OVERVIEW OF ISO

9001:2008

What is ISO?

International Organization for

Standardization
ISO -Greek word isos means equal
Worldwide federation of national
standards bodies
More than 140 countries represented
Non-governmental organization

Why ISO 9000.

QMS ( Quality Management Syatem)

Method of working that helps us to achieve

our objectives in an enjoyable, efficient &
effective manner at consistently and reliably.

ISO 9001

Initial objectives of ISO 9001:2008:

to improve the existing standard;
to provide greater clarity and ease of
use,
to improve compatibility with ISO
14001:2004

ISO 9001

(a)

(b)

Scope

This international standard specifies requirements

for a Quality Management System where an
Organization
Needs to demonstrate its ability to cosistently
provide product that meets customer and applicable
statutary and regulatory requirements, and
Aims to enhance customer satisfaction through the
effective application of the system,including
processes for continual improvement of the system
and the assurance of conformity to customer and
applicable statutory and regulatory requirements.

ISO 9001

1.
2.
3.
4.
5.
6.
7.
8.

Sections

SCOPE
NORMATIVE REFERENCE
TERMS AND DEFINATIONS
QUALITY MANGEMENT SYSTEM
MANAGEMENT RESPONSIBILITY
RESOURCE MANAGEMENT
PRODUCT RELIZATION
MEASUREMENT , ANALYSIS AND IMPROVEMENT
6

ISO 9001

4.0 QUALITY MANGEMENT SYSTEM

-- Section
4.1 GENERAL REQUIREMENTS
-- Clause
4.2 DOCUMENTATION REQUIREMENTS -- Clause
4.2.1 GENERAL
-- Sub-Clause
4.2.1. (a)
-- Alphabetical Sr.
No.

Exclusion
Where any requirement(s) of standard
cannot be applied due to the nature of
an organization and its products , this
can be considerd for exclusion.
In our organization
7.3 Design and Development
Is ecluded.

Documented Procedure
1.
2.
3.
4.
5.
6.

4.2.3
4.2.4
8.2.2
8.3
8.5.2
8.5.3

Control of Documents
Control of Records
Internal Audit
Control of NC product
Corrective Action
Preventive Action

Records
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

5.6
6.2.2
7.1
7.2.2
7.3.2
7.3.4
7.3.5
7.3.6
7.3.7
7.4.1

Management Review
Competence,Training & Awareness
Planning for Product Realization
Review of requirements related to the product
Design & Development inputs
Design & Development review
Design & Development verification
Design & Development validation
Control of Design & Development changes
Purchasing process

Records
1.

2.
3.
4.
5.
6.
7.
8.
9.

7.5.2 Validation of process for production & service

provision
7.5.3 Identification & Tracebility
7.5.4 Customer Propery
7.6 Control of Monitoring & Measuring Equipments
8.2.2 Internal Audit
8.2.4 Monitoring & Measuring of Product
8.3 Control of NC product
8.5.2 Corrective Action
8.5.3 Preventive Action

Quality Management
Principles

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

Quality Management
Principles

Sr. Particulars
No

Clause Reference

Customer Focus

1.1(b), 5.1(a), 5.2, 5.3, 5.4.1,

5.5.2(c), 6.1(b), 7.2.1, 8.2.1

Leadership

5.0, 6.2.2(d), 5.3(d), 5.4.1, 5.5.2(c),

5.3

Involvement of People

6.2.2(d), 6.4

Process Approach

4.1(a), 4.2.1(d), 5.5.2(a), 7.1, 8.2.3

Systems Approach in
Management

4.2.2( c), 5.4.2, 5.5.3, 5.6.1, 6.1(a),

7.1

Continual Improvement

1.1(b), 4.1, 5.1, 5.3, 5.4.1, 5.6.1,

5.6.2, 5.6.3(a), 6.1(a), 8.1( c),
8.2.2, 8.5

Factual Approach to
Decision Making

4.1(e), 5.4.1, 8.2, 8.4

Mutually Beneficial
Supplier Relationship

4.1, 7.1, 7.2.1, 7.2.3, 7.4

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Basic process approach

MANAGEMENT

Customer

INPUT

ACTIVITIES

OUTPUT

Customer

RESOURCES

Process is defined as an activity or group of activities,

that takes an input, adds value to it, and provide an
output to an internal or external customer. Processes
use an organizations resources to provide definitive
results.
14

Process Model (ISO 9001:2008)

Continual Improvement of the Quality Management System
Management
Responsibility

Customer

Customer

(5)
Measurement
Analysis and

Resource
Management

Satisfaction

Improvement

( 6)

(8)
Requirements

Input

Product

Output

Product

Realization (7)
15

Continuous improvement ?
Demings
Demingswheel
wheel
(P.D.C.A.)
(P.D.C.A.)

PLAN
4,5,6

DO
7

ACT
8.4,8.5

CHECK
8.1,8.2,8.3

Continuous
Improvement

ISO
9000
16

Process approach
Continual improvements of Process
Understandings &
meeting requirements
PLAN ( 4,5,6 )

Processes in terms
Of Added Value
DO ( 7 )

PDCA Cycle

Continual improvements
of Processes based on
objective measurements
ACTION ( 8.4,8.5 )

Measure results of process

Performance and effectiveness
- Objective Measurements
CHECK ( 8.1,8.2,8.3 )
17

System Requirements / Structure of

the Standard
4 Quality
Management
System

4.1 General
requirements

5 Management
Responsibility

5.1 Management
Commitment

6 Resource
Management

6.1 Provision of
resources

5.2 Customer focus

4.2 Documentation
Requirements

5.3 Quality policy

6.2 Human
resources

6.3 Infrastructures

7 Product
Realization

7.1 Planning

5.6 Management
Reviews

Work
environment

8.1 General

7.2 Customer
related
processes

8.2 Monitoring &

measurement

7.3 Design &

development

8.3 Control of NCP

7.4 Purchasing

8.4 Analysis of data

Production &
service provision

8.5 Improvements

5.4 Planning

5.5 Res. ,
authority &
communication

8 Measurement
Analysis &
improvement

7.6 Control
of Monitoring &
Measuring Equip.

18

Inherent Benefits of ISO 9000

It adds to your market goodwill and enhance acceptability

of your product/services.
Acts as a silent marketing tool to an unknown customer.
Makes the working transparent which leads to recognizing
opportunity for improvement and thus to higher
profitability.
Continuous improvement in terms of product
quality/services, competitive edge and timely deliveries
strengthens your customer base.
Clear definition of work enhances efficiency, sense of
achievement leading to pleasure among employees, which
is a vital motivation factor for managing business
effectively.

Questions?

20