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Iso Process Audit Training

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ISO 9001 -2000 Internal Auditor Trainng program

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Iso Process Audit Training

  1. 1. Process Auditing Chapter 1 Course Introduction
  2. 2. Chapter 1 Agenda <ul><li>Day 1 </li></ul><ul><li>Chapter 1 Introduction/Welcome </li></ul><ul><li>Chapter 2 Customer Satisfaction </li></ul><ul><ul><li>Team Workshop </li></ul></ul><ul><ul><li>Break </li></ul></ul><ul><li>Chapter 3 Continual Improvement </li></ul><ul><ul><li>Team Workshop </li></ul></ul><ul><li>Lunch </li></ul><ul><li>Chapter 4 Process Auditing </li></ul><ul><ul><li>Team Workshop </li></ul></ul><ul><li>Feedback </li></ul>
  3. 3. Chapter 1 Agenda <ul><li>Day 2 </li></ul><ul><li>Chapter 5 Audit Performance </li></ul><ul><ul><li>Break </li></ul></ul><ul><ul><li>Team Workshop Feedback </li></ul></ul><ul><li>Audit Reporting </li></ul><ul><li>Chapter 6 Nonconformance Reporting </li></ul><ul><li>Lunch </li></ul><ul><ul><li>Workshop Non Conformance </li></ul></ul><ul><li>Chapter 7 Top Management </li></ul><ul><ul><li>Break </li></ul></ul><ul><ul><li>Top Management Workshop </li></ul></ul><ul><li>Chapter 8 Session Wrap-up </li></ul>
  4. 4. Chapter 1 Introduction <ul><li>Objectives of Training: </li></ul><ul><ul><li>The Process Audit workshop is designed to provide auditors with necessary skills to add value to their organization </li></ul></ul><ul><ul><li>Workshop will highlight the need for experienced auditors to audit top management, understand the continual improvement and the company’s quality management system </li></ul></ul><ul><ul><li>This workshop will : </li></ul></ul><ul><ul><ul><li>Provide a “definition” for process auditing </li></ul></ul></ul><ul><ul><ul><li>Provide Examples of process audits </li></ul></ul></ul><ul><ul><ul><li>Discuss linkages between objectives, process measurement and continual improvement </li></ul></ul></ul>
  5. 5. Chapter 1 Introduction
  6. 6. Chapter 1 Process Definition Auditors Clients Quality Management System Consultants Process Approach Why not doing Process Auditing? Element Approach Mind set No clear understanding of Process Approach Reluctance to Change Inconsistent Knowledge Of Process Auditing Processes and interaction Not Defined Management System Not Process Oriented Objective not established for Processes No “process maps” Reports and Forms in Element style Lack of Global Strategy Not Implementing Process Driven systems Taking Path of Least resistance No training on Process Audits No Knowledge of Processes “ boiler Plate” systems
  7. 7. Chapter 1 Auditor Demographics <ul><li>BVQI Assumptions </li></ul><ul><ul><li>20% of Auditors are from process industries, i.e. Chemical Manufacturing, Automotive, and environmental </li></ul></ul><ul><ul><li>60% of Auditors need basic overview to be able to implement Process Auditing methodology </li></ul></ul><ul><ul><li>20% of Auditors need training and mentoring if they are to achieve an acceptable level of knowledge </li></ul></ul>
  8. 8. Chapter 1 Benefits of Training <ul><li>Knowledge of principals and methods of process auditing </li></ul><ul><li>Understanding the need for clear knowledge of the organizations defined processes </li></ul><ul><li>Ability to plan, conduct and report a process based audit </li></ul><ul><li>Confidence to discuss the “process approach” requirements of the ISO Management system </li></ul><ul><li>Ability to link organizational objectives to Process and sub-process measurable objectives </li></ul>
  9. 9. Process Auditing Chapter 2 Customer Satisfaction
  10. 10. Chapter 2 Customer Satisfaction <ul><li>ISO9001:2000 Clause 8.2.1 </li></ul><ul><li>As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined . </li></ul>
  11. 11. <ul><li>Customer Satisfaction is determined by the organization measuring its customers perception as to whether they have satisfied their customers’ requirements – and may be somewhat subjective or ‘qualitative’ or ‘quantitative’. </li></ul><ul><li>Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction. </li></ul><ul><li>Simply capturing customer complaints and product returns will only gauge ‘dis-satisfaction’ – which does not fully meet the intent of the clause and will not satisfy these requirements. </li></ul><ul><li>The organizations management should analyze the implications of the absence or existence of customer complaints. </li></ul>Chapter 2 Customer Satisfaction
  12. 12. <ul><li>The organization should identify sources of customer and end-user information, available in written and verbal forms, from internal and external sources and analyze this data for trends, negative and positive. Examples of customer related information include </li></ul><ul><li>Customer and user surveys </li></ul><ul><li>Feedback on aspects of product </li></ul><ul><li>Customer requirements and contract information </li></ul><ul><li>Market needs </li></ul><ul><li>Service delivery data </li></ul><ul><li>Information relating to competition </li></ul><ul><li>Customer disruptions </li></ul><ul><li>Special status customer notification related to quality or delivery issues </li></ul>Chapter 2 Customer Satisfaction
  13. 13. <ul><li>Examples of sources of information on customer satisfaction include: </li></ul><ul><li>Customer complaints; customer notifications, delivery issues </li></ul><ul><li>Communicating directly with customers; questionnaires and surveys </li></ul><ul><li>Customer meetings, interviews </li></ul><ul><li>Reports from consumer orgs </li></ul><ul><li>Reports in various media </li></ul><ul><li>Sector and industry studies </li></ul><ul><li>Delivered part quality performance </li></ul><ul><li>Customer returns </li></ul><ul><li>Delivery schedule performance </li></ul>Chapter 2 Customer Satisfaction
  14. 14. <ul><li>Team Exercise: </li></ul><ul><ul><li>Identify 4 ways of determining Customer Satisfaction </li></ul></ul><ul><ul><li>Keep an open minded approach to auditing customer satisfaction </li></ul></ul><ul><ul><li>Visualize the potential for variety of methodologies </li></ul></ul><ul><ul><li>Discuss potential Pros’ and Con’s of various methods </li></ul></ul>Chapter 2 Customer Satisfaction
  15. 15. Process Auditing Chapter 3 Continual Improvement
  16. 16. Chapter 3 Continual Improvement <ul><li>8.5.1 Continual Improvement </li></ul><ul><li>The organization shall continually improve the effectiveness of the quality management system through the use of the: </li></ul><ul><ul><li>- quality policy </li></ul></ul><ul><ul><li>- quality objectives </li></ul></ul><ul><ul><li>- internal audits </li></ul></ul><ul><ul><li>- analysis of data </li></ul></ul><ul><ul><li>- corrective and preventive actions </li></ul></ul><ul><ul><li>- management review </li></ul></ul>
  17. 17. Chapter 3 Continuous vs. Continual Improvement Time Improvement Continuous Continual
  18. 18. <ul><li>There are two fundamental ways to audit continual improvement process: </li></ul><ul><li>Breakthrough projects which either lead to a revision and improvement of existing processes or the implementation of new processes; these are usually carried out by cross-functional teams outside routine operations; </li></ul><ul><li>Small-step ongoing improvement activities conducted within existing processes by people. </li></ul><ul><li>(as defined in ISO 9004-2000 Appendix B) </li></ul>Chapter 3 Continuous vs. Continual Improvement
  19. 19. <ul><li>Breakthrough projects usually involve significant redesign of existing processes and should include : </li></ul><ul><li>Definition of objectives and an outline of the improvement project. </li></ul><ul><li>Analysis of the existing process (the “as-is” process) and realizing opportunities for change </li></ul><ul><li>Definition and planning of improvement to the process </li></ul><ul><li>Implementation of the improvement </li></ul><ul><li>Evaluation of the improvement achieved, including the lessons learned. </li></ul>Chapter 3 Continuous vs. Continual Improvement
  20. 20. Chapter 3 Continuous vs. Continual Improvement
  21. 21. <ul><li>People in the organization are the best source of ideas for small-step or ongoing process improvement. </li></ul><ul><li>Small-step ongoing process improvement activities should be controlled in order to understand their effect. </li></ul><ul><li>The people in the organization that are involved should be provided with the authority, technical support and necessary resources for the changes associated with the improvement. </li></ul>Chapter 3 Continuous vs. Continual Improvement
  22. 22. <ul><li>Team Exercise: Prepare a presentation on: </li></ul><ul><li>How would you conduct an audit of continual improvement at the following levels of an organization and/or the following personnel. Including audit trails/questions and acceptable evidence of conformance. </li></ul><ul><li>1. Top Management </li></ul><ul><li>2. Process Owner </li></ul><ul><li>3. Operator/ Employee (non-management) </li></ul><ul><li>Each team is to record the results of the team discussion </li></ul><ul><li>on the flip chart and/or overheads. Each team must prepare the presentation using a small to medium org. </li></ul>Chapter 3 Continuous vs. Continual Improvement
  23. 23. <ul><li>Continual Improvement by either of the methods identified should involve the following : </li></ul><ul><li>a) Reason for improvement: a process problem should be identified and an area for improvement selected, </li></ul><ul><li>b) Current situation: the effectiveness and efficiency of the existing process evaluated. </li></ul><ul><li>c) Analysis: the root causes of the problem should be identified and verified. </li></ul><ul><li>d) Identification of the possible solutions: alternative solutions should be explored.. </li></ul>Chapter 3 Continuous vs. Continual Improvement
  24. 24. <ul><li>e) Evaluation of effects: it should then be confirmed that the problem and its root causes have been eliminated </li></ul><ul><li>f) Implementation and standardization of the new solution: the old process should be replaced with the improved process </li></ul><ul><li>g) Evaluation of the effectiveness and efficiency of the process with the improvement action completed :. </li></ul><ul><li>The process for improvement should be repeated on remaining problems, developing objectives and solutions for further process improvement. </li></ul>Chapter 3 Continuous vs. Continual Improvement
  25. 25. Chapter 3 Objectives/Performance Top Management Top Management Process Owners Quality Policy Project/Product Team Planning and Resource Management QMS Process Objectives Project/Product Objectives
  26. 26. Chapter 3 Organization and Process Goals OTD Order Process Maintenance Process Purchasing Process Warehouse Process Production Process To achieve OTD you must collect Data to understand reason for late Delivery. Establish Metrics for Improvement Engage entire organization in this process
  27. 27. <ul><li>Quality Policy - Defect free product, on time to the customer at reasonable price and continually improving all process in accordance with the ISO 9001-2000 standard. </li></ul><ul><ul><li>Organizational objective – 98% on time to customer promise date </li></ul></ul><ul><ul><li>Process objectives established to meet organizational goal </li></ul></ul><ul><ul><ul><li>Order review process – all orders processes within 2 days of receipt </li></ul></ul></ul><ul><ul><ul><li>Warehouse process – 100% compliance with FIFO, 18 inventory turns </li></ul></ul></ul><ul><ul><ul><li>Maintenance Process – 97% uptime, no past due scheduled items </li></ul></ul></ul><ul><ul><ul><li>Purchasing Process – 95% of tier 1 suppliers on time and within window </li></ul></ul></ul><ul><ul><ul><li>Production Scheduling – all shop routers completed within 1 day of receipt and all orders scheduled to be completed 2 days prior to required ship date </li></ul></ul></ul><ul><ul><li>Progress towards objectives will be posted monthly and discussed at the quarterly management review meeting in addition to the bi-weekly production meeting. </li></ul></ul><ul><ul><li>A negative trend occurring in 3 consecutive months towards the objective will require a corrective action. </li></ul></ul>Chapter 3 Organization and Process Goals
  28. 28. Process Auditing Chapter 4 Process Auditing
  29. 29. Chapter 4 What is a Process? Procedure * Process Set of interrelated or interacting activities Product Result of the process Input Monitoring and Measurement of Effectiveness This is the definition of Procedure given in ISO 9000-2000 This is not necessarily one of the 6 documented procedures required by ISO 9000-2000 “ Specified way to carry out an activity or a “process”- May be documented or not Output
  30. 30. <ul><li>The 6 documented procedures </li></ul><ul><ul><li>Management Review 4.2.2, 5.1 </li></ul></ul><ul><ul><li>Control of Documents 4.2.3 </li></ul></ul><ul><ul><li>Internal Audit 8.2.2 </li></ul></ul><ul><ul><li>Control of non performing product 8.3 </li></ul></ul><ul><ul><li>Corrective Action 8.5.2 </li></ul></ul><ul><ul><li>Preventative Action 8.5.3 </li></ul></ul>Chapter 4 Required Documents
  31. 31. Chapter 4 Comparison of 1994 with 2000 <ul><li>Procedures: </li></ul><ul><li>Are driven by completion of a task </li></ul><ul><li>Are implemented </li></ul><ul><li>Are steps completed by different people in different departments with different objectives </li></ul><ul><li>Are discontinuous </li></ul><ul><li>Focus on satisfying the rules </li></ul><ul><li>Define the sequence of steps to execute a task </li></ul><ul><li>May be used to process information </li></ul>
  32. 32. <ul><li>Processes: </li></ul><ul><li>Are driven by achievement of a desired result </li></ul><ul><li>Are operated </li></ul><ul><li>Stages are completed by different people within the organization </li></ul><ul><li>Flow to a conclusion </li></ul><ul><li>Focus on satisfying interested parties </li></ul><ul><li>Transform inputs into outputs through the use resources </li></ul><ul><li>Information is processed through the use of a procedure </li></ul><ul><li>Behave- the are dynamic </li></ul>Chapter 4 Comparison of 1994 with 2000
  33. 33. Chapter 4 Process Methodology <ul><li>All Processes have 6 characteristics that need to be verified: </li></ul><ul><ul><li>Process has an owner </li></ul></ul><ul><ul><li>Process is defined </li></ul></ul><ul><ul><li>Process is documented (if necessary), and understood </li></ul></ul><ul><ul><li>Process linkages are established </li></ul></ul><ul><ul><li>Process is monitored and measurable </li></ul></ul><ul><ul><li>Process has records maintained </li></ul></ul>
  34. 34. Chapter 4 Process Methodology <ul><li>Processes have 4 questions: </li></ul><ul><ul><li>With what? (materials/equipment) </li></ul></ul><ul><ul><li>With who? (qualifications, skills, training, experience, etc.) </li></ul></ul><ul><ul><li>With what key criteria? (measurable objectives, assessment) </li></ul></ul><ul><ul><li>How? (methods and techniques) </li></ul></ul>
  35. 35. Chapter 4 COPS – MOPS - SOPS COPS MOPS SOPS
  36. 36. Chapter 4 Customer Oriented Processes <ul><li>Processes that begin with a customer requirement, specification or implied contract and end with a fulfillment of the requirement : </li></ul><ul><ul><li>Market Analysis/Customer Requirements </li></ul></ul><ul><ul><li>Bid/Tender </li></ul></ul><ul><ul><li>Order </li></ul></ul><ul><ul><li>Product Design </li></ul></ul><ul><ul><li>Product Verification </li></ul></ul><ul><ul><li>Delivery </li></ul></ul><ul><ul><li>Payment </li></ul></ul><ul><ul><li>Warranty Service </li></ul></ul>COPS
  37. 37. Chapter 4 Support Oriented Processes <ul><li>Any Process whose input, output and transformation activities are established and maintained by an organization to comply with requirements or specifications . </li></ul><ul><ul><li>Documents/Records Control </li></ul></ul><ul><ul><li>Inspection and Testing </li></ul></ul><ul><ul><li>Equipment Calibration </li></ul></ul><ul><ul><li>Training </li></ul></ul><ul><ul><li>Human Resources </li></ul></ul><ul><ul><li>Purchasing </li></ul></ul><ul><ul><li>IT </li></ul></ul>SOPS
  38. 38. Chapter 4 Management Oriented Processes <ul><li>Those Processes /activities necessary for Management to comply with requirements of the standard </li></ul><ul><ul><li>Management Review </li></ul></ul><ul><ul><li>Corporate Objectives </li></ul></ul><ul><ul><li>Internal Audit </li></ul></ul><ul><ul><li>Corrective Action </li></ul></ul><ul><ul><li>Preventative Action </li></ul></ul><ul><ul><li>Communication </li></ul></ul><ul><ul><li>Customer Satisfaction </li></ul></ul>MOPS
  39. 39. Chapter 4 Process Turtle 1. Process _______ ________________ ________________ 4. With What? _____ __________________ __________________ 5. With Who?_____ ________________ 6. How? _________ _________________ _________________ 7. How Effective? ___________________ ___________________ 3. Inputs 2. Outputs
  40. 40. Chapter 4 Processes linked to the Standard Model
  41. 41. Chapter 4 Process Workshop <ul><li>Work Shop Exercise : </li></ul><ul><li>1. Each team to develop “ process turtle ” for typical </li></ul><ul><li>COP , SOP or MOP </li></ul><ul><li>2. Spokes Person present team ideas </li></ul><ul><li>3. Time: 1/2 Hour </li></ul>
  42. 42. Chapter 4 Process Workshop <ul><li>Work Shop# 2 </li></ul><ul><li>Team to review graphs/charts indicating performance of a particular process. </li></ul><ul><li>a. Analyze Graphs </li></ul><ul><li>b. Determine standard requirements that may have prevented the poor performance. </li></ul><ul><li>c. Categorize the requirements under the appropriate legs of the turtle </li></ul><ul><li>1 hour for team discussion </li></ul>
  43. 43. Close of Day 1 <ul><li>Review </li></ul><ul><li>Lessons Learned today? </li></ul><ul><li>What to expect for tomorrow! </li></ul>
  44. 44. Process Auditing Day 2
  45. 45. Agenda Day 2 <ul><li>Day 2 </li></ul><ul><li>Chapter 5 Audit Performance </li></ul><ul><ul><li>Break </li></ul></ul><ul><ul><li>Team Workshop Feedback </li></ul></ul><ul><li>Audit Reporting </li></ul><ul><li>Chapter 6 Nonconformance Reporting </li></ul><ul><li>Lunch </li></ul><ul><ul><li>Workshop Non Conformance </li></ul></ul><ul><li>Chapter 7 Top Management </li></ul><ul><ul><li>Break </li></ul></ul><ul><ul><li>Top Management Workshop </li></ul></ul><ul><li>Chapter 8 Session Wrap-up </li></ul>
  46. 46. Process Auditing Chapter 5 Audit Performance
  47. 47. Chapter 5 Audit Planning <ul><li>Manual Review </li></ul><ul><ul><li>Standard States: 4.1, 4.2.2 </li></ul></ul><ul><ul><ul><li>The Organization shall establish and maintain a quality manual that includes: </li></ul></ul></ul><ul><ul><ul><ul><li>A. The Scope of Q uality M anagement S ystem </li></ul></ul></ul></ul><ul><ul><ul><ul><li>B. Documented procedures established for the QMS </li></ul></ul></ul></ul><ul><ul><ul><ul><li>C. A description of the interaction between the processes and the QMS </li></ul></ul></ul></ul>
  48. 48. Chapter 5 Audit Planning <ul><li>ISO 9001-2000 Standard Interpretation </li></ul><ul><ul><li>Processes of the organization need to be identified, per 4.1.a </li></ul></ul><ul><ul><li>Graphical representations such as process maps/flowcharts are perhaps the most easily understandable method of describing interaction between processes (but not required) </li></ul></ul><ul><ul><li>Interactions may be described by way of references and/or cross reference </li></ul></ul>
  49. 49. Chapter 5 Audit Planning <ul><li>Audit Planning – Schedule </li></ul><ul><ul><li>Complete Applicability Matrix </li></ul></ul><ul><ul><li>Audit Schedule developed from the results of the Quality manual review and the completion of the applicability matrix </li></ul></ul><ul><ul><li>Schedule based on process in the organization </li></ul></ul><ul><ul><li>Schedule shall be based on status and importance of processes </li></ul></ul><ul><ul><li>Schedule is NOT to be based on the clauses of the standard! </li></ul></ul>
  50. 50. Chapter 5 Audit Planning <ul><li>Workshop - Manual Review </li></ul><ul><ul><li>Review of Zap Electronics Quality Manual </li></ul></ul><ul><ul><ul><li>Conclude on the likelihood of a successful site audit and overall conclusions on the manual, </li></ul></ul></ul><ul><ul><ul><li>Does manual meet the intent of the standard? </li></ul></ul></ul><ul><ul><ul><li>Complete ISO 9001:2000 Process Matrix </li></ul></ul></ul><ul><ul><ul><li>Develop a process based audit schedule </li></ul></ul></ul>
  51. 51. Chapter 5 Audit Planning <ul><li>Audit Reporting </li></ul><ul><ul><li>Sample Report Format </li></ul></ul><ul><ul><li>Process Oriented </li></ul></ul><ul><ul><li>Intended to be “Value Add” for the organization </li></ul></ul><ul><ul><li>Auditor notes and records aligned with processes </li></ul></ul><ul><ul><li>Process Applicability Matrix should be part of report </li></ul></ul><ul><li>Review of new Audit Report - Q&A </li></ul>
  52. 52. Process Auditing Chapter 6 Nonconformance
  53. 53. Chapter 6 Nonconformity <ul><li>Nonconformity </li></ul><ul><ul><li>ISO 9001:2000 Standard states: </li></ul></ul><ul><ul><ul><li>The non-fulfillment of a requirement </li></ul></ul></ul><ul><li>Audit Findings </li></ul><ul><ul><li>Nonconformities are to be recorded and supported by evidence </li></ul></ul><ul><ul><ul><li>Major – Systematic failure within entire organization and/or failure to address an entire clause or sub clause of the standard within a process </li></ul></ul></ul><ul><ul><ul><li>Minor – Isolated lapse of a clause or sub clause of the standard detected within a process </li></ul></ul></ul>
  54. 54. Chapter 6 Nonconformity <ul><li>Nonconformity Reports – </li></ul><ul><ul><li>Clear and precise </li></ul></ul><ul><ul><li>Concise and accurate </li></ul></ul><ul><ul><li>Comprehensive </li></ul></ul><ul><ul><li>Describe the problem </li></ul></ul><ul><ul><li>Explain the requirement </li></ul></ul><ul><ul><li>Reference the evidence </li></ul></ul><ul><ul><li>Completed on the appropriate forms </li></ul></ul><ul><ul><li>Actions Taken without undue delay </li></ul></ul>
  55. 55. Chapter 6 Nonconformity <ul><li>Workshop -Nonconformity Reports </li></ul><ul><ul><li>Determine for each incident if there is enough evidence, based on the information given, to identify a nonconformance </li></ul></ul><ul><ul><ul><li>If you feel there is enough evidence complete the top portion of the form </li></ul></ul></ul><ul><ul><ul><li>If not enough evidence, as the auditor, what actions do you take? </li></ul></ul></ul>
  56. 56. Process Auditing Chapter 7 Top Management
  57. 57. Chapter 7 Top Management <ul><li>Auditing Top Management </li></ul>
  58. 58. Chapter 7 Top Management <ul><li>Conversation Threads : </li></ul><ul><ul><li>Please explain the Management Structure </li></ul></ul><ul><ul><li>Explain how Quality policy was developed </li></ul></ul><ul><ul><li>Explain how objectives were developed and communicated </li></ul></ul><ul><ul><li>How are objectives linked to quality policy </li></ul></ul><ul><ul><li>How has management identified objectives at all levels </li></ul></ul><ul><ul><li>How does management ensure that policy and objectives are understood at all levels </li></ul></ul>
  59. 59. Chapter 7 Top Management <ul><li>Avoid: </li></ul><ul><ul><li>Quoting Specific Requirements of the Standard </li></ul></ul><ul><ul><li>Requesting specific evidence </li></ul></ul><ul><ul><li>Ask questions that are related to very specific areas of business </li></ul></ul><ul><ul><li>Taking too much time </li></ul></ul>
  60. 60. Chapter 7 Top Management <ul><li>Remember: </li></ul><ul><ul><li>We are trying to gather information that will help us understand the level of top Management commitment </li></ul></ul><ul><ul><li>The true test of the answers to the conversation threads will be when we talk to the people in the organization </li></ul></ul><ul><ul><li>Top Management puts their pants on the same way you do, One leg at a Time! </li></ul></ul>
  61. 61. Process Auditing Chapter 8 Session Wrap-up
  62. 62. Chapter 8 Wrap-up Session What are some of the concepts you’ve learned that have added to your level of knowledge from this training?
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ISO 9001 -2000 Internal Auditor Trainng program

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