1. ISO 9000 Certification- an overview
Presented by
Mohamad Fawaz, Managing Partner
UMB-QMI

2. Outline
Introduction
8 Quality Management Principles
ISO 9001:2000 Standard- Overview
Benefits of ISO 9001:2000

3. ISO 9001:2000
Introduction

4. Introrduction
International Organization for Standardization (Why do we call them ISO standards?)
Central Secretariat in Geneva, Switzerland
Members - National Standards Bodies (100 member bodies worldwide)
Approx. 200 Technical Committees (TCs)
15,600 International Standards (as of December, 2005) 1 1

5. Introduction
Since its introduction, ISO 9000 series of Standards have gained recognition worldwide and is now used and adopted as national standards by almost every country in the world.
ISO 9000 series evolution:
1987- initial publishing
1994- first revision
2000- current edition
According to the ISO Survey- 2005*, undertaken by ISO, Certifications have been granted by the end of the year 2005 in 161 countries.
The 2005 total represents an increase of 18% over the year 2004 and 90% increase over the year 2000, when the new edition of ISO 9001 was published.
* Available on

6. ISO/TC 176 ISO/TC 176 on Quality Management JCG Joint Coordination
Group
CSAG Chair’s
Strategic Advisory
Trevor Smith
(Chair)
David
Zimmerman
(Acting Secretary)
SC1
Concepts and Terminology
SC2
Quality Systems
SC3
Supporting Technologies

7. Number of countries/ economies
ISO Survey 2005
World results
Dec. 2001
Dec. 2002
Dec. 2003
Dec. 2004
Dec. 2005
World Total
44 388
660132
776608
World Growth
116476
Number of countries/ economies 97
133
149
154
161

8. ISO Survey 2005 (cont’d)

9. Introduction (cont’d)
Arab Countries
Dec. 2001
Dec. 2002
Dec. 2003
Dec. 2004
Dec. 2005
Algeria 6 16 43
126
185
Bahrain 3 2 30 99
107
Egypt 18
222
754
810
1326
Jordan 34
112
278
293
Kuwait 11 7 25
101
111
Lebanon 14 27 62
154
167
Libya 1 4 35
Mauritius 32 93
212
202
Morocco 46 64
296
403
Oman 86
250
267
Palestine 13 29
Qatar 17 94 97
Saudi Arabia
131
247
394
642
Sudan 9 26 37
Syria 38
215
240
248
Tunisia 10
119
123
380
UAE
407
892
819
963
Yemen 12
Total
242
1063
2813
4077
5497
Introduction (cont’d)

10. 8 Quality Management Principles
ISO 9001:2000
8 Quality Management Principles

11. Quality Management Principles
New Model of
ISO 9000
is based on
“8” Quality Management Principles

12. Customer focused organization
Principle “1”
Customer focused organization
Organizations depend on their customers
and therefore should understand current
and future customer needs, meet
customer requirements and strive to
exceed customer expectations.

13. Leadership Principle “2”
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s benefit.

14. Involvment of People Principle “3”
People at all levels are the essence of an organization and their full involvment enables their abilities to be used for the organization’s benefit.

15. Process Approach Principle “4”
A desired result is achieved more efficiently when related resources and activities are managed as a process.

16. System Approach to Management
Principle “5”
System Approach to Management
Identifying, understanding and managing a system of interrrelated processes for a given objective improves the organization’s effectiveness and efficiency.

17. Continual Improvement
Principle “6”
Continual Improvement
Continual improvement should be a permanent objective of the organization.

18. Factual Approach to Decision Making
Principle “7”
Factual Approach to Decision Making
Effective decisions are based on the analysis of
data and information.

19. Mutually Beneficial Supplier Relationships
Principle “8”
Mutually Beneficial Supplier Relationships
An organization and its suppliers are interdependent, & a mutually beneficial relationship enhances the ability of both to create value.

20. Quality Management System
Quality Management System Continual Improvement
Act
Management
responsibility
Customer C u s t o m e r R e q u i r m n t s
Plan S a t i s f c o n
Measurement,
analysis,
improvement
Resource
management
Check Do
Product
(and/or service)
realization
Output
Product/
Service
Quality Management System

21. ISO 9001:2000
Overview

22. ISO 9001:2000 Quality Management Systems – Requirements
Structural Content of the Standard
Foreword
Introduction
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 1

23. ISO 9001:2000 Quality Management Systems – Requirements
Foreword
Brief about ISO
ISO 9001 prepared by Technical Committee ISO/TC 176
Member participation and standard approval (75% vote)
ISO 9001-title no longer includes “Quality Assurance” – reflecting the aim to enhance customer satisfaction

24. ISO 9001:2000 Quality Management Systems – Requirements
Introduction
0.1 General
0.2 Process approach
0.3 Relationship with ISO “consistent pair”
0.4 Compatibility with other Management Systems

25. ISO 9001:2000 Quality Management Systems – Requirements
1 Scope
1.1 General
1.2 Application

26. ISO 9001:2000 Quality Management Systems – Requirements
2 Normative Reference
ISO 9000:2000 Quality Management Systems -Fundamentals and Vocabulary

27. ISO 9001:2000 Quality Management Systems – Requirements
3 Terms and Definitions
As provided in ISO 9000:2000 Quality Management Systems - Fundamentals and Vocabulary
Wherever the term “product” is used, it can also mean “service”
SUPPLIER  ORGANIZATION  CUSTOMER

28. ISO 9001:2000 Quality Management Systems – Requirements
4.1 General requirements
4.2 Documentation Requirements

29. ISO 9001:2000 Quality Management Systems – Requirements
4.1 General requirements
The organization shall establish, documents, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
a) identify the processes needed for the quality management system and their application throughout the organization (refer clause 1.2 Application)
b) determine the sequence and interaction of these
processes
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective

30. ISO 9001:2000 Quality Management Systems – Requirements
4.1 General requirements
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes
e) monitor, measure and analyze these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes
These processes shall be managed by the organization in accordance with the requirements of this International Standard.

31. ISO 9001:2000 Quality Management Systems – Requirements
4.1 General requirements
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes and control of such outsourced processes must be identified within the quality management system.
NOTE: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

32. ISO 9001:2000 Quality Management Systems – Requirements
Examples of Processes - Service Sector, e.g. Travel Agency
PRODUCT REALIZATION PROCESS (Operational Processes)
Receive/ record customer’s travel requirements
Verify sector availability/hotel/car rental
Make bookings (hotel, flight/cruise, car rentals)
Prepare tickets, statements, itinerary
Deliver to customer
(Each of the above activities/processes may be handled by separate functions.)

33. ISO 9001:2000 Quality Management Systems – Requirements
Examples of Processes -Travel Agency (cont’d)
MANAGEMENT SYSTEM PROCESSES (Enablers/ Support Processes)
Training
Document Control
Record Keeping
I.T. Support
Data Analysis

34. Schematic of Order - Receiving Process
ISO 9001:2000 Quality Management Systems – Requirements
Schematic of Order - Receiving Process
PROCESS 1
Customer’s Record Customer’s Information
stated travel requirements, recorded
requirements other requirements (electronic/paper)
INPUT ACTIVITY OUTPUT

35. ISO 9001:2000 Quality Management Systems – Requirements
Schematic of Order - Receiving Process
PROCESS 2
Information Make bookings Confirmation
received from (Phone/ online) record/ statement.
order desk (Call hotel/ car rental/ (electronic/ paper)
airline/ cruise company)
The Sequence and Interaction of all the processes
must be determined by the organization
INPUT ACTIVITY OUTPUT

36. ISO 9001:2000 Quality Management Systems – Requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of documents
4.2.4 Control of records

37. ISO 9001:2000 Quality Management Systems – Requirements
4.2.1 General
The quality management system documentation shall include:
a) a quality policy and quality objectives, (documented statements)
b) a quality manual
c) documented procedures required by this International Standard, i.e. the following:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal Audit
8.3 Control of nonconforming product
8.5.2 Corrective Action
8.5.3 Preventive Action
d) documentation as required by the organization to ensure the effective planning, operation and control of its processes (as identified earlier under 4.1(a)), and
e) records required by this International Standard
(ref )

38. Typical Quality Management System Documentation Hierarchy
Document Contents
A. Includes the scope of the QMS, including details of and justification for any exclusions, documented procedure (or reference to them), description of the interaction between the processes of the QMS.
Quality manual
(Level A)
B. Describes the interrelated processes and activities required to implement the quality management system. Required where specified by the standard & where needed by the organization to ensure the effective planning, operation and control of its
processes
Quality Management
System Procedures
(Level B)
Work instructions and other documents for quality management system
(Level C)
C. Consists of detailed work documents.
Note The number of levels may be adjusted to meet the organization’s needs.
Note Forms may be applicable at all levels of hierarchy
Ref. ISO/TR Guidelines for quality management system documentation

39. ISO 9001:2000 Quality Management Systems – Requirements
5 Management responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal Communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.2 Review output

40. ISO 9001:2000 Quality Management Systems – Requirements
6 Resource management
6.1 Provision of resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment

41. ISO 9001:2000 Quality Management Systems – Requirements
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
Review of requirements related to the product
Customer communication
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes

42. ISO 9001:2000 Quality Management Systems – Requirements
7 Product realization (cont’d)
7.4 Purchasing
Purchasing process
Purchasing information
Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices

43. ISO 9001:2000 Quality Management Systems – Requirements
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
7.5.5 Preservation of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective action
8.5.3 Preventive action

44. ISO 9001:2000
Benefits

45. Benefits
The following facts represent the most important benefits of ISO 9000 Certification

46. 1 Customer Satisfaction 2 Top management commitment/Leadership
Major Benefits
1 Customer Satisfaction
2 Top management commitment/Leadership
3 Clear understanding of the difference between
ISO 9000 and product/ service standards.
4 Involvement of people in setting the system
5 Gaining competence and expertise in quality control.
6 Increased consistency, effectiveness,
and efficiency
7 Increased market share
8 Reduced cost

47. Major Benefits (cont’d)
9 Reduced waste (Time,rework,etc)
10 Better Integration between Quality system
and other management systems in the organization
11 Gained international recognition/confidence
12 Continual improvement
13 Better relation with suppliers
14 Updated facts
15 Wide applicability and basis for various
sectors
16 Preservation of Know How

48. High Product Quality Poor Product Quality
Economic Depression
Improved Economy
Satisfied Customers
Dissatisfied Customers
Happy Citizens
Pressure on the government to provide employment opportunities
Greater possibility of Investment and Development
Increased Sales (Locally & Exports)
Decreased Sales
No Improvement & decreased Employment
Higher Revenue
Less Revenue

49. Less Pressure on the Economy
Improved Quality
Reduced Waste
Reduced Costs
Less Pressure on the Economy
Positive Balance of Trade (Export >Imports)

50. Thank you!
Questions?