ISO 9001:2015 Revision Update Part 5

1. DQS-ULManagementSystemsSolutions 1 FDIS ISO9001:2015 Overview Welcome Revisions & Impact

2. DQS-ULManagementSystemsSolutions 2 [email protected] Joe Mansour ISO9001:2015 Program Manager Lead Auditor 760-458-3879 (office/cell)

3. DQS-ULManagementSystemsSolutions Todays 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. DQS-ULManagementSystemsSolutions 4 www.ul-dqsusa.com http://ul-dqsusa.com ISO9001:2015 Revision

5. DQS-ULManagementSystemsSolutions Questions? 5 [email protected] Please send your questions to: Next Webinar: As needed.

6. DQS-ULManagementSystemsSolutions Questions From The Last Webinar 6 Q40 How should we address the exclusion of design process in our organization Clause 4.3 requires justification for any instance where a requirement of ISO9001:2015 cannot be applied... It may be defined in any document, or any media. (i.e. a process map).

7. DQS-ULManagementSystemsSolutions Questions From The Last Webinar 7 Q41 Is traceability back to a specific gage number required for product acceptance? Section 8.3.5 does require the design and development outputs to include or reference monitoring and measuring requirements, and acceptance criteria, but not monitoring and measuring equipment.

8. DQS-ULManagementSystemsSolutions Questions From The Last Webinar 8 Q42 Where is the documnt N-1222 located? on the ULDQS wbsite? This document is not available on our website. Please refer to question C3 on how it could be accessed.

9. DQS-ULManagementSystemsSolutions Questions From The Last Webinar 9 Q44 Will element-based audits definitely not meet the requirements of the standard? YES!

10. DQS-ULManagementSystemsSolutions Questions From The Last Webinar 10 Q47 Will Risk Analysis need to be done to processes such as Purchasing, Human Resources, Training, etc. ? Clause 4.4, item (f) requires that the risks and opportunities be determined for all processes. Clause 6.1 requires the risks to be addressed. Also, actions taken to address risks and opportunities may be proportional to the potential impact on the conformity of the products and offered services. .

11. DQS-ULManagementSystemsSolutions Questions? 11 [email protected] Please send your questions to:

12. DQS-ULManagementSystemsSolutions DIS to FDIS Changes 12 FDIS is now available IS (International Standard) is on track for release by September 15, 2015 ISO 9001 2015

13. DQS-ULManagementSystemsSolutions DIS to FDIS Changes 13 ISO 9001 2015 Document of Compromise 163 countries - November 2014 - Galway, Ireland - February 2015 - Vilnius, Lithuania - 89% approval 3200 comments received and considered.

14. DQS-ULManagementSystemsSolutions ISO9001:2015 ISO14001:2015 14 No Major Changes!

15. DQS-ULManagementSystemsSolutions Key Changes 15 Removed from Section 3 and moved to ISO9000 Terms and Definitions

16. DQS-ULManagementSystemsSolutions Section 3 Terms & Definitions 3.08 OBJECTIVE Result to be achieved. 16

17. DQS-ULManagementSystemsSolutions Section 3 Terms & Definitions 3.09 - RISK Effect of uncertainty on an expected result. The effect can be positive or negative consequence - Risk is characterized by potential events and consequences. 17

18. DQS-ULManagementSystemsSolutions Section 3 Terms & Definitions 3.11 DOCUMENTED INFORMATION Information (3.50) required to be controlled and maintained by an organization (3.01) and the medium on which it is contained. 18

19. DQS-ULManagementSystemsSolutions Key Changes 19 Quality Management System Principles removed from Appendix B and moved to ISO9000

20. DQS-ULManagementSystemsSolutions Key Changes 20 New Figure added in Introduction Single figure that depicts the concept of Process Approach Text has been slightly revised as well.

21. DQS-ULManagementSystemsSolutions Key Changes 21 RISKS OPPORTUNITIES

22. DQS-ULManagementSystemsSolutions Key Changes 22 Use of Continual Improvement Clarified

23. DQS-ULManagementSystemsSolutions Key Changes 23 KEY CHANGES Processes Customer Focus Planning Resource Work Environment Organizational Knowledge

24. DQS-ULManagementSystemsSolutions Key Changes 24 7.3 - Awareness 7.4 - Communication 7.5.3.2 - Unintended Change in Documented Information 8.2 - Product and Service - Changes 8.3 Design - Retention of records; Review, Verification, Validation

25. DQS-ULManagementSystemsSolutions Key Changes 25 8.2.1 Customer Communication 8.2.2 Requirements for Products/Services 8.2.3 Review of Requirements 8.2 DETERMINATION OF REQUIREMENTS FOR PRODUCTS AND SERVICES

26. DQS-ULManagementSystemsSolutions Key Changes 26 8.4 Externally Provided Processes - clarification 8.6, 8.6, 8.7 - Outputs 8.5.1 The implementation of action to prevent human error

27. DQS-ULManagementSystemsSolutions Key Changes April Webinar 27 Tester Reject

28. DQS-ULManagementSystemsSolutions Key Changes April Webinar 28 Tester Reject

29. DQS-ULManagementSystemsSolutions Key Changes 29 8.5 Minor changes in Production and Service Provision 8.7 Removal of term Corrective related to Nonconformity Control

30. DQS-ULManagementSystemsSolutions Key Changes 30 9.1.3 Analysis and Evaluation 9.1.1 - Customer Satisfaction Minor Changes in Sections 9 and 10

31. DQS-ULManagementSystemsSolutions Key Changes 31 9.2 Reference to consider Quality Objectives deleted 9.3 Information for Management Review 10.1 Improvement - General 10.2 Nonconformity and Corrective Action 10.3 Outputs replaced by Results

32. DQS-ULManagementSystemsSolutions Key Changes 32 9.2 Reference to consider Quality Objectives deleted 9.3 Information for Management Review 10.1 Improvement - General 10.2 Nonconformity and Corrective Action 10.3 Outputs replaced by Results

33. DQS-ULManagementSystemsSolutions Key Changes 33 Overall Minimal Impact on Intent

34. DQS-ULManagementSystemsSolutions 34 Transition Process ISO9001:2015 & ISO14001:2015

35. DQS-ULManagementSystemsSolutions Transition Plan UL DQS TRANSITION PLAN ISO9001:2008 To ISO9001:2015 ISO14001:2004 To ISO14001:2015 35

36. DQS-ULManagementSystemsSolutions Transition Plan September 2015: Start of 3 years transition period to September 2018 September 2015: Published International Standard

37. DQS-ULManagementSystemsSolutions 37 Part Of Its Scheduled Recertification Audit; with additional days, if needed In a Planned Manner During Continuous Assessment/Added Days Through a Special Transition Audit. Transition Plan An Organization may be upgraded to ISO9001:2015 or ISO14001:2015

38. DQS-ULManagementSystemsSolutions The most cost-effective way is to upgrade during the normally scheduled Recertification Audit. Upgrade audits done as part of the Continuous Assessment and Special audits will be carried out for the same number of days as a recertification audit (including Stage 1 and Stage 2) 38 2008 to 2015 Transition

39. DQS-ULManagementSystemsSolutions 39 2008 to 2015 Transition Stage 1 Stage 2 ALL UPGRADE AUDITS

40. DQS-ULManagementSystemsSolutions 40 Stage 1 Agenda Items Identification of Interested Parties and their requirements. Identification of Gaps and actions needed Identification of Risks and Opportunities Identification of Processes Context of the Organization and Leadership Requirements

41. DQS-ULManagementSystemsSolutions 41 Stage 1 Agenda Items Review of one round of process-based Internal Audits to ISO9001:2015 At least one management review after the completion of the audits. Ensure Understanding of the Requirements Deployment of Process-based Management System Stage 1 to be done about eight weeks prior to Stage 2.

42. DQS-ULManagementSystemsSolutions 42 Is a complete MR and IA expected before certification/upgrade against ISO :2015 For Stage 1? Yes; with Risk. 2008 to 2015 Transition

43. DQS-ULManagementSystemsSolutions 2015 Standards Transition 43

44. DQS-ULManagementSystemsSolutions 2008 to 2015 Transition Please let your Customer Service Professional know well in advance of your audit when you are ready to upgrade. 44 2008 to 2015 Transition

45. DQS-ULManagementSystemsSolutions 45 ISO9001:2015 Transition Process and Requirements Availability of Gap Assessments ISO9001:2015 Available Services Services

46. DQS-ULManagementSystemsSolutions Quality System Checklist 46

47. DQS-ULManagementSystemsSolutions Quality System Checklist 47

48. DQS-ULManagementSystemsSolutions 48 Informational Sessions ISO9001:2015 & ISO14001:2015

49. DQS-ULManagementSystemsSolutions 49 4 Hour Executive Review 8 Hour Overview 2 day Internal Auditing 2.5 day Integrated Audit 9K/4K Informational Offerings

50. DQS-ULManagementSystemsSolutions 50 Informational Offerings 8:00 am Start, Welcome 8:30 Reasons for the revision of the Standard & their benefits 9:30 FAQ document 10:15 Transition Policy, Stage 1 & 2 10:45 UL DQS Readiness Reviews 11:30 Q&A additional topics, as needed 12:00 pm End of Event Executive Review 4 Hours ISO9001:2015 or ISO14001:2015

51. DQS-ULManagementSystemsSolutions 51 Informational Offerings 8:30 am Start, Welcome 9:00 Reasons for the revision of ISO 9001 & their benefits 9:15 Roadmap to revision 9:30 Review of Section 0-4 10:30 Break 10:45 Review of Sections 5-7 12:00 Lunch 12:30 pm Review of Sections 8-10 1:30 FAQ document 2:30 Break 2:45 Transition Policy, Stage 1 & 2 3:30 UL DQS Readiness Reviews 4:00 Q&A additional topics, as needed 5:00 pm End of event Changes to the Standard 8 Hours ISO9001:2015 or ISO14001:2015

52. DQS-ULManagementSystemsSolutions 52 Informational Offerings Completion of an on line study module designed to ensure better understanding of the requirements. - Takes about 8 hours to complete. - Successful completion needed before the two day in-person presentation. Auditing to ISO9001:2008 or ISO14001:2015

53. DQS-ULManagementSystemsSolutions 53 Informational Offerings 8:30 am Start, Welcome Reasons for the revision & their benefits 9:00 am Review of Sections 0-4 10:00 Review of Sections 5-7 10:45 Break 11:00 Review of Sections 8-10 12:00 Lunch 12.30 Workshop Interested parties and identification of their expectations 1:30 Review of workshop results 2:30 Break 2:45 Workshop on Risk-Based Thinking 3:30 Introducing tools on how to identify risks 4:15 Presentation of Workshop result 5:00 pm End of Day. Auditing to ISO9001:2008 or ISO14001:2015 Day 1

54. DQS-ULManagementSystemsSolutions 54 Informational Offerings 8:30 am Start, Mind Map Lessons Learned 9:30 Process-based Internal Audits 10:30 Break 10:45 Workshop: Preparing an internal audit program 12:00 Lunch 12:30 pm Presentation of results 1:30 Leadership and commitment (presentation) 2:30 Role Play : Interviewing the General Manager 3:30 Documented Information (presentation) 4:00 UL DQS readiness reviews and Transition Process 4:30 Q&A Session 5:00 pm End of event Auditing to ISO9001:2008 or ISO14001:2015 Day 2

55. DQS-ULManagementSystemsSolutions 55 Informational Offerings Integrated Audits to ISO 9001:2015 and ISO 14001:2015 how to conduct internal audits for organizations with integrated ISO 9001 and ISO 14001 systems Auditing to ISO9001:2008 and ISO14001:2015 2.5 Days

56. DQS-ULManagementSystemsSolutions 2008 to 2015 Transition Please let your Customer Service Representative or Regional Sales Representative know should you be interested in these services. 56 2008 to 2015 Transition

57. DQS-ULManagementSystemsSolutions Questions From The Last Webinar 57 Q1 What is the current difference between element approach and process approach? Explanation of Process Approach was included in slides 30-49. ISO9001:2015 requires all Processes (value-added activities of the organization) be identified and managed as a process. Element-based standards just outline the requirements.

58. DQS-ULManagementSystemsSolutions Questions From The Last Webinar 58 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. Q31 Is the Context Of The Organization directed only towards the Quality Management System or the Entire Business Management System

59. DQS-ULManagementSystemsSolutions Questions From The Last Webinar 59 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.

60. DQS-ULManagementSystemsSolutions Questions? Contact: Joe Mansour ISO9001:2015 Program Manager 60 [email protected] Please send your questions to:

ISO 9001:2015 Revision Update Part 5

Education

fdis iso9001

fdis changes

final webinar

requirement of iso9001

joe mansour iso9001

major changes

organization clause

improvement iso