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ISO 9001:2000

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For the benefit of business and people

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SUMMARY1 >OVERVIEW OF ISO9001:2000

2 >BENEFITS OFCERTIFICATION

3 >IMPLEMENTATION OF ISO 9001:2000

4 >CONCLUSION

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2 OVERVIEW OFISO 9001:2000

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Consolidation of ISO 9000 family - Current 20standards to be replaced by four:

ISO 9000: Quality management systems- Fundamentals

& vocabulary

ISO 9001: Quality management systems - Requirements

ISO 9004: Quality management systems - Guidance forperformance improvement

*ISO 19011: Guidelines for auditing quality &environmental management systems

To be supported by technical reports

Overview Of ISO 9001 : 2000

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1ISO 9001 : 2000

Some basics

Applicability : Universal

Aim : Enhancing customer satisfaction

Scope : As per the requirements of the organization

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01 General

Strategic decision - adoption of QMS

QMS design & implementation is organisation

specific

Standard can be used by internal & external partiesto assess the ability to meet customer, regulatoryand organisations own requirements

QMS requirements are complementary to technicalrequirements for product

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The Process Approach. Process approach to quality

management encouraged

. Introduces & explains the processmodel as conceptual presentation ofQMS requirements specified

ISO9001:2000

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1Processes

ProcessActivities+

Resources

Input Output

Controls(e.g.procedure)

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1Processes - understand interactions

Process

A

Process

D

Process

B

Process

C

Input

OutputControls

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C

U

S

T

O

M

E

R

C

U

S

T

O

M

E

R

Management

responsibility

Resource

managementMeasurement, analysis,

improvement

ProductProductrealisation

Quality Management System

Continual Improvement

R

e

qu

i

r

e

m

e

nt

s

S

a

t

i

s

fa

c

t

i

o

n

Input

Output

The QMS Model

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1Process and System Approach

Identify and manage processes

Determine the sequence and interaction of processes

Determine the criteria and methods to ensure effective

operation of the processes Measure, monitor, analyse the processes and

implement actions necessary to achieve plannedresults and continual improvement

Ensure availability of information necessary to operateprocesses

(ISO 9001:2000 clause 4.1)

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Plan

Do

Verify

Correct

The Demming Cycle

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1The recognition process

Understanding the standard requirements

Establishment of a quality management system

Certification

Accrual of benefits

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The requirements :

Quality Management System

Management Responsibility Resources Management

Product Realization

Measurement, Analysis & Improvement

ISO 9001:2000

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Clauses 0 - 3

Introduction

Scope

Normative references

Terms and definitions

ISO 9001:2000

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Clause 4

QMS requirements

Process approach

Documentation requirements

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Clause 5

Management responsibility

Commitment, Customer focus

Policy, Objectives, Planning, Communication

ISO 9001:2000

ISO 9001 2000

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1ISO 9001:2000

Clause 6

Resource Management

Human resources

Infrastructure

Work Environment

ISO 9001 2000

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1ISO 9001:2000

Clause 7

Product Realization

Planning

Marketing, selling, design, production, purchase

ISO 9001 2000

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1ISO 9001:2000

Clause 8

Measurement, Analysis & Improvement

Measure, Analyse and improve

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1Myths

ISO is only documentation

ISO is expensive

ISO is for the auditor

ISO is the responsibility of MR

ISO will drastically improve results immediately

ISO is TQM

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3 BENEFITS OFCERTIFICATION

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B fit f tifi ti

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1Benefits of certification

Commercial

Non-commercial

B fit f tifi ti

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Enhanced customer satisfaction and loyalty

Reduced quality costs

Increased competitiveness

Improved internal transfer of know how

Improved morale and motivation of staff

Benefits of certification

B fit C i l

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1Benefits : Commercial

Competitiveness

Customer confidence

Exports

Governmental recognition

B fit N i l

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1Benefits : Non-commercial

Quality, an essential requirement todayContinual improvement, another necessity

Effect on costs

Higher quality costs less

Quality has one of the highest ROI

Almost the entire standard is preventative in

nature !

B fit N i l

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1Benefits : Non commercial

Opportunity to integrate systems

Inspiring confidence to the management and people ofthe organization

Transparency

Identification of non conformities

Reduced errors

Internal quality audits

Prestige

Improved morale of staff Improvements becoming a way of life

A stepping stone to TQM

T S i

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1To Summarise

Generic

Goes beyond quality assurance to includecustomer satisfaction

Based on 8 quality management principles

Process approach

Allows tailoring to business but does not loosesight of customer focus

Low on documentation and high oneffectiveness (performance)

Focuses on continual improvements through:Quality objectives

Corrective and Preventive actions


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Certification of quality system to ISO 9001 asa bonus:

Tangible proof that the companys quality

system complies with internationallyrecognised standard.

Avoidance of multiple second party audits.

Marketing edge.

Certificate

ISO 9001




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An opportunity to eliminate any excessivedocumentation requirements


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THE CERTIFICATION

PROCESS

THE CERTIFICATION PROCESS

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Top management

commitmentFormation of

Steering committee Understanding

The standardReview of the

Existingsystem Gap AnalysisTime bound

Action plan toFill gaps

Internal Audits

And

Management

ReviewsPre-assessment

review CertificationAudit

THE CERTIFICATION PROCESS

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1Continual Improvement

Problem SolvingTechniques

Cause & effect diagram

Pareto analysis

Flowcharting Brain storming

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How to effectively approach the project? Steering committee and task force

Diagnosis of an existing system

Execution plan

Training

Planning, Re- engineering,Documenting

Implementation Audits and review

Possible changes

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Identification andcontrol ofprocesses, theirsequence andinteraction is criticalfor effective quality

management

IMPLEMENTING THE STANDARD

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STEP 1

TOP MANAGEMENT COMMITMENT

A basic requirement for any quality

initiative

Direction,monitoring and motivational

aspects


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STEP 2

FORMATION OF A STEERINGCOMMITTEE

To legitimise the issue

Should include top/middle/junior

management personnel

Regular review of progress


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STEP 3

UNDERSTANDING THE STANDARD

Attend training programmes

Organise Awareness programmes for all

Interpretation to the organisational practice

Appointment of a external expert ifnecessary


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STEP 4 REVIEW OF THE EXISTING SYSTEM

Review of all current practices, written or

otherwise Review for

1. Adequacy

2. Suitability3. Effectiveness


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STEP 5

GAP ANALYSIS

Gap between the current

practices and ISO 9001

requirements

A checklist could be useful


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STEP 6

TIME BOUND ACTION PLAN TO FILLTHE GAPS

For documentation

For compliance

For suitability

For adequacy

For effectiveness

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STEP 7

INTERNAL AUDITS & MANAGEMENTREVIEWS

To evaluate adequacy of documentation

To evaluate compliance

To evaluate effectiveness


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STEP 8

PRE-ASSESMENT

By an external agency usually the

certification body

In good time before the certification audit


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STEP 9

CERTIFICATION AUDIT

By the certification body


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STEP 10

CONTINUED COMPLIANCE

By reviews

By audits internal

By audits -- external

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Quality system is for the organisation,and not organisation for the system.

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Unnecessary changes should not beimposed.

Always consider:

company culture;

operating philosophy;

nature of business;

market environment.

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Flaws to avoid:

System that is not tailored to suit theorganizations mode of operation

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Flaws to avoid:

Insufficient training, communication &awareness

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Certification Process Contract Review

Initial Audit

Certification

Surveillance

Re-certification audit

CertificateISO 9001

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Scope of certification

Standard

Products covered

Locations covered

Elements of organisation covered

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Accreditation

To ensure uniform standard of certification

To ensure recognition of certificates

YOUR SESSION NOW ..

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YOUR

QUESTIONS

PLEASE

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Thank You !

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5 CONCLUSION>

iso 9000-2001

Documents