INTRODUCTION TO

ISO 9001:2000
Packages Limited
CONTENTS
1 Background

2 Eight Quality Management Principles

3 ISO 9001:2000 Requirements

2
 1
BACKGROUND
What is ISO 9000?
ISO 9000
The word “iso” or The series allocated
International Organization for for
Standardization Quality System
standards

 “ISO 9000” is a series of standards

describing the requirements for establishing
and maintaining a quality management
system in an organization

4
Origin of ISO 9000

ISO 9000:87
ISO 9000:94
ISO 9000:2000

BS5750
1979

AQAP1
(NATO)
1970’s
MIL-STD-9858
(1940’s)

5
 Revisions of ISO 9000

Second revision named

as ISO 9000:2000

2000
First revision named
as ISO 9000:1994

1994
Originally released as
ISO 9000:1987

1987 ISO 9000 is revised after five years

6
 ISO 9000:1994 Models

ISO 9001:1994
Applies to organizations involved in design and
development of products/services, production of
products/provision of services, and delivery of
products/services
ISO 9002:1994
Applies to organizations that do not design/develop their
products or services but are only involved in production
of products/ provision of services and delivery of
products/services
ISO 9003:1994
Applies to organizations that do not design/develop
and produce their products or services but are only
involved in final inspection and delivery of the finished
product 7
Elements of ISO 9000:1994
Clause # Clause Title 9001:1994 9002:1994 9003:1994
4.1 Management Responsibility A A A
4.2 Quality System A A A
4.3 Contract Review A A A
4.4 Design Control A
4.5 Document and Data Control A A A
4.6 Purchasing A A
4.7 Customer-supplied products A A A
4.8 Identification & Traceability A A A
4.9 Process Control A A
4.10 Inspection and Testing A A A
4.11 Inspection and Test Equipment A A A
4.12 Inspection and Test Status A A A
4.13 Control of Non-conforming Product A A A
4.14 Corrective and Preventive Action A A A
Handling, Storage, Preservation, Packing
4.15 A A A
and Delivery
4.16 Control of Records A A A
4.17 Internal Quality Auditing A A A
4.18 Training A A A
4.19 Servicing A A
4.20 Statistical Analysis A A A 8
 2
Eight Quality
Management Principles
8 QUALITY MANAGEMENT
PRICINIPLES
Customer-focus
Mutually
beneficial supplier Leadership
relationship

Factual
8 QUALITY Involvement of
Approach to MANAGEMENT People
Management PRINCIPLES

Continual
Process
Improvement
Approach
System approach to 10
management
1. CUSTOMER FOCUSED

 Organizationsdepend on
their customers and
therefore should:
➲ understand current and future
customer needs,

➲ meet customer requirements, and

➲ strive to exceed customer

expectations.

11
2. LEADERSHIP

 Leaders should:
➲ establish unity of purpose (vision and mission)
➲ provide direction to the organization (policy and objectives)
➲ provide resources to achieve organization’s objectives

Corporate
Goal

12
3. INVOLVEMENT OF PEOPLE
 Peopleat all levels are the essence of an organization.
Therefore,
➲ their full involvement enables their abilities to be used for the
organization’s benefit

13
 4. PROCESS APPROACH
 Organizations need to do more than simply monitor process outputs, (typically through inspection activities)
➲ they must also control all process inputs, (people, facilities/equipment, material and methods)
➲ and, they must establish appropriate controls over the transformation activities, (if desired results are to be achieved consistently and efficiently)

Resources

Inputs
Transformation
Outputs
14
5. SYSTEM APPROACH TO
MANAGEMENT
 Organizations must understand a system is a set of interrelated processes, and
➲ the output of one process is the input to one or more subsequent processes, so …
➲ It is critical to manage the “white space” (or interface) between processes to ensure that the overall system is effective

15
6. CONTINUAL IMPROVEMENT

 Continual improvement should be

a permanent objective of the
organization

Continual
Improvement
Act Plan

Results ➲ Measure/Monitor Results

Check Do against Objectives
➲ Improve Process, and
➲ Change QMS as needed to
QMS
achieve and sustain Desired
Results
16
Baseline Performance
7. FACTUAL APPROACH TO
DECISION MAKING
 Effective decisions should be
based on:
➲ the analysis of data and information

COLLECTION
ANALYSIS DECISION
OF DATA

17
8. MUTUALLY BENEFICIAL
SUPPLIER RELATIONSHIPS

 Anorganization and its

suppliers are interdependent.
Therefore:
➲ a mutually beneficial relationship should be established between them to enhance the
ability of both to create value

VENDORS
PRODUCT
PRODUCT
+ OR
OR
SERVICE
SERVICE
ORGANIZATION
18
ISO 9001:2000
3
Requirements
ISO 9000:2000
 ISO 9002:1994 & ISO 9003:1994 dropped and merged into a single
ISO 9001:2000 standard

New
New Standards
Standards
•• ISO
ISO 9000:2000
9000:2000 Fundamentals
Fundamentals and and Vocabulary
Vocabulary
•• ISO
ISO 9001:2000
9001:2000 QMS
QMS Requirements
Requirements
•• ISO
ISO 9004:2000
9004:2000 Guidelines
Guidelines for
for Performance
Performance
Improvement
Improvement

20
NEW STRUCTURE
20 Clauses have been abandoned and merged into 5
sections with additional requirements

Clause 4: Clause 7:
Quality System Product Realization

Clause 6:
Resource
Management
Clause 8:
Clause 5: Measurement,
Management Analysis &
Responsibility Improvement

Permissible Exclusions from Clause 7 only if it does not 21

apply
Contents

1 Scope 1.1 General

1.2 Application

2 Normative Reference

3 Terms and Definitions

22
 Contents (cont.)
4 Quality
Management 4.1 General Requirements
System 4.2 Documentation Requirements
5 Management 5.1 Management Commitment
Responsibility 5.2 Customer focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, authority and
communication
6 Resource Management5.6 Management Review
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
7 Product Realization 7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision 23
7.6 Control of monitoring and measuring
devices
Contents (cont.)
8 Measurement,
Analysis and 8.1 General
Improvement 8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement

24
 DEMING’S CYCLE
• Analyze the Gaps • Define Policy
• Take corrective and • Set Objectives &
preventive actions to Targets
fill the gap • Assign Responsibilities
PLAN • Provide Resources
ACT

DEMING’S
CYCLE

CHECK DO

• Monitor and Measure • Implement according

the actual to planned
implementation arrangements
against the planned
• Identify the Gaps 25
Process Model

CONTINUAL IMPROVEMENT OF
THE QUALITY MANAGEMENT
SYSTEM

C R
C S
e Manageme a
U q
nt U
t
i
u
S i responsibili S
s
f
ty Measureme
r
T e Resource
nt, analysis T a
c
O m manageme and
e
nt O t
M n
t
improvemen
M
i
o
Input t
E s Product Outp
E
n

R realizati Produc ut
on t R
26
Scope

 Consistency of products/services
 Compliance with requirements including
customer and regulatory requirements
 Enhanced Customer Satisfaction

 Continual Improvement

27
4 QUALITY SYSTEM
4.1: General Requirements

4.2: Documentation
Requirements
Policy/
Objectives

Quality 4.2.3 Control of

Manual Documents

Quality System Procedures

Process Procedures, Plans

4.2.4 Control of Records

Records/Reports/Log
s 28
 4.4.5 DOCUMENT CONTROL
Review & Approval

Obsolete Document Distribution

Control Control

DOCUMENT
CONTROL

External Document Change Control 29

Control
4.5.3 CONTROL OF RECORDS

Retrieval

Identification Indexing

Disposition RECORDS Retention

CONTROL

Maintenance Filing

Storage
30
5 MANAGEMENT
RESPONSIBLITY
New New
5.1: Management 5.2: Customer Focus
Commitment
5.3: Quality Policy

5.4: Quality Objective & New

Planning
5.5: Responsibility, Authority and Communication
5.5.1: Responsibility & Authority

5.5.2: Management Representative

5.5.3: Internal Communication New

5.6: Management Review

31
 5.1 MANAGEMENT
COMMITMENT
Establishing
Setting Quality Quality
Policy Objectives

Supporting
Quality Initiatives Participating in
& Programs Quality Reviews
& Meetings

Providing Motivating &

Resources Involving people

32
5.2 CUSTOMER FOCUS

IDENTIFY & MONITOR &

REVIEW MEASURE

CC
C
RR SS

UU
ee
qq
Complaints
C aa
tt
uu Feedback UU ii
SS ii ss
rr SS ff
TT ee Organizatio
Organizatio
mm Inputs n’s TT aa
OO n’s cc
ee
Processes
Processes OO
tt
MM
nn ii
tt MM oo
EE ss Produc
Produc
nn
tt EE
RR
RR
33
5.3 QUALITY POLICY

QUALITY
POLICY

REQUIREMENTS

IMPROVEMENT
CONTINUAL
MEETING

COMMITMENT 34
5.4 PLANNING

Rejection Rate = ?? On-time delivery = ??

Rework rate = ?? Response time = ??
Failure rate = ?? Complaints = ??

QUALITY
OBJECTIVES
MEASURABLE
ACHIEVABLE

TIME-BOUND
REALISTIC
SPECIFIC

35
5.5 Responsibility,
Authority & Communication

Defining responsibilities & authorities

in the form of:
• Organizational Charts
• Job Descriptions

Appointing the ISO 9000 Project

Coordinator, called Management
Representative (MR)

Establishing Internal Communication

Channels, which may include:
• intranet, memos, internal 36

meetings, emails, phones, etc.

5.6 MANAGEMENT REVIEW

INPUTS OUTPUTS

Results of Audits
Resource needs
Complaints/Feedback Top
Top
Managemen
Managemen Revision of policy
Product Quality Status
tt Review
Review Revision of objectives
Pending Actions
Meeting
Meeting
Corrective Actions
External Market Status
Improvement Actions
Improvement Suggestions
37
6 RESOURCE MANAGEMENT

6.1: General
6.2: Human Resources New
New
6.3: Infrastructure
6.2.1: General

New

6.2.2: Awareness & Training 6.4: Work Environment

38
6.2 HUMAN RESOURCES

Education Experience Skills Training

COMPETEN
CE

Identify training needs

TRAINING
& Provide training

AWARENES
Evaluate the
S effectiveness of training

Maintain records of
training
39
6.3/6.4 INFRASTRUCTURE &
WORK ENVIRONMENT

WORK
ENVIRONMENT
po s

Temperature Humidity
ns te
r t)

Temperature Humidity
ra lita

Bu
. , t ci

ild
m Fa

in
om r t

g Noise Dust
(C ppo

&
Fa Noise Dust
Su

cil
INFRASTRUCTURE
iti
Work
Work
es
Ventilation
Ventilation Space
Space

Health
Health&&
Equipment Cleanliness
Cleanliness
Safety
Safety
(hardware, software)

40
7 PRODUCT REALIZATION

7.1: Planning of 7.5: Production

Realization
Processes
7.2: Customer-related
processes
7.2.1 Determination of
requirements
7.2.2 Review of requirements
7.2.3 Customer Communication
7.5.1 Control of Production
7.5.2 Validation of Processes
New
7.5.3 Identification and
Traceability
7.5.4 Customer Property
New 7.5.5 Preservation

7.3: Design &

Development 7.6: Control of
Monitoring &
7.4: Purchasing
Measurement
41
Equip.
7.1 PLANNING OF
REALIZATION PROCESSES

QUALITY PLAN
•• Process
Processstages
stages
•• Inspection
Inspectionand
andtest
teststages
stages
•• Parameters
Parametersto
tobe
becontrolled/checked
controlled/checked

•• Reference
Referencestandards
standards
•• Related
Relatedrecords
records
•• Responsible
Responsiblepersons
persons

42
7.2 CUSTOMER-RELATED
PROCESSES

CUSTOMER’S SPECIFIED CUSTOMER’S INTENDED

REQUIREMENTS REQUIREMENTS

STATUTORY & REGULATORY ORGANIZATION’S INTERNAL

REQUIREMENTS REQUIREMENTS

43
 7.2.2 REVIEW OF
REQUIREMENTS
Product requirements are defined

Records of review are Differences/ conflicts

maintained
Review of are resolved
Requirements

Organization has the ability to

44
meet the requirements
7.3 DESIGN & DEVELOPMENT
DESIGN & DEVELOPMENT PLAN

DESIGN REVIEW

Requirements
- Customer Design &
INPUT OUTPUT
- Technical Development
- Legal

VERIFICATION

VALIDATION
45
 7.4 PURCHASING
Procedure

Purchasing Purchasing
PurchasingInformation
PurchasingProcess
Process ••Complete
Information
Verification
(Evaluation
(Evaluation andselection
and selection Completeproduct
productspecs.
specs. Verification
••Personnel qualifications
Personnel qualifications of
ofPurchased
Purchased
of suppliers)
of suppliers) ••Approval
Approvalof
ofpurchase
purchase Product
Product
documents
documents

Records
46
7.5.1 CONTROL OF PRODUCTION
Product Specifications
Availability of
Production planning work Instructions

Production CONTROL OF Use of suitable

records Equipment
PRODUCTION

In-process
Maintenance of monitoring &
equipment measurement
Availability of
47
monitoring equipment
7.5.3 IDENTIFICATION &
TRACEABILITY

INSPECTION
IDENTIFICATION TRACEABILITY
& TEST STATUS

Article #/Model #/ Lot #/Batch #/ Tags/Stickers/Trays for

Item #/Design # Serial #/Mfg. date rejected/reworked
items

48
7.5.4 CUSTOMER PROPERTY

ss
lo/
ge
ma

Ve
da

rif
ica
of

CUSTOMER

tio
ng

n
rti

PROPERTY
po
Re

Segregation & Maintenance

49
7.5.5 PRESERVATION
Handling

Delivery Storage

PRESERVATION

Protection Packing
50
8 MEASUREMENT, ANALYSIS
& IMPROVEMENT
8.1: General
8.2: Monitoring and
Measurement
8.2.1: Customer Satisfaction
8.2.2: Internal Audit
8.2.3: Measurement of New
Processes
8.2.4: Measurement of Products
8.3: Control of
Nonconformity
8.4: Analysis of Data
New
• Customer feedback
• Product Performance
New
• Product & Process
Trends
• Suppliers
8.5: Improvement New
8.5.1: Continual Improvement
8.5.2: Corrective Action
8.5.3: Preventive Action
51
8.2.2 QUALITY AUDITS

Procedure
Procedure

CORRECTIVE
AUDIT AUDIT AUDIT
ACTION &
PLANNING EXECUTION REPORTING
FOLLOW UP

Records
Records

52
8.2.3/8.2.4 Monitoring of Processes
& Products
Quality Plan or Inspection/Test Plans

INSPECTION &
TESTING Availability of
Test records
specifications
•Receiving
•In-process
•Final

Inspection and Test Methods 53

8.3 CONTROL OF
NONCONFORMITY
Procedure
Procedure

Alternative Reject/
use Rework

Control
of non-
conformity

Accept-as-is Re-grade

Records
Records 54
8.4 ANALYSIS OF DATA

Analysis of
Customer
Data

Analysis of Analysis of
Suppliers Product Data
Data

Analysis of
Process
Trends
55
8.5.1 CONTINUAL IMPROVEMENT
Quality
Objectives

Management Data Analysis

Review

CONTINUAL
IMRPROVEMENT

Corrective/ Quality Audits

56
Preventive
8.5 CORRECTIVE &
PREVENTIVE ACTION
Identify the problem

Investigate the root

CORRECTIVE causes PREVENTIVE
PREVENTIVE
CORRECTIVE
ACTION ACTION
ACTION
ACTION
Action Action
Actiontaken
takento
Actiontaken
takento to Propose solutions to
eliminate eliminate
eliminatethe
eliminatethe
the the
problems potential
potential
problems
occurred problems
problemsto
occurredtoto Implement solution
to
avoid avoid
avoidtheir
avoidtheir
their their
recurrence occurrence
occurrence
recurrence

Evaluate the
effectiveness of 57
solution
SUMMARY OF NEW
REQUIREMENTS
 Defining function-wise and level-wise Quality Objectives
 Defining internal communication
 Defining competence based on education, training,
experience and/or skill
 Evaluating effectiveness of Training
 Identification and provision of infrastructure and work
environment
 Compliance with legal and regulatory requirements
 Defining external communication with customers
 Monitoring and Measurement of customer satisfaction
 Defining mechanism for identifying continual improvement
opportunities
58
59