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What’s

ISO 9001:2015
changing?

Update
What
should you
do to
prepare?
When will
it be
released?

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Why is ISO 9001 changing?

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

*ISO 9001 was last updated in 2008

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

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

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The common structure will
especially benefit organizations
with integrated management
systems
QMS EMS ISMS

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What is the new structure
of ISO 9001?

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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

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What are the major changes?

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The “context of the organization”
must be determined

*i.e., internal and external issues relevant


to the organization

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

*refers to customers and other


stakeholders

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

*many organizations have already


implemented a process-based system

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

*implies the need for risk assessment


and risk management activities

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“Documented information”
replaces procedures and records

*there is no longer a specific requirement


for having a quality manual

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The term “goods and services”
replaces “products”

*broadens the applicability


of the standard

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When will the new standard
be released?

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April 2014 November 2014 September 2015

Draft International Final Draft International ISO 9001:2015


Standard (DIS) Standard (FDIS) Published

*dates are subject to change

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

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Educate yourself and your
organization

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Identify the gaps between your
current system and the new
requirements

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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: jdrysdale@issi-inc.com

web: www.issi-inc.com

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