1




ISO 9000 AND 14000 VALIDATION


 SUBMITTED BY:
 SAINATH KARI             SUBMITTED TO:
                          MR.A.V.S.ASHOK,
                          ASST.PROFESSOR,
       RVR AND JC COLLEGE OF ENGINEERING,
                          CHOWDAWARAM,
                           GUNTUR.
2




                 Contents
1.Introduction
2.Principles
3.ISO 9000
4.Objectives
5.Advantages
6.ISO 14000
7.Conclusion
3




           Definition
ISO 9000 is a series of standards ,
 development and published by the
 ISO that define , establish and
 maintain an effective quality
 assurance system for manufacturing
 and service industries.
4




                  What is ISO
ISO is a name used for the
 International Organization for Standardization
ISO is not an acronym
It was formed in 1947 in Geneva Switzerland.
It is a federation of national standard bodies of
 143 countries.
5




                 OBJECTIVES


To Facilitate International Trade Of Goods and
 Services.
To obtain competitiveness by obtaining required
 quality in a cost effective way.
Promoting a Total Quality Control System(TQC)
6



               ISO 9000 Series


ISO 8402-Quality Terms
ISO 9000-General terms and fundamentals
ISO 9002-Manufacturing Standards
ISO 9001-Suppliers
ISO 9003-Test houses
ISO 9004-Systems and Elements
7


        PRINCIPLES OF ISO

1.   Customer focus
2.   Leadership
3.   Involvement of people
4.   Process approach
5.   System approach to management
6.   Continual improvement
7.   Factual approach to decision making
8.   Mutually beneficial supplier relationships
8



   PRINCIPLES OF NEW STANDARD
                     Customer
         Mutual        focus
       beneficial
                                     Leadership
        supplier
      relationship

  Factual              Based on
approach to          eight quality         Involvement
  decision           management              of people
   making              principles


        Continual                     Process
      improvement      System         approach
                     approach to
                     Management
9




           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.
 Key benefits : Increased revenue and market Share
  obtained through flexible and fast Responses to market
  opportunities.
10



                 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.
 Key benefits : 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.
11



           3.Involvement of people
 People at all levels are the essence of an organization and their
  full involvement enables their abilities to be used for the
  organization’s benefit.
 Key benefits : Motivated, committed and involved people
  within the organization.
 Innovation and creativity in furthering the organization’s
  objectives.
 People being accountable for their own performance. People
  eager to participate in and contribute to continual
  improvement.
12




           4.Process Approach
 A desired result is achieved more efficiently when activities and
  related resources are managed as a process.
 Key benefits : Lower costs and shorter cycle times
  through effective use of resources.
   Improved, consistent and predictable results.
  Focused and prioritized improvement opportunities.
13



      5.System Approach to Management
 Identifying, understanding and managing interrelated
  processes as a system contributes to the organization’s
  effectiveness and efficiency in achieving its objectives.
 Key benefits : Integration and alignment of the processes that
  will best achieve the desired results.
 Ability to focus effort on the key processes.
 Providing confidence to interested parties as to the consistency,
  effectiveness and efficiency of the organization.
14



          6.Continual Improvement
 Continual improvement of the organization’s overall
  performance should be a permanent objective
 of the organization.
 Key benefits : Performance advantage through improved
  organizational capabilities.
 Alignment of improvement activities at all levels to an
  organization’s strategic intent.
 Flexibility to react quickly to opportunities.
15




  7.Factual approach to decision making
 Effective decisions are based on the analysis of data and
  information.
 Key benefits : Informed decisions.
 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.
16



8.Mutually beneficial supplier relationships
 An organization and its suppliers are interdependent and a
  mutually beneficial relationship enhances the ability of both to
  create value.
 Key benefits : Increased ability to create value for both parties.
 Flexibility and speed of joint responses to changing market or
  customer needs and expectations.
 Optimization of costs and resources.
17
 ISO 9001:2000 – Model of a process-based quality management system
                              CONTINUAL IMPROVEMENT OF
                            THE QUALITY MANAGEMENT SYSTEM



                                5.MANAGEMENT
                                RESPONSIBILITY




                                                                                 CUSTOMERS
  CUSTOMERS




                                                                  Satisfaction
                               QUALITY           8. MEASUREMENT
              6. RESOURCE
              MANAGEMENT     MANAGEMENT           ANALYSIS AND
                                                   IMPROVEMENT
                               SYSTEM



                                  7. PRODUCT
Requirements                                           Product    Consumption
                                  REALIZATION
18

New ISO 9001
                               Management
                               Responsibility




  General                                          Measurement,     General
                Resource
requirements   management        QMS                 analysis &
                                                   improvements
                                                                  requirements




                                   Product
                                  Realization




                      Continual Improvement cycle
                                     ISO 9001:2000 explained

                                                                          18
19

ISO 9001:2000
Transition Process

  1st visit       2nd visit           3rd visit       4th visit




  Review of       Review of
                                      Review of       Review of
    QMS &       Measurement
                                    Management        Resource
   Product       , analysis &
                                    responsibility   management
  realization   improvements




                          2 years
20

Challenges in implementing new
standard
                     Management Support


     Encouragement



                                              New ISO



     Communication



                     Other employee Support
21




Requirements of ISO 9001-2000
                1.Scope
        2. Normative reference
       3.Terms and definitions
     4.Quality management system
     5.Management responsibility
       6.Resource management
         7.Product realisation
8.Measurement, analysis and improvement
22



1.Scope:The specified requirements are generic
and applicable to all organizations, regardless of
their type and size.
2.Normative Reference
3.Terms and vocabulary : Supplier, Organization,
Customer.
23




      Quality management system
      QUALITY

Quality is the totality of characteristics of an
 entity that bear on its ability to satisfy stated and
 implied needs.
Customer satisfaction , whole organization
 involvement.



             Quality Service
24




            DOCUMENTATION

I. General
II. Quality manual
III. Control of documents
IV. Control of records
25




DOCUMENTATION PYRAMID
26




  Management responsibility
Management commitment

Customer focus

Quality policy:vission,mission,commitment

Planning
27




1. Responsibility and authority
2. Management representative
3. Internal communication

             MANAGEMENT REVIEW
1. Review input
2. Review output
28




    Resource Management
Human resources
Infrastructure
Work environment
Provision of resources
29




TRAINING
30




Measurement , Analysis, Improvement
It is done
• To demonstrate conformity of product
• To ensure conformity of QMS

• AUDITING : External audit:Auditing by an
  external certification body
• Internal audit:By internal staff trained for this
  process
31




   Improvement

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

 CAUSE INVESTIGATION

  CORRECTIVE ACTION

  PREVENTIVE ACTION
32




Steps to ISO Registration
33




             ADVANTAGES
• For the customer :- Increase satisfaction
  and growth in confidence.
• For the company :- Well defined
  organization and responsibilities,
     i.e., minimize grey areas and possible
                 resources wastage.
• Establishment of proper communication
  channel
34




                ISO 14000
• INTRODUCTION : In the present day, environmental
  matter is not limited only in one country or specific
  area. The environmental impact effects everywhere
  and leads to problem all over the world.
• Environmental conservation has become so
  complicated that it causes pressure to all business
  organizations.
• The International Organization for Standardization
  had led to the development of the International
  Standard for environmental management system
  series (ISO 14000).
35




               ISO 14000 SERIES

           PRODUCT EVALUATION STANDARDS
                               Environmental Labeling
                               14020 Basic Principles
  Environmental Aspects in      14021 Self Discipline
     Product Standards          14022 Symbols
   Guide 64 EAPS Guide          14023 Testing
                                   and Verification
                                 14024 Third Party
    Life Cycle Assessment
  14040 principles Framework
  14041 Goals and Definition
  14042 Impact Assessment
14043 Improvement Assessment
36




• The structure of the standards is as follows:
  ▫ Environmental Management Systems (EMS)
  ▫ Environmental ng and Related Environmental Investigations (EA)
  ▫ Environmental Labeling (EL)
  ▫ Environmental Performance Evaluation (EPE)
  ▫ Life Cycle Assessment (LCA)
  ▫ Terms and Definitions (T&D)

• ISO 14000 Series is the set of standards relating to environmental
  management system.
• Generally, the standard used for certification is
  ▫     ISO 14001 Environmental Management Systems - Specifications
      with Guidance for Use.
37


        ELEMENTS OF ISO 14001

   General Requirements
   Environmental Policy
   Planning
   Implementation & Operation
   Checking & Corrective action
   Management review
38
39

Environmental management system
model
 1.Environmental policy
Initially, the organization’s top management should have commitment and
define the policy on EMS which is used for the direction of implementing and
improving its EMS.


 2. Planning
In order to achieve environmental policy, at least, the organization should :
 Identify the environmental aspects of its activities and specify those which
have significant impacts on the environment.
 Establish objectives and targets of its activities having impacts to
environment.
 Establish environmental programs for achieving its objectives and targets.
40



  3. Implementation


  •In order to achieve environmental planning, at least, the organization
should :

  •Define roles, responsibilities and authorities for facilitating EMS
effectively.

  •Communicate to the staffs at each level for the importance of
conformance to the environmental policy; provide appropriate training to
personnel performing the tasks to gain their knowledge and competence.

  •Identify potential accidents and emergency situations for preventing and
mitigating the environmental impacts that may be associated with them and
periodically test such procedures where practicable.
41


 4. Checking and corrective action
 To ensure that the organization is performing in accordance with
the stated EMS programmes, at least, the organization should:
  Monitor and measure its operations and activities against the
organization’s plans.
 Record the on-going activities of the EMS.
 Conduct periodic EMS audits.


 5. Management review


 The organization’s top management should review and continually
improve its EMS, with the objective of improving its overall
environmental performance.
42



Environmental management system model
43




              CONCLUSION
It can be applied to any type of organization
It help in maintaining an efficient quality system
 in an organization
It creates confidence in customer on quality of
 product supplied
It act as competitive barrier
44




Various logos used in p’industries
45




               REFERENCES
 http://www.iso.org/iso/en/isoonline.frontpage
 S.Bhaskar, Industrial Management,First
  edition,2008,pg.no.29.3-29.10.
 T.Telsang, Production Management, First
  edition,2005,pg.no.277-295.
 www.pharmaworld.com
46

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ISO 9000 AND 14000 PPT

  • 1. 1 ISO 9000 AND 14000 VALIDATION SUBMITTED BY: SAINATH KARI SUBMITTED TO: MR.A.V.S.ASHOK, ASST.PROFESSOR, RVR AND JC COLLEGE OF ENGINEERING, CHOWDAWARAM, GUNTUR.
  • 2. 2 Contents 1.Introduction 2.Principles 3.ISO 9000 4.Objectives 5.Advantages 6.ISO 14000 7.Conclusion
  • 3. 3 Definition ISO 9000 is a series of standards , development and published by the ISO that define , establish and maintain an effective quality assurance system for manufacturing and service industries.
  • 4. 4 What is ISO ISO is a name used for the International Organization for Standardization ISO is not an acronym It was formed in 1947 in Geneva Switzerland. It is a federation of national standard bodies of 143 countries.
  • 5. 5 OBJECTIVES To Facilitate International Trade Of Goods and Services. To obtain competitiveness by obtaining required quality in a cost effective way. Promoting a Total Quality Control System(TQC)
  • 6. 6 ISO 9000 Series ISO 8402-Quality Terms ISO 9000-General terms and fundamentals ISO 9002-Manufacturing Standards ISO 9001-Suppliers ISO 9003-Test houses ISO 9004-Systems and Elements
  • 7. 7 PRINCIPLES OF ISO 1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships
  • 8. 8 PRINCIPLES OF NEW STANDARD Customer Mutual focus beneficial Leadership supplier relationship Factual Based on approach to eight quality Involvement decision management of people making principles Continual Process improvement System approach approach to Management
  • 9. 9 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.  Key benefits : Increased revenue and market Share obtained through flexible and fast Responses to market opportunities.
  • 10. 10 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.  Key benefits : 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.
  • 11. 11 3.Involvement of people  People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.  Key benefits : Motivated, committed and involved people within the organization. Innovation and creativity in furthering the organization’s objectives. People being accountable for their own performance. People eager to participate in and contribute to continual improvement.
  • 12. 12 4.Process Approach  A desired result is achieved more efficiently when activities and related resources are managed as a process.  Key benefits : Lower costs and shorter cycle times through effective use of resources. Improved, consistent and predictable results. Focused and prioritized improvement opportunities.
  • 13. 13 5.System Approach to Management  Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.  Key benefits : Integration and alignment of the processes that will best achieve the desired results. Ability to focus effort on the key processes. Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the organization.
  • 14. 14 6.Continual Improvement  Continual improvement of the organization’s overall performance should be a permanent objective of the organization.  Key benefits : Performance advantage through improved organizational capabilities. Alignment of improvement activities at all levels to an organization’s strategic intent. Flexibility to react quickly to opportunities.
  • 15. 15 7.Factual approach to decision making  Effective decisions are based on the analysis of data and information.  Key benefits : Informed decisions. 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.
  • 16. 16 8.Mutually beneficial supplier relationships  An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.  Key benefits : Increased ability to create value for both parties. Flexibility and speed of joint responses to changing market or customer needs and expectations. Optimization of costs and resources.
  • 17. 17 ISO 9001:2000 – Model of a process-based quality management system CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM 5.MANAGEMENT RESPONSIBILITY CUSTOMERS CUSTOMERS Satisfaction QUALITY 8. MEASUREMENT 6. RESOURCE MANAGEMENT MANAGEMENT ANALYSIS AND IMPROVEMENT SYSTEM 7. PRODUCT Requirements Product Consumption REALIZATION
  • 18. 18 New ISO 9001 Management Responsibility General Measurement, General Resource requirements management QMS analysis & improvements requirements Product Realization Continual Improvement cycle ISO 9001:2000 explained 18
  • 19. 19 ISO 9001:2000 Transition Process 1st visit 2nd visit 3rd visit 4th visit Review of Review of Review of Review of QMS & Measurement Management Resource Product , analysis & responsibility management realization improvements 2 years
  • 20. 20 Challenges in implementing new standard Management Support Encouragement New ISO Communication Other employee Support
  • 21. 21 Requirements of ISO 9001-2000 1.Scope 2. Normative reference 3.Terms and definitions 4.Quality management system 5.Management responsibility 6.Resource management 7.Product realisation 8.Measurement, analysis and improvement
  • 22. 22 1.Scope:The specified requirements are generic and applicable to all organizations, regardless of their type and size. 2.Normative Reference 3.Terms and vocabulary : Supplier, Organization, Customer.
  • 23. 23 Quality management system QUALITY Quality is the totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. Customer satisfaction , whole organization involvement. Quality Service
  • 24. 24 DOCUMENTATION I. General II. Quality manual III. Control of documents IV. Control of records
  • 26. 26 Management responsibility Management commitment Customer focus Quality policy:vission,mission,commitment Planning
  • 27. 27 1. Responsibility and authority 2. Management representative 3. Internal communication MANAGEMENT REVIEW 1. Review input 2. Review output
  • 28. 28 Resource Management Human resources Infrastructure Work environment Provision of resources
  • 30. 30 Measurement , Analysis, Improvement It is done • To demonstrate conformity of product • To ensure conformity of QMS • AUDITING : External audit:Auditing by an external certification body • Internal audit:By internal staff trained for this process
  • 31. 31 Improvement UNSATISFACTORY OUTCOME WORK IMPROVEMENT TEAM CAUSE INVESTIGATION CORRECTIVE ACTION PREVENTIVE ACTION
  • 33. 33 ADVANTAGES • For the customer :- Increase satisfaction and growth in confidence. • For the company :- Well defined organization and responsibilities, i.e., minimize grey areas and possible resources wastage. • Establishment of proper communication channel
  • 34. 34 ISO 14000 • INTRODUCTION : In the present day, environmental matter is not limited only in one country or specific area. The environmental impact effects everywhere and leads to problem all over the world. • Environmental conservation has become so complicated that it causes pressure to all business organizations. • The International Organization for Standardization had led to the development of the International Standard for environmental management system series (ISO 14000).
  • 35. 35 ISO 14000 SERIES PRODUCT EVALUATION STANDARDS Environmental Labeling 14020 Basic Principles Environmental Aspects in 14021 Self Discipline Product Standards 14022 Symbols Guide 64 EAPS Guide 14023 Testing and Verification 14024 Third Party Life Cycle Assessment 14040 principles Framework 14041 Goals and Definition 14042 Impact Assessment 14043 Improvement Assessment
  • 36. 36 • The structure of the standards is as follows: ▫ Environmental Management Systems (EMS) ▫ Environmental ng and Related Environmental Investigations (EA) ▫ Environmental Labeling (EL) ▫ Environmental Performance Evaluation (EPE) ▫ Life Cycle Assessment (LCA) ▫ Terms and Definitions (T&D) • ISO 14000 Series is the set of standards relating to environmental management system. • Generally, the standard used for certification is ▫ ISO 14001 Environmental Management Systems - Specifications with Guidance for Use.
  • 37. 37 ELEMENTS OF ISO 14001  General Requirements  Environmental Policy  Planning  Implementation & Operation  Checking & Corrective action  Management review
  • 38. 38
  • 39. 39 Environmental management system model 1.Environmental policy Initially, the organization’s top management should have commitment and define the policy on EMS which is used for the direction of implementing and improving its EMS. 2. Planning In order to achieve environmental policy, at least, the organization should : Identify the environmental aspects of its activities and specify those which have significant impacts on the environment. Establish objectives and targets of its activities having impacts to environment. Establish environmental programs for achieving its objectives and targets.
  • 40. 40 3. Implementation •In order to achieve environmental planning, at least, the organization should : •Define roles, responsibilities and authorities for facilitating EMS effectively. •Communicate to the staffs at each level for the importance of conformance to the environmental policy; provide appropriate training to personnel performing the tasks to gain their knowledge and competence. •Identify potential accidents and emergency situations for preventing and mitigating the environmental impacts that may be associated with them and periodically test such procedures where practicable.
  • 41. 41 4. Checking and corrective action To ensure that the organization is performing in accordance with the stated EMS programmes, at least, the organization should:  Monitor and measure its operations and activities against the organization’s plans. Record the on-going activities of the EMS. Conduct periodic EMS audits. 5. Management review The organization’s top management should review and continually improve its EMS, with the objective of improving its overall environmental performance.
  • 43. 43 CONCLUSION It can be applied to any type of organization It help in maintaining an efficient quality system in an organization It creates confidence in customer on quality of product supplied It act as competitive barrier
  • 44. 44 Various logos used in p’industries
  • 45. 45 REFERENCES  http://www.iso.org/iso/en/isoonline.frontpage  S.Bhaskar, Industrial Management,First edition,2008,pg.no.29.3-29.10.  T.Telsang, Production Management, First edition,2005,pg.no.277-295.  www.pharmaworld.com
  • 46. 46

Editor's Notes