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ISO

9001:2000

For the benefit of business and people

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SUMMARY
1 > OVERVIEW OF ISO
9001:2000

2 > BENEFITS OF
CERTIFICATION

3 > IMPLEMENTATION OF ISO 9001:

2000

4 > CONCLUSION

> OVERVIEW OF
ISO 9001:2000

Overview Of ISO 9001 : 2000

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

ISO 9000: Quality management systems- Fundamentals

& vocabulary

ISO 9001: Quality management systems - Requirements ISO 9004: Quality management systems - Guidance for
performance improvement

*ISO 19011: Guidelines for auditing quality &

environmental management systems To be supported by technical reports

ISO 9001 : 2000

Some basics

Applicability : Universal

Aim : Enhancing customer satisfaction

Scope : As per the requirements of the organization

ISO 9001:2000

01 General Strategic decision - adoption of QMS QMS design & implementation is organisation
specific

Standard can be used by internal & external parties

to assess the ability to meet customer, regulatory and organisations own requirements

QMS requirements are complementary to technical

requirements for product

ISO 9001:2000

The Process Approach . Process approach to quality

management encouraged

Introduces & explains the process model as conceptual presentation of QMS requirements specified

Processes

Controls
(e.g.procedure)

Input

Process Activities + Resources

Output

Processes - understand interactions

Process A Process B

Process C Process D

Input Output Controls

The QMS Model

Quality Management System Continual Improvement

C U S T O M E R

R e q u i r e m e n t s

Management responsibility

Resource management

Measurement, analysis, improvement

S a t i s f a c t i o n

Input

Product realisation

Product
Output

C U S T O M E R

Process 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 planned results and continual improvement

Ensure availability of information necessary to operate

processes
(ISO 9001:2000 clause 4.1)

The Demming Cycle

Plan

Correct

Do

Verify

The recognition process

Understanding the standard requirements Establishment of a quality management system Certification Accrual of benefits

ISO 9001:2000

The requirements :
Quality Management System Management Responsibility Resources Management Product Realization Measurement, Analysis & Improvement

ISO 9001:2000

Clauses 0 - 3
Introduction Scope Normative references Terms and definitions

ISO 9001:2000

Clause 4
QMS requirements
Process approach
Documentation requirements

ISO 9001:2000

Clause 5
Management responsibility
Commitment, Customer focus
Policy, Objectives, Planning, Communication

ISO 9001:2000

Clause 6
Resource Management
Human resources Infrastructure Work Environment

ISO 9001:2000

Clause 7
Product Realization
Planning
Marketing, selling, design, production, purchase

ISO 9001:2000

Clause 8
Measurement, Analysis & Improvement
Measure, Analyse and improve

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ISO is only documentation

Myths

ISO is expensive
ISO is for the auditor

ISO is the responsibility of MR

ISO will drastically improve results immediately

ISO is TQM

> BENEFITS OF
CERTIFICATION

Benefits of certification

Commercial Non-commercial

Benefits of certification

Enhanced customer satisfaction and loyalty Reduced quality costs Increased competitiveness

Improved internal transfer of know how

Improved morale and motivation of staff

Benefits : Commercial

Competitiveness Customer confidence Exports Governmental recognition

Benefits : Non-commercial

Quality, an essential requirement today Continual 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 !

1 Opportunity to integrate systems Inspiring confidence to the management and people of

the organization

Benefits : Non commercial

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

1 Generic Goes beyond quality assurance to include

customer satisfaction

To Summarise

Based on 8 quality management principles Process approach Allows tailoring to business but does not loose
sight of customer focus

Low on documentation and high on

effectiveness (performance)

Focuses on continual improvements through:

Quality objectives

Corrective and Preventive actions

Benefits of certification

Certification of quality system to ISO 9001 as a bonus:

Tangible proof that the companys quality system complies with certification Benefits of internationally
recognised standard.

Avoidance of multiple second party audits.

Marketing edge.

Certificate

ISO 9001

Benefits of certification
An opportunity to eliminate any excessive documentation requirements

THE CERTIFICATION PROCESS

THE CERTIFICATION PROCESS

Formation of Steering committee Understanding The standard

Top management commitment

Review of the Existing system

Gap Analysis

Time bound Action plan to Fill gaps

Internal Audits And Management Reviews

Pre-assessment review

Certification Audit

Continual Improvement

Problem Solving Techniques

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

Identification and control of processes, their sequence and interaction is critical for effective quality management

IMPLEMENTING THE STANDARD

STEP 1

TOP MANAGEMENT COMMITMENT

A basic requirement for any quality

initiative

Direction,monitoring and motivational

aspects

IMPLEMENTING THE STANDARD

STEP 2

FORMATION OF A STEERING COMMITTEE

To legitimise the issue Should include top/middle/junior

management personnel

Regular review of progress

IMPLEMENTING THE STANDARD

STEP 3

UNDERSTANDING THE STANDARD Attend training programmes Organise Awareness programmes for all Interpretation to the organisational practice Appointment of a external expert if
necessary

IMPLEMENTING THE STANDARD

STEP 4

REVIEW OF THE EXISTING SYSTEM Review of all current practices, written or

otherwise

1. 2. 3.

Review for
Adequacy Suitability Effectiveness

IMPLEMENTING THE STANDARD

STEP 5

GAP ANALYSIS
Gap between the current practices and ISO 9001 requirements A checklist could be useful

IMPLEMENTING THE STANDARD

STEP 6

TIME BOUND ACTION PLAN TO FILL

THE GAPS

For documentation For compliance For suitability For adequacy For effectiveness

STEP 7

INTERNAL AUDITS & MANAGEMENT

REVIEWS

To evaluate adequacy of documentation To evaluate compliance To evaluate effectiveness

IMPLEMENTING THE STANDARD

STEP 8

PRE-ASSESMENT By an external agency usually the

certification body

In good time before the certification audit

IMPLEMENTING THE STANDARD

STEP 9

CERTIFICATION AUDIT By the certification body

IMPLEMENTING THE STANDARD

STEP 10 CONTINUED COMPLIANCE By reviews By audits internal By audits -- external

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

Unnecessary changes should not be imposed.

Always consider:

company culture; operating philosophy;

nature of business;
market environment.

Flaws to avoid: System that is not tailored to suit the organizations mode of operation

Flaws to avoid: Insufficient training, communication & awareness

Certification Process
Contract Review Initial Audit Certification Surveillance Re-certification audit

Certificate ISO 9001

Scope of certification
Standard

Products covered
Locations covered

Elements of organisation covered

Accreditation
To ensure uniform standard of certification To ensure recognition of certificates

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Thank You !

> CONCLUSION