ISO 9001:2008 QUALITY MANAGEMENT

SYSTEMS

AGENDAAGENDA Introduction What is ISO? ISO Family Certification & Registration Benefits What is QMS? Quality Manual Importance of Documentation Quality Manual Outline Facts Certification Audit Procedure Action Items

INTRO

Every 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.

ISO 9001 is the world’s most established quality framework,

currently being used by over ¾ million organizations in 161

countries.

It helps all kinds of organizations to succeed through improved

customer satisfaction, staff motivation and continual

improvement.

WHAT IS ISO?

ISO is a standard for Quality

Management System

ISO 9001:2008 is a model for

a Quality management system

WHAT IS ISO?

The term ‘ISO’ actually stands for

the ‘International Organization for

Standardization’

The Organizations short name was

taken from the Greek word “isos”,

meaning “equal”.

ISO FAMILY

ISO 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

Certification is known as Registration in some countries

An Independent, external body has audited an organizations

management system and verified that it conforms to the

requirements specified in the standard (ISO 9001).

ISO 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?

QMS – Interconnected processes that are used to manage a

business.

Basic Requirements of a Quality Management System

• Able to offer products and services that satisfy a customer’s expectations;

• Agree with the relevant standards and specifications of a contract;• Available to provide products and services at competitive prices;• Supply deliverables at a cost that will still bring a profit to that

organization

QMS PRINCIPLES

A

ny organization can

benefit from

implementing ISO 9001

as its requirements are

underpinned by

8

management principles:

QUALITY MANUAL

A Quality Manual is the main, top-level document which establishes the quality policies and objectives of an organization.

It describes our intent to establish a QMS with an emphasis on continual improvement.

The Quality Manual is at the very heart of an organization's

QMS and describes the interrelationships between: Process,

Quality Procedures and Work Instructions

QUALITY MANUAL

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

THE IMPORTANCE OF DOCUMENTATION

4 LEVELS OF DOCUMENTS

SO, WHAT EXACTLY DO WE FIND IN A TYPICAL QUALITY

MANUAL?

You might just find things like…

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

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

BIS (Bureau of Indian Standards) – Founder

member of ISO and BIS represents India, in

ISO

NQA (Bangalore)

NQAQSR (New Delhi)

Smart Edge Consulting (Hyderabad)

TUV Sud South Asia (Hyderabad)

AUDITORS LIST