04/07/2023 1

WHAT IS ISO ?

• It is

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

WHAT IS ISO ?

04/07/2023 2

WHAT IS ISO?

• ISO is the International Organization for Standardization

• It is a World wide Federation of National Standards Bodies (ISO Member Bodies)

ISO

04/07/2023 3

Why ISO ? Why not ISO ? • ISO brings Quality to the

Quality Management System of an organization- QMS .

ISO is an action Guide to the concept of Management by Objective (MBO)

ISO is a Hands on Management system that stresses on

“ SAY WHAT YOU DO and DO WHAT YOU SAY”

ISO is an absolute Energy saver which avoids Confusion , Mess , chaos , Tensions , Desperation in any enterprise.

ISO is a MANAGEMENT ROUTE MAP with clear Guide lines on Directions , Distances, Mile Stones , Stations and their importance.

ISO implementation is an INVESTMENT with clear ROI Projections and not at all an EXPENSE.

04/07/2023 4

What does ISO practice reveal ?

• It is like a Company’s Balance sheet of Activities showing Policies and Procedures as ASSETS and Performance mistakes as LIABILITIES.

• We can easily judge the Status of Performance of a Company all the time to devise Management strategies .

0

50

100

1stQtr

3rdQtr

East

West

North

Balance Sheet Eye Opener

Guide and Route Map

Indicator

04/07/2023 5

The MAIN Groups for ISO Implementation in an Organization • Top Management • ISO Steering Committee• Department Heads • Complete Company Staff • IQA (Internal Quality

Audit)Team• Trainers and Training

Team • Management review

Committee• Consultants

04/07/2023 6

Objectives of Steering Committee

• Conducting the ISO Implementation in full

• Approval of BUSINESS PROCESS PLAN

• Reporting to TOP MANAGEMENT

• Selection of QMR , DQMR and related management.

• Co ordination with the Consultant and Feedback

04/07/2023 7

Other ISO Standards – Few Examples

• ISO 9000 – 3 : 1997 – Quality Management and Quality Assurance Standards

• ISO 14001 – 2004 – Environmental Management Systems

• ISO /TR 10017: 1999 – Guidance on Statistical techniques for ISO 9001:1994

• ISO 10015:1999 – Quality Management – Guidelines for Training

• ISO 10013 : 1995 – Guide lines for Developing Quality Manuals

• ISO 10011 –1-2- 3 : 1991 – Guidelines for Auditing Quality Systems

• ISO 10006 – 1997 : Guidelines to Quality in Project Management

04/07/2023 8

WHAT IS ISO 9001 – 2000? & WHAT IS ISO 9001-2008?

ISO – 9001 1994

ISO – 9002 1994

ISO 9003 1994(Obsolete)

ISO 9001-2000 ISO9001-2008

04/07/2023 9

What is Quality Management System of an Organization ?

• This is the system designed and developed internally and exclusively to suit an organization, to control the whole total quality of the Product or services , to earn the most important CUSTOMER SATISFACTION coupled with Business enhancement inline with the Company’s Objectives.

QMS

04/07/2023 10

PROCESS APPROACH TO QMS

• This International standard promotes the adoption of Process Approach to enhance Customer satisfaction by meeting Customer requirements.

• PROCESS : An activity which enables the transformation of inputs in to out puts can be considered as a process.

• Often the Out put of one process becomes the input of the next

• The application of a system of processes with in the orgn can be referred to as PROCESS APPROACH

• PDCA METHODOLOGY

APPLY

04/07/2023 11

ISO 9001 and ISO 9004(Consistent Pair of QMS)

• ISO 9001• This specifies requirements for a QMS that can be used for internal

application for certification or contractual purposes. It focuses on the effectiveness of the QMS in meeting customer requirements.

• ISO 9004 • It focuses on CONTINUAL IMPROVEMENT of an organization ‘s

overall performance and efficiency as well as the effectiveness.• It is recommended as a GUIDE for an Organization who want to

move beyond the requirements of ISO 9001.• It is NOT intended or for Certification or contractual purposes.

04/07/2023 12

THE 8 POINT REQUIREMENTS OF ISO 9001-2008

1.General

2.Normative Reference

3.Terms and Conditions.4.QMS

5.ManagementResponsibility6.Resource Management

7.Product Realization8 Measurement., improvement

04/07/2023 13

Quality Management System – General Requirements

• Identify the Process required for the Quality Management System and their application throughout the Organization ----- That is

• QUALITY PLAN or BUSINESS PROCESS PLAN - BPP

• Determine the sequence and the Interaction of these processes .• Determine criteria and methods needed to ensure that both

operation and control are effective.• Ensure availability of resources and information required• Monitor – Measure and Analyse these processes• Impliment actions to achieve planned results and continual

improvement of these processes.

04/07/2023 14

QMS– Documentation Requirements

Major Elements of requirements:

Quality Manual

Quality Policy and Quality Objectives Quality Manual

Procedures Work Instructions

Evidence of Control of Documents

Control of Records

04/07/2023 15

Who Approves the QMR Appointment ?

• The TOP Management of the Company issues an APPOINTMENT LETTER .

• The Deputy QMR is selected by the QMR and QMR issues the Appointment letter to DQMR.

• These letters are part of the POLICY MANUAL of the Company.

04/07/2023 16

Role of Quality Management Representative – QMR

• Main Conduit among Staff – Steering Committee – Consultant – Management and the Certification Auditors.

• The Brain behind the QUALITY MANAGEMENT SYSTEM of the company.

• Total support to the entire staff team of the company. Training the staff in all respects .

• Key Decision maker on Audit Findings

04/07/2023 17

Major Documentation for ISO

QUALITY MANUAL

PROCEDURE MANUAL,

INSTRUCTION MANUAL

1 Quality Records

2 Support Documents like Master Lists, Cause & Effect Diagrams etc

3 Business Process plan , Reference materials of External origin

4 Minutes of the Meetings

5 Audit Reports, Customer feedback on performance

6 Survey reports, QMS Files

7 Customer Complaints and corrective action plan

8 Training Reports

04/07/2023 18

KEY TO SUCCESS in ISO IMPLEMENTATION

• Total Team work • Total Understanding of ISO

and its Need .• Chain Link system

implementation in each department .

• Effective IQA system and Practice

• Training on ISO to all staff • Top Management’s Total

involvement.• Pride In Doing things –

Management by Objective.

04/07/2023 19

FINALIZATION OF SCOPE FOR ISO CERTIFICATION

• This is nothing but the List of Disciplines or Functional Domains practiced and conducted in the Company , set for ISO certification. This means all the Disciplines Need NOT be included for certification if the Top MANAGEMENT Feel so .

• They can be included or excluded in the subsequent Surveillance Audits

04/07/2023 20

Advantages of ISO system implementation

• International Recognition and Pride on excellence.

• Organized Way of Working • Easy Traceability and

Identification of Documents.• Better and Faster Feed

backs to Customers and Clients.

• Earnings through Time Savings.

• Birth of More reliable Management Information system in the Company on time and every time.

• Compatibility among Inter Branch working pattern

• Healthier Inter personal relationship among staff through reduced Confusions and Repetitions of work

• Good Boss – Staff Relationship

• Improved Efficiency in all aspects of Works in the Company.

• Data based Decisions instead of Emotive reactions to Problems.

04/07/2023 21

CONTACT US ……..

CEO GLOBAL PTE LTD ., CEO PVT LTD ., CHENNAI

Contact Person :

C.Eashwer• +919444956432• +919600000626• +914426421443• +914426421441• +914426421442

• E mails :

• eashwer@exploreceo.com• eashwer.murthi@gmail.com• Website :• www.exploreceo.com

• RIGHT FIRST TIME – ON TIME AND EVERY TIME

04/07/2023 22

PROJECT ISO - PLAN FOR ABC Co Pte Ltd - Page – 1

1 Introduction and get to know meet & Submission of Plans & Gantt Chart

0.5 Day 4.12.06

2 Business Process plan Finalization & Gap Analysis

1 Day 4.12.065.12.06

3 Quality Policy and related issues

0.5 Day 5.12.06

4 Control Formats Finalization

1 Day 6.12.067.12.06

04/07/2023 23

PROJECT ISO – PLAN FOR ABC Co Pte Ltd .,– Page - 2

5 Preparation of PROCEDURE MANUAL

1 Day 8.12.06

6 Draft QUALITY MANUAL

1 Day 9.12.06

7 Quality Manual - Finalization

1 Day 11.12.06

8 Guidelines to all Functional Heads

0.5 Day 12.12.06

9 Review of above implementation

1 Day 15 01 07

04/07/2023 24

PROJECT ISO – PLAN FOR ABC Co Pte ltd – Page -3

10 IQA – Identification of Auditors & Trg .

1 Day 160107

11 Internal Audit 1 Day 190207

12 Review of procedures and system amendments.,Identification of certification body

0.5 Day 200207

04/07/2023 25

PROJECT ISO – PLAN FOR ABC Co Pte ltd – Page - 4

13 Submission of Manual to sert. Body

200206

14 Amendments based on inputs from cert body

0.5 Day 210206

15 Management review meet

0.5 Day 210206

16 Certification Audit 1 Day As per Cert Body’s plan

04/07/2023 26

PROJECT ISO – PLAN FOR ABC Co Pte Ltd – Page - 5

17 Assistance in Closure of Audit Findings

0.5 Day Based on the date of certification

18 Awarding ISO Certificate

Date as per Cert Body

Total 12.5 Man Days