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WHAT IS ISO 9000

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WHAT IS ISO 9000

• ISO is a ‘nickname’ to “International Organization for Standardization”.

• An international standard more than 100 countries

• ISO is a non-governmental organization established in 1947 by International Standard Agency headquartered in Geneva.

• Principles are applicable to all organizations

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WHAT IS ISO 9000

ISO 9000 is a written set of standard which describe and define the basic elements/clauses of the quality system needed to ensure that an organization’s products/or services meet or exceed customer needs and expectations

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Principles of ISO 9000

- ISO 9000 is a standard for a quality system, not product.

- ISO 9000 is based on documentation and is premised on the following:-

- Document what you do;

- Do what your document;

- Prove it and improve it

- ISO 9000 emphasizes prevention.

- ISO 9000 is a universal standard; the focus is on what needs to be done and not on how it is to be carried out

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WHY QUALITY SYSTEM - ISO 9000

• to satisfy customers through a quality product

• to gain self confidence – we get what we planned

• to achieve competitiveness in both the local and overseas markets.

• as a blueprint for efforts to improve the quality system of the organization.

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QUALITY SYSTEM = VEHICLE

QUALITY MANAGEMENT = DRIVER

QUALITY POLICY = ROAD MAP

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ADVANTAGES OF ISO 9000 IMPLEMENTATION

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WHAT IS IT INTENDED FOR?WHAT IS IT INTENDED FOR?

This International Standard specifies quality system requirements for use where organization’s capability to design and supply conforming product needs to be demonstrated.

The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing

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BENEFITS OF ISO 9000 IMPLEMENTATIONBENEFITS OF ISO 9000 IMPLEMENTATION

For the company:-

- Well defined organization and responsibilities, i.e., minimize grey areas and possible

resources wastage.

- Standardize practice and establishment of proper communication channel, i.e. maximize productivity and communication efficiency.

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BENEFITS OF ISO 9000 IMPLEMENTATIONBENEFITS OF ISO 9000 IMPLEMENTATION

For the company:-

- A greater degree of internal control.

- Ultimately, increase profitability and market share, improve competitive position.

For the customer:-

- Increase satisfaction and growth in confidence.

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QUALITY MANAGEMENT SYSTEM – ISO 9001:2000

Set of comprehensive and fundamentals rules or beliefs for leading and operating an organization. The aim is to improve

performance continually , by focusing on customers while addressing the needs of all stakeholders.

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ISO 9000-2000 QMS- |Fundamentals and vocabulary

Provides fundamentals of QMS and specifies QM terms and definitions

ISO 9001-2000 QMS- Requirements

Specifies requirements for a QMS where an organization needs to demonstrate its capability to meet customer requirement for product/service and its assessment

ISO 9004-2000 QMS- Guidance for performance improvements

Provides guidance on QMS as a mean of continual improvement of processes that contribute to the satisfaction of customers

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Eight Quality Management Principles which can facilitate any organization in

creating quality work culture

• Customer - focused organization• Leadership• Involvement of people• Process approach

• System approach to management

• Continual improvement

• Factual approach to decision making

• Mutually beneficial supplier relationship

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Customer focused organization

• Identify customer needs• Design a product that respond to customer needs• Produce and deliver the product as per the design• Enhance after sales service• Measure customer satisfaction • Improve quality to delight the customer

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Leadership

• Senior leaders set directions and create customer orientation.

• Values, directions and expectations must address all stakeholders.

• Leaders needs to ensure the creation of strategies, systems and methods for achieving excellence.

• Should encourage participation, learning innovation and creativity.

• Serve as role models who reinforce values and expectations.

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Involvement of people

• Involvement of all people is one way of improving quality and productivity.

• Involvement of people at all levels by providing a good corporate culture

• providing an interesting environment, and building the capability to perform tasks in the organization

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Process Approach

• A desired result is achieved more efficiently when related resources and activities are managed as a process.

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System approach to Management

• Identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organization

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Continuous Improvement

• Continually improve the performance by addressing the needs of all the interested parties is the permanent objective of the organization

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Factual approach to Decision-making

• Effective decisions are based on the logical or intuitive analysis of data and information

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Mutually Beneficial Supplier Relationship

• To create value mutual beneficial relationship between the organization and supplier in necessary

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Structure of the ISO 9001:2000 standard • 20 elements of ISO 9001:1994 still there but in the context of a model based on organizational processes

Core organizational processes covered under:Clause 4. QUALITY MANAGEMENT SYSTEMClause 5. MANAGEMENT RESPONSIBILITYClause 6. RESOURCE MANAGEMENTClause 7. PRODUCT REALISATIONClause 8. MEASUREMENT, ANALYSIS AND

IMPROVEMENT

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Structure of the new ISO 9001:2000 standard

- Process-oriented structure and a more logical sequence of contents

- Allows for more flexibility on amount of documentation

- Changes in terminology for easier interpretation by all sectors.

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QUALITY MANAGEMENT SYSTEMContinual improvement of theQuality management system

Managementresponsibility

Productrealization

Resourcemanagement

Measurement,analysis andimprovement

Customers

Requirements

Customers

Satisfaction

ProductOutputInput

Reference: ISO 9001:2000

Information flowValue-adding activities

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The ISO 9001:2000 standard has new more clearly defined requirements relating to :

Continual improvement;

Increased emphasis on the role of top management;

Consideration of legal and regulatory requirements;

Establishment of measurable objectives at relevant functions and levels;

Monitoring of information of customer satisfaction as a measure of system

performance;

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The ISO 9001:2000 standard has new more clearly defined requirements relating to :

(contd.)

Increased attention to resource availability;

Determination of training effectiveness;

Measurements extended to systems, process and product;

Analysis of collected data on the performance of

the QMS;

Control of outsourced processes .

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ISO 9001: 2001

1. Scope

2. Normative reference

3. Definitions

4. Quality system requirements

4.1 General requirements

Organization shall establish document implement and maintain a QMS and continually improve

4.2 Documentation Requirement

It includes

Quality policy

Quality objectives

Quality manual

Documented procedures

Documents to ensure effective planning

Operation and control of processes and records required by the international standard

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5. Management Responsibility

5.1 Management Commitment

development and implementation of QMS

Continuous Improvement in its effectiveness

5.2 Customer Focus

Constantly endeavor to enhance customer satisfaction

5.3 Quality Policy

The quality policy

is appropriate to the purpose of the organization

includes the commitment to comply with requiremtns and continually improve QMS

framework for reviewing quality objectives

understood in the organization

reviewed for continuing stability

5.4 Planning

Quality Objectives

QMS Planning

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5.5 Responsibility, Authority and Communication

define the responsibilities and authority of the key personnel and ensure they are known throughout the organization.

5.6 Management Review

Review of the QMS at regular intervals

6. Resource Management

6.1 Organization shall determine and provide needed resources

6.2 Workers will be provided necessary education, training skills and experience

6.3 organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirement

7. Product or Service Realization

7.1 Planning of processes needed for Product/Service realization

7.2 Customer Related Processes

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7.3 Design and development

7.3.1 Design and development planning

7.3.2 Design and development inputs

7.3.3 Design and development outputs

7.3.4 Design and development

7.3.5 Design and development verification

7.3.6 Design and development validation

7.3.7 Control of design and development changes

7.4 Purchasing

7.4.1 Purchasing process

7.4.2 Purchasing information

7.4.3 Verification of purchased product

7.5 Production and service provision

7.5.1 Control of production and service provision

7.5.2 Validation of processes for production and service provision

7.5.3 Identification and traceability

7.5.4 Customer property

7.5.5 Preservation of product

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7.6 Control of monitoring and measuring devices

8. Measurement, analysis and improvement (title only)

8.1 General

8.2 Monitoring and measurement (title only)

8.2.1 Customer satisfaction

8.2.2 Internal audit

8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of product

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement (title only)

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

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DOCUMENTING THE SYSTEM BASED ON ISO 9001:2000

STANDARD

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Quality Management System Documentation

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.(Clause 4.1, ISO 9001:2000)

• Documentation is a set of documents, for example specifications and records.

• Document is information (meaningful data) and its supporting medium.

• Quality management system is a management system to direct and control an organization with regard to quality.

• Quality manual is the document specifying the quality management system of an organization.

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APurchasingDepartment

BProductionDepartment

CPersonnel

Department

DQualityControl

EStores

FORMS, LABEL, RECORDS, ETC.

WORK INSTRUCTIONS

OPERATION PROCEDURES

QUALITY/ POLICY MANUAL

LEVEL 1

LEVEL 2

LEVEL 3

LEVEL 4

DOCUMENTATION PYRAMID

LOW

DETAIL

HIGH

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LEVEL 1: QUALITY MANUAL

The quality manual as a highest level

document at the peak of a pyramid

outlining the quality system and acting as

a directory for the documents and

procedures below. It will outline the

company’s policy and commitment to

quality.

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WHY NEED QUALITY MANUAL?

1. Communicating the organization’s quality policy, procedures and requirements;

2. Describing and implementing an effective quality system;

3. Providing improved control of practices and facilitating assurance activities;

4. Providing the documented bases for auditing the quality system;

5. Providing continuity of the quality system and its requirements during changing circumstances;

6. Training personnel;7. Presenting quality system for external purposes;8. Demonstrating compliance of the quality system with

quality requirements

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Quality PolicyClause 5.3

The overall quality intentions and direction of an organization related to quality, as formally expressed by top management