ISO 9001-2000

VERSION

EIGHT QUALITY MANAGEMENT PRINCIPLES

Customer focused organization

Leadership

Involvement of people

Process approach

System approach to management

Continual improvement

Factual approach to decision making

Mutually beneficial supplier

relationship

STRUCTURE OF THE NEW STANDARD

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

DEFINITION OF PROCESS
AS DEFINED IN ISO 8402
A process is a set of inter related resources and activities
which transforms inputs into outputs.
PROCESS is not equivalent to PROCEDURE
PROCESS specifics WHAT Ex. Coach Manufacturing
PROCEDURE specifics HOW Ex. Ways and means of
manufacturing the coach.

PROCESS
MODEL

C
u

t
o

Continual improvement of the

quality management system
Management
responsibility

u
i

C
S
a
t

Resource
management

P A
D C

Measurement,
analysis and
improvement

i
s
f
a

Product realization

Input

P-PLAN
D-DO
C-CHECK
A-ACT

Process

Output

Product

u
s
t
o
m
e
r

PROCESS APPROACH WOULD INVOLVE DESCRIPTION OF

a) The process b) The responsibilities c) The Interfaces
d) The Inter-relations e) Measures.
ADVANTAGES OF PROCESS APPROACH IN DOCUMENTATION

Lead to lean documentation.

Clearly reflects the structure of the Organization.

Simplification in case of service industries.

Increased transparency due to simplified presentation

of co-relations.

Better compatibility with other management systems

like ISO 14001,.

ISO 9001
5 Clauses

Quality Management Systems

Requirements

ISO 9000
Quality Management Systems
Fundamentals and Vocabulary

ISO 9004
Quality Management Systems
Guidance for Performance
Improvement

ADVANTAGES OF PROCESS MANAGEMENT

Concentration on increase in value.

Result orientation with process measures.
Increase in process effectiveness.
Increase impetus for improvement action.
Prioritization of processes derived from organizations objectives.
Stronger involvement of people by creating process owners and
teams.

PREPARATION OF A PROCESS AUDIT

Thus in a process audit, the following features and characteristics of the
process get verified.
Process inputs (procedures, work description, facility descriptions).
Equipment condition services.
Process capabilities and process specifications.
Tools, devices, auxiliary materials.
Measurement descriptions, measurement equipments.
Degree of competence of people.
Statutory, regulatory requirement.

What does not get

measured
What does not get
Recorded
What does not get
monitored
What does not get
controlled

Cannot be
Recorded
Cannot be
Monitored
Cannot be
Controlled
Cannot be
Improved

IMPROVEMENT IS THE
HEART OF THIS STANDARD

MEASURES RELATED TO ...

past

present

future

profit

daily turnover

turnover

orders received per work

scrap

raw materials consumption

waste amounts

Future workload
offers subject to
confirmation
Time arrow

EXAMPLES OF MEASURES IN SELECTED AREAS

Company Processes
Capacity utilization.
Facility wear rates (cumulated write offs.)
J.I.T. production effectiveness (process time / transition time).
Social Commitments

% of profits spent on social projects.

Reduction in packing material.
reduction in deposited waste.
Increase in proportion of recycled waste.

Employment of handicapped personnel.

CONTINUAL IMPROVEMENT
THE MOST POWERFUL ASPECT OF
ISO 9001 : 2000.

CONTINUAL IMPROVEMENT PHILOSOPHY

Basically there are two types of changes.
Quantum changes occur through innovations in technical
organizational or social areas.
In continual improvement, there is improvement in small steps in
many areas of the Organization.
The contents of CIP is made of KA and ZEN (Japanese KAIZEN)
KAI means change
ZEN means for the better.
The process of continual improvement is expressed in these two
components.

INNOVATION

CONTINUAL IMPROVEMENT

Creativity

Adaptability

Individualism

Team Work

Specialist Oriented

Generalist Oriented

Attention to Great Leaps

Attention to Details

Technology Oriented

People Oriented

Closed, Propriety Information

Open, Shared Information

Functional Orientation

Cross Functional Orientation

Seek New Technology

Build on Existing Technology

Limited Feedbacks

Comprehensive Feedbacks

GAINS

IDEAL PATTERN FOR INNOVATION

Time
ACTUAL PATTERN IN INNOVATION
Where the gains
should have
been

GAINS

Where the Gains

are in reality

Time

C.I.P OBJECTIVES

PROCESS APPROACH
Optimize Processes

C.I.P
RESULT APPROACH
Optimize Results

PROCESS APPROACH
Results in optimization of the processes.
Objective is safe control of process in the Organization which run in

a standardized way, needing minimum human intervention.

There is continuing education of people for error free performances,
and creation of conditions enabling active participation in C.I.P
Outside knows how is used and benchmarking adopted for
comparison.

CONTENTS OF CONTINUAL IMPROVEMENT

A fundamental principle of C.I.P is optimization of value

addition in which quality alone takes precedence over all else.
WHAT IS THE CUSTOMER PREPARED TO PAY ?
FOR WHICH PROCESSES

ACTIVITIES CONTRIBUTING
TO INCREASE IN VALUE

UNAVOIDABLE
NECESSARY AT PRESENT

ACTIVITIES NOT CONTRIBUTING

TO INCREASE IN VALUE

AVOIDABLE WASTE

TYPES OF WASTE
1.

Overproduction

2.

Standstill

3. Transport
4.

Standby times

5. Type of production

9. Overfulfillment of customer
requirements, production
10. Tasks unrelated to customer
11. Sequential processing
without practical constraint
12. Demotivation of people

6.

Movement

7.

Non conformities

13. Insufficient use of people

potential

Insufficient process

14. Control mistakes

control

15. Insufficient confidence

CUSTOMER
SATISFACTION
DISSATISFACTION

CUSTOMER LOYALTY

Product quality
Service quality
Contact quality
Communication
quality

Customer
Satisfaction

Customer
Loyalty

THE QUALITY LADDER

Eliminate cause
of the problem
Zero
Defect

Prevent
Act in such
a way that
the problem
does not occur
Think
3rd Ladder

Improve
Take corrective
action, analyse

Rationalise
I dont
have time
Accuse

Establish causes

It is others
fault

Temporary
elimination

It is not
true

Solve for
limited period

Ignore

I am responsible
2nd Ladder

Dont
know
1st ladder

ORGANIZATIONS ARE LOOKING

FOR PROSPERITY
ISO 9001 : 2000 IS A
POWERFUL TOOL
FOR ATTAINING
PROSPERITY

COMPARISON 0F 1994 VERSION WITH 2000 VERSION

ISO 9001 : 1994

ISO 9001 : 2000

4.1.1

QUALITY POLICY

5.3

QUALITY POLICY

4.1.2.1

RESPONSIBILITY AND
AUTHORITY

5.5.1

RESPONSIBILITY AND
AUTHORITY

4.1.2.2

RESOURCES

6.1
6.2
6.2.2

PROVISION OF RESOUCES
HUMAN RESOURCES
COMPETENCE, TRAINING &
AWARENESS
INFRASTRUCTURE
WORK ENVIRONMENT

6.3
6.4
4.1.2.3

MANAGEMENT
REPRESENTATIVE

5.5.2

MANAGEMENT
REPRESENTATIVE

4.1.3

MANAGEMENT REIVEW

5.6

MANAGEMENT REIVEW

COMPARISON 0F 1994 VERSION WITH 2000 VERSION

ISO 9001 : 2000

ISO 9001 : 1994

4.2.1

QUALITY SYSTEM GENERAL

4.2.2

QUALITY MANUAL

4.2.2

QUALITY SYSTEM
PROCEDURES

5.4.2

QUALITY MANAGEMENT
SYSTEM PLANNING

4.2.3

QUALITY PLANNING

4.3.1

CONTRACT REVIEW GENERAL

7.2.1

4.3.2

REVIEW

DETERMINATION OF
REQUIREMENTS RELATED
TO THE PRODUCT

4.3.3

AMENDMENTS TO CONTRACT

7.2.2

4.3.4

CONTRACT REVIEW RECORDS

7.2.3

REQUIREMENTS RELATED
TO THE PRODUCT
CUSTOMER
COMMUNICATION

COMPARISON 0F 1994 VERSION WITH 2000 VERSION

ISO 9001 : 2000

ISO 9001 : 1994

4.4.1

DESIGN CONTROL GENERAL

7.3.1

4.4.2

DESIGN DEVELOPMENT
PLANNING

DESIGN & DEVELOPMENT

PLANNING

7.3.2

ORGANISATION &
TECHNICAL INTERFACES

DESIGN & DEVELOPMENT

INPUTS

7.3.3

DESIGN & DEVELOPMENT

OUTPUTS

7.3.4

DESIGN & DEVELOPMENT

REVIEW

7.3.5

DESIGN & DEVELOPMENT

VERIFICATION

7.3.6

DESIGN & DEVELOPMENT

VALIDATION

7.3.7

DESIGN & DEVELOPMENT

CHANGES

4.4.3
4.4.4.

DESIGN INPUT

4.4.5

DESIGN OUTPUT

4.4.6

DESIGN REVIEW

4.4.7

DESIGN VERIFICATION

4.4.8

DESIGN VALIDATION

4.4.9

DESIGN CHANGES

COMPARISON 0F 1994 VERSION WITH 2000 VERSION

ISO 9001 : 2000

ISO 9001 : 1994

4.5.1

DOCUMENT & DATA

CONTROL GENERAL

4.2.3

CONTROL OF DOCUMENTS

4.5.2

DOCUMENT & DATA

APPROVAL AND ISSUE

4.5.3

DOCUMENT & DATA CHANGES

4.6.1

PURCHASE IN GENERAL

7.4.1

PURCHASING PROCESS

4.6.2

EVALUATION OF
SUBCONTRACTORS

7.4.2

PURCHASING INFORMATION

7.4.3

VERIFICATION OF
PURCHASED PRODUCT

4.6.3

PURCHASING DATA

4.6.4.1

SUPPLIER VERIFICATION AT
SUBCONTRACTORS PREMISES

4.6.4.2

CUSTOMER VERIFICATION OF
SUBCONTRACTED PRODUCT

COMPARISON 0F 1994 VERSION WITH 2000 VERSION

ISO 9001 : 1994

ISO 9001 : 2000

4.7

CONTROL OF CUSTOMER
SUPPLIED PRODUCT

7.5.4

CUSTOMER PROPERTY

4.8

PRODUCT IDENTIFICATION
& TRACEABILITY

7.5.3

IDENTIFICATION &
TRACEABILITY

4.9

PROCESS CONTROL

7.1

PLANNING OF PRODUCT
REALIZATION

7.5.1

CONTROL OF PRODUCTION
& SERVICE PROVISION

7.5.2

VALIDATION OF PROCESSES

4.10.1

INSPECTION & TESTING

GENERAL

8.1

MEASUREMENT ANALYSES
& GENERAL IMPROVEMENT

4.10.2

RECEIVING INSPECTION
& TESTING

8.2.3

MEASUREMENT &
MONITORING OF PROCESS

COMPARISON 0F 1994 VERSION WITH 2000 VERSION

ISO 9001 : 1994

ISO 9001 : 2000

4.10.3

INPROCESS INSPECTION
& TESTING

8.2.4

4.10.4

FINAL INSPECTION TESTING

4.10.5

INSPECTION & TEST RECORDS

4.11.1

CONTROL OF I.M.T.E. GENERAL 7.6

4.11.2

CONTROL OF I.M.T.E. CONTROL PROCEDURE

4.12

INSPECTION & TEST STATUS

7.5.3

4.13.1

CONTROL OF NONCONFORMING PRODUCT

GENERAL

8.3

4.13.2

REVIEW & DISPOSITION OF

NON-CONFORMING PRODUCT

MEASUREMENT &
MONITORING OF PRODUCT

CONTROL OF MEASURING &

MONITORING DEVICES
IDENTIFICATION &
TRACEABILITY
CONTROL OF NONCONFORMING PRODUCTS

COMPARISON 0F 1994 VERSION WITH 2000 VERSION

ISO 9001 : 1994
4.14.1

CORRECTIVE & PREVENTIVE

ACTION - GENERAL

4.14.2

CORRECTIVE ACTION

4.14.3

PREVENTIVE ACTION

4.15.1

GENERAL

4.15.2

HANDLING

4.15.3

STORAGE

4.15.4

PACKAGING

4.15.5

PRESERVATION

4.15.6

DELIVERY

ISO 9001 : 2000

8.4

ANALYSES OF DATA FOR

IMPROVEMENT

8.5.1

CONTINUAL IMPROVEMENT

8.5.2

CORRECTIVE ACTION

8.5.3

PREVENTIVE ACTION

7.5.5

PRESERVATION OF PRODUCT

COMPARISON 0F 1994 VERSION WITH 2000 VERSION

ISO 9001 : 1994

ISO 9001 : 2000

4.16

CONTROL OF QUALITY
RECORDS

4.2.4

CONTROL OF RECORDS

4.17

INTERNAL QUALITY
AUDITS

8.2.2

INTERNAL AUDIT

4.18

TRAINING

6.2.2

COMPETENCE, TRAINING, AND

AWARENESS

4.19

SERVICING

7.5.1

CONTROL OF PRODUCTION
AND SERVICE PROVISION

8.1

MEASUREMENT, ANALYSIS
AND IMPROVEMENT GENERAL

8.4

ANALYSIS OF DATA

4.20.1

IDENTIFICATION OF NEED
OF STATISTICAL
TECHNIQUES
4.20.2

PROCEDURES