A BRIEF INTRODUCTION

TO

ISO 9000

QUALITY MANAGEMENT PRINCIPLES

1.
2.
3.
4.
5.
6.
7.

Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making

ISO 9000 is about QUALITY

Quality is:
defined by customer needs
defined in terms of fitness for purpose
achieved through continuous
improvement
managed through prevention or
detection
getting it right at the first time
measurable
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ISO stands for

I nternational
O rganization for
S tandardization

Self-manageable
P-D-C-A
Plan

what you do
Do what you planned &
record what you did
Check the results
Act on the difference

ISO 9000 REQUIRES :

PLAN, DO, CHECK & ACT
with CONSISTENCY :

CUSTOMER SATISFACTION
MANAGEMENT SUPPORTS
RESOURCES MANAGEMENT
PROCESS MANAGEMENT
RESULTS ANALYSIS

CONTINUOUS

IMPROVEMENT
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THE CONTINUOUS IMPROVEMENT

MECHANISM
UNSATISFACTORY OUTCOME

THE CONTINUOUS IMPROVEMENT

MECHANISM
UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM

THE CONTINUOUS IMPROVEMENT

MECHANISM
UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM
CAUSE INVESTIGATION

THE CONTINUOUS IMPROVEMENT

MECHANISM
UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM
CAUSE INVESTIGATION
CORRECTIVE ACTION

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THE CONTINUOUS IMPROVEMENT

MECHANISM
UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM
CAUSE INVESTIGATION
CORRECTIVE ACTION
PREVENTIVE ACTION

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THE CONTINUOUS IMPROVEMENT

MECHANISM
UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM
CAUSE INVESTIGATION
CORRECTIVE ACTION
PREVENTIVE ACTION
REVIEW
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THE CONTINUOUS IMPROVEMENT

MECHANISM
UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM
CAUSE INVESTIGATION
CORRECTIVE ACTION
PREVENTIVE ACTION
REVIEW
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THE CONTINUOUS IMPROVEMENT

MECHANISM
UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM
CAUSE INVESTIGATION
CORRECTIVE ACTION
PREVENTIVE ACTION
REVIEW
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THE CONTINUOUS IMPROVEMENT

MECHANISM
UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM
CAUSE INVESTIGATION
CORRECTIVE ACTION
PREVENTIVE ACTION
REVIEW
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Quality Plan
Quality Manual
Q Procedures
Working Instruction
Reference Document
16

ISO 9000 - 20 Elements

4.1 Management
Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document & Data Control
4.6 Purchasing
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ISO 9000 - 20 Elements

4.7 Control of Customer Supplied
Product
4.8 Product Identification and
Traceability
4.9 Process Control
4.10 Inspection and Test Status
4.11 Control of Inspection,
Measuring and Test Equipment.

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ISO 9000 - 20 Elements

4.12 Inspection and Test Status

4.13 Control of Nonconforming
Product
4.14 Corrective & Preventive Action
4.15 Handling , Storage, Packaging,
Preservation and Delivery
4.16 Control of Quality Records
4.17 Quality Audits
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ISO 9000 - 20 Elements

4.18 Training
4.19 Servicing
4.20 Statistical Techniques

20

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Self-manageable
Plan

what you do
Do what you planned
Record what you did
Check the results
Act on the difference
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Standardized
Clearly

listed requirements /
guidelines
World-wide acceptance

22

Systematic
Inter-relationship

of elements

Comprehensive
Team

work

23

Customer-oriented
Needs

defined by customer
Stress on customer satisfaction
Enhancement of quality culture

24

Objectively assessed
Internal

audit (Self-assessment)
Audit by 3rd party
The management system governs

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Clearly Documented
Data

and record control

Document process

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Human resources
planning and control
in
ISO 9001 QMS

27

5.1 Management commitment

Top management shall provide evidence of its

commitment to the development and improvement of
the quality management system by:
d) Ensuring the availability of necessary resources

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5.5.2 Responsibility and

authority

Functions and their interrelations within the

organization, including responsibilities and
authorities, shall be defined and communicated
in order to facilitate effective quality
management.
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5.5.4 Internal communication

The organization shall ensure communication

between its various levels and functions
regarding the processes of the quality
management system and their effectiveness.
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6.1 Provision of resources

The organization shall determine and provide,

in a timely manner, the resources needed
a) To implement and improve the processes of
the quality management system, and
b) To address customer satisfaction.
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6.2.1 Assignment of personnel

Personnel who are assigned responsibilities

defined in the quality management system shall
be competent on the basis of applicable
education, training, skills and experience.

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6.2.2 Training, awareness and

competency
The organization shall:
a) Identify competency needs for personnel
performing activities affecting quality;
b) Provide training to satisfy these needs;
c) Evaluate the effectiveness of the training
provided;
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6.2.2 Training, awareness and

competency
d) Ensure that its employees are aware of he
relevance and importance of their activities
and how they contribute to the achievement
of the quality objective;
e) Maintain appropriate records of education,
experience, training and qualifications.

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7.4.1 Purchasing control

The organization shall control its purchasing

processes to ensure purchased product conforms
to requirements.
The type and extent of control shall be dependent
upon the effect of subsequent realization
processes and their output.
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7.4.1 Purchasing control

The organization shall evaluate and select
suppliers based on their ability to supply product
in accordance with the organizations
requirements.
Criteria for selection on periodic evaluation shall
be defined.
The result of evaluations and follow-up actions
shall be recorded
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7.4.2 Purchasing information

Purchasing documents shall contain information

describing the product to be purchased,
including where appropriate:
- personnel

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THANKS!

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Any Questions ?

?
?

?
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THE END
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Thank you
very much for
your patience !!

:)
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