ISO the procedure and Benifits

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Outline

Introduction

8 Quality Management Principles

ISO 9001:2008 Standard- Overview

Benefits of ISO 9001:2008

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ISO 9001:2008Introduction

Introduction

ISO 9001 is for quality managementcan be adopted by any kind of organizationQuality refers to all those features of a product that are required by customers Quality management means what the organization does to:Enhance customer satisfactionAchieve continuous improvement of its performance

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ISO 9001 : 2008

Requirements are generic, applied in any organization regardless of size, type and product provided

Where any requirement cannot apply due to the nature of organization then it can be considered for exclusion

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8 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. Theyshould 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 ImprovementContinual improvement should be a permanent objective of the organization.

Principle “6”

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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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Factual Approach to Decision Making Effective decisions are based on the analysis of data 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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ISO 9001:2000

Overview

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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1 Scope 1.1 General

1.2 Application

ISO 9001:2008 Quality Management Systems – Requirements

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2 Normative Reference ISO 9000:2008 Quality Management Systems -Fundamentals and Vocabulary

ISO 9001:2008 Quality Management Systems – Requirements

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3 Terms and Definitions

As provided in ISO 9000:2008 Quality Management Systems - Fundamentals and Vocabulary

SUPPLIER ORGANIZATION CUSTOMER

ISO 9001:2008 Quality Management Systems – Requirements

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4 Quality management system

4.1 General requirements

4.2 Documentation Requirements

ISO 9001:2008 Quality Management Systems – Requirements

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4.1 Develop Quality Management System (QMS)

Establish your organization's process-based  QMS.

Document your organization's process-based QMS.

Implement your organization's process-based QMS.

Maintain your organization's process-based QMS.

Improve your organization's process-based QMS.

ISO 9001:2008 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 9001:2008 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

Schematic of Order - Receiving Process

ISO 9001:2008 Quality Management Systems – Requirements

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4.2 Documentation requirements

4.2.1 General

4.2.2 Prepare Quality Manual

4.2.3 Control of documents

4.2.4 Control of records

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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

ISO 9001:2008 Quality Management Systems – Requirements

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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 Suitable 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

ISO 9001:2008 Quality Management Systems – Requirements

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ISO 9001:2008Benefits

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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!