what is changing in iso 9001-2015
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Why is ISO 9001 Changing?
Changes to Structure
Changes to Terminology
Significant Changes to Content
The Transition
What Should I do Now?
Summary
Some Facts
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1.1 million certificationsLeading ISO management system standard
In a recent survey of ISO 9001 certified organisations:
75%Improved their levels of customer satisfaction and loyalty
Boosted their operational performance
Acquired new customers and retained existing clients
Achieved cost savings
75%
71%
55%
So Why Change It?
In response to the marketplace Increasingly complex, demanding and
dynamic environments Changes in technology Rapid growth of the service sector Greater focus on controlling business risk Increasingly complex global supply chains
Better alignment with other management system standards
Surveys & forums
Revision & Transition Timeline
2014 2015 2015-18
May
Draft International Standard (DIS)
made available for public comment
July
Final Draft International
Standard (FDIS)
September International
Standard published
September 2018
The transition is complete
Change in Structure
High Level Structure (Annex SL of ISO Directives Part One)
Core text will be used in all management system standards
Support Integra-tion Value Efficiency Less
confusion
ISO 9001:2008 Structure ISO 9001:2015 Structure
0. Introduction 0. Introduction1. Scope 1. Scope2. Normative References 2. Normative References3. Terms and Definitions 3. Terms and Definitions4. Quality Management System 4. Context of the Organization5. Management Responsibility 5. Leadership6. Resource Management 6. Planning7. Product Realization 7. Support8. Measurement, Analysis and Improvement 8. Operations
9. Performance Evaluations 10.Improvement
Changes to Terminology
ProductsProducts & Services
SupplierExternal Provider
ManagementResponsibility
Leadership
Continual ImprovementImprovement
Documentation & Records
Documented Information
Product RealizationOperations
Preventive Action Knowledge ManagementRepresentative
NEWUnderstand organisation’s context
External and internal issues Strategic directionProcess Approach
Content ChangesClause 4
Context of the Organisation
Content ChangesClause 5
Leadership
Content ChangesClause 6Planning
Risk Management
Explicit Opportunities
Actions
Objectives
MeasurementMonitored
Updated Strategic
Resources Competent people Infrastructure & work
environment Monitoring and
measuring technologies Knowledge
Documented Information Other media Maintain Retain
Content ChangesClause 7 - Support
Content ChangesClause 8 - Operation
ControlDesign
CommunicateMonitor
ExternalProvision
Content ChangesClause 9 – Performance
Evaluation
• What to measure, how, when• Evaluate results• Audit • Review the suitability,
adequacy, effectiveness • Monitor customer satisfaction
Content ChangesClause 10 – Improvement
• Identify opportunities
• Control non-conformities
• Take corrective action
• Improve suitability, adequacy, effectiveness
Transition Timeline
2015 2015-18 2015-18
September
International Standard published
Transition period
Can be audited against old & new standard
September 2018
Certification to ISO 9001:2008 no longer valid
What Should I do Now?
Perform gap analysis
Implementation plan
Training & awareness
Update
Implement
Internal audits
Liaise with certification body
1
2
3
7
6
5
4
Summary
• Strengthens implied requirements
• Encourages leadership• Risk based• Better integration• Less left to interpretation
Business Management System
More Information
Changes to ISO 9001Insights into the New
ISO 9001:2015
eBook athttp://
www.groweq.com.au/standards/ISO-9001-Quality-Management-System
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