ISO 9001:2008 QUALITY MANAGEMENT

SYSTEMS

AGENDAAGENDA

1. Introduction• What is ISO?• What are the Clauses and benefits?• Quality Management System?

2. Quality Manual3. Elements of a Quality Manual4. How to achieve certification5. Initial Certification Audit6. Advantages & Summary

INTRO

E

very organization would like to improve the way it operates

A quality management system gives you the framework you need to monitor

and improve performance in any area you choose.

I

SO 9001 is the world’s most established quality framework, currently being

used by over ¾ million organizations in 161 countries.

I

t helps all kinds of organizations to succeed through improved customer

satisfaction, staff motivation and continual improvement.

WHAT IS ISO?

I

SO is a standard for Quality

Management System

I

SO 9001:2008 is a model for

a Quality management

system

WHAT IS ISO?

T

he term ‘ISO’ actually stands for

the ‘International Organization for

Standardization’

T

he Organizations short name was

taken from the Greek word “isos”,

meaning “equal”.

ISO FAMILY

I

SO 9000:2005 Consists of 3 areas• ISO 9000:2005 – Quality Management Systems-

Fundamentals and Vocabulary• ISO 9001:2008 – QMS – Requirements (required for

certification) • Management Responsibility• Resource Management• Product/Service realization• Measurement, analysis, improvement

• ISO 9004-2009 – QMS – Guidelines for performance improvement

CERTIFICATION AND REGISTRATION

C

ertification is known as Registration in some countries

A

n Independent, external body has audited an organizations

management system and verified that it conforms to the

requirements specified in the standard (ISO 9001).

I

SO does not carry out certification and does not issue or approve

certificates,

BENEFITS

The major reason why many companies want ISO 9001 certification is that

they want to portray themselves as a worthy company to do business with,

many of them do not really realize the benefits (some direct and others

indirect):

Direct Benefits:

• Improved customer satisfaction;

• Improved quality of products and services;

• Employees satisfaction and more commitment to the organization;

• Better management and a more effective organization;

• Improve relations with suppliers;

• Improved promotion of corporate image.

BENEFITS

Indirect Benefits: It helps companies to

• Review business goals, and assess how well the organization is meeting

those goals;

• Identify processes that are unnecessary or inefficient, and then remove or

improve

them;

• Review the organizational structure, clarifying managerial responsibilities;

• Improve internal communication, and business and process interfaces;

• Improve staff morale by identifying the importance of their output to the

business, and by involving them in the review and improvement of their work.

WHAT IS QMS?

Q

MS – Interconnected processes that are used to

manage a business.

QMS PRINCIPLES

Any organization can

benefit from implementing ISO 9001 as its requirements are underpinned by

8 management principles:

A

customer focused organization

L

eadership

T

he involvement of people

E

nsuring a process approach

A

systematic approach to management

A

factual approach to decision making

M

utually beneficial supplier relations

C

ontinuous improvement.

QUALITY MANUAL?

A Quality Manual is the main, top-level

document which establishes the quality policies

and objectives of an organization.

WHAT WILL A QUALITY MANUAL PROVIDE TO A COMPANY?

Overall it provides evidence of what specific controls are implemented to ensure product/service quality.

Who will benefit ?• Customers• Suppliers• Employees The Company• ISO

A QUALITY MANUAL SHOULD….

1. Address all Quality System elements

2. Contain or refer to quality procedures

“Documentation”

THE IMPORTANCE OF DOCUMENTATION

BENEFITS OF DOCUMENTATION: QUALITY MANUAL

T

he Key is to move towards:

• Consistently repeating the best practices

and

• Improving those processes which are lacking

4 LEVELS OF DOCUMENTS

SO, WHAT EXACTLY DO WE FIND IN A TYPICAL QUALITY

MANUAL?

You might just find things like…

BASIC QUALITY MANUAL OUTLINE

Introduction

Policy and Objectives

Definitions

Quality System

Organization

Authority and Responsibilities

Compliance

Internal Review and Audit

Documentation and Change

Purchasing

Inspection and Testing

Training

1. To prevent risks

2. To detect deviations

3. To correct errors

4. To improve efficiency

5. To reduce costs

6. To meet customer needs

7. To market company

ADVANTAGES OF QUALITY MANUAL

ADVANTAGES OF QUALITY MANUAL

SOME FACTS

I

SO 9001 certification cost is tax deductible(“Cost incurred by a

taxpayer to obtain, maintain, and renew ISO 9000 certification

are deductible as ordinary and necessary business expenses under

section 162 of the Code”)

G

etting Compliance/Certification does increase sales by 4%

C

ustomer satisfaction increase by 8%.

T

he assessment process for achieving certification consists of a two stage

Initial Certification Audit as follows:

S

tage 1 – the purpose of the auditor visit is to confirm the readiness of

the organization for full assessment.

S

tage 2 – the purpose of the auditor visit is to confirm that the quality

management system fully conforms to the requirements of ISO

9001:2008 in practice.

INITIAL CERTIFICATION AUDIT PROCEDURE

Presentation on ISO 9001:2008 importance to our

Internal Teams

Finalize the Internal Auditor which suits to our

Organization.

Set and start implementing the standards and

procedures to comply with ISO.

Target timeline to acquire ISO 9001:2008

certification is JULY 2012.

ACTION ITEMS