Introduction to ISO 9001:2015
22
© 2014 ISSI, LLC 0 ISO 9001:2015 Update What’s changing? When will it be released? What should you do to prepare?
description
Introduces the changes to the ISO 9001 standard for quality management systems, due in 2015
Transcript of 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?
© 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
