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Introduces the changes to the ISO 9001 standard for quality management systems, due in 2015
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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?
© 2014 ISSI, LLC
Why is ISO 9001 changing?
© 2014 ISSI, LLC 2
ISO standards are reviewed for suitability and effectiveness every 5-7 years*
*ISO 9001 was last updated in 2008
© 2014 ISSI, LLC 3
ISO 9001:2015 will follow the new common structure for management system standards
© 2014 ISSI, LLC 4
All future management system standards will have common high level sections, text, and terms and definitions
© 2014 ISSI, LLC 5
The common structure will especially benefit organizations with integrated management systems
QMS EMS ISMS
© 2014 ISSI, LLC 6
What is the new structure of ISO 9001?
© 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
© 2014 ISSI, LLC 8
What are the major changes?
© 2014 ISSI, LLC 9
The “context of the organization” must be determined
*i.e., internal and external issues relevant to the organization
© 2014 ISSI, LLC 10
The “needs and expectations of interested parties” must be determined
*refers to customers and other stakeholders
© 2014 ISSI, LLC 11
There is an explicit requirement for adopting a “process approach”
*many organizations have already implemented a process-based system
© 2014 ISSI, LLC 12
Requirement for a “risk-based approach” replaces preventive action
*implies the need for risk assessment and risk management activities
© 2014 ISSI, LLC 13
“Documented information” replaces procedures and records
*there is no longer a specific requirement for having a quality manual
© 2014 ISSI, LLC 14
The term “goods and services” replaces “products”
*broadens the applicability of the standard
© 2014 ISSI, LLC 15
When will the new standard be released?
© 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
© 2014 ISSI, LLC 17
What can you do now to prepare for ISO 9001:2015?
© 2014 ISSI, LLC 18
Educate yourself and your organization
© 2014 ISSI, LLC 19
Identify the gaps between your current system and the new requirements
© 2014 ISSI, LLC 20
Plan implementation of the new requirements
© 2014 ISSI, LLC 21
Contact ISSI to get started!
call: + 1 831 239 1575
email: [email protected]
web: www.issi-inc.com