Typical Quality Management System Based On Iso 9001 2008

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Typical Quality Management System Based On Iso 9001 2008

  1. 1. Quality Management System<br />Understanding our QMS for the achievement of organization and business success.<br />
  2. 2. Objectives of the Orientation<br />To learn the benefits of implementing the requirements of the quality management system<br />The effect of not following the requirements. <br />
  3. 3. Course Outline<br />What is ISO and Quality Management System<br />Clauses and Benefits of ISO 9001:2008 <br />
  4. 4. ISO 9001:2008<br />So what about it?<br />ISO 9001 is a standard for QUALITY MANAGEMENT SYSTEM<br />
  5. 5. ISO 9001:2008<br />Quality Management Systems<br />- a web of interconnected processes that are used to manage a business.<br />
  6. 6. International Organization for Standardization<br />ISO is not an acronym for International Organization for Standardization<br />What isISO?<br />The organization’s short name was taken from the Greek word “isos”, meaning “equal”.<br />
  7. 7. 1. CUSTOMER FOCUS<br />2. LEADERSHIP<br />ISO 9001<br />3. INVOLVEMENT OF PEOPLE<br />4. PROCESS APPROACH<br />5. SYSTEM APPROACH<br />6. CONTINUAL IMPROVEMENT<br />7. FACTUAL APPROACH <br />8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS<br />8 MANAGEMENT PRINCIPLES<br />
  8. 8. THE Process Based Approach<br />When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach.<br />All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done.<br />
  9. 9. Model of Process Based QMS<br />
  10. 10. The Customer-Supplier Chain<br />Work team<br />Output<br />Input<br />Customer<br />Requirements<br />Customer<br />Feedback<br />
  11. 11. Elements of a Typical Quality Management System Manual<br />
  12. 12. 4<br />Quality Management System<br />4.1 General Requirements<br />4.2 Documentation Requirements<br />1<br />1.1 General<br />1.2 Application<br />Scope<br />2<br />Normative Reference<br />3<br />Terms and Definitions<br />Contents<br />
  13. 13. Contents (cont.)<br />5<br />5.1 Management Commitment<br />5.2 Customer focus<br />5.3 Quality Policy<br />5.4 Planning<br />5.5 Responsibility, authority and communication<br />5.6 Management Review<br />Management Responsibility<br />6<br />6.1 Provision of resources<br />6.2 Human resources<br />6.3 Infrastructure<br />6.4 Work environment <br />Resource Management<br />
  14. 14. 7<br />7.1 Planning of product realization<br />7.2 Customer-related processes<br />7.3 Design and development<br />7.4 Purchasing<br />7.5 Production and service provision<br />7.6 Control of monitoring and measuring devices<br />Measurement, Analysis and Improvement<br />Product Realization<br />Contents (cont.)<br />8<br />8.1 General<br />8.2 Monitoring and measurement<br />8.3 Control of nonconforming product<br />8.4 Analysis of data<br />8.5 Improvement<br />
  15. 15. Quality Manual(ISO 9001:2008)<br />
  16. 16. Section 1: Scope<br />Includes the design and construction of cleanroom, ventilation and air conditioning system, metal finishing system, environmental control system for automotive and other industrial or commercial applications.<br />Exclusion<br /><ul><li>Design and development validation …</li></li></ul><li>Section 2: Normative References<br />ISO 9000:2005<br />ISO 9001: 2008<br />QMS ISO 9001:2000<br />QMS ISO 9002:1994<br />
  17. 17. ISO 9002:1994<br />4.11 Control of inspection, measuring and test equipment<br />4.12 Inspection and test status<br />4.13 Control of nonconforming product<br />4.14 Corrective and preventive action<br />4.15 Handling, storage, packaging, preservation and delivery<br />4.16 Control of quality records<br />4.17 Internal quality audits<br />4.18 Training<br />4.19 Servicing<br />4.20 Statistical techniques<br />1. Scope<br />2. Normative Reference<br />3. Definitions <br />4.1 Management responsibility<br />4.1.1 Quality Policy <br />4.1.2 Organization<br />4.1.2.1 Responsibility and authority <br />4.1.2.2 Resources <br />4.1.2.3 Management representative<br />4.1.3 Management review<br />4.2 Quality System<br />4.2.1 general<br />4.2.2 quality system procedures<br />4.2.3 quality planning<br />4.3 contract review<br />4.4 design control<br />4.5 document and data control<br />4.6 purchasing<br />4.7 control of customer-supplied product<br />4.8 product identification and traceability<br />4.9 process control<br />4.10 inspection and testing<br />Section 2: Normative References<br />ISO 9001:2000 Elements<br />1. Scope<br />2. Normative Reference<br />3. Terms and Definitions<br />4. Quality Management System<br />5. Management Responsibility<br />6. Resource Management<br />7. Product Realization<br />8. Measurement, Analysis and Improvement<br />
  18. 18. Section 3: Terms and Definition<br />Definitions<br />Terms used by an organization:<br />
  19. 19. Section 4: General requirements<br />Processes, interaction, improvement <br />The focus is on looking at: <br /><ul><li>What we do.
  20. 20. Who we are doing it for.
  21. 21. Improving how we provide service.</li></li></ul><li>Section 4: General requirements<br />Documentation requirements<br /><ul><li> Control of document</li></ul>Documents must show a control number, adoption and revision dates, in order to ensure use of the most recent information.<br /><ul><li>Control of records</li></ul>Each record must be controlled in order to ensure uniform quality.<br />
  22. 22. 22<br />Section 4: General requirements<br />LEVEL 1 - QUALITY MANUAL<br />Quality Policy<br />Quality Objectives<br />Requirement Standard<br />Other Statutory and Regulatory Requirements<br />
  23. 23. Section 4: General requirements<br />Documentation requirements<br /><ul><li> Quality manual</li></ul>The quality manual describes our intent to establish a quality management system with an emphasis on continual improvement.<br />
  24. 24. Section 4: General requirements<br />Quality Policy<br />The staff and management of ___ are committed to consistent provision of quality products and services<br /> that will satisfy the demands and expectations of customers<br />by continual improvement of the QMS and conforming to local standards and prevailing codes of practice. <br />
  25. 25. Section 4: General requirements<br />Current Objectives<br />Maintain good business relationship with the clients.<br />Deliver quality products and services to the satisfaction of the clients<br />Effect efficiency in operations by continual improvement of the Quality Management System.<br />Improve employee’s competence through periodic evaluation and development of skills, knowledge and abilities by providing appropriate training.<br />For revision<br />
  26. 26. LEVEL 2 - QUALITY PROCEDURES<br />Control of Documents<br />Control of Records<br />Internal Quality Audits<br />Control of Non-conforming Products<br />Corrective Action<br />Preventive Action<br />26<br />Section 4: General requirements<br />
  27. 27. 27<br />Section 4: General requirements<br />LEVEL 3 - QUALITY PLAN<br />Incoming Inspection Plan<br />In-Process Inspection Plan<br />Final Test Report/ Inspection Plan<br />Work Instruction<br />
  28. 28. 28<br />Section 4: General requirements<br />LEVEL 4 - FORMS / FORMATS/RECORDS<br />Testing Report forms<br />Commissioning Report Forms<br />Inspection forms<br />Check Sheets/Check List<br />Miscellaneous Documentation Forms<br />
  29. 29. 23 MANDATORY RECORDS<br />Management Review <br />Competence, Training and Awareness <br />Planning and Production <br />Review of Requirement Related to Product<br />Design and Development Input<br />29<br />Section 4: General requirements<br />
  30. 30. 30<br />Section 4: General requirements<br />23 MANDATORY RECORDS (cont’n)<br />Design and Development Output<br />Design and Development Review<br />Design and Development Verification<br />Design and Development Validation <br />Control of Design and Development Changes<br />
  31. 31. 31<br />Section 4: General requirements<br />23 MANDATORY RECORDS (cont’n)<br />Purchasing Process<br />Availability of Monitoring and Measuring Equipment<br />Preservation of Product<br />Customer Property<br />Control of Monitoring and Measuring Equipment<br />Standards used for Calibrating Monitoring and Measuring Equipment<br />
  32. 32. 32<br />Section 4: General requirements<br />23 MANDATORY RECORDS (cont’n)<br />Identify and Enable Calibration<br />Result of Calibration and Verification<br />Internal Audit<br />Monitoring and Measurement of Product<br />Control of Non-conforming Product<br />Corrective Action<br />Preventive Action<br />
  33. 33. Management Responsibility<br />Section 5: Management Responsibility<br />
  34. 34. Summary of Section 5<br />Management Responsibility<br />Commitment<br />Focus<br />Policy<br />Objectives<br />Planning<br />These correspond to the following principles:<br /><ul><li>Customer focus
  35. 35. Leadership</li></li></ul><li>Resource Management<br />Section 6: Resource Management<br />
  36. 36. Summary of Section 6<br />Resource Management<br />Provide quality resources<br />Provide quality personnel<br />Provide quality infrastructure<br />Provide quality environment<br />This corresponds to the following principle:<br /><ul><li>Involvement of People</li></li></ul><li>Section 7: Product Realization<br />Product /Service Realization<br />
  37. 37. Section 7: Product Realization<br />7.1 Plan and develop the processes<br /><ul><li>Include product objectives, relevant processes and resource, appropriate test and validation</li></ul>7.2 Customer related processes<br /><ul><li>Customer requirement - stated and implied
  38. 38. Statutory and regulatory
  39. 39. Product requirements and changes
  40. 40. Organization ability
  41. 41. Communication with customers</li></li></ul><li>Section 7: Product Realization<br />7.3 Design and development<br /><ul><li>Planning, inputs, outputs, systematic reviews, verification and validation, control of changes</li></ul>7.4 Purchasing<br /><ul><li>Supplier evaluation and selection
  42. 42. Relevant purchasing information
  43. 43. Verification of purchased product </li></li></ul><li>Section 7: Product Realization<br />7.5 Production and service provision<br /><ul><li>Controlled conditions including product characteristics, work instructions, suitable equipment, measuring devices, and system
  44. 44. Release, delivery and post delivery activities
  45. 45. Validation of processes when no other method
  46. 46. Identification and traceability of product and it’s status
  47. 47. Care of customer property
  48. 48. Preservation of product
  49. 49. Includes constituent parts</li></li></ul><li>Section 7: Product Realization<br />7.6 Control of monitoring and measuring devices<br /><ul><li>Calibrated where necessary
  50. 50. Adjusted and readjusted
  51. 51. Identifies status
  52. 52. Safeguarded from invalid adjustment
  53. 53. Protected from damage or deterioration</li></li></ul><li>Summary of Section 7<br />Control of the following process<br />realization planning<br />customer communication<br />product development<br />purchasing function<br />operation<br />monitoring<br />These correspond to:<br /><ul><li>Get the facts before you decide
  54. 54. Focus on customers
  55. 55. Use a process approach
  56. 56. Work with your suppliers</li></li></ul><li>CONTINUAL IMPROVEMENT OF THE QUALITY MANGEMENT SYSTEM<br />Section 8: Measurement, Analysis & Improvement<br />
  57. 57. Section 8: Measurement, Analysis & Improvement<br />General<br /><ul><li>Measurement and monitoring processes
  58. 58. To demonstrate product conformity, system conformity and continually improve the Quality Management System.
  59. 59. Customer satisfaction
  60. 60. Perception of fulfillment.</li></li></ul><li>Section 8: Measurement, Analysis & Improvement<br />Monitoring and Measurement<br /><ul><li> Internal planned audit, etc.
  61. 61. Process Auditors, independent of their own work will audit department process.
  62. 62. Processes
  63. 63. Demonstrate achievement of planned results.</li></li></ul><li>Section 8: Measurement, Analysis & Improvement<br />Monitoring and Measurement<br /><ul><li>Product
  64. 64. Monitor and measure characteristics.
  65. 65. Conformity with acceptance criteria.
  66. 66. Waivers / concessions.
  67. 67. Nonconforming process/product
  68. 68. Elimination or correction of nonconforming processes.</li></li></ul><li>Section 8: Measurement, Analysis & Improvement<br />Analysis of data<br /><ul><li>Customer satisfaction
  69. 69. Product and process requirements and trends
  70. 70. Suppliers</li></li></ul><li>Section 8: Measurement, Analysis & Improvement<br />Improvement<br /><ul><li>Continually improve effectiveness of the system
  71. 71. Corrective action
  72. 72. Preventive action</li></li></ul><li>Summary of Section 8<br />Measurement, Analysis and Improvement<br />Perform remedial processes<br />Monitor and  measure quality<br />Control nonconforming products<br />Analyze quality information<br />Make quality improvements<br />This corresponds to:<br /><ul><li>Get the facts before you decide
  73. 73. Encourage continual improvement</li></li></ul><li>End Of Presentation<br />
  74. 74. A SHORT QUIZ<br />
  75. 75. What do you do when accepting a task?(Answerable by Yes or No)<br />Before accepting an assignment, do you make sure you understand completely what you are supposed to do?<br />Are the deadlines clear? <br />Is it clear how much responsibility and authority you have in the project?<br />Do you know which tasks you can perform on your own. Without reporting back to your boss?<br />Do you let your boss know if a new assignment makes it difficult for you to do your other jobs?<br />
  76. 76. What do you do when accepting a task (Continuation)<br />Do you make suggestions to make priorities on how much time you will allow the project?<br />Do you get the information and background material you need to do the job properly?<br />Do you try to imagine all the problems and obstacles that could arise while you are doing the job – then plan accordingly?<br />Is it clear who makes decisions when your boss is not available?<br />If a problem arises that you can’t handle, do you talk to your boss about the situation?<br />
  77. 77. Are You Quality-Conscious?(Answerable by True or False)<br />When it comes to quality, there’s always room for improvement.<br />Nobody can be aware of quality needs all the time.<br />Customers pay little attention to quality.<br />A quality program must mesh with the organization’s goals and profit plans.<br />Quality means conformance to standards.<br />
  78. 78. Are You Quality-Conscious?(Continuation)<br />Quality should operate in all parts of a business<br />Personal quality standards and business quality standards have little in common.<br />Quality requires commitment.<br />Quality relates to the process as much as to the goal.<br /> People who talk about quality are mostly idealists.<br />
  79. 79. Now . . . TELL me what’s is going on !!!<br />Reflection<br />
  80. 80. Prepared by: Sid Calayag<br />Presented by: <br />Sid Calayag – Lead Auditor ISO 9001:2008<br />Reference:<br />Quality Management System<br />ISO 9001:2008<br />

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