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The New

ISO 9001:2015

Are you ready for changes?

Reza Seifollahy
Background
Are you ready for changes?

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.

Prepared by: Reza Seifollahy


ISO 9001 revisions since beginning
Are you ready for Changes?

1994
2000

1987 Revisions

2008

2015

Prepared By: Reza Seifollahy


ISO 9000 Series
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 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.

Prepared by: Reza Seifollahy


Latest ISO 9000 series
Are you ready for changes?

Previous
Add latest Versions

ISO9001:2008 is ISO9004:2009 is
Quality management Managing for the
systems – sustained success of
Requirements an organization – A
quality management
approach

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Looking to the Future
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The vision of standard preparation


committee is looking a head to the
needs of future.

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Are you ready for changes?

Basic Principles are revisited from eight to seven

REVISION OF QUALITY
PRINCIPLES

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The Revised Quality Principles
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Quality Principles

4. Process
Approach
ISO 9001:2015 Time line
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Prepared by: Reza Seifollahy


Ten Clauses
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1. Scope 6. Planning
2. Normative references 7. Support

3. Terms and definition 8. Operations

4. Context of organization 9. Performance Evaluation

5. Leadership 10. Improvement


Proposed Clauses:
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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
Prepared by: Reza Seifollahy
Proposed Clauses:
Are you ready for the changes?

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:
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3.18. Conformity
3.19. Non-conformity
3.20. Correction
3.21. Corrective Action
3.22. Continual improvement

Prepared by: Reza Seifollahy


Are you ready for changes?

Clause 4

WELCOME TO
REQUIREMENTS
Clause 4. Context of The Organization
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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

Prepared by: Reza Seifollahy


Clause 5. Leadership
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5.1 Leadership & Commitment

5.2 Quality Policy 5. Leadership

5.3 Organizational Roles,


Responsibilities & Authorities

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Clause 6. Planning
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6.1 Actions to address risks &


opportunities

6.2 Quality objectives & planning


To achieve them 6. Planning

6.3 Planning of changes

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Clause 7. Support
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Competence

7.2

Resources 7.1 7.3 Awareness

7. Support

Documented 7.5 7.4 Communication


Information

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7.5 Documented Information
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General

7.5
Creating &
Updating

Control of
Documented
Information

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Clause 8. Operation
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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
Prepared by: Reza Seifollahy
Note for consideration
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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.

Prepared by: Reza Seifollahy


Clause 9. Performance evaluation
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Monitoring, measurement , analysis and


evaluation
9.1. 9.1.1.General, 9.1.2.customer satisfaction, 9.1.3.
Analysis & evaluation of data

9.2. Internal Audit

9.3. Management Review

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Clause 10. Continual Improvement
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10.1 Nonconformity and


Corrective Action

10.2 Improvement
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(1 day course or 2 days workshop)

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Are you ready for changes?

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