            M                                                                             C
        M                                                          improvement        M
            E                                                                             T
        E                                                                             E
            N                                                                             I
        R                                                                             R
            T                                                                             O
            S                               Product
                                           realization                      Product       N




        Management also needs to determine and provide resources, which is
        addressed in the forth box (resource management) in the quality
        management system. Resources include work space; equipment and
        people. The management needs to ensure that people are trained and
        competent for the tasks assigned to them.
FICCI
FICCI                                                                                            CE
                    Continual Improvement
                            Continual Improvement of the quality management system




              R                                                                              S
              E                               Management
                                                                                             A
              Q                               responsibility
          C                                                                              C   T
              U                                                                              I
          U                                                                              U
              I                                                                              S
          S                                                                              S
              R                                                       Measurement,           F
          T                Resource                                                      T
              E                                                        analysis &            A
          O               management                                                     O
              M                                                                              C
          M                                                           improvement        M
              E                                                                              T
          E                                                                              E
              N                                                                              I
          R                                                                              R
              T                                                                              O
              S                                Product
                                              realization                      Product       N




        The data analysis activities shown in the box titled ‘Measurement
        Analysis and improvement’ may identify opportunities for
        improvements to the quality management system. This is indicated as
        the arrow pointing to the box at the top titled ‘Continual Improvement
        of the Quality Management System’. In addition, top management as
        a result of management review may suggest investigation of potential
        improvements.
FICCI
FICCI                                                                  CE




             Mechanism for Continual Improvement


          There could      be   two    mechanisms    for   effecting
          improvement.

        A As a part of quality management processes (depicted by
          arrows of inner loop). This could cover rectification,
          corrective action and preventive action.
        B As a result of management review, which look critically at
          the whole quality        management system and make
          improvements.
FICCI
FICCI                                                          CE




                     A Step Towards TQM




        It will be seen that figure 2 ties together concepts
        of quality assurance to continual improvement and
        TQM. In fact, ISO-9004 is specially designed to
        help companies to go beyond quality system
        certification and move towards TQM.
FICCI
FICCI                                                                                  CE

                    Application of PDCA Cycle
                      Continual Improvement of the quality management system




                R                                                                  S
                E                          Management
                                                                                   A
                Q                          responsibility
            C                                                                  C   T
                U                                                                  I
            U                                                                  U
                I                                                                  S
            S                                                                  S
                R                                           Measurement,           F
            T                Resource                                          T
                E                                            analysis &            A
            O               management                                         O
                M                                                                  C
            M                                               improvement        M
                E                                                                  T
            E                                                                  E
                N                                                                  I
            R                                                                  R
                T                                                                  O
                S                           Product
                                           realization              Product        N




        Process model of QMS shown in figure 2 also represents application of
        Deming’s PDCA concept for continual improvement. Top and left boxes
        signify PLAN activity. Product realization box indicates DO activity.
        Measurement and analysis is the CHECK activity, and the top box showing
        improvement measures approved by the management shows ACT phase of
        PDCA cycle.
FICCI
FICCI                                                              CE


                Application of PDCA Cycle


                           The ultimate aim of any management
                           system is continual improvement of
               PLAN        its performance. To achieve this,
                           Deming’s        PDCA        cycle  of
                           improvement is interwoven in the
                           structure of the new standard. Very
        ACT           D0   first operating clause 4.1 of ISO-
                           9000:2000 dealing with General
                           Requirements contain all the four
              CHECK        elements of PDCA cycle as illustrated
                           in figure 3 on the next slide.
FICCI
FICCI                                                             CE
                               Figure 3
        PDCA Cycle applied to ISO 9001:2000 clause 4.1

                ACT                             PLAN
                                             Identification of
           Implementation of
                                          sequence, interaction
             improvement
                                           criteria & methods
             ( Clause 4.1f )
                                           ( Clause 4.1 a,b,c )




              CHECK                               DO
              Monitoring,
                                          Implementation of
             Measurement
                                             the planning
               & Analysis
                                            ( Clause 4.1.d)
             ( Clause 4.1e)
FICCI
FICCI                                                                CE




        Deploying Quality Improvement Process




        Continual improvement process of Quality Management
        System can be deployed throughout the organization by
        undertaking PDCA activities at various levels as explained
        in the subsequent slides.
FICCI
FICCI                                                     CE


  Application of PDCA at top management level


                     Plan
         PLAN        •   Establish Policy
                     •   Define Objectives
                     •   Plan and Provide Resources
                     •   Define organization structure
                     •   Plan development of customer focus
FICCI
FICCI                                             CE


         Top Management

             DO

             • Lead by Example
             • Show commitment
             • Communicate Importance of customer
        D0     throughout Organization
             • Deploy policy throughout Organization
             • Define measurable objectives
             • DELEGATE
FICCI
FICCI                                                       CE


                Top Management


                  CHECK

                  Undertake management review to assess:
                  • Is the system working for us?
                  • Are we meeting objectives?
                  • Is our policy being followed?
                  • Are our customers happy?
                  • How is our business doing?
        CHECK     • Are we planning anything that could
                    affect the system? (New product line;
                    reorganization etc)
FICCI
FICCI                                                    CE



              Top Management



                 ACT
                 • Incorporate review results into
                   strategic planning
                 • Provide for additional resources
        ACT
                 • Reorganize
                 • Hire new staff
                 • “Convert”, “Sideline” or Fire “non-
                   believers/non-performers”
FICCI
FICCI                                                           CE

         Department/Section Heads



                 PLAN
        PLAN     •   Establish procedures and instruction for
                     departmental activities
                 •   Define responsibilities
                 •   Establish objectives
                 •   Plan resources including training of
                     personnel
                 •   Establish communication channel for
                     instructions and feed-back
FICCI
FICCI                                                                CE


        Department / Section Heads of Functional Units




                           DO

                           •   Allocate clear responsibilities
                           •   Provide resources and support
                    D0     •   Coordinate and harmonize activities
                           •   Resolve problems
FICCI
FICCI                                                           CE
         Department/Section Heads



                    CHECK

                    •   How is my department doing?
                    •   Are processes under control?
                    •   What are my employees telling me?
                    •   Are we meeting customer requirements?
                    •   Am I meeting my objectives?
                    •   What are the key problems in my area?
        CHECK       •   How can we improve?
FICCI
FICCI                                                                   CE
              Department / Section Heads




                         ACT

                         •   Systematic problem-solving (based on
                             importance, risks involved etc)
                         •   Develop action plans
        ACT              •   Concentrate on improvement (incremental
                             or “breakthrough” improvements)
                         •   Review existing procedures, and need for
                             new procedures
FICCI
FICCI                                                              CE

         Management Representative

                 PLAN

                 •   Co-ordinate definition of key processes,
        PLAN         their sequences and interactions
                 •   Define needs for documented procedures
                 •   Co-ordinate preparation of Quality Manual
                 •   Co-ordinate elaboration of Inter-functional
                     procedures (Document Control, Internal
                     Audit etc)
                 •   Determine      Legal      and    Regulatory
                     Requirements
                 •   Coordinate Quality Planning
FICCI
FICCI                                                              CE

        Management Representative




                   DO
                   •   Ensure processes are defined & maintained
                   •   Promote customer focus
                   •   Facilitate Internal Communication
             D0    •   Support line management functions
                   •   Coordinate Training Activities (with HR)
                   •   Collate measurement data (Product/
                       Process/System)
FICCI
FICCI                                                          CE

          Management Representative




                   Check (Internal Audits)

                   •   Is everyone managing their processes?
                   •   Are the customers happy?
                   •   Is our system working?
                   •   Are we communicating adequately?
                   •   How can we improve?
        CHECK
FICCI
FICCI                                                           CE



              Management Representative



                          ACT
                          •   Stimulate/co-ordinate inter-
                              functional actions
                          •   Review Internal Audit frequency
        ACT               •   Alert Top Management
FICCI
FICCI                                       CE



                    Section 4
        Key requirements of ISO 9001:2000
FICCI
FICCI                                                                  CE



             Key requirements of ISO 9001:2000

         The requirements of the standard are specified in following
         clauses of the standard:

    4.       Quality Management System
    5.       Management responsibility
    6.       Resource management
    7.       Product realization
    8.       Measurement, analysis and improvement

         Key requirements of the standard are shown in subsequent
         slides.
FICCI
FICCI                                                                             CE




         Clause 4 : General requirements

        The organization shall establish, document, implement, maintain and
        continually improve the effectiveness of a QMS.

        To implement the quality management system, the organization shall:

        a) Identify the processes needed for the QMS;
        b) determine the sequence and interaction of these processes;
        c) Implement actions necessary to achieve planned results and continual
        improvement.

        Ensure control over outsourced processes
FICCI
FICCI                                                               CE

                       Clause 4 requirements (Contd….)
                Documentation requirements


        QMS documentation must include:

        a)   documented quality policy & objectives
        b)   Quality Manual
        c)   documented procedures required in this standard
        d)   documents required by the organization to ensure the
             effective planning, operation and control of its
             processes
        e)   quality records
FICCI
FICCI                                                                CE

            Clause 4 requirements (Contd….)
            Quality Manual




        The quality manual must include:

        -     Scope of QMS, with justification for any exclusions
        -     Documented procedures, or reference to them
        -     Description of interaction between the QMS processes
FICCI
FICCI                                                                  CE

                        Clause 4 requirements (Contd….)

                    Control of Documents and Records



        • Documents required by the quality management system
          shall be controlled for ensuring availability of authentic
          and     updated    documents     for    all    concerned.

        • Records shall be established and maintained to provide
          evidence of conformity to requirements and effective
          operation of Quality Management System.
FICCI
FICCI                                                        CE




         Clause 5 : Management Responsibility
         Requirements




        Customer Focus


        Top management shall ensure that customer
        requirements are determined and fulfilled with the
        aim of enhancing customer satisfaction.
FICCI
FICCI                                                              CE

                     Clause 5 requirements (Contd….)




        Quality policy

        Top management shall ensure that the quality policy:

        a)   is appropriate to the purpose of the organization;
        b)   includes a commitment to meeting requirements and
             to continually improve effectiveness
        c)   provides a framework for establishing and reviewing
             quality objectives;
        d)   is communicated and understood within the
             organization
        e)   is reviewed for continuing suitability.
FICCI
FICCI                                                                 CE

                      Clause 5 requirements (Contd….)




        Quality objectives

        Top management shall ensure that quality objectives,
        including those needed to meet requirements for product
        (see 7.1a) are established at relevant functions and levels
        within the organization..

        The quality objectives shall be measurable and consistent
        with the quality policy.
FICCI
FICCI                                                               CE

                       Clause 5 requirements (Contd….)




           Quality management system planning

           Top management shall ensure that:

        a. Planning of the QMS is carried out in order to meet
           requirements of 4.1. As well as the quality objectives

        b. The integrity of the QMS is maintained when changes
           to the QMS are planned and implemented
FICCI
FICCI                                                               CE

                         Clause 5 requirements (Contd….)




        • Management representative

          Top management shall appoint a member of the
          management who, irrespective of other responsibilities,
          shall have responsibility and authority that includes:

              Ensuring the promotion of awareness of customer
              requirements throughout the organization.
FICCI
FICCI                                                                 CE

                        Clause 5 requirements (Contd….)




        • Internal communication :

          Top management shall ensure that appropriate
          communication processes are established within the
          organization and that communication takes place regarding
          the effectiveness of the QMS.
FICCI
FICCI                                                              CE




             Internal Communications …( contd)

        Since most planning activities are carried by
        multifunctional teams, effective internal communication
        should be established by documenting decisions taken
        during meetings and responsibilities assigned.
        Systems should be established in various departments so
        that information of activities of QMS is passed on to
        persons concerned. Proper distribution of procedures and
        instructions is an important means of internal
        communication
FICCI
FICCI                                                             CE




             Internal Communications …( contd)


        Employees should be encouraged to give feedback about
        effectiveness of QMS and corrective action and problems
        if any.
        One way to improve internal communication is to
        designate a QMS nodal officer in each department who
        could receive feedback and pass on to appropriate
        authority and Management Representative for necessary
        action.
FICCI
FICCI                                                                   CE
        Clause 5 requirements (Contd….)


        Management review input

        Inputs to management review shall include current performance
        and improvement opportunities related to the following:

        a)      results of audits;
        b)      customer feedback;
        c)      process performance and product
                conformity;
        d)      status of preventive and corrective actions;
        e)      follow-up actions from previous management
                reviews;
        f)      changes that could affect the QMS
        g)      recommendations for improvement
FICCI
FICCI                                                                CE

                         Clause 5 requirements (Contd….)


                      Management review output


        The outputs from the management review shall include any
        decisions and actions related to:

        a)     Improvement of the effectiveness of the QMS and its
               processes;
        b)     Improvement of product related to customer
               requirements;
        c)     Resource needs.
FICCI
FICCI                                                                            CE

        Clause 6 : Resource Management Requirements

        Competence, awareness and training



        The organization shall:

        a)      determine the necessary competence for personnel
                performing work affecting product quality;
        b)      provide training or take other actions to satisfy these needs;
        c)      evaluate the effectiveness of actions taken;
        d)      ensure that its personnel are aware of the relevance and
                importance of their activities and how they contribute to
                the achievement of the quality objectives.
FICCI
FICCI                                                                CE


                       Clause 6 requirements (Contd….)

                             Infrastructure




        The organization shall determine, provide and maintain the
        infrastructure needed to achieve the conformity to product
        requirements. Includes:

        a)     buildings, workspace and associated facilities;
        b)     process equipment (hardware and software);
        c)     supporting services (transport, communication)
FICCI
FICCI                                                             CE



        Clause 6 requirements (Contd….)

        Work Environment




           The organization shall determine and manage the work
           environment needed to achieve conformity to product
           requirements.
FICCI
FICCI                                                                          CE

  Clause 7 : Product Realization Requirements


        Planning of product realization

        In planning product realization, the organization shall determine
        the following, as appropriate:

        a)      quality objectives and requirements for the product
        b)      need to establish processes,
                documents and provide resources specific to the product
        c)      Required verification, validation, monitoring, inspection
                and test activities specific to the product and criteria for
                product acceptance
        d)      Records needed
FICCI
FICCI                                                                    CE

        Clause 7 requirements (Contd….)

        Customer-related processes

        Determination of requirements related to product shall
        include:

        a)     requirements specified by the customer, including the
               requirements for delivery and post-delivery activities;
        b)     requirements not stated by the customer but necessary
               for specified or intended use, where known;
        c)     statutory and regulatory requirements related to
               product
        d)     Any additional requirements determined by
        the            organization
FICCI
FICCI                                                                       CE

                         Clause 7 requirements (Contd….)


         Review of requirements related to product


        Where customer provides no documented statement of
        requirement, requirements shall be confirmed before
        acceptance.

        Note: In some situations, such as internet sales, a formal review
        is impractical for each order. Instead the review can cover
        relevant product information such as catalogues or advertising
        material.
FICCI
FICCI                                                              CE

        Clause 7 requirements (Contd….)


        Customer communication



   Customer organization shall determine and implement effective
   arrangements for communicating with customers in relation to:

   a) product information;
   b) enquiries, contracts or order handling, including
   amendments;
   c) customer feedback, including customer complaints
FICCI
FICCI                                                               CE




                  Customer Communications




        ISO 9001: 1994 specifies communication only for contract
        review. The new standard with its focus on customer
        satisfaction goes much further. It requires that
        communication channel be established with the customer
        for general enquiries and for providing information about
        products, contract, order program and customer
        feedback/complaints.
FICCI
FICCI                                                                  CE




             Customer Communications…(contd)


        Marketing, Sales and customer service departments should
        be given clear responsibility for providing requisite
        information concerning their field of activity.
        Customer contact groups such as telephone operators and
        reception should be informed of the responsibilities so that
        customers are directed to the right person. Customers may
        also be informed about departments handling different
        aspects.
FICCI
FICCI                                                               CE

                      Clause 7 requirements (Contd….)


  Other Requirements of Production Realization Clause




        There is no significant change in other requirements of
        product realization processes which were earlier given in
        clauses………………..of ISO 9001:1994.
FICCI
FICCI                                                                     CE


        Clause 8 :
        Measurement, Analysis and Improvement
        Requirements




         General Requirements

         The organization shall plan and implement the monitoring,
         measurement, analysis and improvement processes needed.

         This shall include the determination of applicable methods,
         including statistical techniques, and the extent of their use.
FICCI
FICCI                                                                  CE

                        Clause 8 requirements (Contd….)


                 Monitoring and measurement



        • Customer satisfaction:
          The organization shall monitor information relating to
          customer perception as to whether the organization has
          fulfilled customer requirements. The methods for obtaining
          and using this information shall be determined.
FICCI
FICCI                                                                                    CE
        Clause 8 requirements (Contd….)


        Monitoring and measurement

   • Internal audit:
        The audit criteria, scope, frequency and methods shall be defined. Selection
        of auditors and conduct of audits shall ensure objectivity and impartiality of
        the audit process. Auditors shall not audit their own work.

        The management responsible for the area being audited shall ensure that
        actions are taken without undue delay to eliminate detected non-conformities
        and their causes.
        Follow up actions shall include the verification of the actions taken, and the
        reporting of verification results.
FICCI
FICCI                                                                            CE
                        Clause 8 requirements (Contd….)


                             Analysis of data

        The organization shall determine, collect and analyze appropriate data
        to determine the suitability and effectiveness of the quality
        management system and to evaluate where continual improvement of
        effectiveness of the QMS can be made.

        The organization shall analyze this data to provide information on:

        a)   customer satisfaction;
        b)   conformance to product requirements;
        c)   characteristics and trends of processes and products
             including opportunities for preventive action
        d)   suppliers
FICCI
FICCI                                                                  CE



        Clause 8 requirements (Contd….)


        Continual improvement



        The organization shall continually improve the effectiveness
        of the QMS through the use of the quality policy, quality
        objectives, audit results, analysis of data, corrective and
        preventive actions and management review.
FICCI
FICCI                   CE




          Section 5
        Documentation
FICCI
FICCI                                                               CE


                          Documentation


        What is a document ?


        It   is   information    and   its   supporting   medium.

        Examples: Specification, drawing, procedure and records

        The medium of document could be papers, magnetic,
        electronic,optical disc, photograph or a sample.

        (ISO 9000:2000, 3.7.2)
FICCI
FICCI                                                                CE


                       Need for Documentation




          In managing an organization, documentation is used:
        • As a tool for information transmission and communication
        • Evidence of conformity that what is planned has been
          done.
        • Preservation of knowledge of the organization such as
          design data, studies conducted and documented
          experience.
FICCI
FICCI                                                                       CE

        Documentation Objectives of the New Standards



        Two of the major objectives in the revision of ISO 9000 series of
        standards were:

    • To identify simplified standards that will be equally applicable to
      different types of organizations including small scale industries.
    • For the amount and detail of documentation required to be more
      relevant to the desired results of organization’s activities.
FICCI
FICCI                                                                            CE

                       Extent of Documentation




        ISO 9000:2000 has significantly reduced the documentation
        requirements and is much less prescriptive than the 1994 version of
        the standard. It allows an organization more flexibility in the way it
        chooses to document its quality management system (QMS). This
        enables each individual organization to develop the minimum amount
        of documentation needed in order to demonstrate the effective
        planning, operation and control of its processes and the
        implementation and continual improvement of the effectiveness of its
        QMS.

        It is stressed that ISO 9001 requires a “Documented quality
        management system”, and not a “system of documents”.
FICCI
FICCI                                                                              CE


                      Documentation Requirements



            ISO 9001:2000 clause 4.2.1 states that the quality management system
            documentation shall include:
        •   Documented statements of a quality policy and quality objectives;
        •   a quality manual
        •   documented procedures required by this International Standard
        •   documents needed by the organization to ensure the effective
            planning, operation and control of its processes, and
        •   records required by this International Standard.
FICCI
FICCI                                                                   CE


                      Flexibility in Documentation



          The new standard is less prescriptive than 1994 version and
          allows flexibility to the organization in developing QMS
          documentation which may differ from one organization to
          other due to:

        • Size of the organization and type of its activities
        • Complexity of processes and their interactions, and
        • Training and competence of personnel
FICCI
FICCI                                                                           CE

            Existing Documentation in the Organization


           Most organizations in the organized sector would already be having
           considerable documentation for successful management of their
           business. This documentation may include:
        • Company rules & procedures

        • departmental and operating manuals

        • Product specifications / product drawings

        • Process plans/instructions

        • Production schedules

        • Approved supplier lists

        • Test and inspection plans, etc.
FICCI
FICCI                                                                   CE



        Adoption of Existing Documents in QMS Documentation




         There is a need to analyze existing documentation for their
         usefulness in effective control over important processes for
         assuring customer satisfaction. It has also to be verified
         whether these documents are being followed. If so, these
         documents must be given unique identity and brought
         under document control for integration into QMS
         documentation
FICCI
FICCI                                                                                CE


             Determination of Need for New Documents




        • In addition to adaptation of existing documents for implementation of
          quality management system, the organization may need certain
          additional documents to comply with ISO 9001:2000.

        • The type of documents and records which may possibly be required by
          the companies in the organized sector is given in the succeeding slides.

        • List of clause-wise documents and records is suggestive in nature. The
          management decision to have these documents will depend on the
          complexity of the processes and the training/competence of staff.
FICCI
FICCI                                                                        CE

                           ISO 9001:2000 Clause 4


           Documents
        • Quality manual

        • Flow chart of major processes and their interaction

        • Document control procedure

        • Record control procedure.

        • Description of out sourced services and their control procedure.

           Records
        • Document updating records

        • Disposal of quality records
FICCI
FICCI                                                                      CE


                           ISO 9001:2000 Clause 5

           Documents
        • Quality objectives at organizational and functional level.

        • Organization structure and responsibilities of management
          representative and key functionaries whose job affects product
          quality.
        • Description of internal communication channel. ( This could be
          specified in quality manual. Also see slide 96,97 & 98 )
        • Procedure for management review Records

        • Evidence of quality planning

        • Record of management review
FICCI
FICCI                                                                         CE


                           ISO 9001:2000 Clause 6


           Documents
        • Specific requirement of qualification and competence of personnel

        • Procedure for identifying training needs and yearly training plan

        • List of special facilities or work environments affecting quality

        • Procedure for maintenance of buildings equipment and facilities

           Record

        • Record of training and experience of personnel

        • Maintenance record
FICCI
FICCI                                                                             CE


                           ISO 9001:2000 Clause 7



           Documents
        • Quality plan or other documents showing how quality is planned in
          products/projects

        • Method of capturing customer requirements

        • Review of orders or contracts to assess capability to meet customer’s
          requirements

        • Specifications for company’s products

        • Procedure for design and development

        • Specifications for purchased materials
FICCI
FICCI                                                                                       CE

                                                         ISO 9001:2000 Clause 7 (contd….)



        •   Procedure for selection and approval of suppliers
        •   Procedure for review of suppliers performance
        •   Procedure for verification of purchased products and dealing with non
            conforming supplies.
        •   Procedures or work instruction for critical processes.
        •   Procedure for assessing process capability and approval of processes.
        •   Qualification of operators and processes where quality cannot be
            verified after work is finished.
        •   Procedure for maintenance of critical equipment.
        •   Procedure for identification and traceability of materials (where
            required).
FICCI
FICCI                                                                                       CE

                                                         ISO 9001:2000 Clause 7 (contd….)




        •   Inspection and testing plans/instructions.
        •   Procedure for showing inspection/test status of materials/equipment.
        •   Procedure for calibration measuring devices.
        •   Procedure for handling customer property.
        •   Procedure for preservation, packaging and storage of product.
FICCI
FICCI                                                                                       CE


                                                         ISO 9001:2000 Clause 7 (contd….)


            Records
        •   Contract review of major contracts
        •   Design review record
        •   Results of design verification/validation
        •   Inspection results of purchased materials.

        •   Record of qualification of operators and processes where output
            cannot be assessed for non conformity.

        •   Inspection and testing records

        •   Record of rework and rejection

        •   Calibration record of measuring devices.

        •   Record of damaged or lost customer property (where applicable).
FICCI
FICCI                                                                                     CE

                          ISO 9001:2000 Clause 8
        Documents
    •   Procedure for measurement and monitoring of processes for effective control.
    •   Methods for use of statistical techniques for process control and data analysis
        for improvement.
    •   Procedure for inspection and release of final product.
    •   Procedure for dealing with non conforming product and use of material under
        concession.
    •   Procedure for monitoring customer satisfaction and dealing with customer
        complaints.
    •   Procedure of internal audit of QMS, along with check list.
    •   Procedure for corrective and preventive action.

    •   Procedure for collection and analysis of data for effectiveness and
        improvement of QMS.
FICCI
FICCI                                                                                    CE


                                                      ISO 9001:2000 Clause 8 (contd….)




           Records

        • Process monitoring data and corrective action taken for process
          control

        • Record of product non conformities and products accepted on
          concession.

        • Data analysis and activities for continual improvement.

        • Result of internal audits and follow up action.

        • Data on customer feedback and action taken on customer complaints.
FICCI
FICCI                                                                            CE


                   Formulation of Quality Policy

           Quality policy is the first step in the development of quality
           management system
        • The quality policy emanates from the vision and mission of the
          organization. It should describe what quality means to your business
          and customers.
        • Quality policy should reflect top management’s commitment to
          quality.
        • To make the policy meaningful it must include overall quality goals
          for your business.
        • Quality policy must be brief for ease of understanding by employees.
        • Quality Policy is normally included in quality management manual.
FICCI
FICCI                                                                               CE
                                 Quality Manual




          Quality manual is the basic document which describes the QMS
        • ISO 9001 standard does not prescribe any specific format or a model
          for the quality manual. It could either be structured in the order of
          process flow in the organization or according to the applicable
          elements of the standard. In case of process flow model it may be
          useful to provide cross reference with the standard clauses for ease of
          internal and external audit.
        • Quality manual should contain an overview of the different processes
          of organization and how various requirements of the standard are met.
FICCI
FICCI                                                                          CE
                                                    Quality Manual (contd….)




        Quality manual is high level document as such it contains
        very little detail of the processes. However, it provides
        reference to departmental manuals and other documents
        which give further information of processes.
        As quality manual can also be used as promotional
        material, it should not contain anything that is confidential.
FICCI
FICCI                                                                          CE

                        Contents of Quality Manual



            Quality manual should normally include the following though not
            necessarily in the same order:
        •   Brief background of the company
        •   Scope of the QMS with justification for exclusions if any.
        •   Quality policy
        •   QMS documentation containing list of documents such as
            departmental manuals, procedures and other documents required to
            operate QMS.
        •   Quality records and their control
        •   Organizational structure
FICCI
FICCI                                                                                   CE


                                                 Contents of Quality Manual (contd….)


        • Quality related responsibilities of main functionaries including
          management representative.

        • Document control

        • Management commitment for QMS

        • Method of internal communication

        • Human resource management

        • Infrastructure and work environment

        • Production or service planning

        • Product development (where applicable)

        • Purchase control

        • Control of production and/or service
FICCI
FICCI                                                                                    CE


                                                  Contents of Quality Manual (contd….)



        • Identification and traceability

        • Preservation of product

        • Care of customer property

        • Measurement of products and processes

        • Control of non conforming products

        • Corrective and preventive action

        • Monitoring and measurement of customer satisfaction

        • Internal audit of QMS

        • Continual improvement
FICCI
FICCI                                                                               CE

                        Quality System Procedures




        •   Documented procedures were required to implement almost all clauses
            of ISO 9001:1994.
        •   There is a major change in direction away from documentation to be
            the main output from implementation of ISO 9001:2000.
                The standard requires a documented quality management system
                rather than a system of documents.
        •   The emphasis has shifted from documented procedures to identification
            and definition of processes
FICCI
FICCI                                                                              CE

                              What is a Process?



        •   Process creates change of state and convert inputs into outputs.
        •   The inputs could be material, information or people. These pass
            through a sequence of stages during which inputs are transformed and
            their status changes to emerge as an output with different
            characteristics.
        •   Typical examples are:
        -   Physical or chemical processes to transform material
        -   Computation or analysis to transform data
        -   Training to develop the skill of people.
FICCI
FICCI                                                                            CE

                      Standardization of Processes



        • An organization may be using a number of processes most of which
          are standardized by tradition, practice and training. ISO 9001:2000
          accepts this situation and does not insist on documentation of all
          processes.
        • However, important processes where absence of documented process
          document may pose a risk of non conformity must be documented.
          The documents which describe these processes are termed as
          procedures.
        • ISO 9001:2000 does not specify any format for quality system
          procedures. However, for ease of usage, a company must standardize a
          format for preparation of procedures.
        • One suggested format is given in the next slide.
FICCI
FICCI                                                                        CE


                  Format for Quality System Procedure
                                                           Document No.
                                                             Date of issue
                                                   Title of the procedure



        1   Purpose
        2   Scope of application
        3   Responsibility
        4   Description of activities




        5 Reference of other documents
        6 Records to be generated
FICCI
FICCI                                                                  CE


                        Process flow charts




        Process can also be defined by flow charts which
        schematically shows various activities and gives reference
        to the guidance documents. Flow chart is simple to
        construct and has the advantage that the entire process can
        be viewed at one glance.
        Flow chart for receipt of purchase material is shown in the
        next slide to illustrate this method of defining procedures.
FICCI
FICCI                                                                                  CE
                 Flow Chart:-Receipt of purchased material
                                            SUPPLIER

                                                                       Packing
                                                                       Note
    Supplier                                 DELIVERY
                 Goods receiving note                        Invoice

    Stores                                 RECEIVE GOODS


                  Inspection procedure

    Inspection                           VERIFY CONFORMITY

                                                                 ACCOUNTS
                    Acceptance label
    Inspection           Reject label        ACCCEPT           No
                   Goods Return Note


                                                 Yes                   Stores record

    Stores                                   STORAGE
FICCI
FICCI                                                                              CE


                       Requirement of Procedures


        ISO 9001:2000 specially requires the following documented procedures:
    •   Control of documents (clause 4.2.3)
    •   Control records (clause 4.2.4)
    •   Internal audit (clause 8.2.2)
    •   Control of non conforming products (clause 8.3)
    •   Corrective action (clause 8.5.2)
    •   Preventive action (clause 8.5.3)
        This is a minimum requirement for documented procedures. Most
        organizations in the organized sector would need many more procedures
        depending upon the nature of business processes and scale of operations.
FICCI
FICCI                     CE




           Section-6
        Auditing of QMS
FICCI
FICCI                                                                              CE


                    Audit Philosophy of ISO 9000:1994



        • ISO 9000:1994 was structured on the basis of 20 elements or
          requirements which were to be met by performance of certain tasks.
          The responsibility for meeting these requirements were allocated to
          different departments. Entire methodology of documentation, records
          and audit (both internal and external) were based on this departmental
          approach.
        • For compliance the auditor looked for a documented procedure or
          instruction which defined the task and the way it is to be performed.
          Where required he also looked at record as evidence that the task has
          been performed. The auditor did not concern himself with the purpose
          of the task, what results were desired or whether the task has been
          performed effectively and desired results achieved.
FICCI
FICCI                                                                              CE

            New Approach for Audit of QMS as per ISO 9001:2000




        • The new standard represents a major shift in focus for element related
          tasks to the processes and their results.
        • The organizations and certification bodies would have to adopt a new
          approach to audit of quality management system which concentrates
          on processes and their effectiveness for achieving desired results.
          Major difference in two approaches is shown in subsequent slides.
FICCI
FICCI                                                                                 CE

          Element-oriented Departmental Approach to Auditing




        • Checks compliance of requirements in departments where these are
          applicable.
        • Looks for existence of documents such as quality manual and
          procedures which are specified in the standard.
        • Checks compliance to procedures and not the performance for
          effectiveness in achieving results.
        • Follows the work trail in the departments to verify whether it is carried
          out as per relevant procedures.
        • Linkages between departments and effectiveness of their interaction is
          not checked and mainly relies on records to verify compliance of
          requirements.
FICCI
FICCI                                                                                  CE

                           Process Approach to Auditing


            With the process approach, it is believed that the purpose of carrying
            out various activities is to achieve desired outcome. The auditor
            establishes the results desired by the organization; He then identifies
            processes used in the work and verifies their effectiveness in achieving
            desired outputs. The process approach requires:
        •   Start with the quality objectives and work backwards to see how these
            are achieved.
        •   It focuses on process results and not procedures or tasks performed.
        •   Looks for evidence that processes are under control.
        •   Examines inter-connection of processes within department and
            between departments/functional groups to see smooth flow of work.
        •   Looks for tangible activities for improvement in organizational
            performance for achieving quality objectives.
FICCI
FICCI                                                                                 CE

                              Audit Check-list




        Planned audit of quality management system requires check list which
        can serve as aid memoir for the auditor. The audit need not be limited
        to the questions given in the check-list. It serves as good starting point.
        Further, questions to assess the evidence would depend upon the
        responses by personnel of auditee organization/department.

        A generic questionnaire is given in this section which can form the
        basis for formulation of specific questionnaires or check list applicable
        to the organization.
FICCI
FICCI                                                                             CE

                 Scope and Objective of the Check List


        The questionnaire given in this section is meant for self assessment by
        the organizations implementing ISO 9001-2000. The questions go
        beyond the minimal compliance of the requirements of standard for the
        purpose of certification.
        The questionnaire has been designed to assess whether the spirit of the
        standard has been captured by application of 8 quality management
        principles which form the basis of ISO 9000-2000.
        The aim is that the quality management system should add value to the
        organization and drive it towards achievement of organizational
        objectives and continual improvement.
        The questions help organization in deeper analysis of their processes
        for establishing robust quality management system for better control
        over business processes.
FICCI
FICCI                                                                                  CE

                  Evaluating Responses to the Questionnaire




        While responding to questions the person responsible for the activity has to
        demonstrate that the requirement alluded in the question is being complied.
        Respondent need not always show a document or record as evidence.
        Where a procedure or instruction is not documented the auditor may seek
        response from two or three persons involved in the activity to assess that a
        standardized process has been established and is being operated
        satisfactorily.
        Effectiveness of a process can also be assessed during audit of next process
        which would receive the output of the process being audited. Generic
        questions are given in the following slides
FICCI
FICCI                                                                              CE



                                  Quality Policy




        •   Has the organization defined its mission?
        •   Have the factors critical to accomplishment of mission been analyzed
            to determine subjects to be controlled by the organization?
        •   How and by whom has the quality policy been formulated?
        •   Have the people responsible for implementation been involved in
            development of the policy?
        •   How have regulatory requirements been considered in formulation of
            quality policy?
        •   How is the quality policy communicated throughout the organization?
FICCI
FICCI                                                                             CE



                               Quality Objectives



        •   Have quality objectives been defined in measurable terms?
        •   What is the basis for establishing quality objectives?
            It could be:
             - customer expectations
             - past performance
             - standard of competitors
        •   Have the persons responsible for achieving objectives been involved
            in establishment of quality objective to have their commitment?
FICCI
FICCI                                                                                   CE



                                                         Quality Objectives (contd….)




        • How have the risks to achieving objectives been evaluated?
        • Have appropriate objectives been established in different functional
          areas which contribute to achieving overall objectives?
        • How is the achievement of quality targets verified?
        • What analysis is carried out in case of difference between planned and
          actual results?
FICCI
FICCI                                                                            CE

                                   Organization


        • Have you defined organizational structure with clearly defined
          responsibility and authority at all levels?
        • What is the role of management representative and what is the
          coordination process for ensuring that QMS is implemented and
          maintained in all functional areas?
        • Does MR have appropriate status and authority in the organization to
          effectively coordinate the activities of QMS throughout the
          organization?
        • How does MR promote awareness of customer requirements
          throughout the organization?
        • Does MR have adequate secretariat support for satisfactory discharge
          of his duties?
FICCI
FICCI                                                                              CE
                         Human Resource Management




        • How are the responsibilities within each role defined and assigned to
          the functionaries in the organizational structures?

        • How do you determine the need of additional personnel and their
          qualification and expertise.?

        • How does the recruitment and selection process ensure that defined
          requirements of staff are met?

        • What is the process for identifying training needs and development for
          all staff?
FICCI
FICCI                                                                                CE


                                               Human Resource Management (contd….)




        • What is the process for carrying out skills assessment, taking into
          account current capability and needs based upon future business
          objectives?
        • What is the process for providing training and development?

        • Is training plan and record of training (both in company and outside)
          available?
        • What improvements in HR have been planned?

        • What improvement in results was obtained from the last review of the
          human resource process?
FICCI
FICCI                                                                                 CE

                        Physical Resource Management



            Provision of Resources
        •   What is the process for provision of physical resources like buildings,
            utilities, process equipment and supporting services?
        •   Have the responsibilities for planning and provision of different types
            of physical resources been defined?
        •   Do the users of resources participate in the planning process?
        •   What is the basis of determining additional resources?
        •   Have you identified any specific work environment which affects
            conformity of product requirement?
        •   What is the process to review whether adequate resources have been
            provided?
FICCI
FICCI                                                                            CE
                      Maintenance of Physical Resources




        • Have processes for maintenance of various types of resources such as
          buildings and equipment been defined?
        • Have the standards of various types of resources been established?

        • How are the maintenance processes controlled?

        • How do you determine if any legal requirement impact on
          maintenance?
        • Have you out-sourced maintenance of buildings and certain
          equipment? If so, how are these services monitored and controlled?
        • Have you established improvement objectives for maintenance? If so
          to what extent those objectives have been achieved over a specified
          period?
FICCI
FICCI                                                                              CE


                             Management of Services




        •   Have you determined what kind of services are required by the
            organization? These services could be transportation, communication,
            cleaning, security, etc?
        •   Have the processes for planning, procurement and control of these
            services been defined and responsibilities allocated?
        •   Have the standards for these services been established?
        •   How is the service performance assessed for conformity and
            improvement?
FICCI
FICCI                                                                                CE


                         Product Realization Processes




           General questions
           Following questions are applicable to all processes involved in product
           realization:
        • What is the purpose or output of the process?

        • What are the pre-requisites for commencement of the process?

        • What information and other resources are required for the process?

        • What inputs are needed and where will they come from?
FICCI
FICCI                                                                                   CE


                                                          General questions (contd….)




        •   What are the main stages of the process and how is interconnection
            between stages managed?
        •   What controls are exercised for satisfactory operation of the
            processes?
        •   How are results of process measured?
        •   What action is taken when desired output is not achieved?


            These questions will force the process owner to examine all aspects of
            the process. This will bring clarity about the process and help in
            effective management of processes.
FICCI
FICCI                                                                                CE



                               Marketing Processes



        •   What market research has been carried out to understand the market
            sector in which you operate?
        •   Have you identified factors necessary for your organization to succeed
            in the market?
        •   How do you determine the current and future needs and expectations
            of customers?
        •   How do you evolve the marketing strategy? Are other key functional
            groups involved in this process?
        •   Once customer requirements are determined, how are these
            communicated within the organization?
        •   How do you assess effectiveness of marketing process?
FICCI
FICCI                                                                              CE



                                    Sales Process




        • Have you defined your sales strategy and established sales objectives?

        • What are key stages in the process to achieve sales objectives?

        • How is information on the organization’s products and services
          conveyed to potential customers and how is its integrity maintained?
        • What are the principle activities of the process by which customer
          inquiries are converted into orders?
FICCI
FICCI                                                                               CE



                                                          Sales Process (contd….)




        • How do you determine whether the organization has the capability to
          satisfy customer requirements before accepting orders?
        • How are customer requirements of accepted orders conveyed to those
          responsible for their implementation?
        • How are changes in orders/contracts captured, accepted and conveyed
          to those responsible for their implementation?
FICCI
FICCI                                                                                CE



                                                           Sales Process (contd….)




        • What checks are carried out to verify that the customers receive the
          products and service they have ordered?
        • What analysis has been performed to determine the cause in the case
          of difference between actual and planned results?
        • What improvement in results was obtained from the last review of the
          sales process?
FICCI
FICCI                                                                            CE



                      Design and Development Processes



        • Do you have a system of preparing a design plan before starting
          design and development activity?
        • Does the plan identify various design inputs and how these are to be
          obtained?
        • Have you defined various stages in the development processes
          sequential and parallel work schedules and persons responsible for
          completion of design elements?
        • Have you defined design and development output in verifiable terms?
FICCI
FICCI                                                                                    CE


                                            Design and Development Processes (contd….)




        • Is systematic review of design and development carried out at suitable
          stages? Is a checklist for such review available?
        • What is the process of design verification? Are the results of
          verification recorded?
        • Do you have design and development validation process where you
          have to demonstrate that the resulting product is capable of meeting
          the requirement of intended user?
        • What is the process of making changes in the design. Are these
          changes verified and reviewed by authorized persons before
          implementation?
FICCI
FICCI                                                                               CE




                                Purchase Processes




        • Has the organization formulated purchase policy and guidelines?

        • How and by whom are the items to be purchased determined?

        • Are specifications or detailed particulars of all items to be purchased
          available?
        • What is the process for determining quantities to be purchased?

        • How do you determine the relevant legal requirements that impact on
          the purchase products?
FICCI
FICCI                                                                                 CE


                                                       Purchase Processes (contd….)




        • How are those requiring products involved in the purchase process?

        • How are suppliers assessed for their ability to supply conforming
          product?
        • Do you maintain updated list of approved suppliers?

        • How do you ensure that complete information about specification of
          the products is provided to the suppliers?
        • How it is ensured that supplier is informed about procedure for
          approval of material and critical processes where these are required?
FICCI
FICCI                                                                                   CE

                                                         Purchase Processes (contd….)




        • What is the process for qualification of personnel when their skill is
          critical for ensuring product quality?
        • What is the verification process of critical materials or processes used
          by the supplier (If required by purchase procedures)?
        • What action is taken when there are minor deviations from the
          specification which may not affect serviceability of the product?
        • What actions are taken when whole or part of supplied batch of
          product is found to be not conforming?
FICCI
FICCI                                                                                  CE

                                                        Purchase Processes (contd….)




        •   What extra safeguards are adopted for verification when non
            conforming product is submitted after rectification?
        •   How is the performance of suppliers evaluated? Are results of
            evaluation shared with suppliers to enable them to improve?
        •   Are suppliers involved in quality improvement projects?
        •   What steps are taken to encourage long-term relationship with
            suppliers?
FICCI
FICCI                                                                             CE


                              Production Planning



        • What is your production policy to ensure that right quantity of
          products is produced at the right time to optimize utilization of
          production resources?
        • What are the inputs to production planning? These could be confirmed
          orders, sales forecast and planned inventory levels.
        • Have you carried out process capability study of your equipment to
          determine production capacity?
        • What is the process of machine loading and work scheduling to ensure
          smooth flow of production?
        • How is production control exercised to ensure that planned production
          is achieved?
        • Are causes of production shortfall analyzed to improve the production
          planning process and productivity?
FICCI
FICCI                                                                               CE




                  Process Planning for Product Realization




        •   Have you defined sequence of operations or activities for product and
            output required at each stage?
        •   Have you determined which process stages require written instructions
            for proper compliance?
        •   Does process plans specify parameters to be checked or measured at
            different stages and how these measurements are to be carried out?
        •   Have you defined criteria for acceptance at each stage and actions to
            be taken in case this criteria is not met?
FICCI
FICCI                                                                                         CE

                                         Process Planning for Product Realization (contd….)




        •   Does the process plan give details of tooling, software and measuring
            devices to be used in the process?
        •   Where customer supplied product is to be integrated with the final
            product, does the process plan provide specification of such product
            and instructions for assessing conformity and related issues?
        •   Have you defined method of identification and traceability where these
            are applicable?
        •   Does the process plan contain instructions for preservation, packaging
            and storage of the product where appropriate?
FICCI
FICCI                                                                              CE



                               Production Control



        •   How it is ensured that the concerned personnel fully understand
            process plans and activities to be carried out by them?
        •   Where written instructions are required, have you ensured that these
            are available at the workstations where these are applicable?
        •   What is the method of approval of process before commencing regular
            production?
        •   How do you ensure that specified process controls are being used and
            are effective?
FICCI
FICCI                                                                                   CE

                                                         Production Control (contd….)




        •   Do the operators know what corrective action is to be taken when
            process goes out of control or non conforming product is produced?

        •   How it is ensured that out of control process is not operated till its
            causes are determined and it is again brought under control?

        •   Have you defined action to be taken for dealing with non conforming
            product?

        •   What is the process for accepting product deviations which do not
            significantly affect product serviceability?
FICCI
FICCI                                                                          CE



               Control of Monitoring and Measuring Devices




        •   Are all monitoring and measuring devices uniquely identified?
        •   How it is determined that the devices meet the measurement
            requirements of products and processes?
        •   Do you have calibration procedures and are record of calibration
            maintained?
        •   Is calibration status clearly identifiable on the devices?
FICCI
FICCI                                                                                     CE


                                  Control of Monitoring and Measuring Devices (contd….)




        •   Are concerned personnel aware of proper handling, maintenance and
            storage method to prevent damage/deterioration?
        •   Are suitable environmental conditions maintained for measurement
            and calibration activities?
        •   What is the system of revalidation of previous measurements if the
            measuring equipment is found to be out of calibration?
FICCI
FICCI                                                                            CE




           Measurement, Monitoring and Process Improvement




        • What are the methods for measuring and monitoring of product
          realization processes?
        • Are there records to show that the processes are being monitored and
          necessary follow up action is taken to keep them under control?
        • Is there documented plan for inspection and testing of the product
          (including acceptance criteria) before release of the product?
FICCI
FICCI                                                                                       CE
                                Measurement, Monitoring and Process Improvement (contd….)




        • Is there a documented procedure for control of non conforming
          products?
        • Have they defined what action is to be taken if defects are found after
          delivery and is there adequate product recall procedure?
        • Is there a procedure for corrective and preventive action to prevent
          occurrence of defects. Does it address the root causes on the basis of
          investigation and analysis of non conformities?
FICCI
FICCI                                                                                     CE



                              Measurement, Monitoring and Process Improvement (contd….)




        • Is there a documented procedure for measuring customer satisfaction
          and handling of customer complaints?
        • Are internal audits carried out according to a plan, and necessary
          follow up action taken?
        • Are there documented audit procedures along with a check list?

        • Is there a formal system for analysis of data for continuous
          improvement of processes and the quality management system?
FICCI
FICCI                                CE




                  Section 7
              Establishment of
        Quality Management Systems
           as per ISO 9001:2000
FICCI
FICCI                                                                             CE


                              Do you Need QMS?


        • Some companies have obtained ISO 9000 certification in the belief
          that it will give them a good marketing image. Where this is the only
          motivation, such companies do not get real value from QMS.
        • Establishing effective QMS is a complex exercise which requires
          considerable effort and resources. Therefore an organization must
          have extensive deliberation about all aspects of QMS, and benefits it
          will obtain to establish the need of QMS based on ISO 9001:2000.
        • The initiative in the direction is usually taken by the chief of the
          quality function in the organization who would be aware about ISO
          9000 standards, their benefits and limitations in dealing with the
          quality problems in the company.
        • First activity should be to evaluate the present system of quality
          management in the company
FICCI
FICCI                                                                               CE

                     Assessment of Existing Quality System

        • Any company in organized sector would have some form of quality
          functional system, though it may called by different names such as
          Quality Control, Quality Assurance or Quality System as per ISO
          9000:1994 version.
        • For objective assessment we should ask the following questions:
        - Is it used and reflects the way we work (i.e., it is not only on paper)
        - Is it useful and adds value?
        - If you have established ISO 9000 system, have the customers found
          any improvement in products/services?
        - Is it integrated with day to day business management?
        - Do we still use fire fighting approach to deal with quality problems?
        • There is a high probability that answers would reveal that existing
          system is partially used and is of limited value. If it is so, it will
          establish a clear need for a more effective quality management system.
FICCI
FICCI                                                                               CE



                       Convincing the Top Management


        • Quality management system as per ISO 9001:2000 is driven by top
          management. As such, it needs their full involvement and commitment.
          Therefore, the concept has to be sold to them. This would require:
        - Organization of an awareness seminar by an expert faculty to explain
          the concept of new standard and what is involved in its implementation.
        - Projection of current quality related problems and how the new system
          will help in their resolution.
        - Thorough discussions with functional heads to remove their
          apprehensions and misgivings about loss of their authority.
        • The aim should be to evolve a consensus about need and take a strategic
          decision to establish QMS as per ISO 9001:2000.
        • Top management should be willing to walk the talk.
FICCI
FICCI                                                                              CE



              Creating Awareness of QMS Among Personnel




        • Establishment and maintenance of QMS requires active cooperation
          and involvement of all employees as such there is a need to create
          awareness about QMS. It will facilitate participation of key personnel
          in the design of quality management. This may be achieved by:
        - Organising seminars for various categories of personnel to explain the
          concept, need and benefits of QMS.
        - Holding discussions with unions to remove their apprehensions if any
          and secure their active support and co-operation.
FICCI
FICCI                                                                            CE

            Creating Institutional Structure for ISO 9000 Project




        • Establishment of QMS is like any other major project. Its
          implementation may require some changes in the operating systems
          and work culture in the company. Establishment of QMS cannot be
          left to quality manager or even director of quality function however
          competent he may be. The leadership and direction for QMS project
          has to be provided by CEO himself, thus demonstrating commitment
          and resolve of the management.
        • Since establishing Quality Management System is a major task,
          suitable entities will need to be created in the form of a steering
          committee and task force to assist CEO in this task.
FICCI
FICCI                                                                            CE


                             Steering Committee


            This committee should comprise the chief executive and heads of
            various functional departments. Its functions will include the
            following:
        •   Adopting the company’s quality policy
        •   Nominating the management representative
        •   Overall planning and direction of the ISO 9000 project
        •   Allocating resources to the project
        •   Co-ordinating project work carried out by different departments on
            major issues
        •   Monitoring and controlling the project
FICCI
FICCI                                                                         CE


                   Steering Committee ...contd.




        Secretarial support for the steering committee could be provided by
        the quality assurance department or the project management group.
        The committee could meet fortnightly or monthly, review and resolve
        problems if any, and fix targets for various work elements.
FICCI
FICCI                                                                             CE


                      ISO 9000 Project Task Force


          The task force or project team will normally have the following
          composition:
          Project leader
        • A senior executive with the requisite competence and experience, who
          will usually also be the designated management representative.
          Members:
        • one representative from each functional area. This representative
          should have a thorough knowledge of the function of his or her
          department and should be enthusiastic about setting up quality
          systems.
          The task force should have its own secretarial support in order to be
          self-contained in its operations.
FICCI
FICCI                                                                                 CE

                       Responsibilities of Task Force


            The task force will have the following responsibilities, among others:
        •   Evaluating the effectiveness of existing quality-control operations
        •   Detailed planning of the ISO 9000 Project
        •   Preparing procedures and the quality manual
        •   Training personnel in ISO 9000
        •   Coordinating the implementation activities of various departments
        •   Monitoring the progress of implementation and providing status
            reports to the steering committee
        •   Organizing periodic audits to assess the state of conformity to the ISO
            standard
        •   Arranging assessment by the certification agency and taking follow-up
            action.
FICCI
FICCI                                                                 CE

                            Designing QMS



        • ISO 9001:2000 is less prescriptive than ISO 9000:1994
          version. The new standard allows much greater flexibility
          to the organisation in designing a QMS appropriate to its
          business.
        • The new standard has strong customer focus as such
          various processes of QMS should be designed to ensure
          customer satisfaction as a strategy to meet long term
          organizational objectives.
        • Main activities for design of QMS are given in succeeding
          slides.
FICCI
FICCI                                                                           CE

               Determination of Functional Responsibility




        To design the quality management system we must analyze various
        requirements of ISO 9001:2000 and determine which are the business
        functions that must address various requirements of the standard. In
        most cases the existing business functions should be able to design
        their processes to comply with specific requirements of the standard
        which are applicable to the organization. In some cases, a new
        functional group may be created to comply with a particular
        requirement if none of the existing groups can be given this
        responsibility. To facilitate this analysis a suggested matrix of ISO
        9001:2000 requirements and the business functions which should
        address the same, are given in following slides:
FICCI
FICCI                                                                  CE

        Matrix of ISO 9000:2000 Clauses and Business Functions



            ISO                 CLAUSE TITLE               BUSINESS
         9001:2000                                        FUNCTIONS
          CLAUSE
         4         Quality Management System

         4.1      General requirements                 Business
                                                       management
                                                       All functions
         4.2      General Documentation Requirements

         4.2.1    System documentation                 All functions

         4.2.2    Quality Manual                       Business
                                                       Management
         4.2.3    Control of documents                 All functions

         4.2.4    Control of records                   All functions
FICCI
FICCI                                                                      CE
                       Matrix of ISO 9000:2000…contd..



    ISO 9001-                        CLAUSE TITLE          BUSINESS
      2000                                                FUNCTIONS
     CLAUSE
   5.           Management responsibility


   5.1          Management commitment                Business management

   5.2          Customer focus                       Business management
                                                     Marketing
                                                     Sales
   5.3          Quality Policy                       Business Management

   5.4          Planning

   5.4.1        Quality Objectives                   All functions

   5.4.2        Quality Management system planning   Business management
FICCI
FICCI                                                                      CE
                     Matrix of ISO 9000:2000…contd..

   ISO 9001-                 CLAUSE TITLE                      BUSINESS
       2000                                                   FUNCTIONS
    CLAUSE
   5.5       Responsibility, authority and communication

   5.5.1      Responsibility and authority                 HR Management

   5.5.2      Management representative                    Business
                                                           management
   5.5.3      Internal communication                       All functions

   5.6        Management review

   5.6.1      General                                      All functions

   5.6.2      Review input                                 All functions

   5.6.3      Review output                                All functions
FICCI
FICCI                                                                       CE
                       Matrix of ISO 9000:2000…contd..


        ISO 9001-              CLAUSE TITLE               BUSINESS
          2000                                           FUNCTIONS
         CLAUSE
        6         Resource management

        6.1      Provision of resources               All functions

        6.2      Human resources

        6.2.1    General                              HR Management

        6.2.2    Competence, training and awareness   HR Management

        6.3      Infrastructure                       Physical resource
                                                      maintenance
        6.4      Work environment                     Business
                                                      management/Physical
                                                      resource management
FICCI
FICCI                                                                       CE
                    Matrix of ISO 9000:2000…contd..

   ISO 9001-                CLAUSE TITLE                         BUSINESS
     2000                                                       FUNCTIONS
    CLAUSE
   7         Product realization

   7.1       Planning of product realization                 Business
                                                             management
   7.2       Customer-related processes

   7.2.1     Determination of requirements related to the    Marketing
             product                                         Sales
   7.2.2     Review of requirements related to the product   Sales

   7.2.3     Customer communication                          Marketing
                                                             Sales
FICCI
FICCI                                                                          CE
                   Matrix of ISO 9000:2000…contd..
   ISO 9001-               CLAUSE TITLE                      BUSINESS
       2000                                                 FUNCTIONS
    CLAUSE
   7.3       Design and Development

   7.3.1     Design and development planning             Product development

   7.3.2     Design and development input                Product development

   7.3.3     Design and development outputs              Product development

   7.3.4     Design and development review               Product development

   7.3.5     Design and development verification         Product development

   7.3.6     Design and development validation           Product development

   7.3.7     Control of design and development changes   Product development
FICCI
FICCI                                                             CE
                    Matrix of ISO 9000:2000…contd..



    ISO 9001-                CLAUSE TITLE              BUSINESS
        2000                                          FUNCTIONS
     CLAUSE
    7.4       Purchasing

    7.4.1     Purchasing process                   Purchasing

    7.4.2     Purchasing information               Purchasing

    7.4.3     Verification of purchased products   Purchasing
FICCI
FICCI                                                                            CE
                     Matrix of ISO 9000:2000…contd..


    ISO 9001-               CLAUSE TITLE                              BUSINESS
        2000                                                         FUNCTIONS
     CLAUSE
    7.5       Production and service provision

    7.5.1      Control of production and service provision       Production

    7.5.2      Validation of processes for production and service Production
               provision
    7.5.3      Identification and traceability                    Production

    7.5.4      Customer property                                 Production

    7.5.5      Preservation of product                           Distribution

    7.6        Control of monitoring and measuring devices       All functions
FICCI
FICCI                                                                              CE
                        Matrix of ISO 9000:2000…contd..

        ISO 9001-              CLAUSE TITLE                      BUSINESS
          2000                                                  FUNCTIONS
         CLAUSE
        8         Measurement, analysis and improvement

        8.1        General                                   All functions

        8.2        Monitoring and measurement

        8.2.1                                                Business management
                   Customer satisfaction                     Marketing
                                                             sales
        8.2.2      Internal audit                            All functions

        8.2.3      Monitoring and measurement of processes   All functions

        8.2.4                                                Purchasing
                   Monitoring and measurement of product
                                                             Production
FICCI
FICCI                                                               CE
                      Matrix of ISO 9000:2000…contd..

    ISO 9001-                      CLAUSE TITLE          BUSINESS
      2000                                              FUNCTIONS
    CLAUSE
                                                    Purchasing
    8.3         Control of non conforming product
                                                    Production
    8.4         Analysis of data                    All functions

    8.5         Improvement

    8.5.1       Continual Improvement               All functions

    8.5.2       Corrective action                   All functions

    8.5.3       Preventive action                   All functions
FICCI
FICCI                                                                                  CE

                          Identification of Processes


            The new standard advocates process approach. Having determined the
            functional responsibilities, the next step is to identify key processes
            which affect product quality and/or customer satisfaction, so that these
            can be structured to comply with various requirements of the standard.
            These processes can be considered under following groups:
        -   General business management
        -   Human Resource Management
        -   Resource management
        -   Marketing and sales
        -   Design and development
        -   Purchase
        -   Production/service delivery processes
        -   Measurement and improvement process
FICCI
FICCI                                                                              CE

                      General Business Management




            The primary function of management of an enterprise is to manage all
            aspects of business including quality management system. QMS
            processes under this group include:
        -   Strategic business management and policy planning
        -   QMS document control
        -   Quality record control
        -   Communication between functions and processes
        -   Management review of QMS
FICCI
FICCI                                                               CE

                  Human Resource Management




          Human resource is the most vital input which can affect
          quality of products or service. This could have the
          following processes:
        - Personnel selection, recruitment and deployment
        - Training and competency building
        - Performance appraisal and rewards
FICCI
FICCI                                                                         CE

                       Physical Resource Management



        • Normally planning and provision of resource may come under the
          responsibility of business management and administration.
        • Maintenance activities are normally dealt with by two functional
          departments. General maintenance may be part of general
          administration and the equipment maintenance comes under
          production. Whatever be the organizational structure, following
          processes would be needed for QMS:
        - Planning of infrastructure and equipment for new project/products
        - Maintenance of buildings and utilities
        - Maintenance of process plant and equipment
        - Control of in-house and out-sourced services
FICCI
FICCI                                                                              CE

                             Marketing and Sales



            These are processes through which an organization determines the
            customer requirements and deliver products and services. These would
            involve following processes:
        •   Marketing including market research to identify customer segments to
            be served and determine customer requirements, for various products
            and services.
        •   Sales process for interaction with customers and secure
            orders/contracts
        •   Review of orders/contracts to assess capability for fulfillment
        •   Sales, delivery and installation (wherever required)
        •   After sales services
        •   Handling of customer complaints
FICCI
FICCI                                                      CE

                Design and Development

        This requirement is relevant only for those
        organizations that actually carry out design and
        development. It should be noted that provision
        of control for design and development in no
        way restricts the creativity of designer. This
        would require following process:
   •    Design and development planning covering
        definition of design objectives, resources,
        material inputs and information required and
        description of main design activities including
        time schedule
   •    Design review at important stages
   •    Design verification and validation where
        required
   •    Incorporation of changes in design
FICCI
FICCI                                                                              CE

                                    Purchasing



           Purchasing is an important function because it not only accounts for
           50 to 60% of cost of products but also has a direct impact on the
           quality of end product. Following purchase related processes would be
           involved in the quality system:
        • Selection and approval of suppliers
        • Issue of purchase order
        • Verification of purchased product
        • Dealing with non conforming supplies
        • Monitoring and review of suppliers
FICCI
FICCI                                                                                CE

                    Production and Service Delivery



           Quality is actually built into the product during its production stage.
           Therefore, this has to be given maximum attention during
           establishment of quality management system. This would include
           following process:
        • Quality planning for new contracts or products. For existing products,
          quality plan may already be established through production documents
        • Review of process plans to identify risk of non conformity
        • Development of process controls
        • Validation of critical process and qualification of personnel where
          quality cannot be verified after completion of work.
FICCI
FICCI                                                            CE

                     Production and Service Delivery




        • Inspection and testing of products
        • Process for ensuring identification and traceability
        • Process for care of customer property
        • Packaging and storage of products
        • Maintenance of process equipment
        • Calibration of measuring devices
        • Process for dealing with non conforming products
FICCI
FICCI                                                                                 CE

                     Measurement and Improvement



            There is no separate department for undertaking these activities. These
            are inherent part of various functions who are responsible for
            monitoring their own processes. However, monitoring of QMS as a
            whole is a new responsibility which will need to be assigned. The new
            standard specifically requires the organization to monitor and analyze
            the processes/activities with a view to continually improving the
            effectiveness of quality management system. This would involve
            following processes:
        -   Monitoring/measurement of different processes
        -   Measurement of customer satisfaction
        -   Monitoring the QMS performance through internal audits
        -   Analysis of data for taking action for improvement.
FICCI
FICCI                                                                            CE

                              Defining Processes



            Having identified the processes, there is a need to define each
            process so that it can be effectively controlled. This is the core
            of quality management system. This would involve:
        -   Designation of process owner
        -   Defining the output of the process
        -   Specification of inputs by way of resources, material and
            information
        -   Description of process activities
        -   Specifying guidance documents to the used and records to be
            generated.
FICCI
FICCI                                                                         CE


                      Defining Processes…contd..




        - Defining interfaces between process stages and input providers
          and sequential processes which receive the outputs.
        - Establishing mechanism for monitoring and control.
        - Delegation of authority for corrective action if the process goes
          out of control.
FICCI
FICCI                                                                           CE

                     Development of QMS Documentation




        • Once Quality Management System has been designed, this has to be
          institutionalized by developing suitable documentation. Most of the
          documents required for QMS would already be existing as explained
          in section-5.
        • Following new documents may be required to be developed:
        -   Quality Policy
        -   Quality Objectives
        -   Quality Manual
        -   Quality System Procedures
FICCI
FICCI                                                                                CE

                  Defining and Deployment of Quality Policy


        •   If there exists a quality policy, it should be revisited and we should
            ask:
        -   Is it for real?
        -   Is it consistent with overall business plan?
        -   Are quality objectives tangible and realistic?
        •   Define an actionable quality policy aligned to vision and mission of
            company involving key personnel who have to implement the policy.
        •   Establish realistic and measurable quality objectives with full
            agreement of management team.
        •   Deploy quality policy throughout organization by cascading quality
            objectives to relevant functions and levels.
FICCI
FICCI                                                                                CE

                   Establishment of Quality Objectives



            In order to implement quality policy, the organization needs to
            establish specific quality objectives to be achieved over a given time
            frame.
        •   The standard now calls for measurable quality objective, not only of
            management system but also for products or services.
        •   Appropriate quality objectives must be set for functional areas and
            different levels of the organization to deploy quality policy in the
            entire organization.
        •   Since quality objectives are liable to change from time to time these
            may not be included in quality management manual which is of semi-
            permanent nature.
        •   Quality objectives could be defined in a separate document or included
            in quality improvement plan.
FICCI
FICCI                                                                                 CE

                        Typical Quality Objectives


           To maintain credibility of QMS the quality objectives should be
           realistic and achievable. They must present a challenge and require
           extra effort for achievement. Some of the possible quality targets could
           be:
        • Meeting the customers requirements of product quality and delivery.

        • Identifying opportunities for improvement in products.

        • Increase in process yield or production per hour.

        • Reduction in rejection or rectification level for manufactured products

        • Improving specific service quality parameters.
FICCI
FICCI                                                                          CE


                       Developing Quality Manual




        • Quality manual is an apex document which describes how various
          requirements of the standard are complied with.
        • Draft quality manual is developed by the members of QMS task force
          who should be given special training on interpretation of ISO
          9001:2000. They need to understand all the processes in the
          organization which impact on quality management system. Guidance
          on contents of quality manual is given in Section-5.
FICCI
FICCI                                                                             CE


                     Finalization of Quality Manual




        • Once the draft Quality Manual has been prepared by the task force, it
          should be circulated to all the departments and functional groups for
          their study and observations. The comments received from various
          groups should be considered and suitable changes may be made after
          consultation with the departments who may be affected by the
          changes.
        • The task force should then present the quality manual to the steering
          committee for their consideration and formal approval.
FICCI
FICCI                                                                                CE


                  Preparation of Quality System Procedures



        • Preparation of procedures requires careful consideration. It should be
          noted that the standard specifies only six procedures which must be
          documented as explained in section-5.
        • A procedure is essentially a list of steps or activities to accomplish a
          task. This can be defined by standardized training of personnel
          responsible for performing these tasks. If a documented procedure is
          considered necessary, it should be prepared as explained in Section-5.
        • In most companies documented procedures or instructions for
          important processes would already be existing. There is no need to re-
          document these procedures if the processes meet the requirement of
          the standard and are being operated as per existing procedure. All it
          requires is that these procedures should be brought under document
          control.
FICCI
FICCI                                                                               CE
            Preparation of Quality System Procedures…contd.




        • If new procedures need to be documented these should be prepared
          based on the existing processes and practices provided they are able to
          ensure quality conformance.
        • Procedures must also cover interfaces with the processes which
          provide inputs and succeeding process which receive the output.
        • The personnel performing these activities should be involved in
          preparation of new procedures so that they accept ownership of
          processes.
FICCI
FICCI                                                                               CE


                 Approval of Documented Procedures




        •   The documented procedures must be formally approved by the head of
            the functional group of the relevant process for incorporation in QMS
            documentation.
        •   Where a procedure is applicable to more than one functional groups,
            the group with prime responsibility of the process should be
            designated as coordinating group. In such cases the procedure must be
            approved by the head of coordinating group in consultation with other
            functional groups.
FICCI
FICCI                                                                                CE

                 Training of Personnel in Operation of QMS




        • Effective implementation of QMS requires active cooperation and
          involvement of all employees.
        • After the quality management system has been developed, the
          organization should arrange seminars and short training programs in
          different functional areas to train staff on QMS processes and their
          own role and responsibilities.
        • Special training programs should be organized for training of internal
          auditors.
        • Since statistical tools may be required for analysis of data to plan for
          improvement, selected staff should also be trained on use of statistical
          techniques.
FICCI
FICCI                                                                              CE


                             Implementation Steps


            Following steps are involved in actual implementation of QMS:
        •   Formal issue of executive instruction for QMS and distribution of
            QMS documentation.
        •   Training of personnel on new processes where required.
        •   Trial implementation of QMS.
        •   Training of internal auditors.
        •   First internal audit to assess status of implementation and identify
            problems if any.
        •   Fine tuning of QMS and resolution of problems and difficulties in
            implementation.
FICCI
FICCI                                                                            CE


                          Implementation Steps…contd.
                            Implementation Steps




        • Conduct of second internal audit after giving reasonable time for
          implementation
        • Analysis of audit findings and taking necessary corrective and
          preventive action.
        • Conduct of third internal audit and stabilization of QMS.
        • Selection of certification agency and application for certification.
        • Audit by certification agency and grant of certificate.
        • Celebrate and acknowledge efforts of all involved in the ISO 9000
          project.
FICCI
FICCI                                                                             CE


                         Moving beyond ISO 9001


        • Implementation of QMS as per ISO 9001:2000 is only the first major
          step in the quality journey. Quality never stays at one level. It has
          strong gravitational pull to come down unless you make conscious
          efforts to improve continually.
        • Tremendous enthusiasm would have been generated during
          implementation of ISO 9001. Use this momentum to move higher
          towards ISO 9004 which has well charted road map.
        • FICCI QUALITY FORUM is there to help you. Please see next slide
          for free customer support services.
FICCI
FICCI                                                                                    CE

                   Free Customer Support Services
   Please fax / email your problem / query to us in the following format:-


   Customer Code No………………………………………………………………………….
   Name ………………………………………………………………………………………..
   Designation………………………………………………………………………………….
   Organization………………………………………………………………………………...
   Organization Address……………………………………………………………………….
   Tel………………………….Fax………………………..Email……………………………
   Nature of business…………………………………………………………………………...
   Nature of problem / Query…………………………………………………………………..
   ………………………………………………………………………………………………
   ………………………………………………………………………………………………
   ………………………………………………………………………………………………
   ………………………………………………………………………………………………
  Lt. General H.Lal , Director General, FICCI Quality Forum, Federation of Indian Chambers
        of Commerce & Industry, Federation house, Tansen Marg, New Delhi: 110001
         Tel: 011-3739947, 011-3738760-70 , Fax: 011-3320714, Email: fqf@vsnl.net
FICCI
FICCI                                                                                                             CE
                                        ABOUT THE AUTHOR



   This CD-ROM has been developed by Lt.. Gen. H. Lal.

   General Lal joined Defence Quality Assurance Organization in 1971 and rose to the highest position as
   its Director General. On 26th January, 1990, he was awarded Param Vashisht Sewa Medal (PVSM) - the
   highest peace time award by the President of India for distinguished services of most exceptional order
   in the field of Quality Assurance.

   After retirement from Army, he was appointed Director General, Bureau of Indian Standards. In this
   capacity, he played an active role in the activities of International Organization for Standardization (ISO)
   in projecting the quality problems in developing countries.

   He has published numerous papers and books. He is internationally recognized quality management
   expert and two editions of his book entitled “ISO 9000 : GUIDELINES FOR DEVELOPING COUNTRIES”
   have been published by ISO and UNCTAD/WTO International Trade Centre, Geneva. Both these books
   were published in English, French and Spanish for worldwide circulation. These have become reference
   books and have been translated in over 10 languages in different countries of Asia, Africa and Latin
   America.

   He is the Chairman of Management & Systems Division Council of Bureau of Indian Standards. In this
   capacity he is leader of Indian delegation to ISO/TC 176 and was member of the international expert
   group, which developed ISO 9000:2000 series of standards.

   He has also been ADVISER to UNITED NATIONS DEVELOPMENT ORGANISATION (UNIDO) for
   some quality improvement projects undertaken by them.

   On full time basis, he is the Director General, FICCI Quality Forum.
FICCI
FICCI                                                                             CE

             Research, Artwork, Design and development




        Pravin Rajpal
        Mr. Pravin Rajpal is a Chartered Accountant with more than 12 years of
        work experience in some of the best professionally managed companies in
        India. He worked for Eicher Consultancy services , a premier management
        consultancy company in India for 4 years .
        At present he is the CEO of Competitive Edge, Management Consultants .

				
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