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Introduction to ISO 9001:2008Quality Management System

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What is ISO 9001:2008

ISO stands for INTERNATIONAL

ORGANIZATION for STANDARDIZATION.Itis an organization based in Geneva, Switzerland.

This is a comprehensive set of standards andguidelines for Quality Systems.

It is system-based and not product-based. This is a distillation of Quality System that havebeen tried and proven by the industry.

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What is ISO 9001:2008

Is all about quality

QUALITY

CUSTOMERSATISFACTION

Fast & Efficient Service+

ReliableResults

+Conformance to Standards+

Safe Environment+

Value for Money

The challenge of everybusiness is to ensurecustomer satisfaction in

every transaction

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Quality

Is the totality of features and characteristics of a

product or service that bears on its ability tosatisfy stated or implied needs.

(This is the formal definition of Quality as per ISO 9000 standard)

The success of an organization is inunderstanding and satisfying the customersexpectations in totality.

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Customer Satisfaction according toMahatma Gandhi Customer is the most important visitor on our

premises

He is not dependent on us. We are dependent onhim.

He is not an interruption on our work.He is thepurpose of it.

He is not an outsider on our business.He is part ofit.

We are not doing him a favor of serving him.He isdoing a favor by giving us an opportunity to do so.

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In ensuring Quality, Standards matter

It ensures desirable characteristics of product

and services such as quality, environmentalfriendliness, safety, reliability, efficiency , and ateconomical cost.

When products, systems, machinery and

equipment work well and safely, it is oftenbecause they meet standards.

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What Standards do?

Higher Customer Satisfaction Conformity of products and services to standards

provides assurance about their quality, safety andreliability

Increase profitability Makes the development, manufacturing, and

supply of products and services more efficient MarketAdvantage

Businesses using International Standards cancompete on many more markets around the world

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What must we do?

Standard requires that certain documentation to

be developed, established, and implemented inan organization.

For any management system to operateeffectively, there is a need for documentation of

policies, authorities and responsibilities,procedures and guidelines, and other pertinent

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What must we do?

Document our work procedures / system

What we do Who does it

When we do it

How we do it

Once our system is developed and documented ,all members of the organization should followthe procedures or rules and make improvementsto the system.

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What must we do?

Ensure that the procedures are being followed in

actual PRACTICE.

Keep RECORDS of what you practice

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Quality System DocumentationPyramid

Quality manual

& SystemsProcedure

WorkInstructions

Manual

Forms, QualityRecords,Master lists, Etc.

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Quality Manual & Systems Procedures

Quality manual and systems procedures give

broad guidelines for implementation of eachclause in the specific setup of the company.These procedures have to be strictly followed.Non-compliance of procedures can result in

losing the certificate. They are confidential documents and should notbe distributed to any outsiders

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Work Instructions Manual

Step-by-step instructions for carrying out service

activities

Quality records shall be maintained in specifiedformats. Blank forms, when filled up, becomes arecord.

Master lists are meant for reference.

Forms, Quality Records, Master Lists,Etc.

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Why is certification needed?

Market Pressure

Tangible proof that the quality management systemestablished by our organization meets therequirements of and internationally recognizedstandard.

Provide marketing edge over competitors

It enhanced customers satisfaction an loyalty; becauseit is assured that their requirements are met.

Increased competitiveness and profitability as qualityproducts are being delivered and operational cost are

reduced.

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Why is certification needed?

Internal Effectiveness and Productivity Benefits

Increased productivity Less scrap and rework

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Why is certification needed?

Benefits to the Employee

It will ensure that they will have the training thatthey needs and information to do their taskeffectively.

Better working conditions, increased jobsatisfaction.

Stability of employment.

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Benefits of ISO 9001:2008

Systems approach to management Clarity in definition of authorities and

responsibilities Better record keeping and documentation Better traceability to root causes of quality problems Rectification of errors at the earliest stage

Lesser repetition of errors Reduction in the need for multiple assessments Use of recognized mark(of certifying agency) on

letterheads, advertisements, etc

Enhanced corporate image and market positioning