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© 2014 ISSI, LLC 0 ISO 9001:2015 Update What’s changing? When will it be released? What should you do to prepare?

Introduction to ISO 9001:2015

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

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Page 1: Introduction to ISO 9001:2015

© 2014 ISSI, LLC 0

ISO 9001:2015 Update

What’s changing?

When will it be

released?

What should you

do to prepare?

Page 2: Introduction to ISO 9001:2015

© 2014 ISSI, LLC

Why is ISO 9001 changing?

Page 3: Introduction to ISO 9001:2015

© 2014 ISSI, LLC 2

ISO standards are reviewed for suitability and effectiveness every 5-7 years*

*ISO 9001 was last updated in 2008

Page 4: Introduction to ISO 9001:2015

© 2014 ISSI, LLC 3

ISO 9001:2015 will follow the new common structure for management system standards

Page 5: Introduction to ISO 9001:2015

© 2014 ISSI, LLC 4

All future management system standards will have common high level sections, text, and terms and definitions

Page 6: Introduction to ISO 9001:2015

© 2014 ISSI, LLC 5

The common structure will especially benefit organizations with integrated management systems

QMS EMS ISMS

Page 7: Introduction to ISO 9001:2015

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What is the new structure of ISO 9001?

Page 8: Introduction to ISO 9001:2015

© 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

Page 9: Introduction to ISO 9001:2015

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What are the major changes?

Page 10: Introduction to ISO 9001:2015

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The “context of the organization” must be determined

*i.e., internal and external issues relevant to the organization

Page 11: Introduction to ISO 9001:2015

© 2014 ISSI, LLC 10

The “needs and expectations of interested parties” must be determined

*refers to customers and other stakeholders

Page 12: Introduction to ISO 9001:2015

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There is an explicit requirement for adopting a “process approach”

*many organizations have already implemented a process-based system

Page 13: Introduction to ISO 9001:2015

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Requirement for a “risk-based approach” replaces preventive action

*implies the need for risk assessment and risk management activities

Page 14: Introduction to ISO 9001:2015

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“Documented information” replaces procedures and records

*there is no longer a specific requirement for having a quality manual

Page 15: Introduction to ISO 9001:2015

© 2014 ISSI, LLC 14

The term “goods and services” replaces “products”

*broadens the applicability of the standard

Page 16: Introduction to ISO 9001:2015

© 2014 ISSI, LLC 15

When will the new standard be released?

Page 17: Introduction to ISO 9001:2015

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Draft International Standard (DIS)

April 2014

Final Draft International Standard (FDIS)

November 2014 September 2015

ISO 9001:2015 Published

*dates are subject to change

Page 18: Introduction to ISO 9001:2015

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What can you do now to prepare for ISO 9001:2015?

Page 19: Introduction to ISO 9001:2015

© 2014 ISSI, LLC 18

Educate yourself and your organization

Page 20: Introduction to ISO 9001:2015

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Identify the gaps between your current system and the new requirements

Page 21: Introduction to ISO 9001:2015

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Plan implementation of the new requirements

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Contact ISSI to get started!

call: + 1 831 239 1575

email: [email protected]

web: www.issi-inc.com