Introduction to ISO 9000

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Introduction to ISO 9000

  1. 1. By Ketan Shahade 2010B4AB671P BITS Pilani 1
  2. 2.  International Organization for Standardization ◦ Worldwide federation of national standards bodies from 130 countries ◦ Over 11,000 standards ◦ Over 97 categories 2
  3. 3.  ISO 9000 can benefit many industries, such as: Banking Health Care Manufacturing, etc.  ISO 9000 is generic, so it can be applied virtually anywhere!  Remember, ISO 9000 is just one part of an entire system needed to create value for customers 3
  4. 4.  ISO is not an acronym  ISO is a name used for the International Organization for Standardization  The ISO was formed in 1947 in Geneva, Switzerland 4
  5. 5.  ISO 9000 is a European Standard  The organization has two stated objectives: 1. To promote development of standardization to facilitate international exchange of goods and services. 2. To promote cooperation in intellectual, scientific, technological, and economic activity. 5
  6. 6.  The “Plan-Do-Check-Act” cycle, also known as the “Deming Cycle”  A dynamic cycle that is deployed to organization’s processes  Associated with the planning, implementation, control and continual improvement 6
  7. 7. Note in Clause 0.2 Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies; Do: implement the processes; Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results; Act: take actions to continually improve process performance; 7
  8. 8. THECONTINUOUSIMPROVEMENTMECHANISM UNSAUNSATISFACTORY OUTCOME TISFACTORY OUTCOME 8
  9. 9. THECONTINUOUSIMPROVEMENTMECHANISM UNSATISFACTORY OUTCOME WORK IMPROVEMENT TEAM 9
  10. 10. THECONTINUOUSIMPROVEMENTMECHANISM UNSATISFACTORY OUTCOME WORK IMPROVEMENT TEAM CAUSE INVESTIGATION 10
  11. 11. THECONTINUOUSIMPROVEMENTMECHANISM UNSATISFACTORY OUTCOME WORK IMPROVEMENT TEAM CAUSE INVESTIGATION CORRECTIVE ACTION 11
  12. 12. THECONTINUOUSIMPROVEMENTMECHANISM UNSATISFACTORY OUTCOME WORK IMPROVEMENT TEAM CAUSE INVESTIGATION CORRECTIVE ACTION PREVENTIVE ACTION 12
  13. 13. THECONTINUOUSIMPROVEMENTMECHANISM UNSATISFACTORY OUTCOME WORK IMPROVEMENT TEAM CAUSE INVESTIGATION CORRECTIVE ACTION PREVENTIVE ACTION REVIEW 13
  14. 14. THECONTINUOUSIMPROVEMENTMECHANISM UNSATISFACTORY OUTCOME WORK IMPROVEMENT TEAM CAUSE INVESTIGATION CORRECTIVE ACTION PREVENTIVE ACTION REVIEW 14
  15. 15. THECONTINUOUSIMPROVEMENTMECHANISM UNSATISFACTORY OUTCOME WORK IMPROVEMENT TEAM CAUSE INVESTIGATION CORRECTIVE ACTION PREVENTIVE ACTION REVIEW 15 21
  16. 16.  ISO 9000 is composed of 5 different, but related parts: ISO 9000, 9001, 9002, 9003 and 9004  ISO 9000 and 9004 are guidelines,  ISO 9001, 9002, and 9003 are the categories in which a company may apply for certification 16
  17. 17.  ISO 9000: “Quality Management and Quality Assurance Standards – Guidelines for Selection and Use”  Written in order to determine which category your organization should apply for 17
  18. 18.  ISO 9001: “Quality Systems – Model for Quality Assurance in Design/Development, Production, Installatio n, and Servicing”  This is the category for companies which are involved in manufacturing or the creation and delivery of a service. 18
  19. 19.  ISO 9002: “Quality Systems – Model for Quality Assurance in Production and Installation”  Companies who perform many functions, with the exception of design and development, may apply to this category 19
  20. 20.  ISO 9003: “Quality Systems – Model for Quality Assurance in Final Inspection and Test”  This category is useful for outside of the manufacturing sector, such as in distributors  ISO 9003 is being used less and may be dropped in the future 20
  21. 21.  ISO 9004: “Quality Management and Quality System Elements – Guidelines”  Used in order to help interpret the categories included in ISO 9000 certification 21
  22. 22.  21 elements organized into five major sections: 1. System Requirements 2. Management Responsibility 3. Resource Management 4. Product Realization 5. Measurement, Analysis, and Improvement 22
  23. 23. 1. System Requirements ◦ Establish a quality management system ◦ Document the quality management system 23
  24. 24. 2. Management Responsibility ◦ Management Commitment ◦ Customer Focus ◦ Quality Policy ◦ Planning ◦ Administration ◦ Management Review 24
  25. 25. 3. Resource Management ◦ Provision of Resources ◦ Human Resources ◦ Facilities ◦ Work Environment 25
  26. 26. 4. Product and/or Service Realization ◦ Planning of Realization Processes ◦ Customer-Related Processes ◦ Design and/or Development ◦ Purchasing ◦ Production and Service Operations ◦ Control of Measuring and Monitoring Devices 26
  27. 27. 5. Measurement, Analysis, and Improvement ◦ Planning ◦ Measurement and Monitoring ◦ Control of Nonconformity ◦ Analysis of Data ◦ Improvement 27
  28. 28.  Implementing ISO 9000 in an organization can be very beneficial  The goal of this implementation is to achieve customer satisfaction at its highest level 28
  29. 29.  Manual (philosophy, policy, objectives, approach)  Procedures  Work instructions (department, product, process)  Records (proof and objective evidence)  Ad-hoc, temporary documents 29
  30. 30. 1.The company first implements the control and documentation procedures outlined in the series. 2. Internal Audit 3. It then involves a thorough audit by an independent certification organization (i.e., a Registrar) that is licensed to register quality systems by an accreditation body (e.g., Registrar Accreditation Board in U.S.) 30
  31. 31. 4. Upon compliance, it receives a registration certificate and its name is included in a published directory of registered suppliers. 5. The systems will be continually verified by the registrar in periodic surveillance and full audits are conducted every few years. 31
  32. 32.  Through Dec. 2002, at least 561,747 ISO 9000 certifications have been issued in 159 countries and economies. In North America, 53,806 certifications were issued. In Europe, 292,970 certifications were issued – The ISO Survey  Some beginning to question its usefulness 32
  33. 33.  Documentation of quality management system  Reduction of variation  Help develop and expand business  Reduction or elimination of customer audit  Increased profitability/reduced costs 33
  34. 34.  Improved communication, both internal and external  Greater awareness of quality by employees  Provision of training to all employees  An internationally recognised QMS  Increased opportunities in specific markets  Increased customer satisfaction 34
  35. 35.  Costs - application & maintenance  Time - maintenance  Executive commitment  Selection of registration 35
  36. 36. How to select ISO model ? Has significant product/service design activities Manufactures products or services according to approved design or customer specifications. (This may be the case of companies without significant new product/design activities.) Has a product/service where the quality of this product/service is solely dependent on final inspection and testing. (This may be the case of distributors of certain products.) 36
  37. 37. 37

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