ISO-9000 for Small Business

ISO Management Systems – September-October 2002 37

I N T E R N A T I O N A L

ISO publishes advice for thesmall business on implementingISO 9001:2000A completely revised second edition has been published of the ISO handbook that givessmall and medium-sized enterprises (SME’s) advice on implementing ISO 9000-basedquality management systems. ISO 9001 for Small Businesses aligns the advice with ISO 9001:2000, the single standard which has replaced the 1994 versions of ISO 9001,ISO 9002 and ISO 9003. The handbook explains the standard in plain language, givingexamples to illustrate its application.

John Owen was formerly Directorfor Systems, Management andBusiness with StandardsAustralia International and isnow Corporate Secretary of the International AccreditationForum (IAF).

In addition to being the Convenerof the Small Business Task Group,he was also the Deputy ProjectLeader for the revisions of ISO 9001 and ISO 9004 as wellas the Co-convener of the JointISO/TC 176-ISO/TC 207 TaskGroup dealing with the harmo-nization of ISO 9001 and ISO 14001.

n 1996, ISO published the hand-book, ISO 9000 for Small

Businesses – What to do – Advicefrom ISO/TC 176, which had beenprepared in order to overcome prob-lems that small and medium enter-prises (SME’s) were experiencing intrying to implement the 1994 versionsof ISO 9001, ISO 9002 or ISO 9003.This project had been carried out as a

matter of urgency and the hand-book had been developed over

five meetings in a period ofjust over 10 months. This ISOpublication had used anAustralian Handbook as itsstarting point and whilewell received in that coun-try, no-one had any ideahow successful the inter-national version wouldbecome.

When the revisedISO 9000 series waspublished at the endof 2000, ISO technicalcommittee ISO/TC176, Quality man-agement and qualityassurance, to deter-mine if the hand-book was stillrequired, con-ducted a survey.

E-mail [email protected]

Web www.iaf.nu

BY JOHNOWEN

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38 ISO Management Systems – September-October 2002

It seemed that with the advent of atotally new ISO 9001 which was notonly presented in a completely differ-ent format and contained newrequirements, but was also based on anew philosophy called “ the processmodel ”, there was still a strongdemand for the style and type ofinformation that the handbook hadprovided.

After having accepted the invita-tion to reconvene the Small BusinessTask Group (SBTG), I was informedthat the revision was just as urgentlyrequired as the first edition, but onthis occasion the timetable was eventighter with publication beingrequired within six months using adevelopment programme whichwould only allow for two meetings!

As time was critical, the TaskGroup Secretary, Brian Rowe, andmyself started the work with the cir-culation to ISO/TC 176 of aStandards Australia Handbook forSME’s which had been prepared forthe release of the 2000 versions ofISO 9001 and ISO 9004. This tacticnot only saved a significant amount oftime and effort in that the Task Groupdid not have to start from scratch, oreven adapt the earlier edition of thehandbook, but it also enabled us tofocus immediately on the concernsidentified by ISO/TC 176.

Issues

From the comments received, anumber of key issues were raisedwhich required resolution. Theseincluded :

! The purpose of the handbook wasconfirmed again as being toexplain in clear and simple lan-guage what ISO 9001 requires,using examples to illustrate theapplication of various parts of thestandard.

! The target audience was the smallbusiness operator who has neithertime nor resources to spend onISO 9001 training courses.

! It was not possible to include guid-ance on ISO 9004 as well as ISO9001 without the handbook becom-ing unmanageable in size.

! The existing structure, i.e. the textof the standard followed byexplanatory guidance would beretained.

! The text should not emphasizewhat an auditor would expect, butinstead provide implementationguidance and examples.

! The size of the handbook shouldnot be significantly larger than the1996 edition.

The target audience

was the small business

operator who has

neither time nor

resources to spend on

ISO 9001 training

courses


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As a result the Task Group agreedon a set of operational guidelines todirect the revision and ensure consis-tency. These were :

! Guidance provided should be readin conjunction with the text of thestandard, not in isolation.

! Repeating or paraphrasing thestandard was not guidance.

! The guidance provided must notcreate or even imply requirementsadditional to those of the stan-dard.

! It is not always necessary to havespecific SME guidance as SME’scan often adapt general explana-tions and examples to their ownsituations.

! It is the way or style in which theguidance is expressed that willhelp SME’s and common expres-sions are often better at conveyingthe message more clearly.

! Diagrams should only be used ifthey are instantly understood, oth-erwise they create problems.

Task Group operation

To maximize the contact timeavailable at meetings, the Task Groupoperated through three teams, led byCanada, the United Kingdom andIreland. Each team was responsiblefor separate sections of the handbookand this division of labour paralleledthat used by the drafting groups inthe actual revision of ISO 9001.

At the Birmingham, UnitedKingdom, meeting of ISO/TC 176 inOctober 2001, some countries feltthat they had not had sufficient timeto translate the draft handbook intotheir own languages to ensure itreceived the best opportunity forcomment. As a result, a further three-month comment period was agreedto and a third meeting scheduled toconsider the final comments. In total,over 160 pages of comments werereceived and reviewed over the threeTask Group meetings.

Membership of the Task Group asa whole consisted of delegates fromapproximately 20 countries, plus liai-son representatives from INLAC(the Latin American Institute forQuality) and the United NationsInternational Trade Centre. In addi-tion, the ISO Central SecretariatEditor, Pauline Jones, and the ISO/TC 176 Subcommittee 2 Secretary,Charles Corrie, provided invaluablesupport.

New focuses

The revised guidance offers anumber of improvements which havebeen made in response to user feed-back. As a first step, it summarizesthe significant changes which havebeen made to the revised ISO 9001and includes the eight quality man-agement principles on which the newstandard has been based. This wasfelt to be an important addition as,while ISO 9001 uses these principlesas a foundation, theyare not included inthis standard andthe user has togo to ISO 9000or ISO 9004to findthem.


It summarizes

the significant changes

which have been made

to the revised ISO 9001

and includes the eight

quality management

principles

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Hence, requests to include a sim-ple explanation of terms used in thehandbook were supported by theTask Group. To ensure alignment, theISO 9000 main definition is includedwhere it exists, but without the addi-tional qualifying notes. To this, thehandbook adds its own guidance as tohow the term is applied to the specif-ic field of small business. An explana-tion is also provided for terms whichhave special meaning in standardsand which would not necessarily beunderstood in this context by SME’s.These include shall, should/may,appropriate, suitable and adequate.

Of particular importance is theclarification of the intent of Clause1.2 Application which has beendesigned to provide the necessaryflexibility to cater for those organiza-tions which had an ISO 9002 or ISO9003 quality system.

Emphasis is given to the need toconsider fully all the requirements ineach subclause in Clause 7 Productrealization, as there may be circum-stances where some specific require-ments might need to be includedwhile the rest of the requirements inthat subclause could be excluded. Theoverriding rule is that you cannotleave out any requirement that willaffect the quality of the product orservice and by no means can Clause 7be dealt with simply at the subclauselevel only.

The philosophy of the new ISO9001 process model aligned well withthe message being promoted in theoriginal small business handbook inthat a quality management systemshould not be proposing somethingcompletely different to what the

The Task Group felt that most SME’swould not bother to do so and if thisinformation was to be of benefit, ithad to be contained in the same doc-ument.


A major concern which had beenidentified in using the previous ISO9000 standards was the difficulty inunderstanding the terminology used.It had been suggested that while ISO9000 was available as the referencefor the interpretation of terms, it wasnot regarded as being particularlyuser friendly. Apart from being a sep-arate document which was unlikelyto be purchased by an SME, it tendsto be very clinical and complex.

The text should not

emphasize what an auditor

would expect,

but instead provide

implementation guidance

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clearly indicates that it is notthe intent of ISO 9001 toimpose a totally new way ofmanaging the business and itcertainly does not mean thatthe owner has to change theactual business activities. It isthe means of controlling thebusiness and keeping track ofwhat is happening that has tobe focussed on.

A detailed explanation isoffered for the new Clause8.2.1 Customer satisfactionand the ongoing monitoringrequirements. Advice on howto find out what customers arethinking and the differencebetween satisfaction anddissatisfaction is given.Not having dissatisfiedcustomers does not necessarily mean thatcustomers are satisfied –they might just not besaying anything ! Satis-faction tends to produce

neutral responses while dissatis-faction can produce strong neg-ative responses.

In the new Clause 8.5.1Continual improvement, it isexplained that it should beintended as a recurring activity,i.e. step by step, so that whenopportunities for improvementare identified and justified,decisions need to be made as tohow they can be implementedusing available resources to bringabout positive benefits.

For Clause 7.4 Purchasing, thehandbook deals in detail with thecomplex area of contracting outprocesses, products or services whichis commonly referred to as “ out-sourcing ” or “ subcontracting ”. Itcovers who is responsible, the rela-tionship between outsourcing, yourorganization and your customers,how to ensure that you get what youexpect, plus how to select companieswith the necessary capability to meetyour requirements.

organization is currently doing.Sections on, “ What is an ISO 9001Quality Management System ?”, and,“Why have one?”, strongly empha-size this. The handbook refers tothose organizations which mightalready have a quality system inaccordance with the 1994 editions ofISO 9001, ISO 9002 or ISO 9003 andmakes it quite clear what is necessaryto meet the 2000 version of ISO 9001.

As many SME’s are often quitekeen on trying to implement a systemas much as they can themselvesrather than having to hire someoneelse, the sections on, “ How to start”,“ Do it itself”, “ Use of a consultant”and the comprehensive Annex,“ Steps towards a Quality Manage-ment System”, have all been retainedand revised.

The handbook highlights the factthat all businesses already have someform of a management system inplace and may already be carryingout many of the requirements of thestandard, but have not necessarilystated how they are being done. It


It is not the intent

of ISO 9001

to impose a totally

new way of managing

the business

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As always, the degree to which anorganization needs to provide docu-mentation and to document its proce-dures is a point of contention. Thehandbook clarifies the differentforms of documentation covered bythe standard, those procedures thatabsolutely must be documented andhow to deal with other types of infor-mation.

Where special guidance moduleshave been developed by ISO/TC 176(Frequently Asked Questions, Transi-tion Planning, Clause 1.2 Application,Documentation Requirements, Ter-minology and the Process Approach– all these documents can be accessedfree of charge on ISO’s Web site,www.iso.org) to help users under-


stand the intent of the requirement inthe standard and how it is expectedto be applied, cross references areprovided to these in a comprehensiveBibliography.

ISO 9001 forSmall Businesses

ISO 9001 for Small Businesses(ISBN 92-67-10363-6, English edition), 186 pages, A5 format, hard cover, ring binder, costs 44Swiss francs. A joint publication byISO and the International TradeCentre (ITC – www.intracen.org)UNCTAD/WTO, it is available fromISO’s national member institutes (a complete list is available on ISO’s Web site : www.iso.org), and the ISO Central Secretariat([email protected]).

The full text of ISO 9001:2000 isincluded in boxes, section by section,accompanied by explanations,examples and implementation guidance in everyday terms.

The first edition of the handbookwas eventually published by morethan a dozen of ISO’s national member institutes. French, German,Spanish and Swedish editions of ISO 9001 for Small Businesses arealready planned and other languages will no doubt follow.

Now that the new ISO 9001 forSmall Businesses has been complet-ed, I am confident that it will contin-ue to offer the same style of easy tounderstand guidance and usefulexamples as the first edition. It is alsohoped that it will again receiveworldwide acceptance by SME’s andhelp them to gain a better apprecia-tion of the benefits of ISO 9001.

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ISO-9000 for Small Business

Documents

Transcript of ISO-9000 for Small Business