1. ISO 9001:2015 Just around the corner ASQ Ottawa Chapter – June 30, 2015

2. 2 Participant Objectives What would you like to find out in the next hour?

3. 3 July 2015 Draft FDIS July 2015 Draft FDIS August 2015 FDIS for ballot August 2015 FDIS for ballot September 2015 Published September 2015 Published August 2014 Comments closed August 2014 Comments closed May 2014 DIS for comment and ballot May 2014 DIS for comment and ballot

4. The 'Structured Layer' design of the new Standard

5. 5 1.Scope 2.Normative references 3.Terms and definitions (0) 4.Quality Management System 5.Management Responsibility 6.Resources 7.Product Realization 8.Measurement, Analysis and Improvement 9001:2008

6. 6 1.Scope 2.Normative references 3.Terms and definitions (69) 4.Context of the organization 5.Leadership 6.Planning 7.Support 8.Operation 9.Performance evaluation 10.Improvement 9001:2015 DIS

7. 7 Quality Management Principles Were 8:Now 7: Customer focus Leadership Involvement of peopleEngagement of people Process approach System approach to management(Included in the process approach) Continual improvementImprovement Factual approach to decision making Evidence based decision making Mutually beneficial supplier relationships Relationship management

8. ISO/DIS 9001:2015 Requirements The Clauses

9. 9 5 Leadership 6 Planning 7 Support 9 Performance Evaluation 10 Improvement 4 Context of the organization 8 Operation products services

10. 10 4.1 a)-f) 4.1, 4.4.1, 4.4.2 4.2 4.3 You’ll want to review: 4.2 – Understanding needs and expectations of customers 4 Context of the organization 8 Operation products services 2008 2015

11. 11 5.1 5.1.1 5.2 5.1.2 5.3 5.2 5.5.1 5.3 5 Leadership 8 Operation products services

12. 12 Leadership, policy and responsibilities are linked in a number of ways…

13. 13 5.1 5.1.1 5.2 5.1.2 5.3 5.2 5.5.1 5.3 5 Leadership Leadership and commitment Customer Focus Quality Policy Organizational Roles, Responsibilities and Authorities

14. 14 “Leaders establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.” ISO 9001:2015 B3 QMP2

15. 15 “Creation of unity of purpose and direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives.” ISO 9001:2015 B3 QMP2

16. 16 Leaders lead by example whether they want to or not

17. 17 Leaders have to demonstrate commitment…

18. 18 Discussion: Based on what you see in the handout, how will you explain these requirements to Management at your organization?

19. 19 5.4 6.2 You’ll want to review: 6.1 – Actions to address risks and opportunities, 6.3 – Planning of changes 6 Planning 8 Operation products services There is no requirement for a formal risk management methodology

20. 20 Exercise 1.In teams, explain how you currently identify risks – use the sticky notes provided 2.The other teams: Explain how you currently manage change (create an explanation that your team can present)

21. 21 6.3 7.1.3 6.2.1 7.1.5 6.2.2 7.1.2, 7.2, 7.3 5.5.3 7.4 4.2.1 7.5, 7.5.1 4.2.3/4 7.5.2 7.6 7.1.4 7 Support 6.4 7.1.4 8 Operation products services

22. 22 7.1 8.1 7.5.1/2 8.5.1/2 7.2 8.2.2, 8.2.3 7.3 8.3.1 - 8.3.6 7.4 8.4.1, 8.4.2, 8.4.3 8.3 8.7 7.2.3 8.2.1 7.5.3 8.5.2 7.5.4 8.5.3 7.5.5 8.5.4, 8.5.5 8 Operation products services You’ll want to review: 8.5.6 Control of changes 8.6 Release of…

23. 23 8.1 9.1.1 8.2.1 9.1.2 8.4 9.1.3 8.2.2 9.2 5.6 9.3 8.2.3 9.1.3 e) 8.2.4 9.1.3 a) 9 Performance Evaluation 8 Operation products services

24. 24 Exercise 1.In teams, create a list of the kinds of processes and products and/or service delivery that you measure now. 2.Identify whether you’ll have to develop any additional measurements 3.Be ready to present your findings.

25. 25 8.5.2/3 10.2 8.5.1 10.3 10 Improvement 8 Operation products services

26. 26 Improvement Corrective Actions Preventive Actions Clients Internal External Audits Internal External Management Review Metrics -measurements Reactive Proactive

27. 27 Now that you’ve seen an overview of the changes, where do you think your organization will need to do the most work? Exercise

28. 28 5 Leadership 6 Planning 7 Support 9 Performance Evaluation 10 Improvement 4 Context of the organization 8 Operation products services

29. 29 Session Summary: You now understand the 'Structured Layer' design if the new Standard You have learned about the new requirements for Management Involvement and the Leadership requirements linked to it. You understand new the requirements for Risk Management and Change Management You understand the application of requirements to Operations You have learned about the requirements for activities that support Operations including Improvements You now recognize the benefits of employee engagement and related requirements You have seen the link between the QMS, EMS and OHSAS requirements You have a framework for migrating from your existing system to ISO 9001:2015 and you can begin any time

30. 30

31. 31 Contact Information Jim Moran: jim@simplifyISO.com

32. Thank You for Participating! Transition to ISO 9001:2015