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
ISO 9001:2000 Quality Management Systems – Requirements
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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
ISO 9001:2000 Quality Management Systems – Requirements
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1 Scope 1.1 General
1.2 Application
ISO 9001:2000 Quality Management Systems – Requirements
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2 Normative Reference ISO 9000:2000 Quality Management Systems -Fundamentals and Vocabulary
ISO 9001:2000 Quality Management Systems – Requirements
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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
ISO 9001:2000 Quality Management Systems – Requirements
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4 Quality management system 4.1 General requirements
4.2 Documentation Requirements
ISO 9001:2000 Quality Management Systems – 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
ISO 9001:2000 Quality Management Systems – Requirements
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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.
ISO 9001:2000 Quality Management Systems – Requirements
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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.
ISO 9001:2000 Quality Management Systems – Requirements
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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.)
ISO 9001:2000 Quality Management Systems – Requirements
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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
ISO 9001:2000 Quality Management Systems – Requirements
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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
ISO 9001:2000 Quality Management Systems – Requirements
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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
ISO 9001:2000 Quality Management Systems – Requirements
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
ISO 9001:2000 Quality Management Systems – Requirements
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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)
ISO 9001:2000 Quality Management Systems – Requirements
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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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
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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
ISO 9001:2000 Quality Management Systems – Requirements
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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
ISO 9001:2000 Quality Management Systems – Requirements
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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
ISO 9001:2000 Quality Management Systems – Requirements
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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
ISO 9001:2000 Quality Management Systems – Requirements
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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?