ISO 9000ISO 9000

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AIM OF TRAINING

To promote awareness and understandingawareness and understanding of ISO9000 standards and its requirements among staff.

To communicate our Quality Policy and ObjectivesQuality Policy and Objectives for ensuring its understanding at all levels.

To explain howhow we will achieveachieve our quality policies and objectives.

To educate all the staff to perform their activities in accordance with the documented proceduresdocumented procedures.

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INTRODUCTION

WHAT IS ISO 9000 ? ISO 9000 describes fundamentalsfundamentals of quality management systems, and specifies the terminologyterminology for quality for quality management management systems.systems.

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ISO 9000 : 1994ISO 9000 : 1994

ISO 9001, Quality systemsISO 9001, Quality systems- Model for quality assurance in design / design / developmentdevelopment, production, installation and servicingproduction, installation and servicing

ISO 9002, Quality systemsISO 9002, Quality systems- Model for quality assurance in production, installationproduction, installation and servicingand servicing

ISO 9003, Quality systemsISO 9003, Quality systems- Model for quality assurance in final inspection and testfinal inspection and test

ISO 9004, Quality management & quality systemISO 9004, Quality management & quality systemelementselements- GuidelinesGuidelines

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GENERIC COMPARISON OF ISO 9001 : 1994 TO GENERIC COMPARISON OF ISO 9001 : 1994 TO ISO 9003 : 1994ISO 9003 : 1994

Quality System Elements ISO 9001 ISO 9002 ISO 9003

4.1 Management Responsibility

4.2 Quality System

4.3 Contract Review

4.4 Design Control N.A. N.A.

4.5 Document and Data Control

4.6 Purchasing N.A.

4.7 Control of Customer-Supplied Product

4.8 Product Identification and Traceability

4.9 Process Control N.A.

4.10 Inspection and Testing

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Quality System Elements ISO 9001 ISO 9002 ISO 9003

4.11 Control of Inspection, Measuring and

Test Equipment

4.12 Inspection and Test Status

4.13 Control of Non-conforming Product

4.14 Corrective and Preventive Action

4.15 Handling, Storage, Packaging,

Preservation and Delivery

4.16 Control of Quality Records

4.17 Internal Quality Audits

4.18 Training

4.19 Servicing

4.20 Statistical Techniques

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GENERIC COMPARISON OF ISO 9001 : 1994 TO GENERIC COMPARISON OF ISO 9001 : 1994 TO ISO 9003 : 1994ISO 9003 : 1994

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ISO 9000 : 2000ISO 9000 : 2000

ISO 9001, Quality management systems ISO 9001, Quality management systems - Specifies requirementsrequirements for demonstrating an organization’s capability to provide products that meet customer and applicable regulatory requirements. (Revision of ISO 9001 : 1994, ISO 9002 : 1994 and ISO 9003 : 1994)

ISO 9004, Quality management systemsISO 9004, Quality management systems- GuidelinesGuidelines for performance improvements

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ISO 9001 : 2000ISO 9001 : 2000

5 Clauses :5 Clauses :

4.0 Quality Management System4.0 Quality Management System

5.0 Management Responsibility5.0 Management Responsibility

6.0 Resource Management6.0 Resource Management

7.0 Product Realization7.0 Product Realization

8.0 Measurement, Analysis and 8.0 Measurement, Analysis and ImprovementImprovement

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4 Quality Management system

The organization shall establish, document, implement, maintain and continually improve its quality management system in accordance with ISO 9001 requirements.

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Level1

2

3

4

Quality ManualQuality Manual

Quality ProcedureQuality Procedure

Work InstructionWork Instruction

DataData

Document HierarchyDocument Hierarchy

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Document Hierarchy (Cont’d)Document Hierarchy (Cont’d)

Level 1 : Quality ManualExplanation of overall quality system of Stamping Division.

QMQM

Level1

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Level 2 : Quality Procedure

Conventions relating to operation methods and responsibilities related to carry out some specific task or operation.

Document Hierarchy (Cont’d)Document Hierarchy (Cont’d)

QPQP

Level2

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Document Hierarchy (Cont’d)Document Hierarchy (Cont’d)

Level 3 : Work Instruction

Describes conditions, criteria, methods, procedures andresponsibilities related to carry out some specific task or operation.

WIWI

Level 3

Level 4 : Data

Type of records, forms, cards, etc.

Document Hierarchy (Cont’d)Document Hierarchy (Cont’d)

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Level4

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Why the need for Documentation?Why the need for Documentation?

It describes the management system.

It provides a positive means of communicating company’s policy and requirements.

It defines process control and provides for quality control.

It ensures continuity of the system through controlled changes.

It provides the basis for auditing.

What is written carries authority and provide record for reference.

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5 Management Responsibility5 Management Responsibility

5.1 Management commitments5.1 Management commitments Top management shall provide evidence of its commitment by:

a) communicating the importance of meeting customer requirements

b) establishing Quality Policy and Quality Objectives

c) conducting management reviews

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5.2 Customer focus5.2 Customer focus Top management shall ensure that customer needs and

expectations are determined, converted into requirements and fulfilled with the aim of achieving customer satisfactioncustomer satisfaction.

5 Management Responsibility

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5 Management Responsibility5 Management Responsibility

5.3 Quality policy5.3 Quality policy Top management shall ensure that the Quality Policy:

b) is communicated and understood

c) is reviewed for continuing suitability

QUALITY

POLICY

a) includes a commitment to meeting requirements and to continual improvement

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Quality policy Quality policy of Singapore EPSON

We build quality into our product in

every process by all the staff performing

to their maximum capacity.

1.1.QUALITY ASSURANCEQUALITY ASSURANCE

QUALITYQUALITY

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Quality policy Quality policy of Singapore EPSON

2.2.CUSTOMER FIRSTCUSTOMER FIRST

Customer satisfaction

is our first priority in our

activities and we constantlyimprove to achieve it.

CUSTOMER

SATISFACTION

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Quality policy Quality policy of Singapore EPSON

3.3.FACT CONTROLFACT CONTROLWe act on the decision from realitiesprinciple :

“Go to the real location,

Look at the real thing, and

Consider the real circumstances.”

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5 Management Responsibility

5.4 Planning5.4 Planning

Quality objectivesQuality objectives : Top management shall ensure that Quality objectives are established at relevant functions within

the organization. The objectives shall be measurable and consistent with the Quality Policy.

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SEP STAMPING QUALITY OBJECTIVES

1. To attain a LOT PASSING RATELOT PASSING RATE of

98 % 98 % OR HIGHEROR HIGHER in the Fiscal Year 2000.

LOT PASSING RATELOT PASSING RATE

=No. of Lots Passed

No. of Lots InspectedX 100 %

Definition :

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SEP STAMPING QUALITY OBJECTIVES

2. To attain a PROCESS YIELD RATEPROCESS YIELD RATE of

99.5 % OR HIGHER99.5 % OR HIGHER in the Fiscal Year

2000.

Total GOOD Quality Parts (k)

Total Quantity Produced (k)X 100 %

PROCESS YIELD RATEPROCESS YIELD RATE

=

Definition :

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SEP STAMPING QUALITY OBJECTIVES

3. To attain a DIE SET MAKING F-COSTDIE SET MAKING F-COST

of 3 % OR LOWER3 % OR LOWER in the Fiscal Year 2000.

DIE SET MAKING F-COSTDIE SET MAKING F-COST

=Total F-Cost

Total SalesX 100 %

Definition :

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5 Management Responsibility

5.4 Planning5.4 Planning Quality planningQuality planning

Top management shall ensure

that the resources needed to

achieve the quality objectives

are identified and planned.

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5 Management Responsibility

5.5 Administration5.5 Administration Responsibility and authority

QMQM

Management representative

Internal communication

Quality manual

Control of document

Control of quality records

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5 Management Responsibility

5.6 Management review5.6 Management review

Management review shall be conducted at planned planned intervalsintervals to ensure its continuing suitability, adequacycontinuing suitability, adequacy & effectiveness.& effectiveness.

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6 Resource Management6 Resource Management

6.1 Provision of resources6.1 Provision of resources

The organization shall determine and provide the resources needed:

a) to implement and improve the processes.

b) to address customer satisfaction.

These resources include people, suppliers, information, infrastructure, work environment & financial resources.

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6 Resource Management

6.2 Human resources6.2 Human resources

6.2.16.2.1 Assignment of personnelAssignment of personnel

The assigned personnel shall be competent on the basis

of applicable education, training, skills and experienceeducation, training, skills and experience..

GREAT JOB

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6 Resource Management

6.2.26.2.2 Training, awareness and competencyTraining, awareness and competency

The organization shall :

a) identify competency needs for personnel

performing activities affecting quality ;

6.2 Human resources6.2 Human resources

b) Provide training to satisfy these needs ;

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6 Resource Management

6.2.26.2.2 Training, awareness and competency (cont...)Training, awareness and competency (cont...)

The organization shall :

6.2 Human resources6.2 Human resources

c) Evaluate the effectiveness of the training

provided ;

d) Maintain appropriate qualifications &

training records.

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6 Resource Management6 Resource Management

6.3 Facilities6.3 Facilities

The organization shall provide and maintain the facilities to ensure

that the facilities continue to meet operational needs.

Workspace Equipment

Communication

Transport

Hardware & software

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6 Resource Management6 Resource Management

6.4 Work environment6.4 Work environment

The work environment is a combination of human and physical

factors. These factors influence motivation, satisfaction and

performance of people, potentially enhancing the performance

of the organization.

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6 Resource Management6 Resource Management

6.4 Work environment (cont...)6.4 Work environment (cont...)

Examples of human factorshuman factors affecting the work environment include :

creative work methodologies and opportunities for greater involvement of all people

safety rules and guidance, including use of protective equipment

special facilities for people in the organization

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6 Resource Management

6.4 Work environment (cont...)6.4 Work environment (cont...)

Examples of physical factorsphysical factors affecting the work environment include :

heat noise

light

hygiene

humidity

cleanliness

vibration pollution

air flow

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7 PRODUCT REALIZATION7 PRODUCT REALIZATION

7.1 Planning of realization processes7.1 Planning of realization processes

Product realization is that sequence of processes required to

achieve the product.

START

CUSTOMER REQUIREMENTS

DESIGN OFDIE-SET

DIE-SET ASSEMBLY

FIRST ARTICLE

MASS PRODUCTION

INSPECTION

SECONDARYPROCESSES

QA INSPECTION

DELIVERY

END

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7 PRODUCT REALIZATION

7.1 Planning of realization processes (cont...)7.1 Planning of realization processes (cont...)

In planning the processes for realization of product, the

organization shall determine:

quality objectivesquality objectives for the product

the need to provide resources and facilitiesresources and facilities

verification and validationverification and validation activities, and the criteria forcriteria for acceptabilityacceptability

recordsrecords to provide confidence of conformity of the processes and resulting product

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7 PRODUCT REALIZATION7 PRODUCT REALIZATION

7.2 Customer-related processes7.2 Customer-related processes

7.2.1 Identification of customer requirements

7.2.2 Review of product requirements

product requirements

availability, delivery and support

conducted prior to acceptance of an order to ensure:

7.2.3 Customer communication

contract review

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7 PRODUCT REALIZATION7 PRODUCT REALIZATION

7.3 Design and / or development7.3 Design and / or development

7.3.1 Design and / or development planning

The planning shall determine:

stages of design processes

review, verification and validation activities

responsibilities and authorities

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7 PRODUCT REALIZATION7 PRODUCT REALIZATION

7.3 Design and / or development7.3 Design and / or development

7.3.2 Design and / or development inputs