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

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ISO 9000Certification- an overview

Presented by Mohamad Fawaz, Managing Partner

UMB-QMI

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Outline

Introduction

8 Quality Management Principles

ISO 9001:2000 Standard- Overview

Benefits of ISO 9001:2000

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ISO 9001:2000

Introduction

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)

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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 publishing1994- first revision2000- current edition

According to the ISO Survey- 2005*, undertaken by ISO, 776 608 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 www.iso.org

Introduction

ISO/TC 176

ISO/TC 176 on Quality Management

JCGJoint Coordination

Group

CSAG Chair’s Strategic Advisory

GroupTrevor Smith

(Chair)

David Zimmerman

(Acting Secretary)

SC1Concepts and Terminology

SC2 Quality Systems

SC3Supporting Technologies

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ISO Survey 2005

World results Dec. 2001

Dec. 2002

Dec. 2003

Dec. 2004

Dec. 2005

World Total 44 388 167 124 497 919 660132 776608

World Growth 122 736 330 795 162 213 116476

Number of countries/ economies

97 133 149 154 161

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ISO Survey 2005 (cont’d)

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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 2 4 6 35

Mauritius 3 32 93 212 202

Morocco 14 46 64 296 403

Oman 25 32 86 250 267

Palestine 13 18 29 27

Qatar 13 11 17 94 97

Saudi Arabia 6 131 247 394 642

Sudan 2 9 26 37 32

Syria 4 38 215 240 248

Tunisia 10 30 119 123 380

UAE 112 407 892 819 963

Yemen 4 6 9 12

Total 242 1063 2813 4077 5497

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ISO 9001:2000

8 Quality Management Principles

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New Model of

ISO 9000

is based on

“8” Quality Management Principles

Quality Management Principles

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Customer focused organization

Organizations depend on their customersand therefore should understand currentand future customer needs, meetcustomer requirements and strive toexceed customer expectations.

Principle “1”

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Leadership

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.

Principle “2”

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Involvment of People

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.

Principle “3”

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Process Approach

A desired result is achieved more efficiently when related resources and activities are managed as a process.

Principle “4”

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System Approach to Management

Identifying, understanding and managing a system of interrrelated processes for a given objective improves the organization’s effectiveness and efficiency.

Principle “5”

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Continual Improvement

Continual improvement should be a permanent objective of the organization.

Principle “6”

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Factual Approach to Decision Making

Effective decisions are based on the analysis ofdata and information.

Principle “7”

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Mutually Beneficial Supplier Relationships

An organization and its suppliers are interdependent, & a mutually beneficial relationship enhances the ability of both to create value.

Principle “8”

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Customer

Requirements

Resourcemanagement

Managementresponsibility

Measurement,analysis,

improvement

Product(and/or service)

realization

Customer

Satisfaction

Output Product/ Service

Quality Management System Continual Improvement

PlanPlan

DoDo Check Check

Act Act

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ISO 9001:2000

Overview

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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

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ForewordBrief 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


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Introduction0.1 General

0.2 Process approach

0.3 Relationship with ISO 9004- “consistent pair”

0.4 Compatibility with other Management Systems


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1 Scope 1.1 General

1.2 Application


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2 Normative Reference ISO 9000:2000 Quality Management Systems -Fundamentals and Vocabulary


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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


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4 Quality management system 4.1 General requirements

4.2 Documentation Requirements


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4.1 General requirementsThe 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

processesc) determine criteria and methods needed to ensure that both the operation and control of these processes are effective


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4.1 General requirementsd) ensure the availability of resources and information

necessary to support the operation and monitoring of these processes

e) monitor, measure and analyze these processes, andf) 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.


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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.


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Examples of Processes - Service Sector, e.g. Travel AgencyPRODUCT 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.)


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Examples of Processes -Travel Agency (cont’d) MANAGEMENT SYSTEM PROCESSES (Enablers/ Support Processes)

• Training

• Document Control

• Record Keeping

• I.T. Support

• Data Analysis


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Customer’s Record Customer’s Informationstated travel requirements, recordedrequirements other requirements (electronic/paper)

INPUT ACTIVITY OUTPUT

Schematic of Order - Receiving Process

PROCESS 1PROCESS 1


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Information Make bookings Confirmationreceived 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

PROCESS 2PROCESS 2

INPUT ACTIVITY OUTPUT


Schematic of Order - Receiving Process

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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


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4.2.1 General The quality management system documentation shall include:

a) a quality policy and quality objectives, (documented statements)b) a quality manualc) documented procedures required by this International Standard, i.e.

the following:4.2.3 Control of documents4.2.4 Control of records8.2.2 Internal Audit8.3 Control of nonconforming product8.5.2 Corrective Action8.5.3 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. 4.2.4)


Typical Quality Management System Documentation Hierarchy

Ref. ISO/TR 10013 - Guidelines for quality management system documentation

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.

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

C. Consists of detailed work documents.

Document ContentsDocument Contents

Quality manual

(Level A)

Quality ManagementSystem Procedures

(Level B)

Work instructions and other documents for quality management system

(Level C)

Note 1 The number of levels may be adjusted to meet the organization’s needs.

Note 2 Forms may be applicable at all levels of hierarchy

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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

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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


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7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes

» 7.2.1 Determination of requirements related to the product » 7.2.2 Review of requirements related to the product » 7.2.3 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


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7 Product realization (cont’d) 7.4 Purchasing

» 7.4.1 Purchasing process » 7.4.2 Purchasing information » 7.4.3 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


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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


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ISO 9001:2000

Benefits

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

Benefits

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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

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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

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Poor Product Poor Product QualityQuality

High Product High Product QualityQuality

Satisfied Satisfied Customers Customers

Increased Increased Sales Sales (Locally & (Locally & Exports) Exports)

Improved Improved EconomyEconomy

Higher Higher RevenueRevenue

Greater possibility Greater possibility of Investment of Investment and Development and Development

Dissatisfied Dissatisfied Customers Customers

Less Less RevenueRevenue

Pressure on the Pressure on the government to government to

provide employment provide employment opportunities opportunities

Economic Economic Depression Depression

No Improvement No Improvement & decreased & decreased Employment Employment

Decreased Decreased Sales Sales

Happy Citizens Happy Citizens

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Improved Quality

Reduced Waste

Reduced Costs

Less Pressure on the Economy

Positive Balance of Trade (Export >Imports)

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Thank you!

Questions?

Documents

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