Iso9000

Understanding ISO9000
n
io
rs
ve
Presented by
al
tri
ne
Tahir Mehmood Younes

hi
ac
GM Quality Assurance (FCI)

fM
IS
pd
O9
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Tahir Mehmood Younes, Frontier Cable Industries, Hattar

1
Foundation & familiarization
n
io
rs
ve
tri
alISO 9000:2000
STANDARDS
ne
hi
ac
INTRODUCTION AND
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KEY LEARNING OBJECTIVES

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2
n
io
rs
ve
al
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Discuss what you think the definition

hi
ac
of Quality is. Give as many examples

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as you can
pd

3
ISO -Language of Quality System
QUALITY
n
io
- Degree to which a set of inherent characteristics
rs
fulfill REQUIREMENTS (9000:3.1.1)
ve
Conformance
al Right First Time,
tri
ne
to specification All the time.

“Zero Defect”
hi
ac
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Build Right Meet implied/Market

Characteristics Needs

4
Quality
Ability of a set of inherent characteristics of a
n
io
product, system or process to fulfill requirements
rs
ve
of customers and other interested parties.
al
tri
(ISO 9000:2000)
ne
hi
ac
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pd

5
What Customers buy?
n
io
Customers do not buy goods and services;
rs
ve
they want solutions of problems, and
al
fulfillment of their needs & wants.
tri
ne
hi
A high standard of service at a low price is what all

ac
customers would like. If our competitors are able to

provide the same standard of service as us, but …..
fM
pd
at a lower price, or a higher standard at the same price,
then we have a problem!!!

6
Quality Management
n
io
- Coordinated activities to direct and control an
rs
ve
organization with regard to quality (9000:3.2.8)
al
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7
QUALITY ASSURANCE
n
io
rs
- Part of Quality management focused on
ve
providing confidence that quality requirements
al
will be fulfilled (9000:3.2.11)
tri
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ac
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pd

8
QUALITY CONTROL
n
io
rs
- Part of Quality management focused on
ve
fulfilling quality requirements (9000:3.1.2)
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9
QUALITY MANAGEMENT SYSTEM
n
io
Management System to Direct and Control an
rs
ve
Organization with Regard to Quality
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Procedure
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processes
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QC
QA

10
Quality Assurance
n
io
rs
Quality Evaluation
Quality Management System
ve
Policies and procedures
al Checking to see that
tri
what should be happening
detailing how we do
ne
is happening and
the work.
hi
is it effective?
ac
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Quality Control
Auditing
Auditing !!
Checks performed
as we do the work.

11
PRODUCT
n
io
THE RESULT OF ACTIVITIES
rs
ve
OR PROCESSES
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Services
Software
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Hardware
Processed
Materials

12
Foundation & Familiarization
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ISO 9000:2000 Quality
ve
al
Management Systems
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ne
an Overview
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ac
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pd

13
How to get Started?
n
io
Determine whether
rs
ve
our organization wants
to register to ISO 9001:2000
al
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Yes
ne
No
hi
ac
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Get a commitment
pd
from the top

management
End We may need to engage
external expertise!!
14
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM
n
io
rs
C
ve
Management
R
e
Management
Responsibility
Responsibility
C S
U q al U a
tri
5 t
S u
Measurement, S i
ne
I Resource
Resource Measurement,
analysis&& s
T Management 6
Management 8 analysis
T
hi
r improvement
improvement f
ac
e
O m 7 O a
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c
M e Input Product/services Product/
Output
M t
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n realization Service
i
E T E o
s
R Quality Management Process Model R n

15
The Deming process
Improvement Cycle
n
Establish expectations
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Formalize
rs
Define Process
ve
improvement ACT PLAN Procedures
Corrective al
tri
Action
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ac
Establish
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Evaluate
Implementation
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Compare CHECK DO
Mechanisms

16
Evolution of ISO9000
n
io
es
rs
r n
su n io s)
ve
e a s ) t io c t d
t rI ar
n m raf o lu odu a d r II
ylo
an
d (C
al e v P r W t a n a
50 0 00
b s s l R s ld S W 7 9
Ba ight ld as or ld 5
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ui t ria M W a ry or S IS
O
we
G us ilit W B
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d (M
In
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ac
3000 1850s 1914 1979

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Middle 1939 1987-1994

B.C. Ages. 2000
pd

17
What is ISO 9000
n
io
ISO 9000 stands -- International Organization
rs
ve
for Standardization
al
World Wide Federation -- 125 + Countries
tri
ne
Identical in most respect -- European Standard, EN-

hi
29000 and the American

ac
standard, QS 9000
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Four Primary Standards
n
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rs
1. ISO9000: Quality Management Systems-
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Fundamentals and Vocabulary
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2. ISO9001: Quality Management Systems-
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Requirements
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ac
3. ISO9004: Quality Management System Guideline

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for performance improvement

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4. ISO10011: Guidelines for Auditing Quality

Systems (soon to be revised to ISO19011)

19
The ISO 9000:2000 is
applicable to:
n
io
rs
 Suppliers
ve
 al
Developers of the standards
tri
 Customers.
ne

hi
Consultants, university, and Institute.

ac

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Auditors, regulatory , certification body,

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accreditation Body.
 End users.

20
Roles of ISO 9000:2000
n
io
rs
 Isintended to replace ISO 8402:94 and
ve
ISO 9000-1:94, clause 4 and 5.al
tri
 Specifies quality management terminology

ne
hi
and their definition.

ac
 Provides fundamentals for Quality

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pd
Management Systems

21
Roles of ISO9001:2000

n
ISO 9001:2000- The combination of ISO 9001-9003:94
io
series and the new requirements.
rs
ve
 ISO 9001:2000 – Presents the requirements for Quality
al
tri
Management System.
ne
 Being developed based on a process model using

hi
ac
Quality Management Principals” to move the

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organization towards business excellence.

pd
 Emphasis on customer satisfaction.

 Consist of 8 clauses which contain all 20 requirements
in the old version of ISO 9001
22
Roles of ISO9004:2000
n
io

rs
It is not a guideline for implementing ISO9001.
ve
 It is not intended for certification, regulatory or
tri
al
contractual use.
ne
 Covers all aspect of a Quality Management

hi
ac
system beyond the requirements of ISO 9001.

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 Increase competitive advantage in the market.

pd
 Better respond to customer needs and

expectations.

23
Roles of ISO 9004:2000
n
io
 Designed to address the need of all interested
rs
ve
parties to improve overall organization’s quality
tri
al
performance.
ne
 Use of the same “ Quality Management

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ac
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Principles” but emphasis on satisfying the needs

pd
of other interested parties through sustained

customer satisfaction.

24
The Close Relationship
ISO 9001-ISO 9004
n
io
ISO 9004:QMSGuidelines
rs
ve
Focus: Achieving business success
Degree of al
and continual improvement of the
tri
applying the performance of the organization to
ne
quality sustain customer satisfaction.

management
hi
principles to ISO 9001:QMS Requirements

ac
management
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practices and Focus: Achieving conformance to

pd
its system established requirements and managing

processes to provide confidence in
products or service
Identified system of interrelated processes affecting the

organizations objectives
25
Standard Relationship
ISO Product Line
n
Vocabulary:
io
replaces ISO 8402
rs
ve
ISO 9000 concepts
and Definitions Principals of Quality
al Management
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ne
hi
ISO 9001 Quality ISO 9004 Guidelines

Consistent
ac
Management for performance

Requirements Pair improvement
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Replaces ISO 190011

ISO9001/2/3 Tools and
techniques
Guides for Auditing
and measurements etc

26
ESSENCE OF ISO-9000

n
io
You say what you are going to do (Write whatever you do)

rs
You do whatever you write

ve
You prove that you have done it
 It is not one of the things on our list.
al
It is the way we do all the things on our list
tri
ne
Finding of UK Govt.. Survey

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ac
89 percent of ISO 9000

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registered companies reported

greater operational efficiency,
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48 percent increased
profitability, 76 percent
improvement in marketing, 26
percent reported increased
export sales

27
ESSENCE OF ISO-9000
Preventive Action
n
io
 Action to eliminate the cause of the
rs
ve
potential nonconformity or other
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undesirable potential situation
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ac
Corrective Action
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 Action to eliminate the cause of a

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detected nonconformity or other

undesirable situation
28
ESSENCE OF ISO-9000
n
io
Continuous Improvement
rs
ve
The organization shall continually improve the
al
effectiveness of QMS through use of :
tri
ne
• Quality Policy
hi
• Quality Objectives
ac
• Audit Results
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• Analysis of Data
• Corrective and Preventive action
• Management Review

29
Journey Beyond ISO 9000
n
33.BENCHMARKING
io
BENCHMARKING
rs
Best
Best in
in industry,
industry, best
best in
in
ve
nation,
nation, best
best in
in the
the world
world
Capable Leader-ship
al
tri
2.Total
2.Total Quality
Quality Management
Management
ne
Continuous
Continuous improvement,
improvement, and
and
Involvement
Involvement of
of every
every person
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person
ac
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1.
1. ESTABLISH
ESTABLISH ISO
ISO 9000
9000 SYSTEMS
SYSTEMS
Basic
Basic Quality
Quality System
System infra-structure
infra-structure

30
Total Quality Management
Optimizing Seven Main Areas
n
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1
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ve
Capable Leadership
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2 3 4
Human Resource
ac
Customer Driven Systems Development

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5 6
7
Process Control & Product control and
Improvement
Resource
Improvement Utilization

31
Step 9
Road Map To ISO-9000 Registration Step 8 Registratio

n
n
Final
io
Step 7 Assess
rs
ment
Pre
ve
Step 6
Assessment
Internal
al Step 5
Quality
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Audit
Implementation of
Documented QMS
ne
Step 4
and Progress
Documentati monitoring
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on process
ac
Step 3
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Review of
Current
pd
QMS
Step 2
Setup/ Appointment of
- Quality Council
Step 1 - MR
-Task Team
Management - Coordinators
Decision &
Commitment
32
Benefits of Implementation
n
Better Co-ordination
io
rs
Consistency in Processes
ve
Builds Data Base for the Company al
tri
Increases Efficiency & Effectiveness
ne
Reduces Costs
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ac
Minimizes Defects & Rework

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Creates a Quality Culture

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Increases Customer Confidence/ Loyalty
FOUNDATION FOR TOTAL QUALITY

33
Typical Failings
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Over Documentation
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Emphasis on Adherence & not on Adequacy
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Just get the Certificate !
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ac
Loss of Direction & Credibility

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Short term Corrective/ Preventive Actions

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Weak Internal Audit Programme

PRODUCT QUALITY DOES NOT IMPROVE
34
Some Myths of ISO 9000
n

io
Once you've got ISO, you can only buy from ISO
rs
certified companies
ve
 ISO is only for big companies
al
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 It produces lots of paper
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 It's only for manufacturers

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
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It is only for exporters

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 It is conspiracy by Jews
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 ISO will force us to adopt a specific level of

quality
 ISO certification involves high costs

35
n
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How to start ISO9001 implementation

36
Sequence of Activities
in Implementing QMS
n
io

rs
Appreciation for Senior Managers
ve
 Formation of implementation team & understanding of
al
tri
requirements by key personnel.

ne
Establishing quality policy & objectives

hi
 Setting up documentation system

ac

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Writing quality Manual & Plans


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Writing quality procedures & instructions

 Understanding quality audit system
 Setting up internal quality audit.

37
Sequence of Activities
in Implementing QMS (continued..)
n

io
Performing internal Audit & reviewing noncompliance of
rs
actual practice against documented.
ve
 Taking corrective actions on non-compliances
al
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 Performing follow-up audit reviewing new/recurring non
ne
compliances
hi

ac
Taking final corrective actions


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Ready for application/assessment

pd
Note: For proper implementation make

Implementation Plan & Progress Work Flow
defining responsibility and duration required for
each activity
38
There is a need for a good standard
n
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ac
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pd
UP
The need for conformity to

international standards is
Tahir Mehmood Younes, Frontier Cable Industries, Hattar glaringly obvious
39

Iso9000

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Understanding ISO9000

Tahir Mehmood Younes

GM Quality Assurance (FCI)

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

KEY LEARNING OBJECTIVES

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Discuss what you think the definition

of Quality is. Give as many examples

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

to specification All the time.

Build Right Meet implied/Market

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

A high standard of service at a low price is what all

customers would like. If our competitors are able to

at a lower price, or a higher standard at the same price,

then we have a problem!!!

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

QUALITY MANAGEMENT SYSTEM

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

from the top

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

3000 1850s 1914 1979

Middle 1939 1987-1994

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Identical in most respect -- European Standard, EN-

29000 and the American

3. ISO9004: Quality Management System Guideline

for performance improvement

4. ISO10011: Guidelines for Auditing Quality

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

Consultants, university, and Institute.

Auditors, regulatory , certification body,

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

 Specifies quality management terminology

and their definition.

 Provides fundamentals for Quality

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

 Being developed based on a process model using

Quality Management Principals” to move the

organization towards business excellence.

 Emphasis on customer satisfaction.

 Covers all aspect of a Quality Management

system beyond the requirements of ISO 9001.

 Increase competitive advantage in the market.

 Better respond to customer needs and

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

 Use of the same “ Quality Management

Principles” but emphasis on satisfying the needs

of other interested parties through sustained

Tahir Mehmood Younes, Frontier Cable Industries, Hattar

quality sustain customer satisfaction.

principles to ISO 9001:QMS Requirements

practices and Focus: Achieving conformance to

its system established requirements and managing