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.

1. The New
ISO 9001:2015
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Reza Seifollahy

2. 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.

3. Are you ready for Changes?
Prepared By: Reza Seifollahy
ISO 9001 revisions since beginning
1987
1994
2000
2008
2015
Revisions

4. 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.
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5. Are you ready for changes?
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Latest ISO 9000 series
ISO9001:2008 is
Quality management
systems –
Requirements
Previous
Add latest Versions
ISO9004:2009 is
Managing for the
sustained success of
an organization – A
quality management
approach

6. Looking to the Future
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The vision of standard preparation
committee is looking a head to the
needs of future.

7. REVISION OF QUALITY
PRINCIPLES
Basic Principles are revisited from eight to seven
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8. 4. Process
Approach
Quality Principles
The Revised Quality Principles
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9. ISO 9001:2015 Time line
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10. 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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11. Proposed Clauses:
1. Scope
2. Normative references
3. 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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12. 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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13. Proposed Clauses:
3.18. Conformity
3.19. Non-conformity
3.20. Correction
3.21. Corrective Action
3.22. Continual improvement
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14. WELCOME TO
REQUIREMENTS
Clause 4
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15. 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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16. Are you Ready for the changes?
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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
Documented
Information

20. 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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21. 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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22. 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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23. 10.1 Nonconformity and
Corrective Action
10.2 Improvement
Clause 10. Continual Improvement
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