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Introduction to ISO 9001:2015

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Introduces the changes to the ISO 9001 standard for quality management systems, due in 2015

Published in: Business

Introduction to ISO 9001:2015

  1. 1. © 2014 ISSI, LLC 0 ISO 9001:2015 Update What’s changing? When will it be released? What should you do to prepare?
  2. 2. © 2014 ISSI, LLC Why is ISO 9001 changing?
  3. 3. © 2014 ISSI, LLC 2 ISO standards are reviewed for suitability and effectiveness every 5-7 years* *ISO 9001 was last updated in 2008
  4. 4. © 2014 ISSI, LLC 3 ISO 9001:2015 will follow the new common structure for management system standards
  5. 5. © 2014 ISSI, LLC 4 All future management system standards will have common high level sections, text, and terms and definitions
  6. 6. © 2014 ISSI, LLC 5 The common structure will especially benefit organizations with integrated management systems QMS EMS ISMS
  7. 7. © 2014 ISSI, LLC 6 What is the new structure of ISO 9001?
  8. 8. © 2014 ISSI, LLC 7 0 Introduction 1 Scope 2 Normative References 3 Terms and Definitions 4 Context of the Organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance Evaluation 10 Improvement Source: ISO/CD 9001 2013-06-03
  9. 9. © 2014 ISSI, LLC 8 What are the major changes?
  10. 10. © 2014 ISSI, LLC 9 The “context of the organization” must be determined *i.e., internal and external issues relevant to the organization
  11. 11. © 2014 ISSI, LLC 10 The “needs and expectations of interested parties” must be determined *refers to customers and other stakeholders
  12. 12. © 2014 ISSI, LLC 11 There is an explicit requirement for adopting a “process approach” *many organizations have already implemented a process-based system
  13. 13. © 2014 ISSI, LLC 12 Requirement for a “risk-based approach” replaces preventive action *implies the need for risk assessment and risk management activities
  14. 14. © 2014 ISSI, LLC 13 “Documented information” replaces procedures and records *there is no longer a specific requirement for having a quality manual
  15. 15. © 2014 ISSI, LLC 14 The term “goods and services” replaces “products” *broadens the applicability of the standard
  16. 16. © 2014 ISSI, LLC 15 When will the new standard be released?
  17. 17. © 2014 ISSI, LLC 16 Draft International Standard (DIS) April 2014 Final Draft International Standard (FDIS) November 2014 September 2015 ISO 9001:2015 Published *dates are subject to change
  18. 18. © 2014 ISSI, LLC 17 What can you do now to prepare for ISO 9001:2015?
  19. 19. © 2014 ISSI, LLC 18 Educate yourself and your organization
  20. 20. © 2014 ISSI, LLC 19 Identify the gaps between your current system and the new requirements
  21. 21. © 2014 ISSI, LLC 20 Plan implementation of the new requirements
  22. 22. © 2014 ISSI, LLC 21 Contact ISSI to get started! call: + 1 831 239 1575 email: jdrysdale@issi-inc.com web: www.issi-inc.com

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