The New

ISO 9001:2015

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Divyesh Sanghani

Background
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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.
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ISO 9001 revisions since beginning

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1994

2000

Revisions

1987

2008
2015

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ISO 9000 Series

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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.

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Latest ISO 9000 series

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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

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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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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
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ISO 9001:2015 Time line

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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

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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
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Proposed Clauses:
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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

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Are you ready for changes?

Clause 4

WELCOME TO
REQUIREMENTS
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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

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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
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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.

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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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