hb 90.7-2000 education and training - guide to iso 9001-2000 education and training - guide to iso...

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HB90.72000

Education and Training

Guide to ISO 9001:2000


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EDUCATION and TRAINING

GUIDE TO ISO 9001:2000

COPYRIGHT

Standards Australia Intern ational

All rights are reserved. No part of this work may be reproduced or copied in any form or by anymeans, 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 0 7337 3709 9


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PREFACE

This handbook, designated HB 90.7, is a revision of AS/NZS 3905.5:1995, 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Part 5: Guide to AS/NZS ISO 9001:1994 for education and training, which is now withdrawn.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 9001.

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 systemsModel for quality assurance in design,development, production, installation and servicing, AS/NZS ISO 9002:1994, Quality

systemsModel for quality assurance in production, installation and servicing and

AS/NZS ISO 9003:1994, Quality systemsModel for quality assurance in final inspection and

testare 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 theintent 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 9001.

Attention is drawn to AS/NZS ISO 9004:2000, Quality management systemsGuidelines 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 9001.

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, MonashUniversity, Queensland University of Technology, The University of Sydney, RMIT, Hunter Institute

of Technology, Southern Cross University, Victoria University of Technology, Chisholm Institute ofTAFE, Sunraysia Institute of TAFE, South West Institute of TAFE, Kangan Institute of TAFE.

The contribution of all these parties is acknowledged.


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CONTENTS

FOREWORD.............................................................................................................................. 5

GLOSSARY............................................................................................................................... 8

Introduction.............................................................................................................................. 10

0.1 General........................................................................................................................... 10

0.2 Process approach............................................................................................................ 10

0.3 Relationship with ISO 9004 ........................................................................................... 14

0.4 Compatibility with other management systems .............................................................. 14

1 Scope................................................................................................................................... 15

1.1 General........................................................................................................................... 15

1.2 Application..................................................................................................................... 16

2 Normative reference ............................................................................................................ 17

3 Terms and definitions .......................................................................................................... 18

4 Quality management system................................................................................................ 19

4.1 General requirements ..................................................................................................... 19

4.2 Documentation requirements.......................................................................................... 20

5 Management responsibility.................................................................................................. 26

5.1 Management commitment .............................................................................................. 26

5.2 Customer focus .............................................................................................................. 27

5.3 Quality policy................................................................................................................. 27

5.4 Planning ......................................................................................................................... 28

5.5 Responsibility, authority and communication................................................................. 30

5.6 Management review ....................................................................................................... 32

6 Resource management ......................................................................................................... 34

6.1 Provision of resources .................................................................................................... 34

6.2 Human resources............................................................................................................ 35

6.3 Infrastructure.................................................................................................................. 37

6.4 Work environment.......................................................................................................... 37

7 Product realization............................................................................................................... 387.1 Planning of product realization....................................................................................... 38

7.2 Customer-related processes............................................................................................ 40

7.3 Design and development ................................................................................................ 43

7.4 Purchasing...................................................................................................................... 53

7.5 Production and service provision.................................................................................... 55

7.6 Control of monitoring and measuring devices................................................................ 61

8 Measurement, analysis and improvement ............................................................................ 63

8.1 General........................................................................................................................... 63

8.2 Monitoring and measurement ......................................................................................... 64

8.3 Control of nonconforming product................................................................................. 68

8.4 Analysis of data.............................................................................................................. 698.5 Improvement .................................................................................................................. 70

BIBLIOGRAPHY..................................................................................................................... 73


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APPENDICES

A BRIEF OUTLINE OF THE CERTIFICATION PROCESS ................................................ 74

B ANSWERS TO COMMONLY ASKED QUESTIONS....................................................... 76

C BRIEF OUTLINE OF A METHOD OF IMPLEMENTATION OF A QUALITY

MANAGEMENT SYSTEM ................................................................................................ 79


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FOREWORD

WHAT HAS CHANGED?

While the 2000 version of ISO 9001 still contains nearly all the requirements for a qualitymanagement 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 anindication 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.
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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 thequality 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 thatprocess.

What has not changed is that the standard identifies what needs to be done, but it is up to you to decidehow to implement it in your organization.

WHY ADOPT A QUALITY SYSTEM?

NOTEThose 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 establishingcommercial 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 thecustomers stated or implied needs;

provide the basis for certification;

establish a baseline for continuous improvement.

WHAT DOES THE ISO 9001 QUALITY MANAGEMENT SYSTEM STANDARDREQUIRE 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.


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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. Thisinformation 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 keepthe 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.


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GLOSSARY

This Glossary contains explanations of terms commonly used in this handbook and in the quality

management field.

Education and trainingprovider

used in this handbook where of the termorganization

is used in

ISO 9001:2000. Education and training providers who would use this

handbook include

a school, college, university, training organization, assessmentcentre;

a department or section within a college, university, trainingorganization or assessment centre; or

a training unit within a company, industry body or governmentdepartment.

Customer used in this handbook to imply any or all of the following, as appropriate

in the context:

A student.

A students parents or employer.

A company or organization with whom a research contract, aconsultancy agreement or a training contract is entered into.

An industry.

An internal customer (i.e. within the education and training

providers 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 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.

Management 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.


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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 systemsFundamentals 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, attitudeand/or values.

Where the product is defined asprovision

, it is desirable that thepurpose 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 generalknowledge base in which case society is the customer.


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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 organizations qualitymanagement system is influenced by varying needs, particular objectives, theproducts provided, the processes employed and the size and structure of theorganization. It is not the intent of this International Standard to imply uniformity inthe structure of quality management systems or uniformity of documentation.

The quality management system requirements specified in this InternationalStandard are complementary to requirements for products. Information markedNOTE is for guidance in understanding or clarifying the associated requirement.

This International Standard can be used by internal and external parties, includingcertification bodies, to assess the organizations ability to meet customer,regulatory and the organizations 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 standards 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 whendeveloping, implementing and improving the effectiveness of a qualitymanagement system, to enhance customer satisfaction by meeting customerrequirements.

For an organization to function effectively, it has to identify and manage numerouslinked activities. An activity using resources and managed in order to enable thetransformation of inputs into outputs, can be considered as a process. Often theoutput from one process directly forms the input to the next.

The application of a system of processes within an organization, together with theidentification and interactions of these processes, and their management, can bereferred to as the "process approach".

An advantage of the process approach is the ongoing control that it provides overthe linkage between the individual processes within the system of processes, aswell as over their combination and interaction.


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When used within a quality management system, such an approach emphasizesthe 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 1illustrates the process linkages presented in clauses 4 to 8. This illustration showsthat customers play a significant role in defining requirements as inputs.Monitoring of customer satisfaction requires the evaluation of information relating tocustomer perception as to whether the organization has met the customerrequirements. The model shown in Figure 1 covers all the requirements of thisInternational Standard, but does not show processes at a detailed level.

NOTE: In addition, the methodology known as Plan-Do-Check-Act (PDCA) can be

applied to all processes. PDCA can be briefly described as follows:

Plan: establish the objectives and processes necessary to deliver results inaccordance with customer requirements and the organizations policies;

Do: implement the processes;

Check: monitor and measure processes and product against policies, objectives and

requirements for the product and report the results;

Act: take actions to continually improve process performance.

STANDARD

Figure 1 Model of a process-based quality management system


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GUIDANCEThe 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 APROCESS 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 variousactivities you carry out which deliver the output in the form of a product and/or

service.


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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 becarried 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 theinner loop). This includes nonconformity rectification, corrective action

and preventive action.

Review processes, and in particular management review, which lookcritically 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.


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STANDARD 0.3 Relationship with ISO 9004

The present editions of ISO 9001 and ISO 9004 have been developed as aconsistent pair of quality management system standards which have beendesigned to complement each other, but can also be used independently.

Although the two International Standards have different scopes, they have similarstructures in order to assist their application as a consistent pair.

ISO 9001 specifies requirements for a quality management system that can beused for internal application by organizations, or for certification, or for contractualpurposes. It focuses on the effectiveness of the quality management system inmeeting customer requirements.

ISO 9004 gives guidance on a wider range of objectives of a quality managementsystem than does ISO 9001, particularly for the continual improvement of anorganizations overall performance and efficiency, as well as its effectiveness.ISO 9004 is recommended as a guide for organizations whose top managementwishes to move beyond the requirements of ISO 9001, in pursuit of continualimprovement 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 0.4 Compatibility with other management systems

This International Standard has been aligned with ISO 14001:1996 in order toenhance the compatibility of the two standards for the benefit of the usercommunity.

This International Standard does not include requirements specific to othermanagement systems, such as those particular to environmental management,occupational health and safety management, financial management or riskmanagement. However, this International Standard enables an organization toalign or integrate its own quality management system with related managementsystem requirements. It is possible for an organization to adapt its existingmanagement system(s) in order to establish a quality management system thatcomplies with the requirements of this International Standard.

GUIDANCE Much of the above is self-explanatory. This 2000 version of ISO 9001 has been

aligned with ISO 14001 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 14001 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 integrationGuidance to

business, government and community organizations, and HB 139(Int):1999, Step by Step Guidance on

Integrating Management SystemsHealth and Safety, Environment, Quality.


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STANDARD 1 Scope

1.1 General

This International Standard specifies requirements for a quality management

system where an organizationa) 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 thesystem, including processes for continual improvement of the system and theassurance 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 toa 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 andthe 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 indesign, 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

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HB 90.7-2000, Education and Training - Guide toISO 9001:2000 Education and Training - Guide toISO 9001:2000
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