ISO IntroductionISO Introduction

BY MUHANNAD AL-SHREEF

What is QualityWhat is QualityQuality:Quality:

Degree to which a set of inherent Degree to which a set of inherent characteristics fulfils requirementscharacteristics fulfils requirements

System:System:

Set of interrelated or interacting elementsSet of interrelated or interacting elements

Quality Management:Quality Management:

Coordinated activities to direct and control Coordinated activities to direct and control an Organization with regard to Qualityan Organization with regard to Quality

Quality managementQuality management..

• QualityQuality refers to all those features of a product refers to all those features of a product (or service) which are required by the customer.(or service) which are required by the customer.

• Quality management Quality management means what the means what the organization does to ensure that its products or organization does to ensure that its products or services satisfy the customer's services satisfy the customer's quality quality requirementsrequirements and comply with any and comply with any regulationsregulations applicable to those products or services. applicable to those products or services.

Why Quality system is Why Quality system is required?required?

• Quality has been widely accepted as the Quality has been widely accepted as the most powerful and sustaining factor most powerful and sustaining factor

• Inspection to assure quality of products Inspection to assure quality of products and or services and or services

• In earlier days there is no single In earlier days there is no single standardstandard

• Globalization: impacted on the need to Globalization: impacted on the need to develop International Standards for develop International Standards for products and services. products and services.

What is ISOWhat is ISO

• ISO : International Organization for ISO : International Organization for Standardization: Standardization:

• ISO 9001 and ISO 14001 are among ISO 9001 and ISO 14001 are among ISO's ISO's most well known standardsmost well known standards ever. ever.

• The The worldwide totalworldwide total of certificates toof certificates to ISO ISO 9001:20009001:2000 at the end of at the end of 20052005 was 776 608 was 776 608 in 170 countriesin 170 countries

• This was This was increase of 18 %increase of 18 % over 2004 when over 2004 when the total was 660 132 certificates. the total was 660 132 certificates.

• They are implemented by some They are implemented by some 887 770 887 770 organizationsorganizations in in 161 countries161 countries..

ISO An Introduction:ISO An Introduction:o ISO was formed in 1947 ISO was formed in 1947

o Headquarters at Geneva, Switzerland, Headquarters at Geneva, Switzerland, It is a part of UN. It is a part of UN.

o ISO is a world-wide federation of ISO is a world-wide federation of standards bodies from more than 151 standards bodies from more than 151 countries. countries.

o It’s mission is to promote the It’s mission is to promote the developments of standardization and developments of standardization and related activities .related activities .

What is ISO 9000?What is ISO 9000?

• ISO 9000 is a standard in which to ISO 9000 is a standard in which to conduct businessconduct business

• It is a set of rules which should be It is a set of rules which should be followed in order to meet the needs followed in order to meet the needs and understand the wants of and understand the wants of customerscustomers

• The standard is genericThe standard is generic

How is ISO 9000 Being How is ISO 9000 Being Implemented Today?Implemented Today?

• ISO 9000 is being used in many ISO 9000 is being used in many organizations with mixed resultsorganizations with mixed results

• If an organization implements ISO If an organization implements ISO 9000 in order to simply remain 9000 in order to simply remain competitive and without mutually competitive and without mutually beneficial goals in mind, it will most beneficial goals in mind, it will most likely fail in the long term likely fail in the long term

ISO ImplementationISO Implementation

• Implementing ISO 9000 in an Implementing ISO 9000 in an organization can be very beneficialorganization can be very beneficial

• The goal of this implementation is The goal of this implementation is to achieve customer satisfaction at to achieve customer satisfaction at its highest levelits highest level

Advantages

• creates a more efficient, effective operation• increases customer satisfaction and retention• reduces audits• enhances marketing• improves employee motivation, awareness, and morale• promotes international trade• increases profit• reduces waste and increases productivity• common tool for standardization.

How can ISO 9000 be used How can ISO 9000 be used in a business?in a business?

• ISO 9000 can benefit many industries, such ISO 9000 can benefit many industries, such as:as:

BankingBankingHealth CareHealth CareManufacturing, etc.Manufacturing, etc.

• ISO 9000 is ISO 9000 is genericgeneric, so it can be applied , so it can be applied virtually anywhere!virtually anywhere!

• Remember, ISO 9000 is just one part of an Remember, ISO 9000 is just one part of an entire system needed to create value for entire system needed to create value for customerscustomers

How can ISO 9000 be used How can ISO 9000 be used in business?(cont.)in business?(cont.)

• To begin the process, a To begin the process, a commitment must be madecommitment must be made

• Once a commitment is made, what Once a commitment is made, what should an organization do? How should an organization do? How can the organization benefit from can the organization benefit from implementation of ISO 9000?implementation of ISO 9000?

ISO 9001 RequirementsISO 9001 RequirementsIso document it is a document of approximately 30 pages which is available

from the national standards organization in each country. It is supplemented by two other standards: ISO 9000:2005 Quality management systems — Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach. Only ISO 9001 is directly audited against for third party assessment purposes. The other two standards are supplementary and contain deeper information on how to sustain and improve quality management systems; they are therefore not used directly during third party assessment.

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• Outline contents for ISO 9001 are as follows:• Page iv: Foreword• Pages v to vii: Section 0 Intro• Pages 1 to 14: Requirements

– Section 1: Scope– Section 2: Normative Reference– Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO

9000)– Section 4: Quality Management System– Section 5: Management Responsibility– Section 6: Resource Management– Section 7: Product Realization– Section 8: Measurement, analysis and improvement

• Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards

• Page 23: Bibliography

Provision of Resources

Human Resources

Infrastructure

Work Environment

6 Resource Management

General Requirements:

#identify QMS processes.

# measure, monitor, analyze ,action & improvement.

Documentation Requirements:

- procedures

Planning

Customer Related Processes

Design & Development

Purchasing

Production & Service Provision

Management Commitment

Customer Focus

Quality Policy

Planning

Responsibility, Authority & Communication

Management Reviews

5Management Responsibility

8 Measurement Analysis & Improvements

RequirementsRequirements of the Standard

4 Quality Management System Requirements

7 Product Realization

General

Monitoring & Measurements

Control of NCP’s

Analysis of Data

Improvements

Certification for our case stady Certification for our case stady Vaughan Industries

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2. Prepare quality manual, policy, processes, planning

3. Prepare procedures, work instructions & records

10. Certification

9. External assessmentISO 9000Certificate

ISO 9000Certificate

Proced-uresProced-ures

WorkInstructs

WorkInstructs

QualityRecords

QualityRecords

1. Brief management team

4. Implement procedures

5. Train internal auditors

6. Conduct internal audits

7. Conduct management review

8. Preliminary assessment

QualityPolicyQualityPolicy

QualityManual

QualityManual

QMS Processes

QMS Processes

QualityPlanQuality

Plan

How long will it take?How long will it take?• It has been done in less than 6 months…It has been done in less than 6 months…• It has taken longer than 18 months…It has taken longer than 18 months…• It can normally be done COMFORTABLY within 12 It can normally be done COMFORTABLY within 12

monthsmonths

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MonthsActions 1 2 3 4 5 6 7 8 9 10 11 12Prepare & approve quality manualPrepare & approve proceduresPrepare documentationImplement proceduresConduct internal audit training Conduct internal auditsConduct management reviewApply for certificationConduct staff awareness trainingReceive external assessmentReceive certification