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ISO 9001:2008

Awareness Program

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Purpose of Program

Awareness of ISO 9001:2008.

Self Improvement

Improvements in routine working

To improve the health of organizations

Quality Management System

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FAQ?

What is ISO?

From where it comes?

How it is helpful for us?

How it works?What we have to do?

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Contents Of Program

Background of ISO

ISO Family

Quality Management Principle

Process Approach

ISO 9001:2008 Overview

Detail Of Different Clauses Of ISO

9001:2008

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What is ISO 9001:2008?

ISO = International Organization for

Standardization

ISO has representation from 162 countriesand has issued many standards

ISO 9001:2008 is a model for a quality

management system.

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Who created the standard?

International Organization for

Standardization - Geneva

Standards created in 1987 To eliminate country to country differences

To eliminate terminology confusion To increase quality awareness

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ISO 9000:2005 Consists of 3 AreasISO 9000:2005 Consists of 3 Areas

ISO 9000:2005 Quality Management Systems:

fundamentals and vocabulary

ISO 9001:2008 Quality Management Systems

Requirements (required for certification)

Management responsibility

Resource management

Product/service realizationMeasurement, analysis, improvement

ISO 9004-2009 Quality Management Systems

Guidelines for performance improvement

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Generic standards

ISO 9001 is a generic standards.

Generic means that the same standards can

be applied: to any organization, large or small,

whatever its product or service,

in any sectorof activity, and whether it is a business enterprise, a public

administration, or a government department.

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Generic standards (cont.)

Generic also signifies that

no matter what the organization's scope of

activity if it wants to establish a quality

management system, ISO 9001 gives the

essential features

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Certification and registration

Certification is known in some countries asregistration.

It means that an independent, external

body has audited an organization'smanagement system and verified that itconforms to the requirements specified in the

standard (ISO 9001). ISO does not carry out certification and

does not issue or approve certificates,

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Accreditation

Accreditation is like certification of the certificationbody.

It means the formal approval by a specialized body -

an accreditation body - that a certification body iscompetent to carry out ISO 9001:2008 certification inspecified business sectors.

Certificates issued by accredited certification bodies- and known as accredited certificates - may beperceived on the market as having increasedcredibility.

ISO does not carry out or approve accreditation.

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Certification not a requirement

Certification is not a requirement of ISO

9001.

The organization can implement and takebenefit from an ISO 9001 system without

having it certified.

The organization can implement them for theinternal benefits without spending money

on a certification programme.

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Certification is a businessdecision

Certification is a decision to be taken for

business reasons:

if it is a contractual, regulatory, or market

requirement,

If it meets customer preferences if it will motivate staff by setting a clear goal.

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Ten Steps to ISO RegistrationTen Steps to ISO Registration

2. Select the appropriate standard

1. Set the registration objective

3. Develop and implement the quality system

4. Select a third-party registrar and apply

5. Perform self-analysis audit

6. Submit quality manual for approval

7. Pre-assessment by registrar

8. Take corrective actions

9. Final assessment by registrar

10. Registration!

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What is a Quality ManagementSystem?

A Quality Management System is aweb of interconnected processes

that are used to manage a

business.

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Operating Cycle of ISO.

The Plan Do Check Act (PDCA) cycle is theoperating principle of ISO's management systemstandards

Plan establish objectives and make plans (analyze yourorganization's situation, establish your overall objectivesand set your interim targets, and develop plans toachieve them).

Do implement your plans (do what you planned to). Check measure your results (measure/monitor how far

your actual achievements meet your planned objectives).

Act correct and improve your plans and how you put

them into practice (correct and learn from your mistakesto improve your plans in order to achieve better resultsnext time).

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ISO 9001:2008

CONTINUAL IMPROVEMENT OF THE QUALITYMANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT OF THE QUALITYMANAGEMENT SYSTEM

Measurement,analysis andimprovement

Measurement,analysis andimprovement

ProductProduct

InputOutput

Managementresponsibility

Resourcemanagement

Resourcemanagement

Clause 5Clause 6

Clause

8

Clause 7

Requirements

Product

realization

Satisfaction

Value adding activities

Information flow

Customers

Customers

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Inputs

With What?(Materials / Equipment)

How?(Methods / Procedure)

Measure

WHO?Special Skills? / Competence?

Outputs

ProcessLinkages

Objectivesand

Targets

Process

PROCESS REQUIREMENTS

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Management Principles

A Quality Management Principle is a

comprehensive and fundamental rule or

belief, for leading and operating anorganization, aimed at continually improving

performance over the long term by focusing

on customers while addressing the needs ofall stakeholders.

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8 Management Principles

Principle 1 : Customer Focus

Principle 2 : Leadership

Principle 3 : Involvement Of People Principle 4 : Process Approach

Principle 5 : System approach to management

Principle 6 : Continual Improvement

Principle 7 : Factual approach to decision making

Principle 8 : Mutually beneficial supplierrelationships

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Principle 1 : Customer Focus

Organizations depend on their customers &

therefore should understand current & future

customer needs, should meet customerrequirements & strive to exceed customer

expectations

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Principle 2 : Leadership

Leaders establish unity & direction of the

organization. They should create & maintain

the internal environment in which people canbecome fully involved in achieving the

organization's objectives.

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Principle 3 : Involvement OfPeople

People at all levels are the essence of an

organization and their full involvement

enables their abilities to be utilized for theorganization's mutual benefit.

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Principle 4 : Process Approach

The application of a system of processes within

an organization, together with the identification

and interaction of these processes, and theirmanagement to produce the desired outcome,

can be called Process Approach

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Principle 5 : System approach tomanagement

Identifying, understanding & managing

interrelated processes as a system

contributes to the organization'seffectiveness & efficiency in achieving its

objectives.

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Principle 6 : ContinualImprovement

Continual Improvement of the organization's overallperformance should be the primary driver of the

organizations Quality Management System.

ContinuousImprovement

Continual Improvement

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Principle 7 : Factual approach todecision making

Effective decisions are based on the analysis

of data & information

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Principle 8 : Mutually beneficialsupplier relationships

An organization & its suppliers are

interdependent, and a mutually beneficial

relationship enhances the ability of both tocreate value

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Clauses of ISO 9001-2008

1.Scope

2.Normative References

3.Term & Definitions 4.Quality Management System

5.Management Responsibility. 6.Resources Management

7.Product Realization

8.Measurment,Analysis and Improvement

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SCOPE OF STANDARD

1. Scope

General

Application

2. Normative reference

3. Terms and definition

e.g., Supplier Organization Customer

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QUALITY MANAGEMENT SYSTEMREQUIREMENTS

4.1 General requirementsDocument, implement, maintain and

continually improve

Identify and determine sequence andinteraction of processes

Determine criteria and methods needed

Ensure availability of resources

Monitor, measure and analyze processes

Implement actions to achieve plannedresults

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QUALITY MANAGEMENT SYSTEMREQUIREMENTS

4.2 Documentation requirements

Management system documentation

Quality ManualControl of documents

Control of records

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QUALITY SYSTEMDOCUMENTATION STRUCTURE

1st Level

Quality Manual

2nd LevelProcedures

3rd LevelWork Instructions

Machine instructions Computer inputs Detailed work instructions

4th LevelTechnical Data

International standards Computer operating manuals Detailed product specifications

Policy and Objectives

What the company wishes toachieve

How the company

implements its policyStructured to reflectprocess flow of events

Detailed instructions

How to completea job or task

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MANAGEMENT RESPONSIBILITY

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

Must be documented

Must be used for setting objectives

5.4 Planning

Document objectives- Must be Measurable Quality management system planning

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MANAGEMENT RESPONSIBILITY

5.5 Responsibility, authority and

communication Responsibility and authority

Management representative

Internal communication

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MANAGEMENT RESPONSIBILITY

5.6 Management Review General

Review input

Review output

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RESOURCE MANAGEMENT

6.1 Provision of resources

6.2 Human resources

General

Competence, awareness and training

6.3 Infrastructure

6.4 Work environment

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PRODUCT REALIZATION

7.1 Planning of productrealization

7.2 Customer-related processes Determination of requirements related to the

product

Review of requirements related to the product

Customer communication

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PRODUCT REALIZATION

7.3 Design and developmentPlanning, inputs, outputs, systematic

reviews, verification and validation, controlof changes

7.4 PurchasingSupplier evaluation and selection

Relevant purchasing information

Verification of purchased product- receiving, source

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PRODUCT REALIZATION

7.5 Production and service provisionControlled conditions including product

characteristics, work instructions (as necessary),

suitable equipment, monitoring and measuringdevices, monitoring and measurement, andrelease, delivery and post- delivery activities

Validation of processes when no other method

Identification and traceability of product and itsstatus

Care of customer property

Preservation of product

Includes constituent arts

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PRODUCT REALIZATION

7.6 Control of monitoring and measuringdevices

Calibrated or verified where necessaryAdjusted and re-adjusted as necessary

Identified to enable calibration status

Safeguarded from invalid adjustmentProtected from damage and

deterioration

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MEASUREMENT, ANALYSIS, ANDIMPROVEMENT

8.1 General

8.2 Monitoring and measurement

Customer satisfaction Internal audit

Monitoring and measurement of

processes

Monitoring and measurement of product

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MEASUREMENT, ANALYSIS, ANDIMPROVEMENT

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 ImprovementContinual improvement

Corrective action

Preventive action

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Any Questions or

Query?

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ThanksVarinder SandhuAbhived Bhardwaj

Balram Sharma