General Overview of ISO 9001:2015

1. Executive Briefing
ISO 9001:2015
by Rizaldi Djamil

3. 3 5 October 2022

4. History of 9001
Minor
Revision
Major
Revision
Minor
Revision
First
Standards
1986/7
1980 1994 2000
Major
Revision
2008 2015
7 – 8
Yrs
7 – 8
Yrs
6
Yrs
8
Yrs
7
Yrs
Start
Two – phase revision process with simultane
ous work on 1994 and 2000 revisions

5. The Evolution of The ISO 9001 Standard

6. Plan For The Changes

7. Reason for Revision

8. ISO 9000 Family of Standards
ISO 9000:2015 – Quality Management Systems - Fundamentals & Vocabulary
ISO 9001:2015 – Quality Management Systems – Requirements
ISO 9004:2009 – Managing for The Sustained Success of An Organization,
A Quality Management Approach
ISO 19011:2011 – Guidelines for Auditing Management Systems

9. What You Need To Know !
A Guide to The Key Points For Your Business

10. The Underlying Philosophy Remains The Same

11. The Eight Seven Quality Management Principles
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. Systems approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier
relationships
QM Principles of ISO 9001:2008
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management
QM Principles of ISO 9001:2015

12. The Quality Management Principles

13. Quality Management System
A quality management system (QMS) is:
the way your organization directs and
controls those activities,
that are related (either directly or indirectly) to
achieving its intended results.
ISO 9001:2015 Quality Management System - Requirements

14. ISO 9001 QMS - Requirements
1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and Improvement
2008 Version
1. Scope
2. Normative Reference
3. Terms and Definitions
4. Context of The Organization
5. Leadership
6. Planning For The QMS
7. Support
8. Operation
9. Performance Evaluation
10. Improvement
2015 Version

15. The Clause of ISO 9001 : 2015
Scope
1.
Normative references
2.
Terms and definitions
3.
Context of the organization
4.
Leadership
5.
Planning
6.
Support
7.
Operation
8.
Performance evaluation
9.
Improvement
10.

16. Key Elements of ISO 9001 : 2015
4. Context of the
Organisation
5. Leadership
6. Planning 7. Support
8. Operation 9. Performance evaluation
10. Improvement

17. Requirements Grouping
4. Context of the
Organisation
5. Leadership 6. Planning 7. Support
8. Operation *
9. Performance
evaluation
10. Improvement
* Most of the unique ISO 9001 requirements are in clause 8
PLAN
DO CHECK ACT

18. 5 6
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s
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8
U o o a
U t e o
p
S m s
Q
L a c
e n o
Q
A a a
Q
o
Pl c
R
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A C
D In
M m an
ev
In
M
re
N a a
C I
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Act
Check
Plan
Do
9.Performance
Evaluation
10. Improvement
Monitoring,
Measurement,
Analysis and
Evaluation
General
Internal audit
Nonconformity
and Corrective
Action
Management
Review
Continual
Improvement
8.Operations
OperationalPlanni
ng and Control
Requirements
for products and
services
Design and
Development
of Products
and Services
Control of Externally
Provided Processes,
Products and Services
Production
and Service
Provisions
Release of
Products and
Services
Control of non-
conforming
outputs
Resources
Competence
Awareness
Communication
Documented
Information
6. Planning for The
Quality Management
System
Action to address
risk and opportunity
Quality
Objectives
Planning of
Changes
4. Context
of The
Organization
5.Leadership
Understanding of
The Organization
and Its Context
Leadership and
Commitment
Quality policy
Understanding The
Needs and
Expectations of
Interested Parties Organizational
roles,
responsibilities
and authorities
Scope of
Management
Systems
QMS
7. Support

19. 4. Context of The Organization
Understanding the organization and its context *
4.1
Understanding the needs and expectations of interested parties *
4.2
Determining the scope of QMS
4.3
Quality management system and its processes *
4.4

20. 5. Leadership
Leadership and commitment
5.1
Quality policy
5.2
Organizational roles, responsibilities and authorities
5.3

21. 6. Planning For The QMS
Actions to address risks and opportunities *
6.1
Quality objectives and planning to achieve them *
6.2
Planning of changes
6.3

22. 7. Support
7.3 Awareness
7.2 Competence
7.1 Resources
7.4 Communication
7.5 Documented
information

23. 8. Operation
8.1 Operational planning and control
8.2 Determination of requirements
for products and services
8.3 Design and development of
products and services
8.4 Control of externally provided
products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of non conforming
process outputs, products and
services

24. 9. Performance Evaluation
9.1 Monitoring, measurement,
analysis and evaluation
9.2 Internal audit
9.3 Management review

25. 10. Improvement
10.1 General
10.2 Non-conformity and corrective action
10.3 Continual improvement

27. TERIMA KASIH