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1 HB Education and Training Guide to ISO 9001:2000

2 EDUCATION and TRAINING GUIDE TO ISO 9001:2000 COPYRIGHT Standards Australia International 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. Published by Standards Australia International Ltd GPO Box 5420, Sydney, NSW 2001, Australia ISBN

3 HB PREFACE This handbook, designated HB 90.7, is a revision of AS/NZS :1995, Quality system guidelines Part 5: Guide to AS/NZS ISO 9001:1994 for education and training, which is now withdrawn. The objective of this handbook is to provide guidance to education and training organizations to develop and implement a quality management system based on ISO 9001:2000, Quality management systems Requirements. A secondary objective is to indicate what changes have occurred during the revision of ISO 9001 and how the changes affect those education and training providers who already have a quality management system in place based on the 1994 version of ISO The following terminology is used in this handbook: This handbook, HB 90.7, is referred to hereafter as the handbook. ISO 9001:2000 is referred to hereafter as the standard, ISO 9001 or the 2000 version depending on the context. AS/NZS ISO 9001:1994, Quality systems Model for quality assurance in design, development, production, installation and servicing, AS/NZS ISO 9002:1994, Quality systems Model for quality assurance in production, installation and servicing and AS/NZS ISO 9003:1994, Quality systems Model for quality assurance in final inspection and test are referred to collectively as the 1994 versions. In this handbook, each clause from the standard is given in a grey shaded box. This is followed by the guidance to that clause, explaining how the clause may be implemented, using appropriate terminology and examples taken from education and training environments. Where examples are given on how the intent may be realised, they should not be taken as prescriptive or exhaustive. There are many ways whereby an education and training provider may achieve the intent of the standard and the education and training provider should use the approach that best suits its methods of operation. Clause numbers and headings used are parallel to those of ISO Attention is drawn to AS/NZS ISO 9004:2000, Quality management systems Guidelines for performance improvements. This document provides insight into ways by which the quality management system can be improved beyond the requirements/certification model of ISO Acknowlegements This handbook was prepared by M. Adermann University of Ballarat N. Barton Quality Assurance Services R. Dallin Kingsway Christian College L. Meek University of New England W. Richards NSW Government Department of Education Additional comment was sought from University of Canberra, Edith Cowan University, Monash University, Queensland University of Technology, The University of Sydney, RMIT, Hunter Institute of Technology, Southern Cross University, Victoria University of Technology, Chisholm Institute of TAFE, Sunraysia Institute of TAFE, South West Institute of TAFE, Kangan Institute of TAFE. The contribution of all these parties is acknowledged.

4 3 HB CONTENTS FOREWORD... 5 GLOSSARY... 8 Introduction General Process approach Relationship with ISO Compatibility with other management systems Scope General Application Normative reference Terms and definitions Quality management system General requirements Documentation requirements Management responsibility Management commitment Customer focus Quality policy Planning Responsibility, authority and communication Management review Resource management Provision of resources Human resources Infrastructure Work environment Product realization Planning of product realization Customer-related processes Design and development Purchasing Production and service provision Control of monitoring and measuring devices Measurement, analysis and improvement General Monitoring and measurement Control of nonconforming product Analysis of data Improvement BIBLIOGRAPHY... 73

5 HB APPENDICES A BRIEF OUTLINE OF THE CERTIFICATION PROCESS B ANSWERS TO COMMONLY ASKED QUESTIONS C BRIEF OUTLINE OF A METHOD OF IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM... 79

6 5 HB FOREWORD WHAT HAS CHANGED? While the 2000 version of ISO 9001 still contains nearly all the requirements for a quality management system that were present in the 1994 version, it now also contains some new requirements and some of the old ones are expressed differently. The most obvious change is the structure of the 2000 version. The old 20 element structure has gone, replace by a process approach. This is explained in detail in clause 0 Introduction, page 10 and will not be elaborated on in any depth here. Briefly, the process approach is based on the concept that all outcomes are a result of a process and that the output of one process becomes the input for another process. The other major change is that ISO 9002 and ISO 9003 have been discontinued. If your quality management system was based on ISO 9002:1994, the concept of permissible exclusions has been developed and is detailed in the guidance to clause 1.2 Application, page 16. This approach allows you to use ISO 9001:2000 without necessarily including all the provisions of ISO 9001, notably the clause dealing with design control. The requirements are now contained in 8 clauses with an Introduction (clause 0) to provide a background to the approach and philosophy. The Table of Contents to this handbook gives an indication of what each of the clauses contains. The requirements are now grouped into five major categories, viz quality management system clause 4; management responsibility clause 5; resource management clause 6; product realization clause 7; measurement, analysis and improvement clause 8. The old clauses 4.1 to 4.20 of ISO 9001:1994 have been distributed over clauses 4 to 8 of the 2000 version. While many have been rewritten, you will find that the intent largely has not changed. WHAT IS NEW? There are a number of new requirements which you will have to address. The 2000 version has three major new approaches to the quality management system: a) The standard now requires you to address the issue of customer satisfaction. This concept appears throughout the standard, from understanding what your customer wants, to monitoring the extent to which your customers are satisfied or dissatisfied. You will need to have due regard for this issue in all your procedures. b) The standard now includes a requirement for continual improvement of the quality management system. This means that as you see the opportunity, and your resources permit, you implement those changes which can be justified to achieve improvement. The continual improvement theme is present throughout the standard. Standards Australia

7 HB c) The standard now quite clearly requires that your top management (i.e. those who direct and control your organization) take an active part in the implementation and operation of your quality management system, including setting quality policy and objectives, taking responsibility for planning, ensuring that your organization is focussed on customer needs and demonstrating its commitment to the quality management system. There are other additional requirements, whose effects are not quite so far reaching as these three. They include : A requirement that you have an internal communication process to enable information about the quality management system to be readily passed to those who need it. A requirement that people who perform tasks should be competent to do so. A requirement that you describe how your processes interact with each other. A requirement that where you outsource any process, you need describe how you control that process. What has not changed is that the standard identifies what needs to be done, but it is up to you to decide how to implement it in your organization. WHY ADOPT A QUALITY SYSTEM? NOTE Those who already have a quality management system in place may ignore this section. Quality management systems are an integral part of the operations of a wide range of industries and service organizations, not only in Australia and New Zealand but also worldwide. Following the virtual worldwide adoption of the ISO 9001 quality management system approach, it is now widely realized that formal recognition of a quality management system to ISO 9001 obtained in one country is comparable to an ISO 9001 quality management system formally recognized in another country. This may provide benefits to those interested in attracting overseas students or establishing commercial links with other countries. Within Australia and New Zealand, many government departments and agencies, as well as companies, are seeking the assurance of a certified quality management system from their suppliers. Besides providing this assurance to customers, a quality system can also be used to improve the performance, coordination and productivity of the organization; identify objectives and focus on customer expectations; provide evidence of its capability to customers and potential customers alike; achieve and maintain the desired quality of the product or service, thus continually meeting the customer s stated or implied needs; provide the basis for certification; establish a baseline for continuous improvement. WHAT DOES THE ISO 9001 QUALITY MANAGEMENT SYSTEM STANDARD REQUIRE TO BE DONE? The standard is not concerned with what is done by an organization but how it is managed. It identifies those processes must be controlled, without prescribing the controls. (That is the prerogative of each individual education and training provider.) The corollary is that there is no right way to implement the requirements of the ISO 9001 quality management system standard. Standards Australia

8 7 HB The requirements of government authorities and other regulatory bodies are not addressed directly in the standard nor in this Handbook. However, where such requirements are applicable, they should be contained in the appropriate process control documents and therefore should become an integral part of the quality management system. In appendix A, guidance is given on the operation of third party certification schemes. This information is for broad guidance only and reference should be made to the appropriate certification body in individual circumstances. ADDITIONAL QUESTIONS COMMONLY ASKED The following questions are commonly asked about quality management systems: Does a quality management system mean excessive bureaucracy and what can be done to keep the system simple? What does a quality management system Standard actually do and not do? What is meant by the terms accreditation and certification? What are education and training products? What part of the organization does a quality management system apply to? What is the difference between review and audit? Appendix B lists some answers to these questions. Appendix C outlines a method of implementation of a quality management system. Standards Australia

9 HB GLOSSARY This Glossary contains explanations of terms commonly used in this handbook and in the quality management field. Education and training provider used in this handbook where of the term organization is used in ISO 9001:2000. Education and training providers who would use this handbook include a school, college, university, training organization, assessment centre; a department or section within a college, university, training organization or assessment centre; or a training unit within a company, industry body or government department. Customer used in this handbook to imply any or all of the following, as appropriate in the context: A student. A student s parents or employer. A company or organization with whom a research contract, a consultancy agreement or a training contract is entered into. An industry. An internal customer (i.e. within the education and training provider s own organization). A government, regulatory body, accreditation body and similar. A relevant society group, such as a parents and citizens group, members of staff, and society as a whole. Senior executive Management used in this handbook to denote a person who exercises management authority. This could mean a principal, departmental head, head of a school, vice-chancellor, general manager, director, managing director or any other person with relevant management authority. This term is used in the handbook where the standard refers to top management i.e. person or group of people who directs and controls an organization. used in this handbook to denote the exercise of management authority in a generic sense. The authority may be exercised by a senior executive or by a collective function within the education and training provider s organization, such as a board, a committee, or a self-directed team. Standards Australia

10 9 HB Product and/or service (see also Appendix B) used throughout this handbook instead of the term product as used in the standard. Broadly speaking, the activity of an education and training provider is focused on the provision of its expertise, resources and knowledge to meet the educational requirements of the customer. In ISO 9000:2000, Quality management systems Fundamentals and vocabulary, product is defined as the result of activities or processes. For an education and training provider, the term result can be interpreted as its provision or as meeting needs, and the product could therefore be seen as either the provision of an educational environment; or the enhancement of skills, knowledge, understanding, attitude and/or values. Where the product is defined as provision, it is desirable that the purpose of the provision is incorporated into the product definition. Without that sense of purpose, it could be perceived that the organization emphasizes input and process rather than outcome, and its product will not necessarily have a clearly defined customer focus. Therefore, options for product definition could include the following: Enhancement skills/knowledge/understanding/attitude/values. Provision of an educational environment, a curriculum and other resources, a community service, or research outputs, for the enhancement of skills/knowledge/understanding/attitude/ values. NOTE In the case of research, the aim may be to increase the general knowledge base in which case society is the customer. Standards Australia

11 HB STANDARD Introduction 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization s quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked NOTE is for guidance in understanding or clarifying the associated requirement. This International Standard can be used by internal and external parties, including certification bodies, to assess the organization s ability to meet customer, regulatory and the organization s own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard. GUIDANCE The standard describes an internationally recognized way for you, as an education and training provider, to run your organization. Your decision to adopt a quality management system, should be a strategic one, based on your particular needs and objectives. In implementing a quality management system, you should take into account the way your organization operates. The quality management system should include, complement and be an adjunct to policies and systems already in use. Note that the quality management system is not concerned with what is done but how it is managed. This means that the quality management system does not dictate the content of programs that you use in your education and training organization or even how you set up and run your quality management system. In some instances, you may exclude parts of the standard s requirements from your quality management system, and this is discussed further in clause 1.2 Application page 16. STANDARD 0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the "process approach". An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. Standards Australia

12 11 HB When used within a quality management system, such an approach emphasizes the importance of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. NOTE: Plan: Do: Check: Act: In addition, the methodology known as Plan-Do-Check-Act (PDCA) can be applied to all processes. PDCA can be briefly described as follows: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization s policies; implement the processes; monitor and measure processes and product against policies, objectives and requirements for the product and report the results; take actions to continually improve process performance. STANDARD Figure 1 Model of a process-based quality management system Standards Australia

13 HB GUIDANCE The standard is based on the conceptual model shown in Figure 1. It is referred to as a process model because it highlights the main processes that are integral to this standard. Figure A presents the same model in a slightly different way based on specific application to education and training. The discussion which follows is based on Figure A. FIGURE A PROCESS MODEL ADAPTED FOR EDUCATION AND TRAINING The model is customer driven, in that everything to do with quality starts and ends with the customer. In the diagram, the customer is shown on both the left and right. The three major customer groups in the education and training field are shown. The input and output can and frequently does relate to all three and even others, such as those listed under customer in the Glossary on page 8. The main process flow that results in the delivery of your product and/or service is shown across the upper part of Figure A, product realization. The model starts with discussions and specification from the customer(s) what the customer(s) wants. NOTE: In the education and training field, this can, and frequently does mean, the customer (student) selecting a particular course or curriculum from a brochure, handbook or similar. This then becomes an input to your quality management system (shown in the diagram as the ellipse). This input feeds into the product and/or service planning and into its production or service provision. This box is intended to depict the various activities you carry out which deliver the output in the form of a product and/or service. Standards Australia

14 13 HB The model highlights the importance of obtaining information on customer satisfaction (the arrow on the right pointing to measurement, analysis and improvement ). This and other measurements and evaluations become vital feedback on your performance. These measurement systems are shown as the box on the right titled measurement, analysis and improvement. The rest of the model depicts activities that are considered fundamental for the smooth operation of your processes for product and/or service realization; i.e. they are ancillary but necessary activities that help assure the product and/or the service delivery. The box, management responsibility, is there to emphazise the need for your management to study the results of the feedback and other information. Management responsibility also covers the need for your senior executives to set policy, objectives and targets. Following from these there is a need for proper planning, which also needs to be based on the results of measurements. Planning includes the study of processes and ensuring that they are adequately documented. These documents need to spell out the standard way that for the processes to be carried out. Your senior management needs to evaluate resources, which is addressed as the fourth area of activity in the quality management system. Resources need to be adequate to assure the quality of the product and/or service. Resources include space, equipment, materials and people. The people need to be trained to ensure that they are competent to do the tasks that are asked of them. The data and analysis activities, shown in the box on the right, titled measurement, analysis and improvement, may suggest improvements to the quality management system, indicated as the arrow pointing to the box at the top, titled quality management system continual improvement. With the endorsement of your senior executive(s), potential improvements should also be investigated and appropriately implemented. So there are two mechanisms for making improvements: As part of the quality management system (depicted by the arrows of the inner loop). This includes nonconformity rectification, corrective action and preventive action. Review processes, and in particular management review, which look critically at the whole quality management system and make improvements to it. Hence the process model in Figure A, ties together the concepts of quality assurance to continual improvement and total quality management. Further information is available in ISO 9004:2000, which is consistent with ISO 9001:2000, e.g. the main clause headings are the same. Standards Australia

15 HB STANDARD 0.3 Relationship with ISO 9004 The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair. ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements. ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization s overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes. GUIDANCE The clause is self explanatory and needs little additional guidance. The key point is that the 2000 versions of 9001 and 9004 now have a common clause structure which simplifies the use of the two standards in conjunction with each other. STANDARD GUIDANCE 0.4 Compatibility with other management systems This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community. This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard. Much of the above is self-explanatory. This 2000 version of ISO 9001 has been aligned with ISO to facilitate integration. 1 1 Standards Australia has published an occupational health and safety guidance standard, AS 4801:2000, Occupational health and safety management systems Specification with guidance for use. This uses ISO as its model, and is very similar in concept to the model shown in Figure 1, above. This too, should make it easier for an education and training provider to integrate systems if it so desires. For assistance with integration see AS/NZS 4581:1999, Management system integration Guidance to business, government and community organizations, and HB 139(Int):1999, Step by Step Guidance on Integrating Management Systems Health and Safety, Environment, Quality. Standards Australia

16 15 HB STANDARD 1 Scope 1.1 General This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. NOTE In this International Standard, the term product applies only to the product intended for, or required by, a customer. GUIDANCE ISO 9001 requires that you develop your quality management system according to a set of specific requirements, which are summarized here and detailed in clauses 5, 6, 7 and 8 of the standard. The quality management system can include the totality of an educational and training organization (e.g. educational and/or training delivery, curriculum development, student services, administrative support) or a part of it (e.g. curriculum development or education delivery). Regardless of whether the quality system covers the whole or only part of the organization, the aim of the system must be to improve conformity (i.e. meeting specified requirements) from the design of the product through to delivery, to meet customer needs and to improve the system. Following are some circumstances when ISO 9001 would apply to education and training: a) A specific contract is entered into with a customer requiring new design and the requirements are measurable. Possible examples of a specific contract are when an organization moves into a new area of activities, e.g. entrepreneurial activities in TAFE, universities or public schools; when an organization undertakes specific research, curriculum development or project; production of learning resources, such as videos or resource kits; or an individual customer purchases a tailored learning package from an education and training organization. b) The customer assumes reliability based on pre-existing capabilities in design, development and delivery of teaching. Examples in this area are standard product lines, such as curriculums that have already been designed, developed and are well established in the educational organization; or courses described in a handbook or listed in a newspaper advertisement. Standards Australia

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