introduction to iso 9001:2015
DESCRIPTION
Introduces the changes to the ISO 9001 standard for quality management systems, due in 2015TRANSCRIPT
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ISO 9001:2015 Update
What’s changing?
When will it be
released?
What should you
do to prepare?
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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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Draft International Standard (DIS)
April 2014
Final Draft International Standard (FDIS)
November 2014 September 2015
ISO 9001:2015 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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