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ISO 9001:2015 webinar Part 3 - UL DQS Inc

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Join Joe Mansour, UL DQS Inc. Lead Auditor and ISO 9001:2015 Program Manager, as he gives an in-depth overview of the changes coming to ISO 9001:2015. Part 3 of the 5 part webinar concentrates on the review of questions received during part 2 and the review of sections 7 and 8 of the standard.

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ISO 9001:2015 webinar Part 3 - UL DQS Inc

  1. 1. DQS-ULManagementSystemsSolutions© 1 DIS ISO9001:2015 Overview Welcome Sections 6-7 Revisions & Impact
  2. 2. DQS-ULManagementSystemsSolutions© 2 Jawaid.Mansour@us.dqs-ul.com Joe Mansour ISO9001:2015 Program Manager Lead Auditor 760-458-3879 (office/cell)
  3. 3. DQS-ULManagementSystemsSolutions© Today’s Presentation ISO9001:2015 1. Scope 2. Normative reference 3. Terms and definitions 4. Context of the organization 5. Leadership March 25, 2015 6. Planning 7. Support April 29, 2015 8. Operation 9. Performance evaluation May 26, 2015 10. Improvement ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards. 3 … Final Webinar on July 29, 2015 .
  4. 4. DQS-ULManagementSystemsSolutions© 4 www.ul-dqsusa.com http://ul-dqsusa.com/iso-90012015/
  5. 5. DQS-ULManagementSystemsSolutions© Questions? 5 ISO9001_2015_Questions@us.dqs-ul.com Please send your questions to: Next Webinar: May 26, 2015
  6. 6. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 6 Q27: Slide 8 of the presentation material for part 1 cross-referenced ISO9001:2008 sections to 2015 sections. I found many errors. You may want to revisit it. The references are as outlined in document N1224 by TC176/SC2.
  7. 7. DQS-ULManagementSystemsSolutions© 7 ISO 9001:2008 ISO/DIS 9001 ISO 9001:2008 ISO/DIS 9001 ISO 9001:2008 ISO/DIS 9001 ISO 9001:2008 ISO/DIS 9001 4 4 5.5.3 7.4 7.2.3 8.2.1 7.5.4 8.5.3 4.1 4.4 5.6 9.3 7.3 8.5 7.5.5 8.5.4 4.2 7.5 5.6.1 9.3.1 7.3.1 8.3, 8.3.1, 8.3.2 7.6 7.1.5 4.2.1 7.5.1 5.6.2 9.3.1 7.3.2 8.3.3 8 9.1 4.2.2 4.3, 7.5.1, 4.4 5.6.3 9.3.2 7.3.3 8.3.5 8.1 9.1.1 4.2.3 7.5.2, 7.5.3 6 7.1 7.3.4 8.3.4 8.2 9.1 4.2.4 7.5.2, 7.5.3 6.1 7.1.1, 7.1.2 7.3.5 8.3.4 8.2.1 9.1.2 5 5 6.2 7.2 7.3.6 8.3.4 8.2.2 9.2 5.1 5.1, 5.1.1 6.2.1 7.2 7.3.7 8.3.6 8.2.3 9.1.1 5.2 5.1.2 6.2.2 7.2 , 7.3 7.4 8.4 8.2.4 8.6 5.3 5.2 6.3 7.1.3 7.4.1 8.4.1,8.4.2 8.3 8.7 5.4 6 6.4 7.1.4 7.4.2 8.4.3 8.4 9.1.3 5.4.1 6.2 7 8 7.4.3 8.6 8.5 10 5.4.2 6, 6.1, 6.3 7.1 8.1 7.5 8.5 8.5.1 10.1, 10.3 5.5 5 7.2 8.2 7.5.1 8.5.1, 8.5.5 8.5.2 10.2 5.5.1 5.3 7.2.1 8.2.2 7.5.2 8.5.1 8.5.3 Clause removed 5.5.2 5.3 7.2.2 8.2.3 7.5.3 8.5.2 see 6.1 ISO9001:2008 vs. ISO/DIS 9001
  8. 8. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 8 Q28 Can we assume the terms of definitions in the draft of ISO9001:2005 will be the definitions in ISO9000’s next revision. ISO9000 Vocabulary is currently under revision as well. The next update is expected to include the definitions currently included in ISO9001:2015. ISO9000-2005 currently does not include all the definitions currently included in DIS ISO9001:2015.
  9. 9. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 9 Q29 The corrective action must eliminate the “cause”. If the cause is an operator do we need to get rid of the operator? Yes and No. Please consider Deming’s 85/15 Rule.
  10. 10. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 10 Tester Reject
  11. 11. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 11 Tester Reject
  12. 12. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 12 Tester Reject
  13. 13. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 13 The definition for corrective action has not changed. The intent is to eliminate the root cause and prevent problems from happening. The corrective action requirements apply to all internal and external nonconformities. Q30 Will this new definition for corrective action imply that the bar will be raised by auditors on the results expected on the determination of the cause of each nonconformity detected internally and/or externally
  14. 14. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 14 With respect to the context of the organization, the Quality Management System requirements are to be considered in meeting customer requirements. Furthermore, those requirements will have to be integrated into the Business Management System of the organization. (Section 4.1) Q31 Is the Context Of The Organization directed only towards the Quality Management System or the Entire Business Management System
  15. 15. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 15 Q32 At what level of the organization will the standard expect that the 4.1 requirements of understanding of the organization and the context can be explained to an external or internal auditor? Determining the Context of the Organization is a Leadership responsibility and is noted under Section 4.0
  16. 16. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 16 Q33 Are you suggesting that the company will now need process maps for each identified process? A process map is not required, but is a good way of identifying the processes and showing their sequence and interaction.
  17. 17. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 17 Q34 Can the processes be grouped? with generic inputs, outputs, measures, responsibilities, etc. or does each specific process need to have each item listed in clause 4.4. Items a-h of section 4.4 has to be addressed for all processes.
  18. 18. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 18 The turtle diagrams and process maps were all examples of how the requirements of the standard may be met. Other methods will equally meet the requirements of the standard as long as items Q35 We have the processes explained in written documents where the information required by 4.4 can be found. Do we have to go to a more graphic approach for process definition as the turtle diagram or equivalent when we certify to ISO9001:2015
  19. 19. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 19 Q36 Is the ISO9001:2015 standard still on track to be released by this September. The current timeline for FDIS publication is July 15, 2015 and for the final Standard by September 2015..
  20. 20. DQS-ULManagementSystemsSolutions© Questions From The Last Webinar 20 Q37 If the company has multiple sites in which sections are excluded, can those sites lose certification if main company don’t maintain those exclusions. That may depend on the type of certification being sought. Single Site vs. Corporate Registration.
  21. 21. DQS-ULManagementSystemsSolutions© Questions? 21 ISO9001_2015_Questions@us.dqs-ul.com Please send your questions to:
  22. 22. DQS-ULManagementSystemsSolutions© Sections 6-7 22 6 Planning For the Quality Management System 7 Support
  23. 23. DQS-ULManagementSystemsSolutions© Sections 6-7 23 6 Planning For the Quality Management System 7 Support
  24. 24. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 24 6.1 Actions to Address Risks and Opportunities 6.2 Quality Objectives and planning 6.3 Planning of Changes
  25. 25. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 25 a) Incorporated in requirements for the establishment, implementation, maintenance and continual improvement of the QMS. b) May Use ISO31000 - but not required. c) Not all processes represent the same level of risk. d) Considering Risk “qualitatively” to define the QMS, processes and activities. Risk is the effect of uncertainty on an expected result.
  26. 26. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 26 WHAT IS RISK-BASED THINIKING?
  27. 27. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 27 • Risk-based thinking is what we do automatically. • Risk-based thinking is already part of the process approach. • Risk is the negative side. • Opportunity is the positive side. • Opportunity not related to risk, but related to objectives.
  28. 28. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 28 6 - Planning Take Action to Identify Risks 5 - Leadership Ensure Clause 4 is Followed 4 - Context Determine Risks
  29. 29. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 29 10 - Improvement Improve by responding to change in Risk 9 - Performance Monitor, Measure, Analyze 8 - Operation Implement Processes
  30. 30. DQS-ULManagementSystemsSolutions© 6.1 – Actions – Risks & Opportunities 30 Addressing Risks/Opportunities Determine Risks and Opportunities per sections 4.1 and 4.2 Actions to Address Risks Establish Quality Objectives Manage QMS Change
  31. 31. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 31 WHY USE RISK-BASED THINIKING?
  32. 32. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 32 • Build a strong knowledge base • Establish a proactive culture of improvement • Assure consistency of quality • Improve customer confidence and satisfaction.
  33. 33. DQS-ULManagementSystemsSolutions© Section 6 33 1 ISO31000 2 Document N1222 “Risk In ISO9001:2015” 3 Examples
  34. 34. DQS-ULManagementSystemsSolutions© Section 6 34
  35. 35. DQS-ULManagementSystemsSolutions© Section 6 – 7 R’s of Risk Management 35 Recognition of Risks Ranking or Evaluation of Risks Responding to Significant Risks Resourcing Controls Reaction Planning Reporting and Monitoring Reviewing Framework
  36. 36. DQS-ULManagementSystemsSolutions© Section 6 – 4 T’s of Risk Management 36 Tolerate Treat Transfer Terminate RespondingTo SignificantRisks
  37. 37. DQS-ULManagementSystemsSolutions© Section 6 37 1 ISO31000 2 Document N1222 “Risk In ISO9001:2015” 3 Examples
  38. 38. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 38 HOW DO I USE A RISK-DRIVEN APPROACH IN MY ORGANIZATION?
  39. 39. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS Identify The Risks Analyze & Prioritize Plan Actions to address Take Action Check Effectiveness Learn & Improve 39
  40. 40. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 40
  41. 41. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 41
  42. 42. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 42
  43. 43. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 43
  44. 44. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 44
  45. 45. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 45
  46. 46. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 46
  47. 47. DQS-ULManagementSystemsSolutions© Section 6 - Risk Management 47 Is Not New Something You Already Do Is Continuous Ensures Greater Knowledge Increases Reaching Goal Reduces Poor Results Makes Prevention a Habit Risk-Based Thinking
  48. 48. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 48 6.1.1 Consider Issues in 4.1 and 4.2 Give assurance QMS can achieve its results Prevent, or reduce, undesired effects Achieve Continual Improvement
  49. 49. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 49 6.1.2 The organization shall plan Actions to address these Risks and Opportunities Integrate actions into its QMS processes Evaluate the effectiveness
  50. 50. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 50 6.2.1 Quality Objectives Be consistent with the quality policy Be measurable Take into account applicable requirements Relevant to conformity of products
  51. 51. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 51 6.2.1 Quality Objectives Be Monitored Be Communicated Be Updated as appropriate Retain Documented Information on the Objectives
  52. 52. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 52 6.2.2 Quality Objectives What will be done. What resources will be required. Who will be responsible. When it will be completed. How the results will be evaluated.
  53. 53. DQS-ULManagementSystemsSolutions© 4.4 – STAMPING Process Map OBJECTIVE ACTUAL GOAL ACTION PPM 25 50 Continue to Monitor Machine Up Time 82 % 95% Increase PM, have spare parts available, staffing Parts Per Hour 235 215 Continue to Monitor Cost of Rework $496 <$500 per month Continue to Monitor/consider risk Quality Objectives For The Stamping Process
  54. 54. DQS-ULManagementSystemsSolutions© Section 6 – Planning for QMS 54 6.2.2 Planning of Changes The Purpose and Consequence of Change The Integrity of the Quality Management System The Availability of Resources The allocation/reallocation of responsibilities
  55. 55. DQS-ULManagementSystemsSolutions© 55 SEVERITY 1 No relevant effect 2 Very Minor, no damage 3 Minor, low damage 4 Moderate 5 Critical (loss of primary function) 6 Catastrophic OCCURANCE 1 Extremely Unlikely 2 Remote 3 Occasionally 4 Reasonably Possible 5 Frequent DETECTION 1 Certain 2 Almost Certain 3 High 4 Moderate 5 Low 6 Undetectable Risk Priority Number (RPN) = Severity * Occurance * Detection FMEA - RPN
  56. 56. DQS-ULManagementSystemsSolutions© Section 6 – Failure-Mode-And-Effect (FMEA) 56 RPN= Severity * Occurrence * Detection RPN= Risk Priority Number
  57. 57. DQS-ULManagementSystemsSolutions© Section 6 - Risk Register 57
  58. 58. DQS-ULManagementSystemsSolutions© Section 6 - Risk Management 58
  59. 59. DQS-ULManagementSystemsSolutions© Section 6 – 7 R’s of Risk Management 59 Recognition of Risks Ranking or Evaluation of Risks Responding to Significant Risks Resourcing Controls Reaction Planning Reporting and Monitoring Reviewing Framework
  60. 60. DQS-ULManagementSystemsSolutions© Sections 6-7 60 6 Planning For the Quality Management System 7 Support
  61. 61. DQS-ULManagementSystemsSolutions© Section 7 – Support 61 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information
  62. 62. DQS-ULManagementSystemsSolutions© Section 7 – Support 62 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment 7.1.5 Monitoring Resources 7.1.6 Organizational knowledge
  63. 63. DQS-ULManagementSystemsSolutions© Section 7 – Support 7.2 Competence Determine competence needed Ensure Competence Acquire Competence Retain Evidence 63
  64. 64. DQS-ULManagementSystemsSolutions© Section 7 – Support 64 Quality Policy Quality Objectives Contributions Implications 7.3 - Awareness
  65. 65. DQS-ULManagementSystemsSolutions© Section 7 – Support 65 What When With Whom How 7.4 - Communication
  66. 66. DQS-ULManagementSystemsSolutions© Section 7 – Support 66 7.5.1 General 7.5.2 Creating and Updating 7.5.3 Control of Documented Information 7.5 Documented Information
  67. 67. DQS-ULManagementSystemsSolutions© Section 7 – Support 67 Distribution, Access, Retrieval, Use Storage, Preservation Control of Changes Retention and Disposition 7.5.3.2 Documented Information
  68. 68. DQS-ULManagementSystemsSolutions© Questions? 68 ISO9001_2015_Questions@us.dqs-ul.com Please send your questions to: Next Webinar: May 26, 2015
  69. 69. DQS-ULManagementSystemsSolutions© Questions? Contact me: Joe Mansour ISO9001:2015 Program Manager 69 ISO9001_2015_Questions@us.dqs-ul.com Please send your questions to: Next Webinar: May 26, 2015

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