ISO 9001 : 2000ISO 9001 : 2000ISO 9004 : 2000ISO 9004 : 2000

AgustiniWest Coast University

(ISO : International Organization for Standardization’s)

ISO 9001 and ISO 9004 in brief

ISO 9001 and ISO 9004 are among ISO's most well known standards ever.

ISO 9001 helps organizations to implement quality management systems-requirements.

ISO 9004 helps organizations to implement quality management systems- guidelines for performance improvements.

Future ISO 9000 Family(Subject to Ballot)

ISO9000 Core

Standards

Brochures

9000 9001 900419011

10012

Withdrawor transfer

to otherTC

9000-39000-49004-29004-39004-410005

OtherISO9000

Standards

TechnicalReports

10006**10007**100131001410015**10017

** Document status TR to be considered at next revision

•QMP•Sel & Use•Small Bus Handbook

TS16949

Technical Specs

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 requirementsThe ISO 9000:2000 requirements

“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

Relationship ISO 9001/ISO 9004 2 stand-alone standards, each being part of a

“consistent pair” Common structure based on “Process

Approach” Harmonized terminology Based on 8 “Quality Management Principles”

previously endorsed by ISO/TC176

TC :Technical Committee

The eight Quality Management Principles (ISO 9000 Principles) :1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. Systems Approach to Management

6. Continual Improvement

7. Factual Approach to Decision Making

8. Mutually beneficial supplier relationship

Process-based structure

Management responsibility Policy, objectives, planning, system, review

Resource management Human resources, information, facilities

Product realization Customer, design, purchasing, production, calibration

Measurement, analysis and improvement Audit, process/product control, improvement

Basic process model

MANAGEMENT

ACTIVITIES

ENABLERS

CUSTOMER

INPUTS

CUSTOMERSATISFACTION

DESIRED

OUTPUTS

The 9 criteria of the EFQM Model

The percentages were established following a wide ranging survey to collect views

We acknowledge here the key role of leadership, policy and strategy, the management of people and the management of partnerships and resources.

EFQM : European Foundation for Quality Management

The percentages were established following a wide ranging survey to collect views

We acknowledge here the key role of leadership, policy and strategy, the management of people and the management of partnerships and resources.

EFQM : European Foundation for Quality Management

Leadership100 points

(10%)

Leadership100 points

(10%)

Processes140 points

(14%)

Processes140 points

(14%)

Key Performance

Results150 points

(15%)

Key Performance

Results150 points

(15%)

People90 points (9%)

People90 points (9%)

Policy and Strategy

80 points (8%)

Partnerships &Resources

90 points (9%)

Partnerships &Resources

90 points (9%)

People Results90 points (9%)

People Results90 points (9%)

CustomerResults

200 points (20%)

CustomerResults

200 points (20%)

Society Results60 points (6%)

Society Results60 points (6%)

Capacity 500 points (50%) Results 500 points (50%)

ResultsEnablers

Management

responsibility

Measurement ,

analysis ,

improvement

Resource

management

QUALITY MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT OF

C

u

s

t

o

m

e

r

Requ

ir

ements

C

u

s

t

o

m

e

rProduct

realizationInput Output

Product

S

atisfaction

Process Model (ISO 9001:2000)

Management

responsibility

Measurement ,

analysis ,improvement

Resource

management

QUALITY MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT OF

Requirements

Productrealization

Input OutputProduct

Satisfaction

Interested

Parties

Interested

Parties

Process Model (ISO 9004:2000)

Development process for

ISO 9001 and ISO 9004 User surveys Specifications Project approach

Review of comments received Verification process Validation pilot studies

Extensive use of electronic communications

“To provide confidence, as a result of demonstration, in product conformance to

established requirements”

ISO 9001:2000 - ISO 9001:2000 - RequirementsRequirements

Understand the role of ISO 9001 standard: Product and/or service quality oriented Confidence to own management Confidence to customers ‘Established requirements’ Customer satisfaction

“Benefits for all interested parties through sustained customer

satisfaction”

ISO 9004:2000 - Guidelines

ISO 9004:2000

ISO 9004 completely re-written Revised terminology, harmonized with ISO

9001 Annex on self-assessment added Includes the requirements from ISO 9001 (in

clearly delineated boxes). More “user-friendly” Benefits “For all interested parties”

Think Performance Improvement… Think ISO 9004!! Increase profits

leadership and customer focus

clear objectives

increased efficiency

improved employee performance

employee and customer satisfaction

efficient use of resources

Potential Benefits Potential Benefits and Opportunities for and Opportunities for

OrganizationsOrganizations

What the new standard What the new standard means for your means for your organisationorganisation Customer focus

Need to stop and think: “Who are my customers?” “What do they really want?” “What are my key processes to be sure they get what

they want?” “Does that tie in with what I want??”

More emphasis on defining objectives Providing leadership

Better integration of Better integration of QMSQMS

Better integration of QMS into the Day-to-Day running of the Business

Need to define and understand key processes Inputs Outputs Measurements

Quality Management StyleQuality Management Style

Focus on the entire system Customer is main concern Communication at all levels Continuous Improvement Responsibility assigned

Why Implement a Why Implement a QMS?QMS?(ISO 9000)(ISO 9000) Ensure Customer Satisfaction Improve Quality System Enhance Control of Resources Improve Suppliers Performance

Analysis of Data

OrganizationalObjectives

Customer requirements

Statutory & regulatory

requirements

Defect rate and customer returns

QMS controls

Purchasing

Examples of objectives set by the Organization

Analysis of Data

Examples of results

recorded by the

Organization

OrganizationalResults

Customer satisfaction

Statutory & regulatory compliance

Quality system metrics

Inspection and test

Supplier performance

OrganizationalObjectivesCustomer

requirements

Statutory & regulatory

requirements

Defect rate and customer returns

QMS controls

Purchasing

Effectiveness of the QMS

OrganizationalObjectives

OrganizationalResults

0 0

100 100

The gap measures the lack of effectiveness of the quality management system.

The narrower the gap, the more effective the QMS.

Things are looking good!

Effectiveness of the QMS

OrganizationalObjectives

OrganizationalResults

0 0

100 100

Management should get a wake up warning!

The gap measures the lack of effectiveness of the quality management system.

Effectiveness of the QMS

OrganizationalObjectives

OrganizationalResults

The Organization is in trouble!

The gap measures the lack of effectiveness of the quality management system.

Improvement in the QMS

OrganizationalObjectives

OrganizationalResults

% 100 75 50 25 0

Improvement can also be measured

Improvement in the QMS

Improvement in the QMS

OrganizationalObjectives

OrganizationalResults

Customer Focus

Corrective Action

Procurement

Improvement Initiatives

These actions may cause the organization to revise its objectives.

Management ReviewManagement Review

OrganizationalObjectives

OrganizationalResults

0 0

100 100

Customer Focus

Corrective Action

Procurement

Improvement Initiatives

Management Review

The improvement processes are also evaluated during management review meetings and appropriate action taken.

Which may cause the organization to again revise its objectives.

OpportunitiesOpportunities

“Use the QMS as a useful MANAGEMENT tool, not just “to show the auditor”

Better understanding of customer needs Beyond “Compliance” towards “Excellence” Beyond “Effectiveness” towards “Efficiency”

Conclusion:Conclusion:

The eight Quality Management Principles are the foundation of a Quality Management System.

Stepping stone to performance improvement.

Stepping-Stone to Stepping-Stone to ExcellenceExcellence

Alignment ISO 9001 and ISO 9004 ISO 9004 for self-assessment of maturity Focus on improvement in performance Compatibility with Quality Awards

Thank YouThank You