The New ISO 9001:2015 Are you ready for changes? Reza Seifollahy
The new ISO 9001:2015
Jan 19, 2015
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
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The New
ISO 9001:2015
Are you ready for changes?
Reza Seifollahy
Are you ready for changes?
Prepared by: Reza Seifollahy
Background
First published in 1987, ISO 9000 has consistently been ISO’s most popular series of standards.
building on 25 years of success, ISO technical committee ISO/TC 176,Quality management and quality assurance, subcommittee SC 2, Quality systems, is busy laying the groundwork for the next generation of quality management standards.
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Prepared By: Reza Seifollahy
ISO 9001 revisions since beginning
1987
19942000
2008
2015
Revisions
ISO 9000 Series
They have: Consistently been ISO’s best-selling
standards ; Firmly established a common platform and
language for organizations to discuss quality ; By defining requirements in ISO 9001, Quality
management systems, that give a base-level confidence in an organization’s ability to provide conforming products, they have facilitated world trade.
Are you ready for changes?
Prepared by: Reza Seifollahy
Are you ready for changes?
Prepared by: Reza Seifollahy
Latest ISO 9000 series
ISO9001:2008 is Quality management systems – Requirements
PreviousAdd latest Versions
ISO9004:2009 is Managing for the sustained success of an organization – A quality management approach
Looking to the FutureAre you ready for the Changes?
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The vision of standard preparation committee is looking a head to the needs of future.
REVISION OF QUALITY PRINCIPLES
Basic Principles are revisited from eight to seven
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5. Improvement
2. Leadership
7. RelationshipManagement
4. Process Approach
1.Customer Focus
6. Evidenced-Based decisionmaking
3. EngagementOf People
Quality Principles
The Revised Quality PrinciplesAre you ready for the changes?
ISO 9001:2015 Time lineAre you ready for changes?
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6. Planning
7. Support
9. Performance Evaluation
10. Improvement
1. Scope
2. Normative references
4. Context of organization
5. Leadership
Ten Clauses
3. Terms and definition 8. Operations
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Proposed Clauses:
1. Scope2. Normative references3. Terms and Definitions
3.01. Organization
3.02. Interested Party (preferred term)
3.03. Requirement
3.04. Management System
3.05. Top management
3.06. Effectiveness
3.07. Policy
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Proposed Clauses:
3.08. Objective
3.09. Risk
3.10. Competence
3.11. Documented information
3.12. Process
3.13. Performance
3.14. Outsource (verb)
3.15. Monitoring
3.16. Measurement process
3.17. Audit
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Proposed Clauses:
3.18. Conformity
3.19. Non-conformity
3.20. Correction
3.21. Corrective Action
3.22. Continual improvement
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WELCOME TO REQUIREMENTS
Clause 4
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Clause 4. Context of The Organization
4.1 Understanding the Organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4. Quality Management System
4.4.1. General
4.4.2. Process Approach
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Clause 5. Leadership
5.1 Leadership & Commitment
5.2 Quality Policy
5.3 Organizational Roles, Responsibilities & Authorities
5. Leadership
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Clause 6. Planning
6.1 Actions to address risks &opportunities
6.2 Quality objectives & planning To achieve them
6.3 Planning of changes
6. Planning
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Clause 7. Support
7. Support
7.2
7.5
7.3
7.4
7.1Resources
Competence
Awareness
Documented Information
Communication
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7.5 Documented Information
7.5
General
Creating & Updating
Control of DocumentedInformation
Clause 8. Operation
8.1 Operational Planning & Control
8.2 Determination of Market needs & interactions with customers
8.3 Operational Planning process
8.4 Control of external Provision of Goods & Services
8.5 Development of Goods & Services
8.6 Production of goods and provision of services
8.7 Release of goods and services
8.8 Nonconforming goods & services
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Note for consideration
The new clause 8 is covered the requirements of clause 7 in last version.
Clause 7.3 design & development in previous versions is simplified to clause 8.5 development of goods and services. The new standard resolved many problems related to design and development.
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Clause 9. Performance evaluation
9.1.
9.2.
9.3.
Monitoring, measurement , analysis and evaluation 9.1.1.General, 9.1.2.customer satisfaction, 9.1.3. Analysis & evaluation of data
Internal Audit
Management Review
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10.1 Nonconformity and Corrective Action
10.1 Nonconformity and Corrective Action
10.2 Improvement10.2 Improvement
Clause 10. Continual ImprovementAre you ready for the changes?
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