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ISO 9001:2008 Quality Management
           System - Requirements
            Quality Management Series
                  y     g




© 2010 www.TechnoSysCon.com. All rights reserved.
Overview

    Evolution of Quality Systems

    Brief about ISO

    History of ISO 9000 Series of Standards,

    Aims, Approach and Principles

    Key benefits to the Organizations
      y                   g

    Clauses of ISO 9001:2008

    Key Requirements of ISO 9001:2008

    Certification Process

    Discussions



TechnoSysCon                 Slide 2           . . . .preferred partner for sustainable systems .
Evolution of Quality Systems
   Contributing factors
      Globalization & increased competition
      Changer over of Market to Buyers Market

      Customer - Quality Conscious




  Need
     Changed perception of Quality - PRICE, DELIVERY, PERFORMANCE,

  Result - Development of common Quality System Guidelines by ISO, which are
     Globally recognized.

TechnoSysCon                 Slide 3            . . . .preferred partner for sustainable systems .
Evolution of Quality Systems
 Quality Systems – Approach recognizes continuous Improvement in Quality can
 be best achieved through planning and preventing problems form arising at
 source with the introduction of Quality Control Tools and Techniques. This
                                       y                         q
 helped to move emphasis from detection to prevention.
 Quality Assurance – Approach recognizes the inherent inefficiency of
 waiting for the mistakes to happen. Analysis of Nonconformance and
                             happen
 Cause in a systematic manner. Design Quality into the process and
 practices so that things cant go wrong
 Quality Control – Approach recognizes that Quality Should be
 Designed into a detailed specification and that Quality Checks should
 be made throughout the Production or Service Delivery. This will not
                g                                        y
 improve the product or Service Quality, it will only high light when it
 will not present.
 Quality Inspection – Simple Approach that relies on identifying
 defects in the Product or service before they reach the customer
 by introducing “Inspection Stage or stages. Against the
 specification
      ifi i

TechnoSysCon                   Slide 4             . . . .preferred partner for sustainable systems .
International Organisation for Standardization
 • ISO is a network of the national standards institutes of 156 countries, on the
   basis of one member per country, with a Central Secretariat in Geneva,
   Switzerland, that coordinates the system.
 • "International Organization for Standardization" would have different
   abbreviations in different languages ("IOS" in English, "OIN" in French for
                                 g g (              g    ,
   (Organisation internationale de normalisation). - a word derived from the
   Greek isos, meaning "equal".
 • International Electro technical Commission (IEC) was established in 1906.
 • National Standardizing Associations (ISA), which was set up in 1926.
 • ISO, officially began operations on 23 February 1947.
 • ISO standards are developed by TECHNICAL COMMITTEES comprising experts
   from the industrial, technical and business sectors which have asked for the
   standards, and usage.


TechnoSysCon                   Slide 5            . . . .preferred partner for sustainable systems .
History of ISO 9000 Series
   In the year 1985 the Quality Management systems Concept came into the
   Existence by ISO
   In the year 1987 First Guidelines as requirements of Q
          y                               q             Quality Management
                                                              y     g
   Systems has been published for the Purpose of Certification.
   In the year 1994 First revision took place to make it more practical for the
   Implementation and Simple to understand. Four Standards published ISO 9001,
   ISO 9002, ISO 9003, ISO 9004.
   In th
   I the year 2000 Second revision t k place t make it generic f th
                    S     d     i i took l     to     k         i for the
   application in any type of Industry and simplified form the Audit Point of View.
   15th November 2008 Third revision published to give more clarity for
   implementation and use. Clauses and structure is same as earlier.

          Process of Drafting and Publication of Standards by ISO –
                ISO Draft Standard (DIS) , ISO / PAS , ISO / TS , ISO



TechnoSysCon                   Slide 6            . . . .preferred partner for sustainable systems .
About ISO 9000 Series

 • Developed by TC 176.
 • Applicable to all types of Industries.
 • This means what the organization does to enhance customer satisfaction by
   meeting customer and applicable statutory & regulatory requirements related
   to product and continually to improve its performance.
 • More focus on awareness and implementation rather than documentation,
   Efforts towards Continual Improvement in Performance, Focus on identifying
   Customer requirements, customer Satisfaction and customer communication.
 • I is a model f Q li M
   It i     d l for Quality Management S
                                       System.
 • An Organisation is assessed by the third party (Certification Body) and
   certificate of ISO 9001 2008 i i
      tifi t f        9001:2008 is issued.
                                        d




TechnoSysCon                    Slide 7           . . . .preferred partner for sustainable systems .
ISO 9001:2008 - Quality Management System

               The Global Management System for all types of Industries
                                            AIM OF QMS
                                                    Q
                           iDefect prevention rather than Detection
                           iData analysis based Planning
                           iReduction in wastage’s
                           iCustomer satisfaction
                           iContinual Improvement




TechnoSysCon                  Slide 8            . . . .preferred partner for sustainable systems .
Approach of ISO 9001:2008 ( QMS )

  • Structured on PDCA Cycle Management Principle                          Plan
                                                          Act
    in every activity.                                                      What to do?
                                                     How to improve
                                                                           How to d it?
                                                                           H   t do
                                                     next time?
  • Process Approach.                                                           When ?


  • Efforts towards Continual Improvement in           Check                    Do
    Performance.                                      Did things happen    Do what was
                                                      according to plan?       planned




  • More focus on awareness and implementation rather than documentation.
  • Focus on identifying Customer requirements, customer Satisfaction and
    customer communication
  •C
   Compatible with ISO 14001:2004 E i
        tibl   ith     14001 2004 Environmental M
                                            t l Management system.
                                                         t    t




TechnoSysCon                 Slide 9            . . . .preferred partner for sustainable systems .
Schematic Representation of Process

                                                                                           EFFECTIVENESS
                                                                                            EFFECTIVENESS
                                 PROCEDURE*                                                 OF PROCESS ==
                                                                                             OF PROCESS
                                                                                            Ability to achieve
                                                                                                  y
            ( Specified
            (“Specified way to carry out an activity or a                                    Ability to achieve
                                                                                             desired results
                                                                                              desired results
               process” - may be documented or not)                                          (Focus of ISO
                                                                                              (Focus of ISO
                                                                                               9001:2000)
                                                                                                 9001:2000)




            Input                PROCESS                                     Output
                                                                                           PRODUCT
          (
          (Includes
                                 (“Set of interrelated
         Resources)            or i t
                                  interacting activities”)
                                         ti     ti iti ”)                                    ( Result
                                                                                             (“Result of a
                                                                                               process”)

                                                                                             EFFICIENCY OF
                                                                                              EFFICIENCY OF
                          MONITORING AND                                                        PROCESS ==
                                                                                                 PROCESS
                    MEASUREMENT OPPORTUNITIES                                                Results achieved
                                                                                              Results achieved
                                                                                            vs resources used
                                                                                             vs resources used
                      (Before, during and after the process)                                   (Focus of ISO
                                                                                                (Focus of ISO
                                                                                                 9004:2000)
                                                                                                  9004:2000)

    * Note – This is the definition of “procedure” given in ISO 9000:2000.
    This does not necessarily mean one of the 6
    “documented procedures” required by ISO 9001:2008




TechnoSysCon                                Slide 10                         . . . .preferred partner for sustainable systems .
Process Approach based QMS
                                    Continual Improvement
                                             of QMS

                                             Management
                                             Responsibility
                                              espo s b l ty
                    nts




                                                                                                            isfaction
                                                                                                                    n
              uiremen
   Custome Requ




                                                                                                  Custom Sati
                                 Resource               Measurement,
                                Management               analysis &




                                                                                                       mer
                                                        improvement
                                                          p ove e t
   C     er




                                                Product
                            Input              Realization                Product

TechnoSysCon                            Slide 11              . . . .preferred partner for sustainable systems .
Process Approach Turtle Diagram

  Enter the details of machine,                        Enter resource requirements, pay
  materials, test equipments,                          particular attention to required
  Software systems, computers                          Knowledge, skills and competence
                                                       criteria, safety equipments etc.

  Enter the details of                                                      Enter the details of
  actual Inputs this                                                        required output this
  may be Information,                        Process                        may be product,
  Documents,
  Documents            Input            Cop
                                        C or Support
                                               S     t        Output        document, record,
                                                                            document record
  Materials, Tooling,                    process name                       and should be actual
  Schedule                                                                  measure of
                                                                            effectiveness


  Methods / procedures - Enter the                         Measurement of Effectiveness -
  details of actual Inputs this may                        Enter the details of process
  be Information, Documents,                               measurement parameters, KPI,
  Materials, Tooling, Schedule
            ,       g,                                     PMI etc
                                                               etc.


TechnoSysCon                      Slide 12               . . . .preferred partner for sustainable systems .
Principles of Management Systems


                                            Customer focus

                                                Leadership

                                     Involvement of people

                                          Process approach

                        System approach to management

                                     Continual improvement

                    Factual approach to decision making

                Mutually beneficial supplier relationships




TechnoSysCon              Slide 13             . . . .preferred partner for sustainable systems .
Key Benefits to the Organisations
 • Increased revenue and market share obtained through flexible and fast
   responses to market opportunities.
 • Increased effectiveness in the use of the organization's resources to enhance
                                             organization s
   customer satisfaction.
 • Improved customer loyalty leading to repeat business.
 • People will understand and be motivated towards the organization's goals and
   objectives.
 • Activities are evaluated, aligned and implemented in a unified way.
 • Miscommunication between levels of an organization will be minimized.
 • Lower costs and shorter cycle times through effective use of resources.
                 d h          l         h    h ff             f
 • Improved, consistent and predictable results. Ability to focus effort on the key
   processes.
 • Focused and prioritized improvement opportunities.
 • Integration and alignment of the processes that will best achieve the desired
       g              g             p
   results.

TechnoSysCon                  Slide 14            . . . .preferred partner for sustainable systems .
Key Benefits to the Organisations
 • Providing confidence to interested parties as to the consistency, effectiveness
   and efficiency of the organization.
 • P f
   Performance advantage th
                d   t    through i
                               h improved organizational capabilities.
                                        d      i ti    l     biliti
 • Alignment of improvement activities at all levels to an organization's strategic
   intent.
   intent
 • Flexibility to react quickly to opportunities. Increased ability to create value
   for both parties.
             p
 • Flexibility and speed of joint responses to changing market or customer needs
   and expectations.
 • Optimization of costs and resources.
 • An increased ability to demonstrate the effectiveness of past decisions through
   reference to factual records.
 • Increased ability to review, challenge and change opinions and decisions.


TechnoSysCon                   Slide 15            . . . .preferred partner for sustainable systems .
Currently available Standards of ISO 9000 series
  •   ISO 9000:2005 - Q lit management systems -- F d
          9000 2005 Quality          t    t       Fundamentals and
                                                          t l    d
      vocabulary
  •   ISO 9001:2008 - Quality management systems -- Requirements
  •   ISO 9004:2000 - Quality management systems -- Guidelines for performance
      improvements
  •   ISO 9004:2009 - Managing for the sustained success of an organization -- A
      quality management approach
  •   ISO 19011:2002 - Guidelines for quality and/or environmental Management
      Systems Auditing
  •   ISO 10005:2005 - Quality management systems -- Guidelines for quality plans




TechnoSysCon                   Slide 16           . . . .preferred partner for sustainable systems .
Important Definition
    Quality - Totality of CHARACTERISTICS and FEATURES of PRODUCT &
    SERVICE that bears on it’s ability to fulfill STATED & IMPLIED needs of
    EXISTING and POTENTIAL CUSTOMERS
                              CUSTOMERS.
    Quality - Degree to which a set of Inherent Characteristics fulfills
    requirements.
    requirements – 2005
    Inspection – conformity evaluation by observation and judgement
    accompanied as appropriate by measurement testing or gauging
                                   measurement,
    Quality control – Part of Quality Management focused on fulfilling quality
    Requirements.
    Quality Assurance – Part of Quality Management focused on providing
    confidence that quality requirements will be fulfilled.
                    q     y q
    Quality Management system – Management system to direct and control an
    organisationwith regard to Quality.


TechnoSysCon                   Slide 17            . . . .preferred partner for sustainable systems .
ISO 9001:2008 Clauses
1.0    Scope
2.0    Normative Reference
3.0    Terms and Definitions
4.0    Quality Management System
       4.1
       41       General R
                G     l Requirements
                            i
       4.2      Documentation Requirements
                4.2.1
                4 2 1 General
                4.2.2 Quality Manual
                4.2.3 Document Control
                4.2.4 Control of Records

5.0    Management Responsibility
       5.1      Management Commitment
       5.2      Customer Focus

TechnoSysCon                   Slide 18      . . . .preferred partner for sustainable systems .
ISO 9001:2008 Clauses Continued ……
5.0    Management Responsibility Continued ……
       5.3      Quality Policy
       5.4      Planning
                5.4.1   Quality Objectives.
                5.4.2   Quality Management System Planning.
       5.5      Responsibility , Authority and Communication
                5.5.1   Responsibility and Authority
                5.5.2   Management Representative
                5.5.3   Internal Communication
       5.6      Management Review
                5.6.1   General
                5.6.2   Review Input
                5.6.3   Review Output

TechnoSysCon                     Slide 19         . . . .preferred partner for sustainable systems .
ISO 9001:2008 Clauses Continued ……
6.0    Resource Management
       6.1      Provision of resources
       6.2
       62       Human resources
                H
                6.2.1   General
                6.2.2
                622     Competence,
                        Competence Training and awareness
       6.3      Infrastructure
       6.4
       64       Work Environment
7.0    Product Realization
       7.1      Planning for Product Realization
                       g
       7.2      Customer Related Processes
                7.2.1   Determination of requirements related to Product
                7.2.2   Review of Requirements related to Product
                7.2.3   Customer Communication.


TechnoSysCon                     Slide 20          . . . .preferred partner for sustainable systems .
ISO 9001:2008 Clauses Continued ……
7.0    Product Realization Continued ……
       7.3      Design and Development
                7.3.1
                731     Design d Development Pl
                        D i and D    l       Planning
                                                  i
                7.3.2   Design and Development Inputs
                7.3.3
                733     Design and Development Output
                7.3.4   Design and Development review
                7.3.5
                735     Design and Development verification
                7.3.6   Design and Development validation
                7.3.7   Control of Design and Development Changes
                                       g            p         g
       7.4      Purchasing
                7.4.1   Purchasing Process
                7.4.2   Purchasing Information
                7.4.3   Verification of purchased Product


TechnoSysCon                  Slide 21           . . . .preferred partner for sustainable systems .
ISO 9001:2008 Clauses Continued ……
7.0    Product Realization Continued ……
       7.5      Production and Service Provision
                7.5.1
                751     Control of P d i and S i P i i
                        C     l f Production d Service Provision
                7.5.2 Validation of processes for production and Service
                Provision
                7.5.3   Identification and Traceability
                7.5.4               p y
                        Customer Property
                7.5.5   Preservation of Product
       7.6      Control of monitoring and measuring Equipments




TechnoSysCon                   Slide 22            . . . .preferred partner for sustainable systems .
ISO 9001:2008 Clauses Continued ……
8.0    Measurement Analysis and Improvement Continued ……
       8.1      General
       8.2
       82       Monitoring d Measurement
                M i i and M
                8.2.1     Customer Satisfaction
                8.2.2
                822       Internal Audit
                8.2.3     Monitoring and measurement of processes
                8.2.4
                824       Monitoring and measurement of product
       8.3      Control of nonconforming product
       8.4      Analysis of Data
                    y
       8.5      Improvement
                8.5.1     Continual Improvement
                8.5.2     Corrective Action
                8.5.3     Preventive Action


TechnoSysCon                    Slide 23           . . . .preferred partner for sustainable systems .
Key Requirements of ISO 9001:2008

      Documentation Structure of QMS

                                                  Company profile, Organization Structure,
             Quality Manual                      Responsibilities, Quality Policy & Objectives
                                                       and brief of QMS requirements
                                           I

                                                 Explains What to do, whom to do it, when
               Procedure                           to do, where to do and how it is done
                                           II

    Instructions, Guidelines,                           Explains how a specific Operations/
                                           III                activity has to be done
               List

                                                                 Formats for recording of
      Forma, Formats,
      Forma Formats                        IV                   Information / d t which
                                                                I f    ti      data hi h
         Registers                                                   forms Records




TechnoSysCon                    Slide 24               . . . .preferred partner for sustainable systems .
Please contact us for any support……….


  We believe in Sustained Relationships……….




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                                                l ti hi      ith

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TechnoSysCon             Slide 25          . . . .preferred partner for sustainable systems .

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ISO 9001:2008 training

  • 1. ISO 9001:2008 Quality Management System - Requirements Quality Management Series y g © 2010 www.TechnoSysCon.com. All rights reserved.
  • 2. Overview Evolution of Quality Systems Brief about ISO History of ISO 9000 Series of Standards, Aims, Approach and Principles Key benefits to the Organizations y g Clauses of ISO 9001:2008 Key Requirements of ISO 9001:2008 Certification Process Discussions TechnoSysCon Slide 2 . . . .preferred partner for sustainable systems .
  • 3. Evolution of Quality Systems Contributing factors Globalization & increased competition Changer over of Market to Buyers Market Customer - Quality Conscious Need Changed perception of Quality - PRICE, DELIVERY, PERFORMANCE, Result - Development of common Quality System Guidelines by ISO, which are Globally recognized. TechnoSysCon Slide 3 . . . .preferred partner for sustainable systems .
  • 4. Evolution of Quality Systems Quality Systems – Approach recognizes continuous Improvement in Quality can be best achieved through planning and preventing problems form arising at source with the introduction of Quality Control Tools and Techniques. This y q helped to move emphasis from detection to prevention. Quality Assurance – Approach recognizes the inherent inefficiency of waiting for the mistakes to happen. Analysis of Nonconformance and happen Cause in a systematic manner. Design Quality into the process and practices so that things cant go wrong Quality Control – Approach recognizes that Quality Should be Designed into a detailed specification and that Quality Checks should be made throughout the Production or Service Delivery. This will not g y improve the product or Service Quality, it will only high light when it will not present. Quality Inspection – Simple Approach that relies on identifying defects in the Product or service before they reach the customer by introducing “Inspection Stage or stages. Against the specification ifi i TechnoSysCon Slide 4 . . . .preferred partner for sustainable systems .
  • 5. International Organisation for Standardization • ISO is a network of the national standards institutes of 156 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. • "International Organization for Standardization" would have different abbreviations in different languages ("IOS" in English, "OIN" in French for g g ( g , (Organisation internationale de normalisation). - a word derived from the Greek isos, meaning "equal". • International Electro technical Commission (IEC) was established in 1906. • National Standardizing Associations (ISA), which was set up in 1926. • ISO, officially began operations on 23 February 1947. • ISO standards are developed by TECHNICAL COMMITTEES comprising experts from the industrial, technical and business sectors which have asked for the standards, and usage. TechnoSysCon Slide 5 . . . .preferred partner for sustainable systems .
  • 6. History of ISO 9000 Series In the year 1985 the Quality Management systems Concept came into the Existence by ISO In the year 1987 First Guidelines as requirements of Q y q Quality Management y g Systems has been published for the Purpose of Certification. In the year 1994 First revision took place to make it more practical for the Implementation and Simple to understand. Four Standards published ISO 9001, ISO 9002, ISO 9003, ISO 9004. In th I the year 2000 Second revision t k place t make it generic f th S d i i took l to k i for the application in any type of Industry and simplified form the Audit Point of View. 15th November 2008 Third revision published to give more clarity for implementation and use. Clauses and structure is same as earlier. Process of Drafting and Publication of Standards by ISO – ISO Draft Standard (DIS) , ISO / PAS , ISO / TS , ISO TechnoSysCon Slide 6 . . . .preferred partner for sustainable systems .
  • 7. About ISO 9000 Series • Developed by TC 176. • Applicable to all types of Industries. • This means what the organization does to enhance customer satisfaction by meeting customer and applicable statutory & regulatory requirements related to product and continually to improve its performance. • More focus on awareness and implementation rather than documentation, Efforts towards Continual Improvement in Performance, Focus on identifying Customer requirements, customer Satisfaction and customer communication. • I is a model f Q li M It i d l for Quality Management S System. • An Organisation is assessed by the third party (Certification Body) and certificate of ISO 9001 2008 i i tifi t f 9001:2008 is issued. d TechnoSysCon Slide 7 . . . .preferred partner for sustainable systems .
  • 8. ISO 9001:2008 - Quality Management System The Global Management System for all types of Industries AIM OF QMS Q iDefect prevention rather than Detection iData analysis based Planning iReduction in wastage’s iCustomer satisfaction iContinual Improvement TechnoSysCon Slide 8 . . . .preferred partner for sustainable systems .
  • 9. Approach of ISO 9001:2008 ( QMS ) • Structured on PDCA Cycle Management Principle Plan Act in every activity. What to do? How to improve How to d it? H t do next time? • Process Approach. When ? • Efforts towards Continual Improvement in Check Do Performance. Did things happen Do what was according to plan? planned • More focus on awareness and implementation rather than documentation. • Focus on identifying Customer requirements, customer Satisfaction and customer communication •C Compatible with ISO 14001:2004 E i tibl ith 14001 2004 Environmental M t l Management system. t t TechnoSysCon Slide 9 . . . .preferred partner for sustainable systems .
  • 10. Schematic Representation of Process EFFECTIVENESS EFFECTIVENESS PROCEDURE* OF PROCESS == OF PROCESS Ability to achieve y ( Specified (“Specified way to carry out an activity or a Ability to achieve desired results desired results process” - may be documented or not) (Focus of ISO (Focus of ISO 9001:2000) 9001:2000) Input PROCESS Output PRODUCT ( (Includes (“Set of interrelated Resources) or i t interacting activities”) ti ti iti ”) ( Result (“Result of a process”) EFFICIENCY OF EFFICIENCY OF MONITORING AND PROCESS == PROCESS MEASUREMENT OPPORTUNITIES Results achieved Results achieved vs resources used vs resources used (Before, during and after the process) (Focus of ISO (Focus of ISO 9004:2000) 9004:2000) * Note – This is the definition of “procedure” given in ISO 9000:2000. This does not necessarily mean one of the 6 “documented procedures” required by ISO 9001:2008 TechnoSysCon Slide 10 . . . .preferred partner for sustainable systems .
  • 11. Process Approach based QMS Continual Improvement of QMS Management Responsibility espo s b l ty nts isfaction n uiremen Custome Requ Custom Sati Resource Measurement, Management analysis & mer improvement p ove e t C er Product Input Realization Product TechnoSysCon Slide 11 . . . .preferred partner for sustainable systems .
  • 12. Process Approach Turtle Diagram Enter the details of machine, Enter resource requirements, pay materials, test equipments, particular attention to required Software systems, computers Knowledge, skills and competence criteria, safety equipments etc. Enter the details of Enter the details of actual Inputs this required output this may be Information, Process may be product, Documents, Documents Input Cop C or Support S t Output document, record, document record Materials, Tooling, process name and should be actual Schedule measure of effectiveness Methods / procedures - Enter the Measurement of Effectiveness - details of actual Inputs this may Enter the details of process be Information, Documents, measurement parameters, KPI, Materials, Tooling, Schedule , g, PMI etc etc. TechnoSysCon Slide 12 . . . .preferred partner for sustainable systems .
  • 13. Principles of Management Systems Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships TechnoSysCon Slide 13 . . . .preferred partner for sustainable systems .
  • 14. Key Benefits to the Organisations • Increased revenue and market share obtained through flexible and fast responses to market opportunities. • Increased effectiveness in the use of the organization's resources to enhance organization s customer satisfaction. • Improved customer loyalty leading to repeat business. • People will understand and be motivated towards the organization's goals and objectives. • Activities are evaluated, aligned and implemented in a unified way. • Miscommunication between levels of an organization will be minimized. • Lower costs and shorter cycle times through effective use of resources. d h l h h ff f • Improved, consistent and predictable results. Ability to focus effort on the key processes. • Focused and prioritized improvement opportunities. • Integration and alignment of the processes that will best achieve the desired g g p results. TechnoSysCon Slide 14 . . . .preferred partner for sustainable systems .
  • 15. Key Benefits to the Organisations • Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the organization. • P f Performance advantage th d t through i h improved organizational capabilities. d i ti l biliti • Alignment of improvement activities at all levels to an organization's strategic intent. intent • Flexibility to react quickly to opportunities. Increased ability to create value for both parties. p • Flexibility and speed of joint responses to changing market or customer needs and expectations. • Optimization of costs and resources. • An increased ability to demonstrate the effectiveness of past decisions through reference to factual records. • Increased ability to review, challenge and change opinions and decisions. TechnoSysCon Slide 15 . . . .preferred partner for sustainable systems .
  • 16. Currently available Standards of ISO 9000 series • ISO 9000:2005 - Q lit management systems -- F d 9000 2005 Quality t t Fundamentals and t l d vocabulary • ISO 9001:2008 - Quality management systems -- Requirements • ISO 9004:2000 - Quality management systems -- Guidelines for performance improvements • ISO 9004:2009 - Managing for the sustained success of an organization -- A quality management approach • ISO 19011:2002 - Guidelines for quality and/or environmental Management Systems Auditing • ISO 10005:2005 - Quality management systems -- Guidelines for quality plans TechnoSysCon Slide 16 . . . .preferred partner for sustainable systems .
  • 17. Important Definition Quality - Totality of CHARACTERISTICS and FEATURES of PRODUCT & SERVICE that bears on it’s ability to fulfill STATED & IMPLIED needs of EXISTING and POTENTIAL CUSTOMERS CUSTOMERS. Quality - Degree to which a set of Inherent Characteristics fulfills requirements. requirements – 2005 Inspection – conformity evaluation by observation and judgement accompanied as appropriate by measurement testing or gauging measurement, Quality control – Part of Quality Management focused on fulfilling quality Requirements. Quality Assurance – Part of Quality Management focused on providing confidence that quality requirements will be fulfilled. q y q Quality Management system – Management system to direct and control an organisationwith regard to Quality. TechnoSysCon Slide 17 . . . .preferred partner for sustainable systems .
  • 18. ISO 9001:2008 Clauses 1.0 Scope 2.0 Normative Reference 3.0 Terms and Definitions 4.0 Quality Management System 4.1 41 General R G l Requirements i 4.2 Documentation Requirements 4.2.1 4 2 1 General 4.2.2 Quality Manual 4.2.3 Document Control 4.2.4 Control of Records 5.0 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus TechnoSysCon Slide 18 . . . .preferred partner for sustainable systems .
  • 19. ISO 9001:2008 Clauses Continued …… 5.0 Management Responsibility Continued …… 5.3 Quality Policy 5.4 Planning 5.4.1 Quality Objectives. 5.4.2 Quality Management System Planning. 5.5 Responsibility , Authority and Communication 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communication 5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output TechnoSysCon Slide 19 . . . .preferred partner for sustainable systems .
  • 20. ISO 9001:2008 Clauses Continued …… 6.0 Resource Management 6.1 Provision of resources 6.2 62 Human resources H 6.2.1 General 6.2.2 622 Competence, Competence Training and awareness 6.3 Infrastructure 6.4 64 Work Environment 7.0 Product Realization 7.1 Planning for Product Realization g 7.2 Customer Related Processes 7.2.1 Determination of requirements related to Product 7.2.2 Review of Requirements related to Product 7.2.3 Customer Communication. TechnoSysCon Slide 20 . . . .preferred partner for sustainable systems .
  • 21. ISO 9001:2008 Clauses Continued …… 7.0 Product Realization Continued …… 7.3 Design and Development 7.3.1 731 Design d Development Pl D i and D l Planning i 7.3.2 Design and Development Inputs 7.3.3 733 Design and Development Output 7.3.4 Design and Development review 7.3.5 735 Design and Development verification 7.3.6 Design and Development validation 7.3.7 Control of Design and Development Changes g p g 7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of purchased Product TechnoSysCon Slide 21 . . . .preferred partner for sustainable systems .
  • 22. ISO 9001:2008 Clauses Continued …… 7.0 Product Realization Continued …… 7.5 Production and Service Provision 7.5.1 751 Control of P d i and S i P i i C l f Production d Service Provision 7.5.2 Validation of processes for production and Service Provision 7.5.3 Identification and Traceability 7.5.4 p y Customer Property 7.5.5 Preservation of Product 7.6 Control of monitoring and measuring Equipments TechnoSysCon Slide 22 . . . .preferred partner for sustainable systems .
  • 23. ISO 9001:2008 Clauses Continued …… 8.0 Measurement Analysis and Improvement Continued …… 8.1 General 8.2 82 Monitoring d Measurement M i i and M 8.2.1 Customer Satisfaction 8.2.2 822 Internal Audit 8.2.3 Monitoring and measurement of processes 8.2.4 824 Monitoring and measurement of product 8.3 Control of nonconforming product 8.4 Analysis of Data y 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action TechnoSysCon Slide 23 . . . .preferred partner for sustainable systems .
  • 24. Key Requirements of ISO 9001:2008 Documentation Structure of QMS Company profile, Organization Structure, Quality Manual Responsibilities, Quality Policy & Objectives and brief of QMS requirements I Explains What to do, whom to do it, when Procedure to do, where to do and how it is done II Instructions, Guidelines, Explains how a specific Operations/ III activity has to be done List Formats for recording of Forma, Formats, Forma Formats IV Information / d t which I f ti data hi h Registers forms Records TechnoSysCon Slide 24 . . . .preferred partner for sustainable systems .
  • 25. Please contact us for any support………. We believe in Sustained Relationships………. ….. and looking forward for having long term relationship with you l ti hi ith +91 20 2749 0009 , Mobile : 0 9423 00 5866 - info@technosyscon.com Visit us at ---------www.technosyscon.com www.technosyscon.com TechnoSysCon Slide 25 . . . .preferred partner for sustainable systems .