The Future of Management ISO 9001:2015

2. Agenda • Introduction and Speakers • Consistent Management System Strucures- Annex SL • Expectations (stated but can it be backed up) • New, major, minor and nonexistent changes • Complexity of issues • Difficulties and Dangers • Why its great! • Transition – your system and certificates • Questions Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 2

3. Colin Gray & Cavendish Scott • Colin Gray – 30 years auditing, training and consulting. – IRCA, EG, PECB Lead Auditor – IRCA ISO 9001:2015 Lead Auditor instructor and training designer • Cavendish Scott, Inc. – ISO 9001:2015 consulting packages – Training, auditing and gap analysis – 30+ Years Experience – Guaranteed Success – IRCA ISO 9001:2015 Lead Auditor Training – ISO 9001, AS, 14001, 17025, 13485 Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 3

4. Management System Structure - Annex SL • Common structure – 4 QMS – 5 Leadership – 6 Planning – 7 Support processes – 8 Operations – 9 Measurement and analysis – 10 Improvement • Common terminology/definitions • ALL management system standards Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 4

5. Other Standards • ISO 14001, 27001 • ISO 45001 (OHSAS 18001) – new issue late 2016 • AS9100 – April 2016 • TS16949 – “boxed text” • ISO 13485 – FDIS Q1 2016 • ISO 17025 – DIS Mid 2016 Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 5

6. New Expectations • Leadership Involvement • Alignment of management system with strategic direction, – organizational context, interested parties, strategic direction reflected in management system planning • Risk based approach/thinking • Process approach • Flexibility in demonstration – Down to the organization to determine how to demonstrate conformance – no mandated procedures and few mandated records Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 6

7. ISO 9001:2015 Annex A • Annex A Clarification new structure, terminology and concepts – A1 Structure and terminology – A2 Products and services – A3 Understanding the needs and expectations of interested parties – A4 Risk based thinking – A5 Applicability – A6 Documented information – A7 Organizational knowledge – A8 Control of externally provided processes, products and services Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 7

8. 5.1 Leadership & commitment • 5.1.1 General • Top management shall demonstrate leadership and commitment with respect to the quality management system by: • a) taking accountability for the effectiveness of the quality management system; • b)ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization; • c) ensuring the integration of the quality management system requirements into the organization’s business processes; • d) promoting the use of the process approach and risk-based thinking; • e) ensuring that the resources needed for the quality management system are available; • f) communicating the importance of effective quality management and of conforming to the quality management system requirements; • g) ensuring that the quality management system achieves its intended results; • h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system; • i) promoting improvement; • j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 8

9. Changes • New – Strategic, issues, interested parties, risk, opportunities – People – Knowledge – Change • Significant change – Scope, QMS – Leadership, Objectives – Communication – Externally Provided – Nonconformance and CA • Minor change – Design – Customer Requirements – Analysis, Improvement • None – Work Environment, Infrastructure – Measuring resources Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 9

10. Gray Areas to Watch • …shall consider…. – Meriam Webster – “to think about (something or someone) carefully especially in order to make a choice or decision” – ISO 14001:2015 Annex A.2 – “The word, ‘consider’ means it is necessary to think about the topic but it can be excluded…” • …to the extent necessary…. – Who decides the extent that is necessary? – How can you prove you went far enough? – Confident answers backed by data will be important Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 10

11. 11 ISO 9001:2015 Model

12. Complexity of Issues (4.1) • Organization purpose • Organization strategy for quality • External and Internal Issues • Interested Parties • Risks and Opportunities • QMS planning • Production/Service Planning • Communication • Knowledge • Objectives, measurements and analysis • Nonconformance and Corrective Action • Change • Etc. Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 12

13. Difficulties and Dangers • Less Prescriptive to demonstrate conformance – What procedures – What records – What will satisfy an auditor – What do we need to make sure we are effective – How will verbal evidence be treated • How do you demonstrate Leadership and Commitment • Auditing leadership – are internal auditors going to be comfortable challenging the CEO on his/her strategy? • Integration with business processes. Quality Manager promoted to top management? Attending senior meetings? • Interrelationships within the new structure Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 13

14. Benefits • Accountability of Leadership • Involvement of Leadership • Integration with strategic and business processes (new role for quality) • More comprehensive and successful QMS • Annex SL – common, consistent and a lot less likely to change • Fix poor processes – Preventive Action, Change, etc. • Deliberately Successful Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 14

15. Certification Transition • It’s a new standard – many additional requirements – losing 3 very minor requirements – Its going to take more time • You have to maintain conformance to 2008 until you are 2015 certified • Best at recertification • Don’t believe the hype – its going to cost you to update your certificate • Going forward may require more audit days (changes in MD5) • Deadlines – Sept 1 2017 No new certifications to 2008 – Sept 1 2018 standard withdrawn Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 15

16. QMS Transition 1. Understand impact and breadth of changes 2. Gap Assessment 3. Project Planning 4. Implementation 1. New designs, management involvement, strategic 2. New procedures – plus substantial training/support 3. Changed procedures – plus training/support 4. Document review 5. Internal audit 5. CB Audit – contact early – timing to start Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com

17. 17 Project Schedule Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 17 Third Party Audit Month 0 93 6 Assuming a Dedicated Resource is Assigned… Address Internal Audit Findings Perform Internal Audit Awareness Training Management Review Document Review Design, Document, Implement Solutions Gap Assessment

18. Critical Path • Leadership awareness, training and engagement • Redevelopment of processes, procedures for process approach • Structure, interrelationships, pervasiveness • New processes • New involvement of Quality into strategic and business processes • Substantial effort Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 18

19. Cavendish Scott, Inc. • Standard ISO 9001:2015 training classes – Free Webinars – Custom leadership training – Awareness presentations – ISO standard review – IRCA Transition Training – IRCA ISO 9001:2015 Lead Auditor • Standard ISO 9001:2016 transition consulting projects – Procedure development/change, leadership and management support/training, document review, auditing • Auditing, document review and gap analysis/project planning Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 19