ISO 9001:2008 ISO 9001:2008

QUALITY MANAGEMENT SYSTEM QUALITY MANAGEMENT SYSTEM

BACKGROUNDBACKGROUND

• The International Organization for Standardization (ISO) is a worldwide organization that develops many different kinds of Standards.

• ISO was formed in February 23, 1947 February 23, 1947 in GenevaGeneva.

• First Family of Quality Standard was released in 1987.

WHAT IS ISO?WHAT IS ISO?

• The official title for the International Organization for Standardization

• It is derived from the Greek isos, meaning “equal”, which is the root of the prefix “iso”.

• ISO is the specialized international agency for standards making.

WHAT IS WHAT IS ISO 9000?ISO 9000?

• Primarily concerned with Quality Management.

• Achieve Customer Satisfaction and continual improvement.

• ISO 9001:2008 is the actual specification for QMS. It can be used irrespective of size or type of organization.

ISO 9000 SERIESISO 9000 SERIES

• ISO is the internationally accepted minimum requirements for quality management systems.

• It provides for 3rd party registration of the organization’s QMS.

• It has become a condition requirement for doing business with many organizations around the world.

WHAT IS ISO 9001: 2008WHAT IS ISO 9001: 2008

Applicable to all types & sizes of Organizations with possible permissible omissions of certain requirements

ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing

requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004.

WHY PURSUE ISO 9001?WHY PURSUE ISO 9001?

• To comply with internationally accepted quality standards

• To meet customer requirements

• To increase customer satisfaction

• To keep up with the competition

• To improve quality management system

• To reduce process variation and rework cost

• To increase personal satisfaction

Top 10 countries for ISO 9001 certificates - 2010

Rank Country No. of certificates

1 China 297,037

2 Italy 138,892

3 Russian Federation 62,265

4 Spain 59,854

5 Japan 59,287

6 Germany 50,583

7 United Kingdom 44,849

8 India 39,250

9 USA 25,101

10 Korea, Republic of 24,778

• 75% Reduction in customer claims• 95% improvement in delivery time• Reduced defects from 3% to 0.5%• 65% reduction in product cycle time• 85% increase in on-time delivery• International acceptance and recognition• Facilitated trade in international markets• Promoting of safety, reliability and

quality

CASE STUDIES SHOWEDCASE STUDIES SHOWEDISO Registration resulted in:

NEW ISO 9001:2008

QMSQMSResource

Management

Measurement, Analysis &

Improvements

Product Realization

Management

Responsibility

Continual Improvements cycle

General Requirements

General Requirements

ISO 9001:2008 STRUCTUREISO 9001:2008 STRUCTURE

• Four major sections

–Management Responsibility

–Resource Management

–Product Realisation

–Measurement, Analysis and Improvement

• Divided into 21 elements

ISO 9001:2008 STRUCTURE IISO 9001:2008 STRUCTURE I

Management Responsibility

1. Management commitment

2. Customer focus

3. Quality policy

4. Planning

5. Administration

6. Management review

ISO 9001:2008 STRUCTURE IIISO 9001:2008 STRUCTURE II

Resource Management

7. Provision of resources

8. Human resources

9. Facilities

10.Work environment

ISO 9001:2008 STRUCTURE IIIISO 9001:2008 STRUCTURE III

Product Realisation

11. Planning of realisation processes

12. Customer-related processes

13. Design and/or development

14. Purchasing

15. Production and service operations

16. Control of measuring and monitoring Equipments

ISO 9001:2008 STRUCTURE IVISO 9001:2008 STRUCTURE IV

Measurement, Analysis and Improvement

17.Planning

18.Measurement and monitoring

19.Control of nonconformity

20.Analysis of data

21.Improvement

KEY QMS PRINCIPLESKEY QMS PRINCIPLES

Create an ISO( QMS ) document like Manual, procedures and processes that affect quality.

Ensure that all processes adhere to those written procedures.

Documented evidence that the quality standard is being implemented effectively.

Periodic internal and external audits to ensure continued suitability, compliance, and effectiveness of the QMS.

Define what shouldbe done?

Do what you say?

Show what you have done?

Verify system effectiveness

ISO 9001:2008 PROCESS MODELISO 9001:2008 PROCESS MODELC

US

TO

ME

R’S

CU

ST

OM

ER

QMS

5.ManagementResponsibility

7. ProductRealization

6. ResourceManagement

8. MeasurementAnalysis and Improvements

Requirements

Satisfaction

Continual Improvement ofthe Quality Management System

ConsumptionProduct

8 PRINCIPLES 8 PRINCIPLES

Based on Eight

Quality

Management

Principles

Leadership

Process

approach

Involvemen

t of people

System

approach to

ManagementContinual

improvement

Factual

approach to

decision

making

Mutual

beneficial

supplier

relationship

Customer

focus

PROCESS APPROACHPROCESS APPROACH

Definition:- Process is a set of interrelated or interacting activities which transforms Inputs into Outputs.

Ensure Continual

Improvement

Identify the

Processes

Do it for all “Value Adding Processes”

Establish Measuring Criteria

Identify the Interactions

to other Processes

Identify the Inputs & Outputs

PROCESS APPROACH PROCESS APPROACH CONTINUAL IMPROVEMENTS OF ALL PROCESSES

PDCA CYCLEPDCA CYCLE

Processes in terms

of Added Value

DODO

Continual Improvements

of Processes Based on

Objective Measurements

ACTIONACTION

Measure Results of Process

Performance and Effectiveness

(Objective Measurements)

CHECKCHECK

Understanding &

Meeting the Requirements

PLANPLAN

PDCAPDCA STANDS FOR STANDS FOR

PP PLAN

DD DO

CC CHECK

AA ACT/ ACTION

E.g. - PURCHASING PROCESSE.g. - PURCHASING PROCESS

Performance Measurements

Delivery status – On-time, On spec, NCP etc

Supplier evaluation

Outputs Receipt of

Materials on right conditions

Right Quality, Right Quantity

Right Time

Purchasing Procedure

Interactions toStorageInspection and TestingManufacturingFinance

Inputs Required item /

quantity / date Applicable specs Supplier source Suppliers

capability to meet our requirements

Provision of Resources

Human Resources

Infrastructure

Work Environment

6.

Resource Management

General Requirements

Documentation Requirements

Planning

Customer Related Processes

Design & DevelopmentPurchasing

Production & Service Provision

Management Commitment

Customer Focus

Quality Policy

Planning

Responsibility, Authority & Communication

Management Reviews

5.

Management Responsibility

8. Measurement Analysis &

Improvements

STRUCTURE OF THE STANDARDSTRUCTURE OF THE STANDARD4.

Quality Management System Requirements

7.

Product Realization

General

Monitoring & Measurements

Control of NCP’s

Analysis of Data

Improvements

CRITERIA FOR CRITERIA FOR MEASUREMENTSMEASUREMENTS

Internal AuditsEffectiveness & Efficiency of ProcessesOpportunities for ImprovementsUse of Data / InformationEffective & Efficient Use of ResourcesAdequacy, Accuracy and Performance of MeasurementsRelationships with customers/ suppliers/ other interested parties

Financial MeasurementsPrevention costNon conforming / failure costLifecycle cost

Self Self AssessmentAssessment

Satisfaction Surveys for customers and other interested parties

Feedback on productsCustomer & market requirements

System System PerformancePerformance

CRITERIA FOR MEASUREMENTCRITERIA FOR MEASUREMENT

Inspection and testing of incoming, in process and final productsProduct verificationProduct validation

Process Capability / Process validationReaction timeCycle time / throughput (Capacity)Utilization of new technologyWaste reductionCost reductionProducts

Processes

CHALLENGES IN CHALLENGES IN IMPLEMENTING STANDARDIMPLEMENTING STANDARD

Communication

Management Support

Other employee Support

ISO 9001ISO 9001

Encouragement

5 M’s OF ISO 5 M’s OF ISO

• Men

• Material

• Machinery

• Measurement

• Methods

LEVELS OF DOCUMENTATIONLEVELS OF DOCUMENTATION

04/10/23 29

QualityManual

Level 1

Level 2

Level 3

Level 4

Methods & Procedures

Job Instructions, Forms & Templates

RecordsDocuments Verifying that Requirements Have Been Met

BENEFITSBENEFITS

• Increased employee morale as they are asked to take control of their processes (empowerment).

• Reduction in conflicts.

• Improved communications.

• Performance evaluation (Continual Improvement).

ISO STANDS FORISO STANDS FOR

INTERNATIONAL ORGANIZATION INTERNATIONAL ORGANIZATION FOR STANDARDIZATIONFOR STANDARDIZATION

WHAT ARE THE WHAT ARE THE INSTRUMENTS FOR INSTRUMENTS FOR

CALIBRATION?CALIBRATION?

CONFORMITY CONFORMITY

The fulfillment of a requirement.

NONCONFORMITYNONCONFORMITY

The preferred term (ISO 19011, ISO 9001) for the non-fulfillment of requirements (also known as deficiency,

discrepancy, finding, infraction, non-compliance). 

CALIBRATIONCALIBRATIONAll the operations for the purpose of determining the values of the errors of a measuring instrument (and if necessary, to determine other metrological properties).

COMPLIANCECOMPLIANCEAn indication or judgment that the product or service meets the requirements of the relevant specification or regulation; also the state of meeting the requirements.

IMPLIED NEEDS- IMPLIED NEEDS- without saying it directly, understood

STATED NEEDS- STATED NEEDS- declared requirements

A SMALL TRUTH TO MAKE A SMALL TRUTH TO MAKE LIFE 100% LIFE 100%

THEN WHAT MAKES 100% ?THEN WHAT MAKES 100% ?

HARD WORK HARD WORK H+A+R+D+W+O+R+K

8+1+18+4+23+15+18+11 = 98%

KNOWLEDGEKNOWLEDGEK+N+O+W+L+E+D+G+E

11+14+15+23+12+5+4+7+5 = 96%

LOVELOVEL+O+V+E

12+15+22+5 = 54%

LUCKLUCKL+U+C+K

12+21+3+11 = 47%

( don't most of us think this is the most important ??? )

THEN WHAT MAKES 100% ?THEN WHAT MAKES 100% ?IS IT MONEY? ... NO ! ! !

M+O+N+E+Y

13+15+14+5+25 = 72%

LEADERSHIPLEADERSHIP ? ... NO ! ! !

L+E+A+D+E+R+S+H+I+P

12+5+1+4+5+18+19+9+16 = 89%

Every problem has a solution, only if we perhaps change our attitude.

To go to the top,

to that 100%,

what we really need to go further... a bit more...

ATTITUDEATTITUDE

A+T+T+I+T+U+D+E 1+20+20+9+20+21+4+5 = 100%

and Work that makes OUR It is OUR ATTITUDE towards Life; Life 100% ! ! !

Change Your Attitude …

And You Change Your Life ! ! !

INSTRUCTIONS FOR INSTRUCTIONS FOR LIFE/WORKLIFE/WORK

Take in to account that great love, great achievement involves great risk.

When you loose don't loose the lesson

Follow the three “ R”s: Respect for self,

Respect for others and,

Responsibility for all your actions

INTERNATIONAL SURVEY INTERNATIONAL SURVEY SHOWS HOW YOU CAN GAIN SHOWS HOW YOU CAN GAIN MAXIMUM BENEFIT FROM MAXIMUM BENEFIT FROM

ISO ISO

• IMPROVED PLANNING & CONTROL 90%

• IMPROVED CUSTOMER SERVICE 95%

• IMPROVED PRODUCTIVITY 90%

• INCREASED ABILITY TO TENDER 9% FOR CONTRACTS

INTEGRITY OF SYSTEM MAINTAINED 80 %

BY OBJECTIVE APPROVAL GAINING A MARKETING ADVANTAGE 84 %

INCREASE IN MARKET SHARE 75 %

REDUCTION IN CUSTOMER AUDITS 90 %

REDUCTION IN COST 90 %

INCREASE IN EXPORTS 40 %

( THIS SURVEY IS BASED ON FEED BACK RECEIVED FROM ISO 9000 ( QMS ) CERTIFIED COMPANIES ON ABOVE POINTS)

ADVANTAGES OF ISOADVANTAGES OF ISO

Marketing Tool

Sets benchmark

Acts as a set of discipline

Basis for TQM

• Serves Export/domestic Customer’s requirement

• Helps to revisit system

• Helps document practices

• Helps in manpower training.

• Brings clarity in roles and responsibilities

• Reduces frustration

• Helps tide over problems arising out of manpower training

EXPECTED EXPECTED BENEFITS OF ISOBENEFITS OF ISO

Inspires confidence in the company’s potential

It helps the company achieve consistent levels of quality.

The overall image of the company in the market is likely to improve

Market share can go up with the resultant improved market credibility.

Company’s own management has greater confidence in its own internal system.

The systematic approach to problem solving results in elimination of chronic problems by taking care of the root causes.

Exports of the organization can be increased as ISO 9000 System standards are Globally accepted in over 150 countries

ISO 9000 implementation puts a company on the road to TQM