iso 9000 an introduction by c.eashwer
DESCRIPTION
This is a beginner friendly document , and it takes you to the world of ISO 9000 .TRANSCRIPT
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
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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.
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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.
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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
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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.
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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
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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
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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.
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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
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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.
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CONTACT US ……..
CEO GLOBAL PTE LTD ., CEO PVT LTD ., CHENNAI
Contact Person :
C.Eashwer• +919444956432• +919600000626• +914426421443• +914426421441• +914426421442
• E mails :
• [email protected]• [email protected]• Website :• www.exploreceo.com
• RIGHT FIRST TIME – ON TIME AND EVERY TIME
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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
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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
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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
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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
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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