0.

Introduction
1.Scope

4. Context of the
organization

5. Leadership

6. Planning

7. Support

DIFFERENT
Difference in clause ISO 9001 2008 Vs 2015

2.Normative reference
3.Terms and definitions
4.Quality Management system
5.Management responsibility

6.Resourse management
7.Product realization
8.Measurment, analysis and improvement

TERMINOLOGY
0.Introduction
1.Scope
2.Normative reference
3.Terms and definitions
4.Context of the organization
5.Leadership
6.Planning
7.Support
8.Operation
9.Performance evolution
10.Improvement

The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, but there are
considerable differences between ISO 9001:2008 and ISO 9001:2015 from the fourth clause onwards.
The last seven clauses are now arranged according to the PDCA Cycle (Plan, Do, Check, Act).

PDCA CYCLE FOR CLAUSES

8. Operation

10. Improvement
O
D
9. Performance
evolution

With this new arrangement, the new ISO 9001 strives to give an additional momentum to the
continuous and systemic improvement of processes
IN ISO
9001:2015
within9001:2008
organizations. AND ISO
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Products
ISO 9001 : 2008

Documentation, quality manual, documented

procedures, records, instruction
Work environment
Monitoring and measuring equipment
Purchased product
Supplier

2. Leadership
ISO 9001 : 2008
Seven Quality Management Principles
1.Customer Focus

3.Engagement of people
4. Process Approach
5.Improvement
6. Evidence-based decision making
7.Relationship management
ISO 9001:2015
Products & services
Documented information

Environment for the operation of processes

Monitoring and measuring resources
Externally provided products and services
External provider

Key ASPECTS- 7 QM PRINCIPLES

ISO 9001:2015
Eight Quality Management Principles
1.Customer Focused organization
2. Leadership
3.Involvement of people
4. Process Approach
5.System approach to
management
6. Factual approach to decision
making
7.Continual improvement
8. Mutually beneficial supplier
relationship.

DEVELOPMENT OF ISO 9001

APPROACH OF ISO 9001

Key is to engage all 3 gears

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Identification
RISKED BASED THINKING

How is process measured?

Efficient
Risk:
Effect of uncertaininty on an expected result- ISO
9001:2015
PROCESS APPROACH

PROCESS

Effective
Management

Improvement
 ISO 9001 REQUIREMENTS

“Shall” mandatory “Should”

recommendation

Requirements

“Such as” “Note”

Guidance only Guidance or clarification

4.0 CONTEXT OF THE ORGANIZATION