ISO 9000 Certification- an overview

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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 90012000 Standard- Overview
• Benefits of ISO 90012000

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ISO 90012000

• Introduction

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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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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, 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

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ISO/TC 176
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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 (contd)
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Introduction (contd)
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 90012000

• 8 Quality Management Principles

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Quality Management Principles

• New Model of
• ISO 9000
• is based on
• 8 Quality Management Principles

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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.

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Principle 2

• 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
  organizations benefit.

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Principle 3

• 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 organizations
  benefit.

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Principle 4

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

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Principle 5

• System Approach to Management
• Identifying, understanding and managing a
  system of interrrelated processes for a given
  objective improves the organizations
  effectiveness and efficiency.

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Principle 6

• Continual Improvement
• Continual improvement should be a permanent
  objective of the organization.

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Principle 7

• Factual Approach to Decision Making
• Effective decisions are based on the analysis of
• data and information.

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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.

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Quality Management System Continual Improvement
Act
Management responsibility
Customer
C u s t o m e r
R e q u i r e m e n t s
Plan
Measurement, analysis, improvement
Resource management
Check
Do
Product (and/or service) realization
Output
Product/ Service
Quality Management System
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ISO 90012000

• Overview

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ISO 90012000 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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ISO 90012000 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

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ISO 90012000 Quality Management Systems
Requirements

• Introduction
• 0.1 General
• 0.2 Process approach
• 0.3 Relationship with ISO 9004- consistent pair
  
• 0.4 Compatibility with other Management
  Systems

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ISO 90012000 Quality Management Systems
Requirements

• 1 Scope
• 1.1 General
• 1.2 Application

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ISO 90012000 Quality Management Systems
Requirements

• 2 Normative Reference
• ISO 90002000 Quality Management Systems
  -Fundamentals and Vocabulary

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ISO 90012000 Quality Management Systems
Requirements

• 3 Terms and Definitions
• As provided in ISO 90002000 Quality Management
  Systems - Fundamentals and Vocabulary
• Wherever the term product is used, it can also
  mean service
• SUPPLIER ? ORGANIZATION ? CUSTOMER

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ISO 90012000 Quality Management Systems
Requirements

• 4 Quality management system
• 4.1 General requirements
• 4.2 Documentation Requirements

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ISO 90012000 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

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ISO 90012000 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.

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ISO 90012000 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.

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ISO 90012000 Quality Management Systems
Requirements

• Examples of Processes - Service Sector, e.g.
  Travel Agency
• PRODUCT REALIZATION PROCESS (Operational
  Processes)
• Receive/ record customers 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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ISO 90012000 Quality Management Systems
Requirements

• Examples of Processes -Travel Agency (contd)
• MANAGEMENT SYSTEM PROCESSES (Enablers/ Support
  Processes)
• Training
• Document Control
• Record Keeping
• I.T. Support
• Data Analysis

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Schematic of Order - Receiving Process
ISO 90012000 Quality Management Systems
Requirements
PROCESS 1

• Customers Record Customers
  Information
• stated travel requirements,
  recorded
• requirements other requirements
  (electronic/paper)

INPUT ACTIVITY OUTPUT
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ISO 90012000 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
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ISO 90012000 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

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ISO 90012000 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. 4.2.4)

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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 1 The number of levels may be adjusted
to meet the organizations needs. Note 2
Forms may be applicable at all levels of
hierarchy
Ref. ISO/TR 10013 - Guidelines for quality
management system documentation
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ISO 90012000 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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ISO 90012000 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

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ISO 90012000 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
• 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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ISO 90012000 Quality Management Systems
Requirements

• 7 Product realization (contd)
• 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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ISO 90012000 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

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ISO 90012000

• Benefits

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Benefits

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

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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 (contd)

• 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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Increased Sales (Locally Exports)
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• Thank you!
• Questions?