GENERAL INTRODUCTION

ISO Means...
International

Organization
for Standardization
A Worldwide Federation of
National Standards
Bodies
Represented by almost
170 Countries.
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When?

ISO 9001 Established in

1987
(i.e. ISO 9001 : 1987).
Latest version is
ISO 9001 : 2008

Both ISO 9001 and ISO 14001

concern the way an organization
goes about its work.

They are not product standards.

They are not service standards.

They are process standards.

Quality Means...

Performance
Goodness
Safety
Freedom
Fineness
Appearance
Meeting Specifications
Maintainability...
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Quality Management Means...

ISO 9001 is for quality
management.
Quality refers to all those features of
a product (or service) which are
required by the customer.
Quality management means what
the organization does to
ensure that its products or services
satisfy the customer's quality
requirements and
comply with any regulations
applicable to those products or
services.
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Quality Management Means

(Cont...)
Quality management also means
what the organization does to

enhance customer satisfaction,

and

achieve continual improvement of

its performance.

Management System Means...

To be really efficient and effective,
the organization can manage its
way of doing things by
systemizing it.

Everyone is clear about who

is responsible for doing what,
when, how, why and where.

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PURPOSE OF ISO 9001 : 2008

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Specifies requirements for

organization to
Demonstrate its ability to
consistently provide product that
meets applicable requirements
Enchance customer satisfaction thru
system processes for improvement
& conformity assurance
Prevent nonconformity
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ISO 9001 : 2008

Does Not Say

HOW TO DO
It Only Says
WHAT TO
DO
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QUALITY MANAGEMENT
SYSTEM
PRINCIPLES

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Customer Focus
Leadership
Involvement of People
Process Approach
System Approach
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier
Relationships

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PDCA
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P Plan
D Do
C Check
A - Act

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Continuous improvement ?

Demings
Demings
wheel
wheel
(P.D.C.A.)
(P.D.C.A.)

PLAN

DO

ACT

CHECK

Continuous
Improvement

ISO
9001
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ISO 9001: 2008

Quality
Management
System
Requirements
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General Requirements (4.2.1)

Documentation Requirements (4.2.2)
Reference Manual Page 26 of 98
Control of document & data control
(4.2.3)
Control of recorts (4.2.4)

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 Providing

evidence of activities
performed.
Shall be Identification, Storage
Protection, Retrieval, Retention
Time & Disposition

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 Top Management (5.1)

Customer Focus (5.2)

Quality Policy (5.3)
Quality management system planning
(5.4)
Responispility, authority & communication
(5.5)
Management Review (5.6)

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Resource Management (6.1)

Human Resources (6.2)
Infrastructure (6.3)
Work Environment (6.4)

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systematic independent
examination to determine
whether quality activities &
related results comply with
planned arrangements and
whether these arrangements
are implemented effectively
and are suitable to
objectives.
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First

Party
Second Party
Third Party

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NC

- Non-Conformance
(Non Fulfill Document /
Process / Product /
Service)
TYPE OF NC:
Major
Minor
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Performance advantage through

improved organizational capabilities
Alignment of improvement activities
at all levels to an organization's
strategic intent.
Flexibility to react quickly to
opportunities.

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System Approach ?

Continuous improvement of the

Quality Management System

Requirements

Input
Data

Product /
Service
Realization

Output
Data

CLIENT

Measurement,
Analysis and
Improvement

Resource
Management

Satisfaction

Management
Responsibility

Product
Service

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Action

taken to
eliminate the cause of
Detected NonConformity

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Action

taken to
eliminate the cause of
Potential NonConformity

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THANKS