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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 ISOs 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

Revisions

1987

2008
2015

Prepared By: Reza Seifollahy

ISO 9000 Series


Are you ready for changes?

They have:
Consistently been ISOs 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 organizations
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
systems
Requirements

Managing for the


sustained success of
an organization A
quality management
approach

Prepared by: Reza Seifollahy

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:
Are you ready for the changes?

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
Prepared by: Reza Seifollahy

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
Information

7.5

7.4

Communication

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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


Are you ready for the changes?

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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9.1.

Monitoring, measurement , analysis and


evaluation
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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Do you want to be among the First


to learn about ISO 9001:2015?
(1 day course or 2 days workshop)

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