Anda di halaman 1dari 48





ISO International Organization for Standardization Established in 1947 to develop common international quality standards. ISO is a worldwide federation of national standard bodies of 140 countries. Bureau of Indian Standards (BIS) is the Indian representative to ISO Located in Switzerland


ISO first published its standards in 1987 ISO derived from the Greek word iso-equal/uniform ISOs are generic as they apply to all functions & industries- one size fits all standards. ISO 9000 focuses on external quality assurance & internal quality system. ISO 9000 series has five international standards on quality management which are ISO 9000, ISO 9001, ISO 9002, ISO 9003 & ISO 9004. Worldwide standards that establishes requirements for quality management & assurance internal & external audits


Principle 1. ISO 9000 is a standard for a quality system and not a product or service standard. Principle 2. ISO 9000 based on documentation & is premised on the following:
Plan what you do. Do what you plan. Record what you did. Check on the result. Act on the variance.


Principle 3. ISO 9000 emphasizes on prevention. Principle 4. ISO 9000 is a universal standard.

ISO 9000 & 9004

The ISO 9000 standards are published in a series of five booklets, each covering a specific area.

ISO 9000 and ISO 9004 are guidance standards. They describe what is necessary to accomplish the requirements outlined in standards 9001, 9002 or 9003.
Organizations choose the standards to which they want to become registered, based on their structure, their products, services and their specific function.

ISO 9001

model for quality

assurance. It has 20 elements covering design, development, production, installation and servicing. Suitable for organizations which develop their own designs of the products manufacture them & supply to the customers.

List of ISO 9001 certified companies

Suzlon Energy Ltd Rolta India DS Kulkarni Developers Ltd Gammon India Ltd Gati J. K. Industries Universal Cables

ISO 9002
Model for quality assurance having 18 elements covering production and installation of manufacturing systems. Suitable for those organization who receive full design & detailed specifications from the customers.

List of ISO 9002 Certified Companies

Nilkamal Plastics Moser Baer India Finolex Industries Ashok Leyland Hindalco Bharat Forge Alembic Ltd Indian Rayon

ISO 9003
Model for quality assurance having 12 elements covering final inspection and testing. Suitable for those organizations that perform final inspection &testing of products purchased from external suppliers. who do not have any design or manufacturing activity of their own ,but simply procure goods from other producers, carry out inspection& testing & then supply to the customer.

List of ISO 9003 Certified Companies

Fastenal (worldwide distributor of industrial & construction supplies) Kuber Industries

Design/ Development





ISO 9003 ISO 9002 ISO 9001


ISO 9000 standard specifies 20 sections of quality systems requirements. They are: 1. Management Responsibility 2. Quality System 3. Contract Review 4. Design Control 5. Document Control 6. Purchasing 7. Purchaser- Supplied product


8. Product Identification and Traceability 9. Process Control 10. Inspection and Testing 11. Inspection, Measuring and Test Equipment 12. Inspection and Test Status 13. Control of Nonconforming Product 14. Corrective Action


15. Handling, Storage, Packaging and Delivery 16. Quality Records 17. Internal Quality Audits 18. Training 19. Servicing 20. Statistical Techniques

Define and document commitment, policy and objectives, responsibility and authority, verification resources and personnel. Appoint a management representative and conduct regular reviews of the system 2 Quality system Establish and maintain a documented quality system ensuring that products conform to specified requirements 3 Contract Review Ensure that customer's contractual requirements are evaluated and met 4 Design Control Requires procedures for controlling & verifying product design to ensure that specified requirements are being met. 5 Document control System for control and identification of all documents regarding quality, e.g. procedures, instructions, and specifications 6 Purchasing Ensure that purchased products conform to specified requirements 7 Product Identif ica- System to identify and control traceability of product at all stages from raw tion & traceability materials through production to the final product as delivered to the customer 8 Process control Ensure and plan the control of production which directly effects quality by documented work instructions, monitoring and control of processes 9 Inspection and Inspect and test incoming products, intermediate and final product; establish testing product conformance to specified requirements and identify non-conforming products; maintain inspection and test records 10 Inspection, Selection and control of equipment to ensure reliability and accuracy in measuring and test measuring data equipment

Quality System Requirements Management responsibility

Quality system elements. Contents

11 Inspection and test status For the whole process the products shall be identified and clearly marked concerning test status, including indication of conformance or nonconformance 12 Control of non-confor- Identification, documentation, evaluation, isolation (if possible) and ming products disposition of non-conforming products 13 Corrective actions Prevention of reoccurrence of failures (non-conforman- ce)

14 Handling, storage Protection of the quality of the product during hand- ling, storage, packaging and delivery packaging and delivery 15 Quality records 16 Internal Quality Audits 17 Training 18 Purchaser Supplied Product 19 Servicing Records, including those which demonstrate that the specified requirements have been met, shall be control- led and maintained Regular, planned internal audits shall be carried out, documented and recorded to verify the effectiveness of the quality system Training requirements at all levels shall be identified and the training planned, conducted and recorded Requires procedures for verification, storage, & maintenance of purchased product Requires procedures for performing servicing to be carried out by competent personnel

20 Statistical Techniques Requires procedures for identifying the use of ST in process, product & service.


Sl No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20 SYSTEM REQUIREMENTS Management Responsibilities Quality System Product Identification & Traceability Inspection Status Inspection & Testing Inspection Measuring & Test Equipments Control of Non-conforming Products Handling, Storage, Packaging & Delivery Document Control Quality Records Training Statistical Techniques Internal Auditing Contract Review Purchasing Process Control Purchaser Supplied Product Corrective Action Design Control Servicing ISO 9001 Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present ISO9002 Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present Present Not Present Not Present ISO 9003 Present Present Present Present Present Present Present Present Present Present Present Present Not Present Not Present Not Present Not Present Not Present Not Present Not Present Not Present

ISO 9000 : Procedure

After a company adopts ISO 9000, an independent official certifying body will access the company & check if that company has covered the basic quality elements pertaining to its industry, business & customers. There are re-audits by the ISO registrars every three years & surveillance audits approx. twice a year in order to ensure continued compliance. ISO 9000 certification is valid for not more than three years.

Accreditation Bodies:
Registrars all over the world are required to obtain the authority to audit and recommend registration of a firm from the Accrediting Bodies. Some famous International registrars include : 1. ABS Quality Evaluations. Inc. 2. American Association for Laboratory Accreditation. 3. AT & T Quality Registrar. 4. British Standards Institution (BSI) Quality Assurance. 5. Bureau Veritas Quality International (BVQI). 6. Canadian General Standards Board. 7. Det Norske Veritas Industry (DNV) etc.

Advantages of ISO 9000 Certification

Improves & maintains product quality Improves customer service & satisfaction Improves employees productivity & efficiency Meets international standard Improves Companys market Image Provides competitive edge to the company Marketing Easier Increases Exports Increased profitability Top line growth & bottom line improvement

Expensive & time consuming System can be burdensome Management capability can be strained Increases workload & employee dissatisfaction


ISO 9000:2000 OUTLINE

US Military & NATO Standards International Standards Organisation MIL AQAP (ISO) Committee Std
CANADA FRANCE GERMANY SPAIN JAPAN USA UK + others ISO 9000: 2000 ISO 9000: 1994 ISO 9000: 1987

BS 5750

National Standards

International Standard

ISO 9000:2000 SERIES

ISO 9000 : 2000 QUALITY MANAGEMENT SYSTEMS Fundamentals and vocabulary
- supersedes ISO 8402 and ISO 9000-1:1994


- supersedes ISO 9001/2/3:1994

ISO 9004 : 2000 QUALITY MANAGEMENT SYSTEMS - Guidelines for improvement

- supersedes ISO 9004-1

Principles of Quality Management

Standard based on 8 quality management principles
1. 2. 3. 4. 5. 6. 7. 8. customer focus leadership involvement of people process approach system approach to management continual improvement factual approach to decision making mutually beneficial supplier relationships

How ISO 9000:2000 is Different From ISO 9000 Standard

The new standard places more emphasis on continual improvement and customer satisfaction than the 1994 versions. It applies to the processes of an organization that influence quality. The major clauses in the new standard are: 4. Quality management system 5. Management responsibility 6. Resource management 7. Product realisation 8. Measurement, analysis and improvement

Certification Milestones
1. Brief management team 2. Prepare quality manual, policy, processes, planning 3. Prepare procedures, work instructions & records
Quality Policy

4. Implement procedures 5. Train internal auditors 6. Conduct internal audits Proced -ures 7. Conduct management review 8. Preliminary assessment 9. External assessment 10. Certification

Quality Manual QMS Processe s Quality Plan

Work Instructs
Quality Records

ISO 9000 Certificate


Internal Benefits of ISO 9000

Better management of core business processes Increased awareness of quality among staff Improved productivity and quality Improved internal communications Reduced wastage and cost per unit/service

External Benefits of ISO 9000

Improved customer satisfaction Higher perceived quality by market place Quick response to the new market requirements. Enhanced competitive edge Increased market share

ISO Registration Resulted In

30% Reduction in customer complaints 95% Improvement in delivery time Reduced defects from 3% to 0.5% 40% Reduction in product cycle time. 20% Increase in on-time delivery International acceptance and recognition Facilitated trade in international markets Promoting of safety, reliability and quality in food products.

Registered Companies Site the Benefits of ISO 9000 Registration as

Improved management 86% of respondents Better customer service 73% of respondents Improved efficiency 69% of respondents Reduced waste 53% of respondents Improved staff motivation 50% of respondents Reduced costs 40% of respondents

Irwin Professional Publishing Survey Reports

70% Of registered companies experience increased customer demand. 69% Of registered companies have a competitive advantage in their market. 83% Of registered companies products have higher perceived quality in the marketplace.


There are different management views about the benefits of ISO 9000. For managers who consider ISO as certification, ISO 9000 process is just a procedure to fix a company to qualify for certification. For other managers process of ISO 9000 involves development of new philosophy of quality management systems. The extent to which managers place priority on first and second view greatly effects the application of ISO 9000 in the organization.

The Implementation Of ISO9000 In Vietnam: Case Studies From The Footwear Industry
Two Vietnamese footwear companies- Nu-An Shoe Company and the Me-An Shoe Company, bring out important role that management attitude plays in determining the process and impact of ISO implementation.

Nu -an Shoe company

Set up -1912, SOE 1960 Objectives for implementation of ISO 1.create an environment that encourage people to practice quality management 2.Improve the production process Companys philosophy ISO as a process to maintain quality & to make continuous improvement.

Steps in implementation of ISO

Step 1. Formation of project team Step 2. Communication to staff about the purpose of the project . Step 3.Development of manual ,training & conducting an internal audit.(1 year) Step 4. Application & Granting of certification (3 months after 1st internal audit)

Physical plant is well maintained Procedures are well defined & systematized Professional working environment Less wastage due to decline in defective rate More summer holidays Jump in profits- salary levels increased & investment increased .

Implementation of ISO 9000 was great success Full commitment & support from the management board Drive staffs attitude in a positive direction

Me- an Shoe company

Set up -1960 -SOE Objectives for implementation of ISO 1.To be able to qualify for contracts 2.Improve shoe quality Companys philosophy ISO was a mere process of certification

Steps in implementation of ISO

Step 1. Formation of project team Step 2. Communication to staff about the purpose of the project . Step 3.Development of manual ,training & conducting an internal audit. Step 4. Application & Granting of certification

Minor changes were made in the working procedures Pessimistic attitude of the employees Profits did not improve ,employees did not get benefits Could not continue with ISO certification

Managements perspective on quality and commitment to ISO is the key to its successful implementation. Management must initiate and take responsibility for the necessary changes, employ policies that encourage innovation and recognize employees motivation and competencies to make ISO a real success