1

New definition of quality:

“Degree to which a set of inherent characteristics fulfils requirements”

ISO 9000:2000, Quality management systems – fundamentals and vocabulary.

2

WHAT IS ISO

• ISO (pronounced aizo) is a Greek word that means equal.

• It is a set of international standards prepared by the International Organisation for Standardization, a voluntary body that has representation from more than 100 countries and is headquartered in Geneva

3

History of ISO The International Organization for Standardization (ISO) was formed in 1946 in Geneva Switzerland. The ISO’s intention was to promote the development of international standards and related activities so as to foster the increased trade of products and services between countries. ISO was initially focused on the increasing technological complexities in engineering and defence industries where consequences of failure were very high. Today the ISO 9000 standards have been mandated by many governments and organizations around the world.

4

Purpose of ISO

• Harmonise standards at international level. • Ensure consistency of output• Make organisations more competitive by

reducing wastage at various places in the company

5

ISO 9000 Standards• A number of standards have been issued since its

inception about 50 years ago. • The first set of harmonised standards on Quality

Assurance were issued in the year 1987. • Subsequent revision was done in the year 1994. • Last revision has been done in 2000• New structure is process based and more generic

in nature,• Clearly based on the Plan – Do – Check – Act

principle• Recommendatory in nature. • They do not over-ride the laws of any country.

6

ISO – 9000:2000 FamilyThe previous 20 standards are now replaced by four:

• ISO 9000: Quality Management Systems – Fundamental & Vocabulary

• ISO 9001: Quality Management System – Requirements

• ISO 9004: Quality Management System – Guidance for performance improvement

• ISO 19011: Guidelines for auditing quality & environmental management systems.

7

EXPECTED QUALITY

by the Customer

PLANNED QUALITY

by the Company

PRODUCED QUALITY

by the Company

PERCEIVEDQUALITY

by the Customer

Measurement of the Performance of the Company

Measurement of theClient’s satisfaction

The ISO 9000:2000 requirements

8

• Customer focus• Leadership• Empowerment• Process approach• Systemic approach• Continuous improvement• Decisions based on facts• Relationship with suppliers mutually beneficiary

• Customer focus• Leadership• Empowerment• Process approach• Systemic approach• Continuous improvement• Decisions based on facts• Relationship with suppliers mutually beneficiary

The 8 principles of TQM …

9

Quality Control Quality Management

Past FutureDetect faults Prevent errorsLook for guilty persons Look for faults in the processesAccuse Help, Moderate, FacilitatePunish MotivateMicro-management Systematic and systemic management

Quality Control Quality Management

Past FutureDetect faults Prevent errorsLook for guilty persons Look for faults in the processesAccuse Help, Moderate, FacilitatePunish MotivateMicro-management Systematic and systemic management

Transition towards TQMThe 8 principles of TQM …

10

VOICE OF THE CUSTOMER

VOICE OF THEMANAGEMENT

VOICE OF THE PERSONNEL

VOICE OF THE SOCIETY

Empowerment?The 8 principles of TQM …

11

Deming’s wheel

(P.D.C.A.)

Deming’s wheel

(P.D.C.A.)

ISO9000

PLAN DO

ACT CHECK ContinuousImprovement

Continuous improvement ?

The 8 principles of TQM …

12

5 sections of requirements to translate in practiceThe 8 principles of TQM

4- QUALITY MANAGEMENT SYSTEMS(QMS, documentation requirements)5- MANAGEMENT RESPONSIBILITY(Management commitment, Customer focus, Quality Policy, Planning, Responsibility, Authority and Communication, Management Review)6- RESOURCE MANAGEMENT(Provision of Resources, Human Resources, Infrastructure, Work Environment)7- PRODUCT REALIZATION(Planning, Customer Related Processes, Design and Development), Purchasing, Service Provision, Control of Measuring Devices)8- MEASUREMENT, ANALYSIS AND IMPROVEMENT(Monitoring and Measurement, Control of Non-conforming Product, Analysis of Data, Improvement)

The ISO 9000:2000 requirements

13

Continuous improvement of theQuality Management System

CLIENT

Product /Service

Realization

ManagementResponsibility

Measurement,Analysis andImprovement

ResourceManagement

InputData

ProductService

OutputData

Require ments

Satisfa ction

CLI ENT

Systemic approach ? The 8 principles of TQM …

14

“A COHERENT PAIR”:

•ISO 9001:2000 – Quality Management Systems: REQUIREMENTS (WHAT ?)ISO 9001 oriented effectiveness and certification,

•ISO 9004:2000 - Quality Management Systems: GUIDELINES FOR PERFORMANCE IMPROVEMENTS(HOW ...?)ISO 9004 oriented effectiveness and efficiency

Presentation of ISO 9000:2000

15

1- Have you defined in writing the Mission of your company?

2- Is it appropriately deployed in operational objectives and action plans?

3- Is there meetings between the personnel and the management on a regular basis?

No

t A

t A

ll /

Ne v

er

Sm

all /

So

met

imes

Str

on

g /

Oft

en

Ver

y S

t ro

ng

/ A

lway

s

Self- Assessment ToolManagement system (sample)

16

1- Are written procedures available?

2- Is there an internal quality audit system in place?

3- Are non-conformities formally recorded and corrected?

Self- Assessment ToolQuality system (sample)

No

t A

t A

ll /

Ne v

er

Sm

all /

So

met

imes

Str

on

g /

Oft

en

Ver

y S

t ro

ng

/ A

lway

s

17

1- Is there job descriptions in place for all the personnel?

2- Is there a formal system in place for the yearly evaluation of performance?

3- Is the training of the personnel well adapted to the needs?

Self- Assessment ToolHuman Resources (sample)

No

t A

t A

ll /

Ne v

er

Sm

all /

So

met

imes

Str

on

g /

Oft

en

Ver

y S

t ro

ng

/ A

lway

s

18

1- Are you formally “listening”the voice of your customers on a regular basis?

2- Is there a system in place for the treatment of the complaints of your customers?

3- Do you measure the level of satisfaction of your customers?

Self- Assessment ToolCustomer focus (sample)

No

t A

t A

ll /

Ne v

er

Sm

all /

So

met

imes

Str

on

g /

Oft

en

Ver

y S

t ro

ng

/ A

lway

s