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1 This is a free 15 page sample. Access the full version online. HB 90.1:2012 The Small Business Handbook Guide to ISO 9001:2008 HB

2 This is a free 15 page sample. Access the full version online. HB 90.1:2012 This Joint Australian/New Zealand Handbook was prepared by Joint Technical Committee QR-008, Quality Management Systems. It was approved on behalf of the Council of Standards Australia on 31 January 2012 and on behalf of the Council of Standards New Zealand on 14 November This Handbook was published on 22 March The following are represented on Committee QR-008: Airways New Zealand Association of Accredited Certification Bodies Australian Chamber of Commerce and Industry Australian Institute of Petroleum Australian Organisation for Quality Bureau of Steel Manufacturers of Australia Commonwealth Department of Transport and Regional Services Department of Agriculture, Fisheries and Forestry (Commonwealth) Department of Housing, NSW Department of Transport and Main Roads, Qld Engineers Australia International Accreditation Forum Joint Accreditation System of Australia and New Zealand Materials Australia New Zealand Organisation for Quality Royal Australian Chemical Institute University of Technology, Sydney Keeping Standards up-to-date Standards are living documents which reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments which may have been published since the Standard was purchased. Detailed information about joint Australian/New Zealand Standards can be found by visiting the Standards Web Shop at or Standards New Zealand web site at and looking up the relevant Standard in the on-line catalogue. For more frequent listings or notification of revisions, amendments and withdrawals, Standards Australia and Standards New Zealand offer a number of update options. For information about these services, users should contact their respective national Standards organization. We also welcome suggestions for improvement in our Standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Please address your comments to the Chief Executive of either Standards Australia or Standards New Zealand at the address shown on the back cover.

3 HB 90.1:2012 This is a free 15 page sample. Access the full version online. Handbook The Small Business Handbook Guide to ISO 9001:2008 Originated in Australia as HB 66(Int) Previous edition HB Jointly revised and designated HB 90.1:2012. COPYRIGHT Standards Australia Limited/Standards New Zealand All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher, unless otherwise permitted under the Copyright Act 1968 (Australia) or the Copyright Act 1994 (New Zealand). Jointly published by SAI Global Limited under licence from Standards Australia Limited, GPO Box 476, Sydney, NSW 2001 and by Standards New Zealand, Private Bag 2439, Wellington ISBN

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5 This is a free 15 page sample. Access the full version online. PREFACE This Handbook was prepared by the Joint Standards Australia/Standards New Zealand Committee QR-008, Quality Management Systems to supersede HB , The Small Business Handbook Guide to ISO 9001:2000. The objective of this revision is to adopt the current edition of the ISO Guide which relates the 2008 edition of ISO 9001 to the development and maintenance of quality management systems in small businesses. This Handbook is identical with, and has been reproduced from the ISO publication, ISO 9001 for Small Business, What to do, Advice from ISO/TC 176. This Handbook includes extracts from ISO 9001:2008 but does not incorporate its full text. International Standards referenced in this Handbook have been adopted as Australian/New Zealand Standards as follows: Reference to International Standard ISO 9000 Quality management systems Fundamentals and vocabulary 9001 Quality management systems Requirements 9004 Managing for the sustained success of an organization A quality management approach Environmental management systems requirements with guidance for use Guidelines for quality and/or environmental management systems auditing Australian/New Zealand Standard AS/NZS ISO 9000 Quality management systems Fundamentals and vocabulary 9001 Quality management systems Requirements 9004 Managing for the sustained success of an organization A quality management approach Environmental management systems requirements with guidance for use Guidelines for quality and/or environmental management systems auditing A number of International Standards listed in the Bibliography have been adopted as Australian or Australian/New Zealand Standards.

6 This is a free 15 page sample. Access the full version online. ISO the International Organization for Standardization ISO has a membership of some 160 national standards bodies from countries large and small, industrialized, developing and in transition, in all regions of the world. ISO s portfolio of more than standards provides business, government and society with practical tools for all three dimensions of sustainable development : economic, environmental and societal. ISO standards make a positive contribution to the world we live in. They facilitate trade, spread knowledge, disseminate innovative advances in technology, and share good management and conformity assessment practices. ISO standards provide solutions and achieve benefits for almost all sectors of activity, including agriculture, construction, mechanical engineering, manufacturing, distribution, transport, medical devices, information and communication technologies, the environment, energy, quality management, conformity assessment and services. ISO only develops standards for which there is a clear market requirement. The work is carried out by experts in the subject drawn directly from the industrial, technical and business sectors that have identified the need for the standard, and which subsequently put the standard to use. These experts may be joined by others with relevant knowledge, such as representatives of government agencies, testing laboratories, consumer associations and academia, and by international governmental and non-governmental organizations. An ISO International Standard represents a global consensus of the knowledge in a particular subject or process, be it the state of the art in that subject, or what is good practice. 2 The Small Business Handbook Guide to ISO 9001:2008

7 The International Trade Centre (ITC) This is a free 15 page sample. Access the full version online. ITC is the joint agency of the World Trade Organization and the United Nations. As the development partner for small business export success, ITC s goal is to help developing and transition countries achieve sustainable human development through exports. We partner with trade support institutions to deliver sustainable and inclusive capacity building services to achieve Export Impact for Good. We have five core business practices to deliver on this goal : business and trade policy, export strategy, strengthening trade support institutions, trade intelligence and exporter competitiveness. Through strategic development and capacity building based on these business services, ITC connects opportunities to markets. As a result, we achieve long-term, tangible benefits at both national and community levels. The Small Business Handbook Guide to ISO 9001:2008 3

8 This is a free 15 page sample. Access the full version online. 4 The Small Business Handbook Guide to ISO 9001:2008

9 Foreword This is a free 15 page sample. Access the full version online. Small business is the world s biggest business. More than 95 % of the world s businesses are small to medium sized and many countries look to small and medium businesses to power economic growth and employment. Therefore International Standards need to assist small business just as much as they do for global enterprises, government and society at large. In particular, small and medium-sized enterprises (SMEs) should be able to share in gains in efficiency and effectiveness offered by ISO This standard, which gives the requirements for quality management systems, is among ISO s most well known and widely implemented standards ever. ISO 9001 is used in some 176 countries by businesses and organizations large and small, in public and private sectors, by manufacturers and service providers, in all sectors of activity to achieve objectives such as the following : Establishing a framework for continual improvement and customer satisfaction Providing assurance about quality in supplier-customer relationships Harmonizing quality requirements in sectors and areas of activity Qualifying suppliers in global supply chains Providing technical support for regulators Giving organizations in developing countries and transition economies a framework for participating in global supply chains, export trade and business process outsourcing Assisting in the economic progress of developing countries and transition economies Transferring good managerial practice Encouraging the rise of services. The management system approach pioneered by ISO 9001 and further developed by ISO (environmental management systems) has since been followed by other standards for the needs of specific sectors, or to address specific issues. They include : information The Small Business Handbook Guide to ISO 9001:2008 5

10 This is a free 15 page sample. Access the full version online. security (ISO/IEC 27001), food safety (ISO 22000), supply chain security (ISO 28000), energy management (ISO under development) and road traffic safety management (ISO under development). This third edition of ISO 9001 for Small Businesses has been updated to take account of the latest edition of the standard, published in In plain language and through numerous concrete examples from a wide range of sectors, it aims to help SMEs to understand and implement ISO This handbook is the latest example of the fruitful cooperation between ISO and the ITC. The two organizations hope that it will enable small businesses in developing, transitional and industrialized economies to draw the maximum benefits from ISO 9001, a standard which has become an essential tool of the world economy. Patricia R. Francis Executive Director International Trade Centre Rob Steele Secretary-General ISO 6 The Small Business Handbook Guide to ISO 9001:2008

11 This is a free 15 page sample. Access the full version online. ISO 9001 Table of Contents About this handbook Quality management systems What is a quality management system? What is an ISO 9001 quality management system? Why have one? How to start First steps What s next? Going ahead Do it yourself Hiring a consultant What does certification/registration mean? Guidance on what the standard means Explanation of terms used Foreword Introduction General Process approach Relationship with ISO Compatibility with other management systems Quality management systems Requirements Scope General Application Normative reference Terms and definitions Quality management system The Small Business Handbook Guide to ISO 9001:2008 7

12 4.1 General requirements This is a free 15 page sample. Access the full version online. 4.2 Documentation requirements General Quality manual Control of documents Control of records Management responsibility Management commitment Customer focus Quality policy Planning Quality objectives Quality management system planning Responsibility, authority and communication Responsibility and authority Management representative Internal communication Management review General Review input Review output Resource management Provision of resources Human resources General Competence, training and awareness Infrastructure Work environment Product realization Planning of product realization The Small Business Handbook Guide to ISO 9001:2008

13 7.2 Customer-related processes This is a free 15 page sample. Access the full version online Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing Purchasing process Purchasing information Verification of purchased product Production and service provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring equipment Measurement, analysis and improvement General Monitoring and measurement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product The Small Business Handbook Guide to ISO 9001:2008 9

14 8.3 Control of nonconforming product Analysis of data This is a free 15 page sample. Access the full version online. 8.5 Improvement Continual improvement Corrective action Preventive action ISO 9001 Annexes and Bibliography Annex A Steps toward a Quality management system. 151 Introduction Annex B Brief outline of certification/registration Starting Who does the certification/ registration? Brief outline Annex C Quality management principles Quality management principles Bibliography Other useful references The Small Business Handbook Guide to ISO 9001:2008

15 About this handbook This is a free 15 page sample. Access the full version online. This handbook gives guidance to small organizations on developing and implementing a quality management system, based on ISO 9001:2008, Quality management systems Requirements. All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. The former editions of the standard as well as of this handbook used the term businesses which is still used in the unchanged title of this handbook. The use of the term organization instead of business demonstrates the much wider use of both standard and handbook, covering not only business in the strict sense as enterprises manufacturing and selling products. Organization also includes businesses providing services (now included in the term products ), such as law firms and financial institutions, as well as non-profit organizations such as foundations, public hospitals or municipial administrations. It is not expected that you will sit down and read this handbook in one sitting. It is broken up into the following sections to be read and used separately and referred to as the need arises. Quality management system How to start This section gives an overview of what an ISO 9001 quality management system is. This gives some practical advice on different options, should you wish to introduce a quality management system into your organization, or update an existing one. The Small Business Handbook Guide to ISO 9001:

16 This is a free preview. Purchase the entire publication at the link below: This is a free 15 page sample. Access the full version online. Looking for additional Standards? Visit SAI Global Infostore Subscribe to our Free Newsletters about Australian Standards in Legislation; ISO, IEC, BSI and more Do you need to Manage Standards Collections Online? Learn about LexConnect, All Jurisdictions, Standards referenced in Australian legislation Do you want to know when a Standard has changed? Want to become an SAI Global Standards Sales Affiliate? Learn about other SAI Global Services: LOGICOM Military Parts and Supplier Database Metals Infobase Database of Metal Grades, Standards and Manufacturers Materials Infobase Database of Materials, Standards and Suppliers Database of European Law, CELEX and Court Decisions Need to speak with a Customer Service Representative - Contact Us

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