ISO 9001:2015 Ready For Change

1. The New
ISO 9001:2015
Ready for changes
Dr. Madhu Aman Sharma
Principal Consultant & Lead Auditor

2. Are you ready for changes?
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.
Dr. Madhu Aman Sharma Lead Auditor

3. Are you ready for Changes?
ISO 9001 revisions since beginning
1987
1994
2000
2008
2015
Revisions
Dr. Madhu Aman Sharma Lead Auditor

4. ISO 9000 Series
 ISO 9001:2015
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?
Dr. Madhu Aman Sharma Lead Auditor

5. Are you ready for changes?
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
Dr. Madhu Aman Sharma Lead Auditor

6. Looking to the Future
Are you ready for the Changes?
Dr. Madhu Aman Sharma Lead Auditor
 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
Are you ready for changes?
Dr. Madhu Aman Sharma Lead Auditor

8. 4. Process
Approach
Quality Principles
The Revised Quality Principles
Are you ready for the changes?
Dr. Madhu Aman Sharma Lead Auditor

9. ISO 9001:2015 Time line
Are you ready for changes?
Dr. Madhu Aman Sharma Lead Auditor

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
Are you ready for the changes?

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
Are you ready for the changes?
Dr. Madhu Aman Sharma Lead Auditor

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
Are you ready for the changes?
Dr. Madhu Aman Sharma Lead Auditor

13. Proposed Clauses:
3.18. Conformity
3.19. Non-conformity
3.20. Correction
3.21. Corrective Action
3.22. Continual improvement
Are you ready for the changes?
Dr. Madhu Aman Sharma Lead Auditor

14. WELCOME TO
REQUIREMENTS
Clause 4
Are you ready for changes?

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
Are you ready for the changes?
Dr. Madhu Aman Sharma Lead Auditor

16. Are you Ready for the changes?
Clause 5. Leadership
5.1 Leadership & Commitment
5.2 Quality Policy
5.3 Organizational Roles,
Responsibilities & Authorities
5. Leadership
Dr. Madhu Aman Sharma Lead Auditor

17. Are you Ready for the changes?
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
Dr. Madhu Aman Sharma Lead Auditor

18. Are you ready for the changes?
Clause 7. Support
7. Support
7.2
7.5
7.3
7.4
7.1Resources
Competence
Awareness
Documented
Information
Communication
Dr. Madhu Aman Sharma Lead Auditor

19. Are you ready for the changes?
7.5 Documented Information
7.5
General
Creating &
Updating
Control of
Documented
Information
Dr. Madhu Aman Sharma Lead Auditor

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
Are you ready for the changes
Dr. Madhu Aman Sharma Lead Auditor

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.
Are you ready for the changes?
Dr. Madhu Aman Sharma Lead Auditor

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
Are you ready for the changes?
Dr. Madhu Aman Sharma Lead Auditor

23. 10.1 Nonconformity and
Corrective Action
10.2 Improvement
Clause 10. Continual Improvement
Are you ready for the changes?
Dr. Madhu Aman Sharma Lead Auditor

24. http://iso-certifications.com
Are you ready for changes?
Dr. Madhu Aman Sharma Lead Auditor
FOR MORE INFORMATION
CONTACT ME AT
CERTIFICATIONS@ISO-CERTIFICATIONS.COM

25. certifications@iso-certifications.com
http://iso-certifications.com