Demonstration of Conformity to a Standard – A Practical ...€¦ · Demonstration of Conformity...

Demonstration of Conformity to a Standard – A Practical Guide for

Suppliers and Customers

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Demonstration of Conformity to a Standard

– A Practical Guide for Suppliers and Customers

Chris Cox

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First published in the UK in 2007

by BSI

389 Chiswick High RoadLondon W4 4AL

© British Standards Institution 2007

All rights reserved. Except as permitted under the Copyright, Designs and Patents Act 1988, no part of this publication may be reproduced,

stored in a retrieval system or transmitted in any form or by any means – electronic, photocopying, recording or otherwise – without prior

permission in writing from the publisher.

Whilst every care has been taken in developing and compiling this publication, BSI accepts no liability for any loss or damage caused, arising

directly or indirectly in connection with reliance on its contents except to the extent that such liability may not be excluded in law.

The right of Chris Cox to be identified as the author of this Work has been asserted by him in accordance with sections 77 and 78 of the Copyright,

Designs and Patents Act 1988.

Typeset in Century Schoolbook and Gill Sans by MonolithPrinted in Great Britain by MPG Books, Bodmin, Cornwall

British Library Cataloguing in Publication DataA catalogue record for this book is available from the British Library

ISBN 978-0-580-50100-5

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Contents

Foreword vii

1 Introduction 1

2 The conformity assessment and standardization industries 6

Conformity assessment 6

Standardization 14

Standards bodies, the DTI and the regulators 17

3 The conformity assessment system 21

Conformity assessment functions 24

4 How suppliers and customers can benefit from knowledge and use of conformity assessment 48

How a user/customer of goods and services can make use of this information 55

5 How suppliers and customers can benefit from knowledge and use of standards 60

Suppliers 60

Customers/consumers/users of goods and services 62

How can they make use of standards? 63

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Appendix 1 67

Appendix 2 71

Bibliography 73

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Foreword

Chris Cox has made a valuable contribution to the literature on quality, bringing to bear his own training in philosophy, his long experience of Further Education, and many years as a specialist in Quality, working with national and international bodies, and on research funded by the European Commission.

The book addresses what could be the dry technical theme of conformity assessment, but the writing is mercifully free of technical complications. As a result, readers are able to grasp the import of the standards that they need to meet if they are to do business in the new globalized market.

The quality movement has taken different forms over the years, as visionary gurus have put forward solutions to major problems in the workplace. For Deming, Quality, and Quality Circles, offered a way forward in place of the atmosphere of fear which had often prevailed. Japan provided an experimental environment for the work of Juran and Ishikawa, transforming Japanese industrial performance and embedding a culture of continuous improvement. Translating the message to the United States, and then to the United Kingdom, tended to reduce Quality to a tool in the hands of management, a mechanism for enforcing control.

In India, Sri Lanka and other countries in South Asia today, the Quality Circles movement has, as it were, gone full circle. From an initial focus on Products, there had been a less clearly defined emphasis on Processes. Now, at grass roots level, People are in the spotlight. There is enormous energy developing as schools deploy what they call ‘Student Quality Control Circles’, taking control of their own learning, breaking the chains of conventional top-down pedagogy. There is cross-fertilization with industrial Quality Control Circles. The World Council for Total Quality and Excellence in Education has run a successful

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series of national and international conventions on Student Quality Control Circles, with the theme ‘Quality for Peace’.

Quality has come of age. There is a growing international market for clearly presented, authoritative, calm exposition of how to navigate through the shoals of terminology. Those for whom English is their mother tongue can perhaps be forgiven for thinking that they under-stand what they are talking about in the international field of Quality, where many of the key texts are in International Business English. There can be the post-colonial assumption that regulations apply to others, ‘No regulation please, we’re British’, thus clinging to the illu-sory protection of voluntarism.

Professor Richard EnnalsKingston Business School, Kingston University

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1 Introduction

This book aims to explain how activities such as testing, inspection, certification and accreditation can help to establish confidence in goods and services, and in their suppliers. Such activities, collectively referred to as ‘conformity assessment’, involve a series of checking processes that may be carried out to show that specified requirements are fulfilled.

We believe that a more focused understanding of all that is involved in the assessment and demonstration of conformity and its benefits held by suppliers, customers and other interested parties will increase its general effectiveness for everyone involved.

The book provides basic technical information to a level of detail considered necessary for the description of what this means for the supplier on the one hand and the user/customer on the other. The whole is treated in as non-technical a manner as is possible when dealing with what is very much a technical subject.

Although the book is about conformity assessment, the central importance of standards and standardization that surrounds the conformity assessment industry requires fairly comprehensive information on standards and standardization where appropriate.

The book is intended to be applicable in any country. Some developing countries may not yet have all the necessary infrastructure available to them, but they may nevertheless be trading with countries that do.

The examples and references to national standards are drawn from conformity assessment activity and standardization as it applies in the UK. Differences in application in other countries will exist but due to the direct influence of the major international standardization bodies and World Trade Organization’s interest in this field, these differences will generally be small and apply in the practice not the principles or framework of the system.

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Assessment of conformity to requirements and making decisions based on the results of the assessment are nothing magical; it is something everyone has done at some point in their everyday lives.

Take a simple example: I need a piece of wood to fit a specific space. I supply the precise measurements to the timber merchant who carries out the necessary steps to provide me with the piece of wood as I have specified. When the timber merchant checks the dimensions of the wood to assure himself and me that it meets my specifications, he is declaring its conformity and this activity can be recognized as a form of ‘first-party’ conformity assessment. If I carry out similar checks on the wood before taking it away to ensure it meets my specifications and confirm that it does (or does not), this activity can be recognized as a form of ‘second-party’ conformity assessment. If I have brought a builder with me and ask him to check the wood against my specifications and he confirms that it does (or does not), this activity can be recognized as ‘third-party’ conformity assessment.

Everyone and every organization will at some time be asked to supply something in circumstances where it is important for them and their customers to have confidence that specified requirements have been met.

Everyone and every organization is at some time a customer of something for which precision in meeting specified requirements is critical to them. Sometimes it is equally critical that the confidence should be provided before delivery.

The simple example of the timber merchant shows how we are all concerned to a greater or lesser extent with all of the viewpoints from which conformity assessment activity needs to be viewed. This enables us to gain maximum benefit from what a conformity assessment service is capable of delivering. The centuries-old system of communication through the production of standards and conformity assessment activity related to those standards remains a very good mechanism for arriving at a common understanding of technical requirements at the appropriate level of precision and of having confidence that stated conformity to that level of precision can be relied upon. At this higher, more complex level of prescribing requirements and providing the mechanism for demonstrating conformity to those requirements, there is a need for professionalism, so it is not surprising that standardization and conformity assessment activities form ‘industries’ in their own right.

This book is being written in the belief that transparency and widespread understanding by all concerned is the best form of policing a system, i.e. the framework within which conformity assessment

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3

Introduction

operates, which has such global application and which properly remains largely unregulated. The more people who use the system to good effect and know what to do when it fails to deliver the greater will be the effectiveness of the system as a whole.

As with any domain of human activity, the community that practices the activity will communicate in language that is generally understood within the community but differently by anyone outside the community. The terms and definitions that apply within the conformity assessment community can be found in ISO/IEC 17000:2004, Conformity assessment – Vocabulary and general principles. This book maintains consistent compatibility with that vocabulary but does not require reference to it since that level of precision is not as necessary for this book as it is for the application and assessment against the standards.

Table 1.1 below contains terms defined as they are used in this book, but apart from ‘conformity assessment’ are not defined in ISO/IEC 17000, and Table 1.2 contains abbreviations.

Table 1.1 – Useful to know conventions used

Term Definition

conformity assessment Demonstration that specified requirements relating to a product, process, system, person, organization or body are fulfilled (ISO/IEC 17000, 2.1).

Note: this definition recognizes the recent understanding that ‘service’ forms one of four categories of ‘product’ for the purposes of product quality specification and quality management system specification.

function(conformity assessment)

One of the sequence of steps taken in conformity assessment, i.e. from selection, through assessment known as determination to review, decision and the statement of success known as attestation of conformity.

sector(conformity assessment)

A type of conformity assessment related to the objects or activities of conformity assessment and for which core ISO/IEC conformity assessment requirements standards have been developed, i.e. accreditation, product, management system, person, inspection, testing and calibration.

service(conformity assessment)

The contracted provision of conformity assessment.

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Term Definition

standard(publicly available standard)

An international, regional, national or provincial standard establishing requirements or recommendations by consensus, approved by the relevant recognized body and made publicly available.

system(conformity assessment)

The national, regional and international framework within which conformity assessment operates.

Note: this has grown out of piecemeal need rather than by grand design.

Table 1.2 – List of abbreviations and acronyms

Abbreviation/acronym Definition

ABCB Association of British Certification Bodies

BMTA British Measurement and Testing Association

BS nnn British Standard (specification or guideline)

BSI British Standards Institution

CEN European Committee for Standardization

CENELEC European Committee for Electrotechnical Standardization

CPA Clinical Pathology Accreditation (UK) Ltd

DTI Department of Trade and Industry

EA European co-operation for Accreditation (i.e. the European Multilateral Agreement Group of Nationally authorized accreditation bodies)

EEA European Economic Area (Europe plus three EFTA countries: Norway, Iceland and Liechtenstein)

EFTA European Free Trade Association (Iceland, Norway, Switzerland and Liechtenstein)

EN European Standard

ETSI European Telecommunications Standards Institute

EU European Union

HD harmonized document

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Introduction

Abbreviation/acronym Definition

IAF International Accreditation Forum

IEC International Electrotechnical Commission

IEC nnn IEC standard

IFIA International Federation of Inspection Agencies

IIOC Independent International Organisation for Certification

ILAC International Laboratory Accreditation Co-operation

IQNet International Certification Network

ISO International Organization for Standardization

ISO nnn ISO standard

ISO/CASCO ISO Conformity Assessment Standards and Policy Committee

ITU International Telecommunication Union

MoU Memorandum of understanding

NSB National Standards Body

PAS nnn Publicly Available Specification (industry standard produced through a national or international standards body’s system)

SAFed Safety Assessment Federation

SDoC supplier’s declaration of conformity

TBT Technical Barriers to Trade Committee

UILI Union Internationale des Laboratoires Indépendants

UKAS United Kingdom Accreditation Service

WTO World Trade Organization

Chapter 2 provides information on the main industries involved and Chapter 3 on the conformity assessment system. Chapters 4 and 5 provide advice to suppliers of goods and services and their customers on how best to make use of the conformity assessment system and standards to demonstrate conformity.

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2 The conformity assessment and standardization industries

Conformity assessment

Conformity assessment as defined in Table 1.1 is an extremely wide-spread practice; this book concentrates only on the standardized system of conformity assessment regulated on a largely voluntary basis by international standards that have been adopted nationally by countries around the world. The standards that make up this system are shown in Appendix 1. The purpose of conformity assessment is to give confidence to whoever needs it that specified requirements have been demonstrably fulfilled.

Conformity assessment services

Conformity assessment services are provided by organizations that can collectively be called conformity assessment bodies. They all provide ‘third-party’ services and as listed below, an accreditation body is on its own among conformity assessment bodies. The service provided takes the full form of a conformity assessment activity, complete with all the functions of conformity assessment, but the body is not treated as a conformity assessment body by the conformity assessment system; it is an ‘accreditation body’. Bodies providing calibration and testing services are referred to as conformity assessment bodies within the standardized system even though some aspects of the functions of calibration and testing do not strictly involve the assessment of conformity but the assessment of accuracy of an instrument or the factual nature of a characteristic. The justification for including these

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The conformity assessment and standardization industries

last two within the system is that they share the same functions and many principles and procedures as are applied by the rest of the forms of conformity assessment service, including accreditation.

Services supplied by conformity assessment bodies include the accreditation of the bodies providing the following conformity assess-ment services:

• certification of management systems;• certification of products (including services and processes);• certification of persons;• inspection;• testing;• calibration (treated as a conformity assessment activity).

Each one of these services is supplied by organizations around the world, each forming an individual industry in its own right within the overall conformity assessment industry. Most, if not all, of the large international conformity assessment organizations will be operating entirely within the conformity assessment system described in this book but there are also a number of organizations that for one reason or another do not.

Some ‘conscientious objectors’ exist in that their decision is based on a difference of opinion with something fundamental in the formal system. These organizations may well provide as reliable and effective a conformity assessment service as those within the standardized system, though one generally needs to find this out from recommendation or experience. Many, however, are in the business of providing conformity assessment results based on a variety of ‘short cuts’ in the functions and their activities allowing them to offer ‘cut prices’ for ‘easy results’; they are the cowboys of the conformity assessment world. They thrive in the free economy but the value provided to their customers is cut to the extent of the price. The maxim caveat emptor, i.e. buyer beware, applies to these services.

Conformity assessment bodies within the standardized system will invariably also belong to a national or international association that adds an additional element of internal regulation through codes of conduct and service guidance as part of the set of benefits that membership provides.

The following explanation includes a reference to the relevant body or bodies and is provided in the list of useful internet contacts in Appendix 2.

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Accreditation services

In general use, the word ‘accreditation’ is often treated synonymously with the word ‘certification’, especially when related to the certification of persons.

In the domain of conformity assessment, ‘accreditation body’ is the term used to designate the concept of a body that is authorized by government to assess the competence of conformity assessment bodies against relevant international standards and issue a statement attesting to fulfilment of the relevant requirements. The resulting demonstration of conformity is therefore identified by exclusive use of the term ‘accreditation’.

Governmental practice varies from countries such as the UK where there is only one authorized accreditation body, the United Kingdom Accreditation Service (UKAS), to countries such as the United States where a number of accreditation bodies have been authorized.

The accreditation service provided by accreditation bodies will conform to ISO/IEC 17011:2004, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies and follow the practical guidance offered by the International Accreditation Forum (IAF).

This service is at the top of the standardized system and is designed to provide assurance to users of any of the variety of objects of conformity assessment that those objects conform to specified standards or regulations. Governments should oversee the proper working of accreditation bodies, but this does not usually amount to a conformity assessment project against ISO/IEC 17011. In the UK, for example, the government through the Department of Trade and Industry (DTI) has a memorandum of understanding (MoU) with UKAS that provides the assurance needed.

By this agreement UKAS is the body that provides, on a purely voluntary basis, the internal regulation of conformity assessment activity in the UK and is the UK voice in the various international fora that have been formed to provide the same form of regulation worldwide on the same voluntary footing. This has the objective of facilitating trade internally and externally through the reduction of barriers to trade and the provision of confidence in the safety, quality and other important characteristics of the entities concerned.

Internationally, UKAS plays a very important role by its participation in the various conformity assessment activity groupings that form the relevant multilateral agreements for mutual recognition of conformity assessment results. Each of the parties forming these agreements

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signifies their willingness to recognize conformity assessment results issued by the others on the basis that each will have undergone a peer assessment in conformity to ISO/IEC 17040:2005, Conformity assessment – General requirements for peer assessment of conformity assessment bodies and accreditation bodies.

These groupings include:

• the International Accreditation Forum (IAF) http://www.iaf.nu/

• the International Laboratory Accreditation Co-operation (ILAC) http://www.ilac.org/

• the European co-operation for Accreditation (EA) http://www.european-accreditation.org/

The existence of these organizations also provides an ultimate forum to which any unresolved appeal, complaint or other query may be addressed.

Services for the certification of management systems

Following in the wake of the ISO 9000 quality management systems standards, a range of other similar standards that provide specification for generic management of an organization’s functions and activities have been published. These now include quality, environment and health and safety, with recent additions appearing for sustainability of the organization, corporate social responsibility and integration of these systems.

There are many bodies offering certification of management systems operating nationally and internationally and again we distinguish between those that do so with accreditation from those that do not. Certification bodies will be accredited against ISO/IEC 17021:2006, Conformity assessment – Requirements for bodies providing audit and certification of management systems.

They will issue certification against the relevant management system standard, which may not only be subject specific, such as ISO 9001:2000, Quality management systems – Requirements or ISO 14001:2004, Environmental management systems – Requirements with guidance for use, but may also be sector specific so that, for example, the automotive industry has developed ISO 16949:2002, Quality management systems – Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations and

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the medical devices industry has developed ISO 13485:2003, Medical devices – Quality management systems – Requirements for regulatory purposes.

Certification bodies may also provide certification services to specifications and regulations that may not fall within the accreditation services allowed to UKAS by the government. They will nevertheless follow the same principles and procedures in order to do so. An example of this would be the issue of a certification against the ISO/PAS 28000:2005, Specification for security management systems for the supply chain. A PAS is a document that has been prepared as a specification by a group of people from industry with the assistance of a national or international standardization organization but without going through the full consensus-building process of a standard. After three years the PAS can be renewed for a further three years or developed into a standard, and after six years it must either be developed into a standard or it will be withdrawn from use.

The conformity assessment selection activity is generally straightforward with the customer’s requirements being based on their management system and the applicable management system standards. The method of determination is by audit carried out by qualified auditors together with relevant technical experts, following the guidance in ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing. Further guidance in auditing techniques can also be found by accessing free information on a website managed by the Auditing Practices Group, put together by experts from the relevant ISO technical committees in collaboration with the IAF: http://www.iso.org/tc176/ISO9001AuditingPracticesGroup

Attestation upon successful review and decision takes the form of the issue of a certificate, registration as a certified organization and the issue of a licence to use the certification body’s mark of certification, which may be accompanied by the UKAS crown and tick logo or other accreditation body’s mark.

Although seemingly obvious, it is important to understand that the certification against a management system standard applies only to an organization’s management system. A management system certification mark must not be placed on a product of the organization, thereby giving the false impression that, for example, the product’s quality is certified. The marks may be placed on the organization’s documentation or vehicles and the relevant certificates are also usually displayed in the organization’s offices. Where a product that falls within the scope of the ISO 9001 certificate has also been certified against the relevant product standard, the customer can have

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confidence in the double assurance that the product is produced to the product standard requirements and that product quality, customer satisfaction and continual improvement are assured by the ISO 9001 quality management system requirements.

The certification bodies within the standardized system will also generally belong to an association that provides internal regulation and other benefits to its members, for example the Association of British Certification Bodies (ABCB) (http://www.abcb.demon.co.uk/) in the UK or the Independent International Organisation for Certification (IIOC), which is perhaps more of a club of the world’s multinational certification bodies than a membership regulating association.

The International Certification Network (IQNet) (http://www.iqnet-certification.com/) provides membership benefits including the formation of a multilateral recognition arrangement based on peer assessment.

Services for the certification of products, processes or persons

This is where it all began a long time ago and certification of products can involve almost every aspect of conformity assessment activity in one form or another depending on the particular circumstances of the project.

The specification standard for application by certification bodies to demonstrate their competence to carry out certification services for products and processes upon accreditation is called ISO/IEC Guide 65:1996, General requirements for bodies operating product certification systems. All the other documents that were specification standards but originally called ISO/IEC Guides have for some time been re-designated as ISO/IEC standards in the 17000 series of standards. (They were originally called Guides because they were produced by a policy committee as opposed to a technical committee.) ISO/IEC Guide 65 is the last to convert because the industry that has used the standard has, until now, seen no reason to revise the current version in recent years. This changed in 2006 with a decision to revise the document that will lead to this specification being updated and published as ISO/IEC 17065 around 2009. Until then the UK and other European countries operate to the EN 45011 European Standard that is identical to ISO/IEC Guide 65, which is the standard applied by the rest of the world.

The standard applies to the certification of products, services and processes (using the language that applied before ISO 9000:2000 established that service is one category of product). Application of the

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standard may include the need for inspection activities incorporating the results of testing and calibration activities applying mainly to assessment of tangible hardware and processed material as well as computer software products. Auditing is the main activity in the determination of conformity to requirements of intangible products such as services and other software products, for example authoring books or articles.

The specification standard for bodies providing certification of persons is ISO/IEC 17024:2003, Conformity assessment – General requirements for bodies operating certification of persons. This standard was added to the ISO/IEC series of standards in 2003, adopting the earlier European Standard EN 45013 with minor changes.

Where an organization has implemented an ISO 9001 quality management system and wishes to obtain certification of its products, it is possible for the certification body to achieve reduction in the product certification process, and therefore costs, by operating a scheme that follows the guidance of ISO/IEC Guide 53:2005, Conformity assessment – Guidance on the use of an organization’s quality management system in product certification. This guidance standard provides recommendations on which parts of, and how, the organization’s certified quality management system removes the need for certain conformity assessment activities generally required for the product certification project.

Services for inspection, testing and calibration

The reasons for, and therefore, types of inspection, testing or calibration service that can be undertaken cover almost every aspect of every manufactured product, processed material and the computer software industry and its trading practices.

The organizations offering inspection services will often also provide any or all of the other conformity assessment services as well to a greater or lesser extent. Certainly the multinational conformity assessment bodies fit into this category but there are also small- to medium-sized companies offering very specific inspection services.

Nationally there are associations of organizations that provide inspection services delivering a range of benefits including internal regulation of its members. An example in the UK is the Safety Assessment Federation (SAFed), which, in its own words, ‘is concerned with safety. It represents the UK independent engineering inspection

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and certification industry, which plays a key role in maintaining high standards of safety within the workplace.’(See http://www.safed.co.uk/)

Internationally the International Federation of Inspection Agencies (IFIA) provides a comprehensive service to its members, is a major contributor to the development of relevant international standards such as the standard ISO/IEC 17020:1998, General criteria for the operation of various types of bodies performing inspection which is used for the accreditation, as well as operation of inspection bodies, and also provides specific guides and standards to be followed by relevant sections of its own membership, for example for pre-shipment inspections and certification of inspectors in the petroleum sector. (See http://www.ifia-federation.org/index.html)

The results of the conformity assessment or conformity assessment-like activities of testing and calibration laboratories often provide vital information to other conformity assessment services.

Operation and accreditation of laboratories is performed against ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories assisted for operational purposes by ISO/IEC Guide 43-1:1997, Proficiency testing by interlaboratory comparisons – Part 1: Development and operation of proficiency testing schemes and for accreditation purposes by ISO/IEC Guide 43-2:1997, Proficiency testing by interlaboratory comparisons – Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies.

The British Measurement and Testing Association (BMTA) was created in 1990 in response to the need for an independent ‘lobby’ for the private sector to speak with one voice to government, UKAS, British Standards Institution (BSI) and other official bodies on issues affecting the whole measurement and testing community within the UK. (See http://www.bmta.co.uk/dev/index.htm)

BMTA and other similar national bodies form the European Federation of National Associations of Measurement, Testing and Analytical Laboratories. (See http://www.eurolab.org/)

The wider international laboratory community has the Union Internationale des Laboratoires Indépendants (UILI) to look after their interests and provide the other membership benefits. (See http://www.uili.org/home/home.aspx)

ILAC provides a similar set of benefits to the accreditation bodies but is additionally the organization through which the multilateral agreements based on mutual recognition of accreditation between participating member countries is based. (See http://www.ilac.org/)

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Standardization

The field with which this book is mainly concerned is that of conform-ity assessment of systems, products (including services), processes and persons against standards, regulations and other specification. Direct regulation by national and regional governments forms a major source of specification against which conformity can be required on a manda-tory basis or, more usually, left to be adopted on a voluntary basis. This book refers to regulation but does not set out to explain the forms of or sources of this regulation. However, we feel that a basic understanding of standards and standardization is an important ingredient for aware-ness of the nature and benefits to be obtained by suppliers and cus-tomers from the results of conformity assessment as well as providing distinct benefits from voluntary and strategic adoption.

Possibly due to the fact that the application and use of standards is mainly voluntary, people and organizations generally know of their existence but not much else about them or the process of standardization.

Whether it is the computational system of children in the good old days or the computerized machines of today, the basics of ‘times tables’ is the ‘boring’ input that is absolutely essential to be able to proceed to the ‘fun’ aspects of mathematics, its related disciplines and certainly to innovative application. We would argue that standards and standardization properly performed fulfils a similar function for the world of inter-organizational dealings and trading.

Writing and implementing standards requires a high degree of laborious and, for some, ‘boring’ precision in the use of technical language within the provision and implementation of requirements or recommendations in the interests of safety, quality, good management and/or interoperability. However, with proper development and implementation of these standards the required sound foundation can be laid. Upon such a foundation the ‘fun’ of innovation and full differentiation of organizational operation, production and product can be achieved. The result also delivers a confident sense of reliability for the organization itself and a sense of trust for customers and other interested parties. Badly written standards or improperly applied standards, on the other hand, can stifle innovation, cause confusion to the conscientious and provide a false sense of security for customers and other interested parties as well as the supplier.

As with most words in the English language, the word ‘standard’ has a number of meanings, so we need to explain what is meant by ‘standard’ for the purposes of this book.

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We are concerned with what ISO/IEC Guide 2:2004, Standardization and related activities – General vocabulary refers to as a ‘publicly available standard’ (henceforth reduced to ‘standard’) as opposed to ‘informal standards’ briefly described below. Standards are further defined in ISO/IEC Guide 2 as ‘documents produced by regional, national or international standardization organizations that contain provisions in the form of specification, recommendation or test method’ issued as a benchmark of good practice or, within the EC as technical requirements designed to meet the essential requirements of directives. Standards consisting of vocabularies or glossaries essential to the technical understanding or application of standards are also produced by these bodies.

Informal standards are issued by government departments, local authorities and companies for their own particular purposes and are usually, but not always, developed and published internally. Sometimes others may, with permission, adopt such standards as their own but this is not usual. The production and use of these internal standards also usually involves the authors in setting up their own conformity assessment schemes.

There are now some organizations, or more frequently consortia of organizations, that produce informal standards and make them freely available on the internet; these are then generally called ‘open’ standards.

All of these types of informal standards are as useable for purpose as are formal standards. However, without the rigour and professional expertise that comes from practice applied by the standardization systems that are based on a consensus of as many interested parties as possible, informal and open standards can be variable in terms of their fitness for purpose for general application, from good to very poor.

Standards for us then are issued by recognized national and international standardization bodies. They are generally industry standards for general industry use, having been developed at national level by a combination of the standards body’s expertise in the field of standardization harnessing a wide range of expertise in the subject field, as well as other interested parties such as consumer organizations, appropriate government or local government departments and universities. At international level the range of expertise is broadened even further to include the linguistic and cultural variation of the national representatives chosen to present the views of each country’s experts in the field. The participants at national and international levels are all brought together to facilitate standards based on a consensus of the whole.

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Take-up of these standards is usually voluntary, the exception being a very few examples where national or regional governments pass legislation making conformity to a standard obligatory.

The vast majority of standards are vertically aligned in their application to a specific technical field and contain technical specifications or other precise criteria to be used consistently as rules, guidelines or definitions of characteristics ensuring that materials, products, processes and services are fit for their purpose, safe in use or interoperable between people or organizations working autonomously in the same area of work or on differing parts of a production or supply chain. Most standards are still concerned with engineering, hardware, processed material or software production but an increasing number of standards are now being developed in the more difficult, people-oriented domains of management, services and even corporate ethics.

Most developed and developing countries have standards bodies and it has recently been recognized good practice, and indeed advantageous for all, that the standards bodies representing developed countries should provide positive encouragement and assistance to developing countries to become active in international standardization activities.

The standards bodies that will be referred to most of the time in this book are briefly described below but there are many other European and international standards bodies in existence, some of which we will refer to in passing. We concentrate mainly on BSI, the European Committee for Standardization (CEN) and the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) because they are the most significant players in the development of the policies and standards that provide the conformity assessment system that applies in the UK, which is the place of application used to provide most of the examples given in this book.

These organizations affect standardization as it applies in the UK (see Appendix 2 for their web addresses). We expect that the transfer of concept to other countries will not be difficult. There are two other very significant players that require introduction within this context owing to the pivotal part they play in guiding the standardization and conformity assessment system nationally and internationally: nationally in the UK it is the DTI and internationally it is the Technical Barriers to Trade Committee (TBT) of the World Trade Organization (WTO).

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Standards bodies, the DTI and the regulators

British Standards Institution (BSI)

BSI was founded as the Engineering Standards Committee in 1901 by the professional engineering institutions (civil, mechanical, electrical, iron and steel, and naval architects). In 1918 it became the British Engineering Standards Association and then the British Standards Institution in 1930.

It is generally known as BSI (not ‘the’ BSI) and today is renowned worldwide for its full range of activities, only one of which is the semi-governmental operation, its responsibilities and authorities as the UK’s National Standards Body (NSB). In this capacity it develops and publishes the British national standards operating within an MoU with the DTI. This MoU reinforces the ring fencing of the national standards body function of BSI from its competitive commercial testing and certification services.

European standardization bodies CEN, CENELEC and ETSI

CENELEC and ETSI produce standards related to electrotechnical and telecommunications industries, whereas CEN produces standards for all other domains. All these bodies also develop the technical standards that will satisfy the ‘essential requirements’ of the new approach directives of the European Union (EU). Initially, the EU directives concerned with technical harmonization attempted to spell out every detail of the requirements as primary legislation, under the new approach, the primary legislation in the directives spell out the ‘essential requirements’ leaving the detail to be added by related European standards. These standards, applicable to meeting EU directive essential requirements, are referred to as ‘harmonized documents’ (HDs). Together with implementation of the global approach to conformity assessment, HDs provide confidence in the regulatory requirements concerning safety and quality of goods and services while at the same time ensuring the removal of barriers to trade within the EU. The ‘global approach’ is the name given to the specific set of rules and procedures specifically designed to meet the conformity assessment needs of new approach directives.

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The related system by which goods are demonstrated to satisfy relevant essential requirements that is peculiar to the EU and its member states is the CE Marking system. Dependant on the relevant new approach directive, the producer or importer of goods into the EU must either (self-) declare or obtain (third-party) notification that the goods meet the relevant essential requirements and place the properly designed CE Mark on the goods. Although this system has been specifically designed for application within the European Free Trade Association (EFTA), it also has significance for all other countries whose organizations wish to export goods to the EU since they too need the CE Mark.

Within the European Union it is mandatory for member states to adopt European Standards (ENs) as their national standards but this does not mean that it is mandatory for citizens or organizations within the countries of Europe to adopt the standards – that is purely voluntary unless made mandatory by European legislation.

ISO and the IEC

It will be noticed that the full description of the organization known as ISO does not match in English what appears to be an acronym. This is because it is neither, for the very reason that it is not possible to have an acronym that remains applicable to all languages. ISO was chosen because it is the Greek word for ‘equal’, which is then applicable in any language and conveys the goal to ‘equalize or standardize across cultures’. There are other international standards organizations such as the International Electrotechnical Commission (IEC) that were operational before ISO but for the purposes of this book the more general nature of ISO provides sufficient standardization background for our explanatory needs so we will generally refer to ISO for references to international standards and their process of standardization in this book.

The IEC is nevertheless an extremely important body in the field of standardization. It was formed and was producing standards for the electrotechnical industry long before ISO was formed and it operates certification schemes for the industry, which will be discussed later in this book. Although it takes an active role in the development of conformity assessment policy and application standards through its membership of the ISO Conformity Assessment Standards and Policy Committee (ISO/CASCO) it is ISO/CASCO that takes the lead in this field.

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People and organizations can benefit from not only using standards and conformity assessment services to their greatest effect but also by participating in the consensus-based process by which standards are developed, especially those with international reach such as ISO and the IEC.

This can be achieved by people or organizations contributing to the work of their national standards bodies through trade associations. A significant benefit from such participation is derived from a ‘free’ form of high-level and up-to-date research and development input obtained from the other participants nationally and internationally, along with the ability to influence the standards that are applicable to the industry concerned.

The Department of Trade and Industry

As one of its responsibilities, this department provides UK government input to European and international policy discussions related to European and worldwide action on conformity assessment in all its aspects and the effect that has on British, European and world trading and economic well-being.

This department provides assistance and ‘hands off’ control to the development of standards through its MoU with BSI and it also provides assistance and ‘hands off’ control of the UK’s formal system of conformity assessment activity through a similar MoU with UKAS.

By ‘hands off’ is meant that the DTI does not carry out a day-to-day system of control over either the standardization or conformity assessment activities within the UK but, through its surveillance of the MoUs at relevant meetings with BSI and UKAS, it ensures that these two bodies, entrusted with these two responsibilities and authorities on behalf of the UK, perform their respective roles in the best interests of the UK economy.

The Technical Barriers to Trade Committee (TBT) of the World Trade Organization (WTO)

The WTO is the international organization dealing with the global rules of trade between nations. Its main function is to ensure that trade flows as smoothly, predictably and freely as possible. The TBT was set up to deal with the problems caused by national and regional governments producing legislation creating barriers to trade from outside their

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borders, which included the proliferation of national standards and regional standards setting differing requirements and test methods for goods and services, particularly where this is done with the specific purpose of protecting a home market from outside traders.

The Agreement on Technical Barriers to Trade, or ‘Standards Code’, obliges member nations of the WTO (currently 102) to ensure that technical regulations, voluntary standards and conformity assessment procedures and practices including cost do not create unnecessary obstacles to trade. Annex 3 of the TBT Agreement is the Code of Good Practice for the Preparation, Adoption and Application of Standards and is known as the WTO Code of Good Practice. In accepting the TBT Agreement, WTO members agree to ensure that their central government standardizing bodies accept and comply with this code and agree also to take reasonable measures to ensure that local government, non-governmental and regional standardizing bodies do the same.

The TBT Agreement recognizes the important contribution that international standards and conformity assessment systems can make to improving the efficiency of production and facilitating international trade. Where international standards exist or their completion is imminent, therefore, the Code of Good Practice says that standardizing bodies should use them, or the relevant parts of them, as a basis for the standards they develop. It also aims at the harmonization of standards on as wide a basis as possible, encouraging all standardizing bodies to play as full a part as resources allow in the preparation of international standards by the relevant international body, including ISO and the IEC.

It is for this reason that BSI and other NSBs will have a policy that includes the aim to ‘standardize once by standardizing internationally’, which means starting new standardization work at ISO or IEC level if possible, or if not possible then at European level. If this is not possible new work should begin at national level, i.e. in the UK by BSI.

The WTO were not only made aware of the problems posed by countries presenting potential traders with differing standards but also of each country operating its own conformity assessment regime so that international traders were required not only to conform to a range of similar, but different and sometimes prohibitive, standards but also costs of certification that arose at every country’s borders. To overcome this second barrier the WTO has required its members to encourage the formation of mutual and multilateral arrangements for the recognition of certification and accreditation carried out by participating members from other countries.

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3 The conformity assessment system

This chapter provides basic information about the ‘system’ known by the generic name ‘conformity assessment’, which involves all that is necessary to provide assured demonstration of conformity to standard-ized or other specifications. This knowledge supports the advice offered in the following two chapters.

The information on conformity assessment in this chapter is provided to the extent needed for an informed decision to be made by a supplier of goods or services as to which of the optional paths towards an attestation of conformity will give optimum value for resource in their particular circumstances.

If people and organizations that have the option to do so are to weigh up the pros and cons of doing it all by themselves or totally through the services of third parties they need to have a good idea of what is involved in the process. They need to know something about the functions applicable to all forms of conformity assessment, how these apply in the various forms of conformity assessment and the various types of activity that may be needed.

Equally, as for the suppliers, customers and other users of goods and services, they can also benefit from this level of knowledge and understanding of what is involved in conformity assessment resulting in a particular form of attestation and how that affects them. This is explained in Chapter 5.

The functions of conformity assessment follow a natural flow from start to finish, beginning with the selection function providing all that will be necessary for the determination function, which in turn supplies what is needed for the final review, decision and attestation function.

The standards specifying requirements for conformity assessment bodies and the bodies that accredit them cover general provisions

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