[QUESTION SUNDAY,

12] 16, 2009

AUGUST

QUALITY POLICY AND QUALITY OBJECTIVES IN ISO 9001:2008

K. R. Singhal QUALITY POLICY Let us begin with the concept of quality policy in QMS. The quality policy of an organization shapes approach of the organization to its customers. A quality policy establishes !i" a commitment to quality# !ii" a commitment to continual impro$ement of the quality management system# !iii" the conte%t for quality ob&ecti$es# an' !i$" how the organization(s ob&ecti$es relate to customers( requirements. A quality policy of an organization must meet the following minimum criteria !a" )t shoul' be lin*e' to o$erall organizational goals# !b" )t shoul' be rele$ant to the nee's an' e%pectations of the customers of the organization. Accor'ingly# the quality policy of an organization must pro$i'e a framewor* for establishing an' re$iewing organization(s quality ob&ecti$es. A quality policy shoul' also inclu'e e%plicit commitments to customer satisfaction an' continual impro$ement. Quality policy of an organization shoul' ha$e a clear statement of outcomes. The policy shoul' ha$e un'erstoo' by the staff of the organization. +ro'uct quality 'epen's both on percei$e' customer satisfaction an' on well moti$ate' staff. ,ere it shoul' be note' that the term -customer satisfaction( coul' refer to both types of customers !a" internal customers !staff of the organization"# an' !b" e%ternal customers !who buy pro'uct from the organization by paying the $alue". There may be a situation that your organization may not ha$e a quality policy# then you shoul' try to 'e$elop a quality policy for your organization. )t is often useful to first 'e$elop the o$erall organization(s policy# inclu'ing policies for mar*eting# sales# pro'uction# finance etc. This e%ercise coul' ma*e the quality policy easier to prepare. .rganization(s commitment to quality shoul' 'escribe organization(s o$erall $ision of what quality means to organization(s business an' its customers. /lause 0.1.2 of )S. 3442 1445 Stan'ar' requires organization to 'ocument quality policy statement. /lause 6.7 of )S. 3442 1445 Stan'ar' frames requirements with regar' to quality policy# which inclu'e to ensure that quality policy is !i" appropriate to the purpose of the organization# !ii" inclu'es a commitment to comply with requirements an' continually impro$e the effecti$eness of the quality management system# !iii" pro$i'es a framewor* for establishing an' re$iewing quality ob&ecti$es# !i$" is

communicate' an' un'erstoo' within the organization# an' !$" is re$iewe' for continuing suitability. Tony 8ohnston !A8 Quality Management /onsulting# )relan'" 'escribes his three fol' approach to writing a quality policy 9 !i" :rite quality policy in a language that anyone can un'erstan'# !ii" Quality policy shoul' be relati$e to the organization an' belie$e by its employees when they rea' it# an' !iii" )t shoul' ma*e reference to the eight quality management principles# namely customer focus# lea'ership !management commitment"# process approach# continual impro$ement# factual approach to 'ecision ma*ing# mutually beneficial supplier relationship# system approach to management# an' in$ol$ement of people. The quality policy shoul' be en'orse' by the managing 'irector an' it shoul' be re$iewe' at least annually for suitability an' up'ate' if necessary. :hile the 8ohn(s approach is goo' for writing quality policy an' in a''ition to his approach if a reference for establishing an' re$iewing quality ob&ecti$es is gi$en in the quality policy# then it will be better.

)f your organization has a quality policy# then you shoul' e$aluate your quality policy. ;$aluate# whether your quality policy clearly lin*e' to your o$erall organizational goals. )f quality policy of your organization is not lin*e' to your organizational goals# then you nee' to re<e%amine your policy an' goals. Also fin' out answers to following questions < =oes the quality policy inclu'e commitment to customer satisfaction> < =oes the quality policy inclu'e commitment to continual impro$ement> < =oes the quality policy inclu'e aspects of ser$ice quality that are to be emphasize'> < =oes the quality policy inclu'e benefits for customers !quality outcomes"> < )s the quality policy focuse' on ma%imizing customer satisfaction with the ser$ices recei$e'> < )s the quality policy focuse' on ma%imizing customer satisfaction with the ser$ice recei$e'> < )s the quality policy focuse' on ma%imizing staff morale in pro$i'ing client ser$ices> .n the basis of answers to abo$e questions# you may wish to re$ise the quality policy of your organization. An illustration of a Quality +olicy ?. !name of the organization" ?. is committe' in achie$ing customer satisfaction by pro$i'ing ? !the quality characteristics of pro'uct pro$i'e' by the organization" ?. @or our customers# in conte%t of continual impro$ement# so that our customers will ? !outcomes in relation to customers( nee's A e%pectations to be met" ?. Another illustration of Quality +olicy :e# ? !name of the organization" ?# manufactures ? !name of the pro'ucts" ?. :e manufacture an' mar*et these pro'ucts both for 'omestic an' abroa' mar*ets. .ur purpose is to pro'uce pro'ucts to satisfy nee's of our customers. :e continually

impro$e our pro'ucts an' ser$ices to satisfy nee's of our customers better. .ur quality management system is 'esigne' to ensure the maintenance of the pro'uct quality through e$aluation# inspection an' $erification processes at all stages of pro'uction. :e are committe' to comply with customer as well as legal requirements an' also committe' to continually impro$e the effecti$eness of our quality management system. .ur organization has 'eci'e' to achie$e quality ob&ecti$es as set in the 'ocumente' statement of quality ob&ecti$es. The top management of our organization in the meeting of boar' of 'irectors# at least once in e$ery si% months# re$iews the quality management system of our organization. QUALITY OBJECTIVES )S. 3442 1445 QMS Stan'ar' requires that organization 'e$elop measurable quality ob&ecti$es# consistent with the quality policy of the organization. )nternal an' e%ternal au'itors re$iew quality ob&ecti$es at each au'it to see if they are being met. @or planning of the quality management system# it is necessary to establish measurable quality ob&ecti$es. Requirements with respect to quality ob&ecti$es are mentione' in clause 6.0.2 of )S. 3442 1445 Stan'ar'. The top management of the organization nee's to establish quality ob&ecti$es. Top management of the organization must ensure that quality ob&ecti$es !inclu'ing those nee'e' to meet requirements for the pro'uct" are establishe' at rele$ant functions an' le$els within the organization. The quality ob&ecti$es must be measurable an' consistent with the quality policy of the organization. /lause B.2 !a" of )S. 3442 1445 QMS Stan'ar' lays 'own that in planning pro'uct realization# the organization must 'etermine quality ob&ecti$es an' requirements for the pro'uct. )t is e$i'ent from this clause that the )S. 3442 1445 Stan'ar' now calls for ob&ecti$es not only for the quality management system but also for the pro'uct. Cow questions arise < ,ow to set or 'e$elop quality ob&ecti$es> < ,ow to monitor quality ob&ecti$es> Developin Q!"li#$ O%&e'#ive(

=e$eloping quality ob&ecti$es pro$i'es the organization with the opportunity to i'entify areas of inefficiency. The organization can a''ress such areas to impro$e customer satisfaction. The Management Representati$e of the organization shoul' frame a committee !with the appro$al of the top management" for 'e$eloping quality ob&ecti$es. This committee shoul' ha$e members from all 'epartments of the organization. The committee members shoul' ha$e conceptual *nowle'ge on )S. 3442 1445 QMS Stan'ar' an' also on eight quality management principles. Members of the committee shoul' be a'$ise' to frame quality ob&ecti$es for their respecti$e 'epartments. Management Representati$e shoul' act as a con$ener an' call a meeting to finalize the quality ob&ecti$es. Quality ob&ecti$es finalize' in such meeting shoul' be sent to the top management for consi'ering the same in the management re$iew meeting an' finalizing them as organization(s quality ob&ecti$es.

@or 'e$eloping measurable quality ob&ecti$es for your organization# you may use a wor*sheet. :or*sheet for creating quality ob&ecti$es may be as un'er < List specific measurable acti$ities that woul' impro$e customer satisfaction. ;%ample 9 Respon'ing to customer(s complaint on the 'ay of its receipt# replying to letters within three 'ays of receipt. < List specific measurable acti$ities that woul' impro$e staff morale. ;%ample 9 Monthly staff fee'bac* on their performance. < List specific measurable acti$ities that woul' impro$e staff efficiency. ;%ample 9 +ro$i'ing computer training to staff. @rom the answers that you woul' ha$e liste' for abo$e questions# you may select quality ob&ecti$es clearly lin*e' to the quality policy of the organization an' for each quality ob&ecti$e# you shoul' specify < :hat is to be 'one> < ,ow often the organization will achie$e the le$el of performance> < The 'ate by which the organization will achie$e that le$el of performance. .n careful stu'y of clause B.2 !a" of )S. 3442 1445 Stan'ar'# you will fin' that the stan'ar' calls for quality ob&ecti$es not only for the quality management system but also for the pro'uct. Quality ob&ecti$es nee' to be realistic an' relate' to achie$able outcomes# such as < Meeting agree' customer requirements for 'eli$ery or other pro'uct characteristics within a certain percentage of time. < Meeting regulatory an' other requirements for pro'uct an' ser$ices. < Meeting the planne' sche'ule for achie$ing the quality ob&ecti$es targets. < )'entifying opportunities for impro$ement. < Minimizing the cost of poor quality# rewor* or scrap. < )'entifying new opportunities. The Stan'ar' also requires that rele$ant ob&ecti$es be establishe' at appropriate parts of the organization. @or e%ample 9 +rocess performance targets# continual impro$ement targets be establishe' at human resources# pro'uction# sales 'epartments. :hen setting up quality ob&ecti$es# loo* for acti$ities or in'icators that employees can relate to an' that can be measure'. A few e%amples may be < Re'ucing the pro'uction time < Achie$ing no failures or 'efects in pro'uction < Achie$ing cost re'uction < )mpro$ing pro'ucti$ity < )ncreasing mar*et share )t is $ery important point that people in the organization must be aware of how they contribute to the achie$ement of the quality ob&ecti$es. Therefore# employees in the organization must *now an' un'erstan' the specific quality ob&ecti$es that ha$e been set up for their functions an' le$el an' how they can achie$e them. @or awareness of quality ob&ecti$es# specific training sessions or campaigns may be organize'. At the ser$ice 'eli$ery# customer interface or at the pro'uction line# quality ob&ecti$es shoul' be $ery simple an' 'irect. Thin* carefully about the quality ob&ecti$es set by you for the organization an' the

timeframe you inten' to allow for them to be achie$e'. Keep in min' that quality ob&ecti$es must be measurable. The organization shoul' be able to chec* that the organization is achie$ing the ob&ecti$e an'# if not# what the organization is going to 'o about the quality management system. )oni#o*in Q!"li#$ O%&e'#ive(

)t is the intention of the )S. 3442 1445 QMS Stan'ar' that the organization is pro'ucing quality pro'uct. Monitoring an' measurement acti$ities are planne' an' carrie' out to carefully impro$e. Question arises 9 how to monitor quality ob&ecti$es> )f we carefully rea' clause 6.D.2 of )S. 3442 1445 QMS Stan'ar'# we will come to *now that it is the responsibility of the top management to ensure continuing suitability# a'equacy an' effecti$eness of the QMS an' to re$iew the organization(s quality management system at planne' inter$als. Re$iew must inclu'e assessing opportunities for impro$ement an' nee' for changes to the quality management system# inclu'ing the quality policy an' quality ob&ecti$es. Quality ob&ecti$es may be monitore' from the input information recei$e' from the following < )nternal an' e%ternal au'its < /ustomer fee'bac* < +rocess performance reports < +ro'uct conformity reports A Management Representati$e !MR" acts a lin* person between the top management an' the organization. ,is role is $ery important for maintaining an' impro$ing the quality management system in the organization. )t is the 'uty of the Management Representati$e to report to the top management on the performance of the quality management system an' any nee' for impro$ement. Accor'ingly# he shoul' monitor quality ob&ecti$es from the input information recei$e' from $arious corners. )t is also important to tell employees in the organization regularly how well specifie' quality ob&ecti$es are being met an' where impro$ements are require'. Quality ob&ecti$es must be re$iewe' an' re$ise' from time to time as part of the continual impro$ement process. Co!*#e($ So!*'e +e,e*en'e( < )S. 3442 1445 QMS Stan'ar' < )S. 3440 1444 < )S. 3442 for small businesses 9 :hat to 'o !8oint publication from )nternational .rganization for Stan'ar'ization an' )nternational Tra'e /entre EC/TA= A :T." < )S. 3442 1444 9 A wor*boo* for ser$ice organizations !8oint publication from )nternational .rganization for Stan'ar'ization an' )nternational Tra'e /entre EC/TA= A :T." < )S. 3442 @itness /hec*er 9 A practical# easy to use chec*list 'esigne' to help SM;s assess their rea'iness for )S. 3442 certification < )mplementing )S. 3442 1444 Quality Management System 9 A Reference Fui'e# =r. =i$ya Singhal an' K. R. Singhal !+ublication from +,) Learning +$t. Lt'.# Cew =elhi" < /omments from Mr. Tony 8ohnston !)relan'" No#e

Author(s profile may be seen at http AAwww.lin*e'in.comAinA*rsinghal

+oste' by Cational /entre for Quality Management# A&mer /entre at 5 13 AM Labels :rite<up

2 comments:

8im sai'... The )S. 3442 process pro$i'es a robust framewor* for impro$ing e$ery organisation(s quality system by a'opting 5 quality management principles

G /ustomer focus G Lea'ership G )n$ol$ement of people G =ocumente' processes G )ntegrate' systems G /ontinuous impro$ement G A factual approach to 'ecision ma*ing G Mutually beneficial supplier relationships

[Question 13] ISO 9001 was first published in 1987. Later, it went through three revisions in 1994, 000 and 008. !he latest version version of the ISO 9001 standard was published on 14th "ove#ber 008. !his is the stru$ture of the standard% &lause 1 S$ope &lause "or#ative referen$e &lause ' !er#s and definitions &lause 4 (ualit) #anage#ent s)ste# &lause * +anage#ent responsibilit) &lause , -esour$e #anage#ent &lause 7 .rodu$t reali/ation &lause 8 +easure#ent, anal)sis and i#prove#ent
!his list of 0re1uentl) 2s3ed (uestions 402(s5 has been prepared b) ISO6!& 17,6S& to support

the publi$ation of ISO 9001% 008 and the revision of ISO 9004. Input has been obtained fro# e7perts and users of the ISO 9000 standards, e7pressed during se#inars and presentations around the world.

!he list will be reviewed and updated on a regular basis to #aintain its a$$ura$), and to in$lude new 1uestions where appropriate. It is intended that this list will also provide a good sour$e of infor#ation for new users of the standards. 0or the latest version of the 02(s, referen$e should be #ade to the open a$$ess web site at www.iso.org6t$17,6s$ . 1. What is ISO?

!he International Organi/ation for Standardi/ation 4ISO5 was established in 1947 and is 4$urrentl)5 an asso$iation of 1,' #e#bers, whi$h ea$h represent their own $ountr). ISO e#plo)s a s)ste# of !e$hni$al &o##ittees, Sub8$o##ittees and 9or3ing :roups to develop International Standards. ;esides the "ational Standards ;odies, ISO per#its other international organi/ations that develop standards to parti$ipate in its wor3, b) a$$epting the# as Liaison #e#bers. ISO wor3s in a$$ordan$e with an agreed set of rules of pro$edure, the ISO/IEC Directives, whi$h also in$lude re1uire#ents on the presentation of standards. 2. Who are the National Standards Bodies, and who represents my country at ISO?

.lease see the relevant page on ISO Online that gives details, in$luding $onta$t infor#ation, of the "ational Standards ;odies. 3. What are the ISO 9 standards ?

!he ISO 9000 standards are a $olle$tion of for#al International Standards, !e$hni$al Spe$ifi$ations, !e$hni$al -eports, <andboo3s and web based do$u#ents on (ualit) +anage#ent. !here are appro7i#atel) * do$u#ents in the $olle$tion altogether, with new or revised do$u#ents being developed on an ongoing basis. 4It should be noted that #an) of the International Standards in the ISO 9000 fa#il) are nu#bered in the ISO 10000 range.5 !. Who is responsi"le #or de$elopin% the ISO 9 standards?

ISO !e$hni$al &o##ittee 4!&5 nu#ber 17, 4ISO6!& 17,5, and its Sub8$o##ittees, are responsible for the develop#ent of the standards. !he wor3 is $ondu$ted on the basis of =$onsensus= a#ong 1ualit) and industr) e7perts no#inated b) the "ational Standards ;odies, representing a wide range of interested parties. &. Where can copies o# the standards "e o"tained?

&opies of the standards #a) be pur$hased fro# )our "ational Standards ;od) 4see list with $onta$t details5, or fro# ISO &entral Se$retariat through the ISO Store of b) $onta$ting the

+ar3eting and &o##uni$ation depart#ent 4sales>iso.org5. +an) "ational Standards ;odies have the# available in lo$al8language versions. '. ? &opies of the ISO 9000 Introdu$tion and Support .a$3age #odules% Where can copies o# the supportin% ISO 9 %uidance notes or other documents "e #ound

:uidan$e on ISO 9001% 008 Sub8$lause 1. ?2ppli$ation? :uidan$e on the @o$u#entation -e1uire#ents of ISO 9001% 008 :uidan$e on the !er#inolog) used in ISO 9001 and ISO 9004 :uidan$e on the &on$ept and Ase of the .ro$ess 2pproa$h for #anage#ent s)ste#s :uidan$e on ?Outsour$ed .ro$esses? as well as details of the (ualit) +anage#ent .rin$iples $an be found at% www.iso.org6t$17,6s$ &opies of the ISO 9001 2uditing .ra$ti$es :roup guidan$e notes. &opies of the san$tioned ISO6!& 17, san$tioned BInterpretationsC of ISO 9001 $an be found at% http%66www.t$17,.org6

(.

Where can in#ormation "e o"tained on the ISO 9

standards?

!here are a nu#ber of sour$es of infor#ation on the ISO 9000 1ualit) #anage#ent s)ste# standards, in$luding ISO?s web site 4www.iso.org5, whi$h $arr) infor#ation on the standards. Dour "ational Standards ;od) should be able to provide $opies of the standards, and registrars6$ertifi$ation bodies will be able to provide guidan$e on registration arrange#ents. ). Why are the standards "ein% re$ised?

ISOEs for#al review pro$ess%

-e1uires $ontinual review to 3eep standards up to date. +ust be initiated within ' )ears of publi$ation of a standard. Aser inputs fro#%

2 global user 1uestionnaire6surve) 2 #ar3et Fustifi$ation Stud) Suggestions arising fro# the interpretation pro$ess Opportunities for in$reased $o#patibilit) with ISO 14001 !he need for greater $larit), ease of use, and i#proved translation &urrent trends%


9.

Geeping up with re$ent develop#ents in #anage#ent s)ste# pra$ti$es. Who is responsi"le #or re$isin% the standards?

!he revision pro$ess is the responsibilit) of ISO !e$hni$al &o##ittee no.17,, Sub8$o##ittee no. 4ISO6!& 17,6S& 5 and is $ondu$ted on the basis of $onsensus a#ong 1ualit) and industr) e7perts no#inated b) ISO +e#ber bodies, and representing all interested parties. 1 . When will the re$ised standards "e a$aila"le?

!he revised 1ualit) #anage#ent s)ste# standards 4ISO 9000, 9001 and 90045 are s$heduled as follows%

11.

ISO 9000% 00* alread) published H no #aIor $hanges e7pe$ted for 009 &urrent plan is for s#all $hanges to ISO 9001 4an Ba#end#entC5 to be published in "ove#ber 008. +ore signifi$ant $hanges are planned for ISO 9004 4a BrevisionC5 to be published in #id 009. *ow much is the implementation o# the new standard %oin% to cost? is to produ$e standards that will #ini#i/e an) potential $osts

One of the goals of ISO6!& 17,6S&

during a s#ooth i#ple#entation. 2n) additional $osts #a) be $onsidered as a value8adding invest#ent. 2 3e) fa$tor in the develop#ent of ISO 9001% 008 was to li#it the i#pa$t of $hanges on users. 12. Where can I o"tain in#ormation on the re$ised standards?

See the ISO &atalogue on ISO Online web site that $arries general infor#ation on the revision progra#. Dour "ational Standards ;od) will give )ou additional infor#ation and the $ertifi$ation6registration bodies will be able to provide guidan$e on transitional arrange#ents in due $ourse. 13. Where can my or%ani+ation %o i# it needs additional clari#ication or interpretation o# the 1,2 ) standard?

ISO 9

!he starting point for an) individual re1uest for an interpretation should be with the en1uirer?s "ational Standards ;od). ISO &entral Se$retariat and ISO6!& 17,6S& $annot a$$ept dire$t re1uests fro# individuals for interpretations of the ISO 9000 standards. ISO6!& 17, has a 9or3ing :roup that onl) a$$epts for#al re1uests for interpretations fro# the "ational Standards ;odies. !he agreed interpretations $an be found at http%66www.t$17,.org6. 1!. Will my or%ani+ation need a #ull reassessment once the re$ised standards are a$aila"le?

!his is pri#aril) an issue between )our organi/ation and )our registration6$ertifi$ation bod). ISO6!& 17, is wor3ing with the I20 4International 2$$reditation 0oru#5 and ISO6&2S&O 4the ISO .oli$) &o##ittee for &onfor#it) 2ssess#ent5 in order to provide relevant infor#ation in a ti#el) #anner. ISO6&2S&O is responsible for the standards to whi$h the &ertifi$ation ;odies wor3 4ISO6IJ& 170 15, and the 2$$reditation ;odies are responsible for #onitoring and approving the perfor#an$e of &ertifi$ation ;odies within their geographi$al area. It is e7pe$ted that $onfor#it) to the new ISO 9001% 008 standard will be evaluated b) $ertifi$ation bodies during regular surveillan$e visits and that full reassess#ent will onl) ta3e pla$e on$e $urrent $ertifi$ates e7pire. <owever, it should be noted that ISO and the I20 have agreed that all $ertifi$ates to ISO 9001 should be upgraded to ISO 9001% 008 within a#ended standard. 1&. Will the re$ised standards "e a$aila"le in my national lan%ua%e immediately a#ter they are )ears of publi$ation of the

pu"lished "y ISO? !he a$tive parti$ipation of e7perts fro# around the world in the preparation of the new standards, and the broad distribution of the draft standards, will fa$ilitate the ti#el) translation of the International Standards. :iven the global i#portan$e of the 1ualit) #anage#ent s)ste# standards, #an) "ational Standards ;odies are alread) wor3ing on the translation issue. ISO itself will publish the new standards in Jnglish and 0ren$h, but if national language translations of the standards are $urrentl) available fro# )our "ational Standards ;od), we e7pe$t that the) will have the translation of the revised standards read) at the ti#e of publi$ation b) ISO or ver) soon thereafter. 0or further details $onta$t )our "ational Standards ;od). 1'. Will my or%ani+ation ha$e to re-write all its documentation?

"o. ISO 9001% 008 doesnEt introdu$e #aIor $hanges to the re1uire#ents, when $o#pared to ISO 9001% 000. <owever, to benefit fro# the $hanges, we suggest )ou get a$1uainted with the new version of the standard and the $larifi$ations introdu$ed. If, during )our anal)sis of the $larifi$ations )ou find there are differen$es fro# )our $urrent interpretation of ISO 9001% 000, then )ou should anal)se the i#pa$t on )our $urrent do$u#entation and #a3e the ne$essar) arrange#ents to update it. It is intended that the a#end#ent of ISO 9001 will have #ini#al or no i#pa$ts on do$u#entation. 1(. Will the re$ised standards address #inancial issues?

0inan$ial issues are not addressed in ISO 9001% 008, whi$h is a re1uire#ents standard.

!he ISO 10014% 00, and ISO 9004% 000, Guidelines for performance improvements standards will e#phasi/e the finan$ial resour$es needed for the i#ple#entation and i#prove#ent of a 1ualit) #anage#ent s)ste#. 1). What are the "ene#its o# the re$ised standards?

0or ISO 9001% 008 the #aIor benefits are%

Si#ple to use &lear in language -eadil) translatable and easil) understandable &o#patibilit) with other #anage#ent s)ste#s su$h as ISO 14001. 0or ISO 9004%

0a$ilitates i#prove#ent in usersE 1ualit) #anage#ent s)ste#s. .rovides guidan$e to an organi/ation for the $reation of a 1ualit) #anage#ent s)ste# that% 8 $reates value for its $usto#ers, via the produ$ts it provides 8 $reates value for all other interested parties 8 balan$es all interested8part) viewpoints.

19.

.rovides guidan$e for #anagers on leading their organi/ation towards sustained su$$ess. 0orward $o#patibilit) to allow organi/ations to build on e7isting 1ualit) #anage#ent s)ste#s. What are the main chan%es in ISO 9 1,2 )?

ISO 9001% 008 has been developed in order to introdu$e $larifi$ations to the e7isting re1uire#ents of ISO 9001% 000 and $hanges that are intended to i#prove $o#patibilit) with ISO 14001% 004. ISO 9001% 008 does not introdu$e additional re1uire#ents nor does it $hange the intent of the ISO 9001% 000 standard. &ertifi$ation to ISO 9001% 008 is not an BupgradeC, and organi/ations that are $ertified to ISO 9001% 000 should be afforded the sa#e status as those who have alread) re$eived a new $ertifi$ate to ISO 9001% 008 2ll $hanges between ISO 9001% 000 and ISO 9001% 008 are detailed in 2nne7 ; to ISO 9001% 008. 2 . What are the main "ene#its to "e deri$ed #rom implementin% an ISO 9 .uality

mana%ement system? !he ISO 9000 standards give organi/ations an opportunit) to in$rease value to their a$tivities and to i#prove their perfor#an$e $ontinuall), b) fo$using on their #aIor pro$esses. !he standards pla$e great e#phasis on #a3ing 1ualit) #anage#ent s)ste#s $loser to the pro$esses of

organi/ations and on $ontinual i#prove#ent. 2s a result, the) dire$t users to the a$hieve#ent of business results, in$luding the satisfa$tion of $usto#ers and other interested parties. !he #anage#ent of an organi/ation should be able to view the adoption of the 1ualit) #anage#ent s)ste# standards as a profitable business invest#ent, not Iust as a re1uired $ertifi$ation issue. 2#ong the per$eived benefits of using the standards are%

!he $onne$tion of 1ualit) #anage#ent s)ste#s to organi/ational pro$esses !he en$ourage#ent of a natural progression towards i#proved organi/ational perfor#an$e, via% 8 the use of the (ualit) +anage#ent .rin$iples 8 the adoption of a =pro$ess approa$h= 8 e#phasis of the role of top #anage#ent 8 re1uire#ents for the establish#ent of #easurable obIe$tives at relevant fun$tions and levels 8 being orientated toward =$ontinual i#prove#ent= and =$usto#er satisfa$tion=, in$luding the #onitoring of infor#ation on =$usto#er satisfa$tion= as a #easure of s)ste# perfor#an$e. 8 #easure#ent of the 1ualit) #anage#ent s)ste#, pro$esses, and produ$t 8 $onsideration of statutor) and regulator) re1uire#ents. 8 attention to resour$e availabilit)

21.

*ow will the implementation o# the amended standard help my or%ani+ation to impro$e its

e##iciency? ISO 9001% 008 ai#s at guaranteeing the effe$tiveness 4but not ne$essaril) the effi$ien$)5 of the organi/ation. 0or i#proved organi/ational effi$ien$), however, the best results $an be obtained b) using ISO 9004 in addition to ISO 9001% 008. !he guiding 1ualit) #anage#ent prin$iples are intended to assist an organi/ation in $ontinual i#prove#ent, whi$h should lead to effi$ien$ies throughout the organi/ation. 22. What "ene#its are there to an or%ani+ation implementin% ISO 9 !?

If a 1ualit) #anage#ent s)ste# is appropriatel) i#ple#ented, utili/ing the eight (ualit) +anage#ent .rin$iples, and in a$$ordan$e with ISO 9004, all of an organi/ation?s interested parties should benefit. 0or e7a#ple% &usto#ers and users will benefit b) re$eiving the produ$ts 4see ISO 9000% 00*, Fundamentals and vocabulary5 that are%

&onfor#ing to the re1uire#ents @ependable and reliable 2vailable when needed

+aintainable .eople in the organi/ation will benefit b)%

;etter wor3ing $onditions In$reased Iob satisfa$tion I#proved health and safet) I#proved #orale I#proved stabilit) of e#plo)#ent Owners and investors will benefit b)%

In$reased return on invest#ent I#proved operational results In$reased #ar3et share In$reased profits Suppliers and partners will benefit b)%

Stabilit) :rowth .artnership and #utual understanding So$iet) will benefit b)%

23.

0ulfil#ent of legal and regulator) re1uire#ents I#proved health and safet) -edu$ed environ#ental i#pa$t In$reased se$urit) /re the standards compati"le with national .uality award criteria?

!he standards are based on 8 (ualit) +anage#ent .rin$iples, whi$h are aligned with the philosoph) and obIe$tives of #ost 1ualit) award progra#s. !hese prin$iples are%

&usto#er fo$us, Leadership, Involve#ent of people, .ro$ess approa$h, S)ste# approa$h to #anage#ent, &ontinual i#prove#ent, 0a$tual approa$h to de$ision #a3ing, and

+utuall) benefi$ial supplier relationships. ISO 9004 re$o##ends that organi/ations perfor# self8assess#ents as part of their #anage#ent of s)ste#s and pro$esses, and in$ludes an anne7 giving guidan$e on this approa$h. !his is si#ilar to #an) 1ualit) awards progra##es.

2!.

Why is the re.uirement #or monitorin% 0customer satis#action0 included in ISO 9

1?

=&usto#er satisfa$tion= is re$ogni/ed as one of the driving $riteria for an) organi/ation. In order to evaluate if a produ$t #eets $usto#er needs and e7pe$tations, it is ne$essar) to #onitor the e7tent of $usto#er satisfa$tion. I#prove#ents $an be #ade b) ta3ing a$tion to address an) identified issues and $on$erns. 2&. 1an the standards impro$e 0customer satis#action0?

!he 1ualit) #anage#ent s)ste# details that are des$ribed in the standards are based on (ualit) +anage#ent .rin$iples that in$lude the =pro$ess approa$h= and =$usto#er fo$us=. !he adoption of these prin$iples should provide $usto#ers with a higher level of $onfiden$e that produ$ts will #eet their needs and in$rease their satisfa$tion. 2'. What is meant "y 0continual impro$ement0?

&ontinual i#prove#ent is the pro$ess fo$used on $ontinuall) in$reasing the effe$tiveness and6or effi$ien$) of the organi/ation to fulfil its poli$ies and obIe$tives. &ontinual i#prove#ent 4where =$ontinual= highlights that an i#prove#ent pro$ess re1uires progressive $onsolidation steps5 responds to the growing needs and e7pe$tations of the $usto#ers and ensures a d)na#i$ evolution of the 1ualit) #anage#ent s)ste#. 2(. What is a process?

2n) a$tivit) or operation, whi$h re$eives inputs and $onverts the# to outputs, $an be $onsidered as a pro$ess. 2l#ost all a$tivities and operations involved in generating a produ$t or providing a servi$e are pro$esses. 0or organi/ations to fun$tion, the) have to define and #anage nu#erous inter8lin3ed pro$esses. Often the output fro# one pro$ess will dire$tl) for# the input into the ne7t pro$ess. !he s)ste#ati$ identifi$ation and #anage#ent of the various pro$esses e#plo)ed within an organi/ation, and parti$ularl) the intera$tions between su$h pro$esses, #a) be referred to as the Kpro$ess approa$hE to #anage#ent. 0or further infor#ation, refer to the paper :uidan$e on the &on$ept and Ase of the .ro$ess 2pproa$h, available fro# www.iso.org6t$17,6s$ . 2). What is the 0process approach0?

!he =pro$ess approa$h= is a wa) of obtaining a desired result, b) #anaging a$tivities and related resour$es as a pro$ess. !he =pro$ess approa$h= is a 3e) ele#ent of the ISO 9000 standards. 0or further guidan$e, please refer to the ISO 9000 Introdu$tion and Support .a$3age #odule% :uidan$e on the &on$ept and Ase of the .ro$ess 2pproa$h for #anage#ent s)ste#s. 29. 1an the 0process approach0 "e applied to other mana%ement systems?

Des. !he =pro$ess approa$h= is a generi$ #anage#ent prin$iple, whi$h $an enhan$e an organi/ationEs effe$tiveness and effi$ien$) in a$hieving defined obIe$tives. 3 . *ow can the 231/ cycle "e used in the 0process approach0?

!he .@&2 $)$le is an established, logi$al, #ethod that $an be used to i#prove a pro$ess. !his re1uires%

4.5 planning 4what to do and how to do it5, 4@5 e7e$uting the plan 4do what was planned5, 4&5 $he$3ing the results 4did things happened a$$ording to plan5 and 425 a$t to i#prove the pro$ess 4how to i#prove ne7t ti#e5. !he .@&2 $)$le $an be applied within an individual pro$ess, or a$ross a group of pro$esses.

31.

1an any or%ani+ation apply the 0process approach0?

Des. +an) organi/ations alread) appl) a =pro$ess approa$h= without re$ogni/ing it. !he) $ould a$hieve additional benefits b) understanding and $ontrolling it. 32. Why should an or%ani+ation apply the 0process approach0?

;) appl)ing the =pro$ess approa$h= an organi/ation should be able to obtain the following t)pes of benefits%

!he integration and align#ent of its pro$esses to enable the a$hieve#ent of its planned results. 2n abilit) to fo$us effort on pro$ess effe$tiveness and effi$ien$). 2n in$rease in the $onfiden$e of $usto#ers and other interested parties as to the $onsistent perfor#an$e of the organi/ation. !ransparen$) of operations within the organi/ation. Lower $osts and shorter $)$le ti#es through effe$tive and effi$ient use of resour$es. I#proved, $onsistent and predi$table results. !he identifi$ation of opportunities for fo$used and prioriti/ed i#prove#ent initiatives. !he en$ourage#ent and involve#ent of people, and the $larifi$ation of their responsibilities. !he eli#ination of barriers between different fun$tional units and the unifi$ation of their fo$us to the obIe$tives of the organi/ation.


33.

I#proved #anage#ent of pro$ess interfa$es. What is meant "y the 4se.uence5 o# processes and their 0interactions0?

!he =se1uen$e= of pro$esses shows how the pro$esses follow, or lin3, to ea$h other to result in a final output. 0or e7a#ple, the output fro# one pro$ess #a) be$o#e the input of the ne7t pro$ess or pro$esses. !he =intera$tions= show how ea$h pro$ess affe$ts or influen$es one or #ore of the other pro$esses. 0or e7a#ple, the #onitoring or $ontrolling of a pro$ess #a) be established in a separate pro$ess. 3!. *ow can the processes in an or%ani+ation "e determined?

Identif) the organi/ation?s intended outputs, and the pro$esses needed for a$hieving the#. !hese will need to in$lude pro$esses for +anage#ent, -esour$es, -eali/ation and +easure#ent and I#prove#ent.

3&.

Identif) all pro$ess inputs and outputs, along with the suppliers and $usto#ers, who #a) be internal or e7ternal. Identif) the se1uen$e and intera$tions of the pro$esses. Should an or%ani+ation de#ine and document all its processes?

!he #ain purpose of do$u#entation is to enable the $onsistent and stable operation of an organi/ation?s pro$esses. 2lthough statutor), standards? or $usto#er re1uire#ents #a) re1uire $ertain do$u#entation, there is no defined B$atalogueC, or list of pro$esses that has to be do$u#ented in ISO 9001, apart fro# the , indi$ated ones. !he organi/ation should deter#ine whi$h pro$esses are to be do$u#ented on the basis of%

!he si/e of the organi/ation and t)pe of its a$tivities, !he $o#ple7it) of its pro$esses and their intera$tions, !he $riti$alit) of the pro$esses and 2vailabilit) of $o#petent personnel. 2 nu#ber of different #ethods $an be used to do$u#ent pro$esses, su$h as graphi$al representations, written instru$tions, $he$3lists, flow $harts, visual #edia, or ele$troni$ #ethods.

3'.

*ow much detail is re.uired in process documentation?

!he e7tent of detail is li3el) to depend upon fa$tors su$h as%

3(.

the si/e of an organisation and its t)pes of a$tivities, the $o#ple7it) of its pro$esses and their intera$tions, and the $o#peten$e 4level of edu$ation, training, s3ills and e7perien$e5 of its personnel. Is there a standard way o# descri"in% a process?

"o, there is no standard wa) to des$ribe a pro$ess. It depends on the $ulture, #anage#ent st)le, staff litera$), personal attributes and their intera$tions. 2 pro$ess #a) be des$ribed using a flow $hart, blo$3 diagra#, responsibilit) #atri7, written pro$edures or pi$tures. .ro$ess flow$harts or blo$3 diagra#s $an show how poli$ies, obIe$tives, influential fa$tors, Iob fun$tions, a$tivities, #aterial, e1uip#ent, resour$es, infor#ation, people and de$ision #a3ing intera$t and6or interrelate in a logi$al order. 3). What should an or%ani+ation do to adopt the 0process approach0?

!o adopt the =pro$ess approa$h= an organi/ation should appl) the following steps%

39.

Identif) the pro$esses of the organi/ation, .lan the pro$esses, I#ple#ent and #easure the pro$esses, 2nal)se the pro$esses, I#prove the pro$esses. What is a 0process owner0?

2 person who is given the responsibilit) and authorit) for #anaging a parti$ular pro$ess is so#eti#es referred to as the =pro$ess owner=. It #a) be useful for an organi/ation?s +anage#ent to appoint individual =pro$ess owners= and to define their roles and responsibilitiesL these should in$lude the responsibilit) for ensuring the i#ple#entation, #aintenan$e and i#prove#ent of their spe$ifi$ pro$ess and its intera$tions. It should be noted, however, that ISO 9001% 008 does not spe$ifi$all) re1uire the appoint#ent of =pro$ess owners=. ! . *ow can a process "e measured?

!here are various #ethods of #easuring pro$ess $ontrols and pro$ess perfor#an$e, ranging fro# si#ple #onitoring s)ste#s up to sophisti$ated statisti$all) based s)ste#s 4e.g. statisti$al pro$ess

$ontrol, or S.&, s)ste#s5. !he sele$tion and use of an) parti$ular #ethod will be dependent on the nature and $o#ple7it) of an organi/ation?s pro$esses and produ$ts. !he effe$tiveness of an individual pro$ess #a) be #easured b) the $onfor#it) of its output or produ$t to $usto#er re1uire#ents. Its effi$ien$) #a) be #easured fro# its use of resour$es. In all $ases the #easure#ent of the pro$ess deter#ines if its 4#easurable5 obIe$tives have been a$hieved. So#eti#es it onl) re1uires #onitoring to $onfir# pro$ess operations. !)pi$al fa$tors that are useful to $onsider when identif)ing #easures of pro$ess $ontrol and pro$ess perfor#an$e in$lude%

!1.

&onfor#it) with re1uire#ents, &usto#er satisfa$tion, Supplier perfor#an$e, On ti#e deliver), Lead ti#es, 0ailure rates, 9aste, .ro$ess $osts. In$ident fre1uen$) What is the di##erence "etween a 0process0 and a 0procedure0?

2 =pro$ess= #a) be e7plained as a set of intera$ting or interrelated a$tivities, whi$h are e#plo)ed to add value. 2 =pro$edure= is a #ethod of des$ribing the wa) or <ow in whi$h all or part of that pro$ess a$tivities shall6should be perfor#ed. ISO 9000% 00* defines a pro$edure as a =spe$ified wa) to $arr) out an a$tivit) or a pro$ess=, whi$h does not ne$essaril) have to be do$u#ented. !2. /n or%ani+ation has a well-esta"lished set o# procedures. 1an these procedures "e used

to help descri"e its processes? Des, if the pro$edures des$ribe inputs and outputs, appropriate responsibilities, $ontrols and resour$es needed to satisf) $usto#er re1uire#ents. !3. What documentation is re.uired "y ISO 9 1?

ISO 9001% 008 refers spe$ifi$all) to onl) , do$u#ented pro$eduresL however, other do$u#entation 4in$luding #ore do$u#ented pro$edures not spe$ifi$all) #entioned in ISO 9001% 0085 #a) be re1uired b) an organi/ation, in order to #anage the pro$esses that are ne$essar) for the effe$tive operation of the 1ualit) #anage#ent s)ste#. !his will var) depending on the si/e of the organi/ation, the 3ind of a$tivities in whi$h it is involved and their $o#ple7it). 0or further guidan$e,

please also refer to the ISO 9000 Introdu$tion and Support .a$3age #odule =:uidan$e on the @o$u#entation -e1uire#ents of ISO 9001% 008= !!. Which standard are or%ani+ations re%istered6certi#ied to?

Organi/ations have their 1ualit) #anage#ent s)ste# registered6$ertified to ISO 9001% 008. !he s$ope of registration6 $ertifi$ation will need to refle$t pre$isel) and $learl) the a$tivities $overed b) the organi/ation?s 1ualit) #anage#ent s)ste#L an) e7$lusion to non8appli$able re1uire#ents of the standard 4per#itted through ISO 9001 $lause 1. =2ppli$ation=5 will need to be do$u#ented and Iustified in the 1ualit) #anual 4see also the ISO6!& 17,6S& ISO 9000 Introdu$tion and Support .a$3age #odule :uidan$e on ISO 9001% 008 $lause 1. ?2ppli$ation?5. !&. What does an or%ani+ation need to do to comply with ISO 9 1?

9hen initiall) starting to use ISO 9001, an organi/ation should fa#iliari/e its personnel with the (ualit) +anage#ent .rin$iples, anal)/e the standards 4espe$iall) ISO 9000 and ISO 90045, and $onsider how their guidan$e and re1uire#ents #a) affe$t )our a$tivities and related pro$esses. If it then wishes to pro$eed to registration6$ertifi$ation, it should perfor# a gap anal)sis against the re1uire#ents of ISO 9001 to deter#ine where its $urrent 1ualit) #anage#ent s)ste# does not address the appli$able ISO 9001% 008 re1uire#ents, before developing and i#ple#enting additional pro$esses to ensure that $o#plian$e will be a$hieved. !'. What will happen to the 2 $ersion o# ISO 9 1?

ISO 9001% 008 will supersede ISO 9001% 000 <owever, noting the I206ISO8&2S&O6ISO !&17, agree#ent that a$$redited $ertifi$ation to the 000 edition should re#ain possible for up to fro# ISO and the national standards bodies during that period, and possibl) for even longer. !(. 1an or%ani+ations remain certi#ied6re%istered to the 2 $ersion? )ears after the publi$ation of ISO 9001% 008, $opies of the 000 edition will still be available on re1uest

Des. &ertifi$ation to ISO 9001% 008 is not an BupgradeC, and organi/ations that are $ertified to ISO 9001% 000 should be afforded the sa#e status as those who have alread) re$eived a new $ertifi$ate to ISO 9001% 008. <owever, $ertifi$ates to ISO 9001% 000 will onl) re#ain valid until )ears after the publi$ation of ISO 9001% 008. &onta$t )our $ertifi$ation6registration bod) to get details on the $ertifi$ates transition pro$ess. !). What will happen to the other standards and documents in the current 72 8 ISO 9

#amily? !he four pri#ar) standards of the $urrent ISO 9000 fa#il) are the following%

ISO 9000% 00* alread) published H no #aIor $hanges e7pe$ted for 009 ISO 9001% 000 to be superseded b) ISO 9001% 008

+ore signifi$ant $hanges are planned for ISO 9004 with a planned publi$ation date of late 009. ISO 19011% 00 is $urrentl) beginning the revision pro$ess, with a new version e7pe$ted in 011. !he other standards and do$u#ents will be reviewed and updated as ne$essar)

!9.

*ow soon can my or%ani+ation see9 certi#ication to ISO 9

1,2

)?

ISO 9001% 008 $ertifi$ates $an onl) be granted after its publi$ation as an International Standard. & . Will I "e a"le to certi#y6re%ister my or%ani+ation to ISO 9 !,2 9?

Sin$e ISO 9004% 009 will be a guidan$e do$u#ent, it is not intended to be used for third part) $ertifi$ation purposes. &1. :y or%ani+ation is thin9in% a"out de$elopin% a ;uality :ana%ement System to ISO 9 1.

Should we wait until the re$ised standards are pu"lished? "o, )ou should not dela) the introdu$tion of the 1ualit) #anage#ent s)ste# in )our organi/ation. Li3e those who are $urrentl) in the pro$ess of being registered6$ertified, an)thing )ou do now to la) the foundation of a 1ualit) #anage#ent s)ste# within )our organi/ation will be benefi$ial. &2. :y or%ani+ation is applyin% #or ISO 9 1 certi#ication in 2 ). What should I do?

Organi/ations in the pro$ess of $ertifi$ation to ISO 9001% 000 are re$o##ended to appl) for $ertifi$ation to ISO 9001% 008, as soon it is published. Ap to its publi$ation )ou $an still appl) for $ertifi$ation to ISO 9001% 000. &3. 1an an or%ani+ation "e certi#ied6re%istered to ISO 9 !?

ISO 9004 is a guidan$e standard, whi$h is not intended to be used for third part) registration6$ertifi$ation purposes. 2 3e) ele#ent of ISO 9004 is the abilit) to perfor# self8 assess#ents. !hird part) 1ualit) #anage#ent s)ste# $ertifi$ations6 registrations are perfor#ed to ISO 9001% 008. &!. Is an or%ani+ation<s ISO 9 1 certi#icate applica"le to all o# its products ?

9hen an organi/ation see3s to have its 1ualit) #anage#ent s)ste# registered6$ertified to ISO 9001% 008, it is re1uired to agree a =s$ope of $ertifi$ation= with its registrar6$ertifi$ation bod). !his will define the produ$ts to whi$h the organi/ation?s 1ualit) #anage#ent s)ste# is appli$able, and against whi$h it will be assessed. 2n organi/ation is not obliged to in$lude within its =s$ope of $ertifi$ation= all the produ$ts that it provides 4note that the ISO 9000% 00* definition of =.rodu$t= in$ludes =servi$es=5, but #a) be sele$tive about those that are in$luded. 2ll appli$able

re1uire#ents of ISO 9001% 008 will need to be addressed b) the organi/ation?s 1ualit) #anage#ent s)ste# that $overs those produ$ts that are in$luded in the =s$ope of $ertifi$ation=. &usto#ers should ensure that a potential supplier?s =s$ope of $ertifi$ation=$overs the produ$ts that the) wish to order. &aveat J#ptorM &&. 9 What can an or%ani+ation do i# it is not a"le to comply with all o# the re.uirements o# ISO 1? ISO 9001 allows for the e7$lusion of so#e of its re1uire#ents 4via $lause 1. B2ppli$ationC5, but onl) if it $an be shown that these re1uire#ents are not appli$able to the organi/ation. J7$lusions are li#ited to the re1uire#ents given in Se$tion 7 4=.rodu$t -eali/ation=5, where individual re1uire#ents #a) onl) be e7$luded if it $an be shown that the) do not affe$t the organi/ation?s abilit) to provide produ$t that #eets $usto#er and appli$able statutor) or regulator) re1uire#ents. Fustifi$ation for su$h e7$lusions is also re1uired to be detailed within the organi/ation?s 1ualit) #anual. 0or e7a#ple, if design a$tivities are not re1uired b) an organi/ation to de#onstrate its $apabilit) to #eet $usto#er and appli$able statutor) 6regulator) re1uire#ents, or if its produ$t is provided on the basis of established design, then it #a) be able to e7$lude so#e of the =design= re1uire#ents but still be able to be registered6$ertified to ISO 9001% 008. 0or further guidan$e, see the ISO 9000 Introdu$tion and Support .a$3age #odule% :uidan$e on ISO 9001% 008 $lause 1. ?2ppli$ation?. &'. *ow will a small or%ani+ation "e a"le to adapt the re.uirements o# ISO 9 1? What

#le=i"ility will "e allowed? !he re1uire#ents of the a#ended ISO 9001% 008 re#ain appli$able to s#all, #ediu#, and large organi/ations ali3e, and su$h organi/ations should a$1uaint the#selves with the $larifi$ations in ISO 9001% 008. ISO6!& 17, has published a handboo3 BISO 9001 for S#all ;usinesses H 9hat to do NC giving spe$ifi$ advi$e to s#all businesses. !he re1uire#ents of ISO 9001 are appli$able to s#all, #ediu#, and large organi/ations ali3e. ISO 9001% 008 provides so#e fle7ibilit), through $lause 1. B2ppli$ationC, on the e7$lusion of $ertain re1uire#ents for spe$ifi$ pro$esses that #a) not be perfor#ed b) the organi/ation. If, for e7a#ple, the nature of )our produ$ts does not re1uire )ou to perfor# design a$tivities, or if )our produ$t is provided on the basis of established design, )ou $ould dis$uss and Iustif) the e7$lusion of these re1uire#ents with )our $ertifi$ation6registration bod) 4see also the ISO 9000 Introdu$tion and Support .a$3age #odule :uidan$e on ISO 9001% 008 $lause 1. ?2ppli$ation?5. <owever, individual organi/ations will still need to be able de#onstrate their $apabilit) to #eet

$usto#er and appli$able statutor) or regulator) re1uire#ents for their produ$ts, and will need to $onsider this when deter#ining the $o#ple7it) of their 1ualit) #anage#ent s)ste#s. 0urther guidan$e for s#all businesses #a) be found in the ISO handboo3% ISO 9001 for S#all ;usinesses H 9hat to do, 2dvi$e fro# ISO6!& 17, &(. What will happen to the ISO hand"oo9 4ISO 9 1 #or Small Businesses5?

It re#ains full) appli$able. 2 proIe$t has been started to update the handboo3 to refle$t the $hanges in ISO 9001% 008. &). What>s the relationship "etween the re$ised ISO 9 1 and ISO 1! 1?

&o#patibilit) with ISO 14001% 004 has been #aintained and enhan$ed. B&o#patibilit)C #eans that $o##on ele#ents of the standards $an be i#ple#ented b) organi/ations in a shared #anner, in whole or in part, without unne$essar) dupli$ation or the i#position of $onfli$ting re1uire#ents. &9. /re there any %uidelines co$erin% ?oint implementation o# ISO 9 1 and ISO 1! 1?

!he two standards are $o#patible. It is not e7pe$ted that an ISO guideline will be prepared on this subIe$t at the present ti#e. If the need for su$h a do$u#ent arises, ISO will $onsider the re1uest as a new proIe$t. <owever, both ISO 9001 and ISO 14001 in$lude an anne7 to show the $orresponden$e between the two standards. ' . Is there a common %uideline standard #or auditin% ;:S and @:S accordin% to ISO 9 1? 1

and 1!

Des, ISO 19011% 00 provides guidelines for 1ualit) and6or environ#ental #anage#ent s)ste#s auditing. "ote that a proIe$t to revise ISO 19011 was started in 008, and is e7pe$ted to be $o#pleted in 011. '1. *ow are the standards applica"le to or%ani+ations that pro$ide ser$ices. ?

!he standards are appli$able to all t)pes of organi/ations, operating in all t)pes of se$tors, in$luding servi$e providers. 4"ote% the definition of the ter# ?produ$t? in ISO 9000% 00* also in$ludes ?servi$es?. ISO 9001% 008 and ISO 9004% 000 have been written to refle$t this definition.5 '2. :y or%ani+ation pro$ides ser$ices. Is the new ISO 9 1,2 ) applica"le to us?

ISO 9001 is e1uall) appropriate to all se$tors, in$luding servi$e providers. !he standard is appli$able to all t)pes of organi/ations.

'3.

What do .uality mana%ement practitioners 7consultant, auditor, or trainer8 need to 9now

a"out the standards? 2s a #ini#u#, 1ualit) #anage#ent pra$titioners should fa#iliari/e the#selves with the re1uire#ents of ISO 9001% 008, and also with the $ontent and philosophies of ISO 9000% 00*, ISO 9004 and the (ualit) +anage#ent .rin$iples. .ra$titioners who are alread) fa#iliar with ISO 9001% 000 should be$o#e aware of the $larifi$ations introdu$ed in ISO 9001% 008, and their i#pli$ations, prior to $ondu$ting audits to that standard, or giving training and $onsultan$). !he) should understand their $lientEs a$tivities and pro$esses, before providing appropriate interpretations of the re1uire#ents of the standards, to add value to the $lient?s operations. ISO6!& 17, has developed the standard ISO 10019 :uidelines for the sele$tion of 1ualit) #anage#ent s)ste# $onsultants and use of their servi$es, whi$h #a) be useful to refer to for further guidan$e. '!. *ow should re%ulatory "odies use the standards?

-egulator) bodies should review their regulations $urrentl) in effe$t 4or under develop#ent5 and identif) points where referen$e to the 1ualit) #anage#ent s)ste# standards would be appropriate, before #a3ing re$o##endations to the legislative bod). '&. What do auditors need to 9now a"out the standards?

2uditors, whether e7ternal or internal, should be able to de#onstrate their $o#peten$e on the stru$ture, $ontent and ter#inolog) of the standards, and also on the underl)ing (ualit) +anage#ent .rin$iples. !he standards re1uire that auditors are able to understand the organi/ation?s a$tivities and pro$esses and appropriatel) audit against the re1uire#ents of the ISO 9001 in relation to the organi/ation?s obIe$tives. 2$$ording to Ioint advi$e fro# the International 2$$reditation 0oru# 4I205, ISO?s .oli$) &o##ittee for &onfor#it) 2ssess#ent 4ISO8&2S&O5 and ISO !& 17,, auditors should be able to de#onstrate $o#peten$) in%

!he re1uire#ents of the ISO 9001% 008. !he $on$epts and ter#inolog) of the ISO 9000% 00*. !he eight (ualit) +anage#ent .rin$iples 2 general understanding of ISO 9004 0a#iliarit) with the auditing guidan$e standard ISO 19011.

ISO6!& 17,, ISO6&2S&O and the I20 have established an ISO 9001 2uditing .ra$ti$es :roup, whi$h has issued a nu#ber of web based guidan$e notes to assist auditors 4see www.iso.org6t$17,6ISO90012uditing.ra$ti$es:roup5 ''. *ow will ISO 9 1,2 ) relate to the needs o# speci#ic "usiness sectors?

ISO 9001% 008 re#ains $o#patible with the e7isting #anage#ent s)ste#s standards for spe$ifi$ business se$tors li3e ISO6!S 1,949, 2S 90006J" 9100 and !L 9000. Asers of a spe$ifi$ se$tor s$he#e are re$o##ended to refer to the organi/ation that is responsible for that se$tor s$he#e, e.g. for%

'(.

ISO6!S 1, 949 refer to the I2!0, !L 9000 refer to the (uJS! 0oru# 0or 2S 90006J" 9100 refer to the I2(: :y or%anisation #ul#ils the ISO 9 1,2 re.uirements. What do I need to do?

2n organi/ation whoEs (+S fulfils the re1uire#ents of ISO 9001% 000 should $he$3 that the) are following the $larifi$ations introdu$ed in the a#ended standard ISO 9001% 008. ISO 9001% 008 has been developed in order to introdu$e $larifi$ations to the e7isting re1uire#ents of ISO 9001% 000. It does not introdu$e additional re1uire#ents nor does it $hange the intent of the ISO 9001% 000 standard. '). What is the impact o# ISO 9 1,2 ) on certi#ication?

&ertifi$ation to ISO 9001% 008 is not an BupgradeC, and organi/ations that are $ertified to ISO 9001% 000 should be afforded the sa#e status as those who have alread) re$eived a new $ertifi$ate to ISO 9001% 008. ISO and the International 2$$reditation 0oru# 4I205 have agreed the following BI#ple#entation .lanC with respe$t to a$$redited $ertifi$ation to ISO 9001% 008% B2$$redited $ertifi$ation to the ISO 9001% 008 shall not be granted until the publi$ation of ISO 9001% 008 as an International Standard. &ertifi$ation of $onfor#it) to ISO 9001% 008 and6or national e1uivalents shall onl) be issued after offi$ial publi$ation of ISO 9001% 008 4whi$h should ta3e pla$e before the end of 0085 and after a routine surveillan$e or re8$ertifi$ation audit against ISO 9001% 008. Oalidit) of $ertifi$ations to ISO 9001% 000

One )ear after publi$ation of ISO 9001% 008 all a$$redited $ertifi$ations issued 4new $ertifi$ations or re8$ertifi$ations5 shall be to ISO 9001% 008. !went) four #onths after publi$ation b) ISO of ISO 9001% 008, an) e7isting $ertifi$ation issued to ISO 9001% 000 shall not be valid.C '9. Is there any way I can participate in the de$elopment o# standards?

Des. If )ou are interested )ou should $onta$t )our "ational Standards ;od) for further details. Infor#ation on ISOEs #e#ber "ational Standards ;odies $an be found at% http%66www.iso.org6iso6about6isoP#e#bers.ht# The follo in! te"t is an inte!ral reproduction of the content of the document #$uality %ana!ement &rinciples#' Introduction !his do$u#ent introdu$es the eight 1ualit) #anage#ent prin$iples on whi$h the 1ualit) #anage#ent s)ste# standards of the ISO 9000% 000 and ISO 9000% 008 series are based. !hese prin$iples $an be used b) senior #anage#ent as a fra#ewor3 to guide their organi/ations towards i#proved perfor#an$e. !he prin$iples are derived fro# the $olle$tive e7perien$e and 3nowledge of the international e7perts who parti$ipate in ISO !e$hni$al &o##ittee ISO6!& 17,, $uality mana!ement and (uality assurance, whi$h is responsible for developing and #aintaining the ISO 9000 standards. !he eight 1ualit) #anage#ent prin$iples are defined in ISO 9000% 00*, $uality mana!ement systems Fundamentals and vocabulary, and in ISO 9004% 000, $uality mana!ement systems Guidelines for performance improvements. !his do$u#ent gives the standardi/ed des$riptions of the prin$iples as the) appear in ISO 9000% 00* and ISO 9004% 000. In addition, it provides e7a#ples of the benefits derived fro# their use and of a$tions that #anagers t)pi$all) ta3e in appl)ing the prin$iples to i#prove their organi/ations? perfor#an$e.

.rin$iple 1% &usto#er fo$us .rin$iple % Leadership .rin$iple '% Involve#ent of people .rin$iple 4% .ro$ess approa$h .rin$iple *% S)ste# approa$h to #anage#ent .rin$iple ,% &ontinual i#prove#ent .rin$iple 7% 0a$tual approa$h to de$ision #a3ing .rin$iple 8% +utuall) benefi$ial supplier relationships

!he ne7t step

2rinciple 1, 1ustomer #ocus Or%ani+ations depend on their customers and there#ore should understand current and #uture customer needs, should meet customer re.uirements and stri$e to e=ceed customer e=pectations. Aey "ene#its% In$reased revenue and #ar3et share obtained through fle7ible and fast responses to #ar3et opportunities. In$reased effe$tiveness in the use of the organi/ation?s resour$es to enhan$e $usto#er satisfa$tion. I#proved $usto#er lo)alt) leading to repeat business. /pplyin% the principle o# customer #ocus typically leads to % -esear$hing and understanding $usto#er needs and e7pe$tations. Jnsuring that the obIe$tives of the organi/ation are lin3ed to $usto#er needs and e7pe$tations. &o##uni$ating $usto#er needs and e7pe$tations throughout the organi/ation. +easuring $usto#er satisfa$tion and a$ting on the results. S)ste#ati$all) #anaging $usto#er relationships. Jnsuring a balan$ed approa$h between satisf)ing $usto#ers and other interested parties 4su$h as owners, e#plo)ees, suppliers, finan$iers, lo$al $o##unities and so$iet) as a whole5.

2rinciple 2, Beadership
Beaders esta"lish unity o# purpose and direction o# the or%ani+ation. Chey should create and maintain the internal en$ironment in which people can "ecome #ully in$ol$ed in achie$in% the or%ani+ation<s o"?ecti$es. Aey "ene#its, .eople will understand and be #otivated towards the organi/ation?s goals and obIe$tives. 2$tivities are evaluated, aligned and i#ple#ented in a unified wa). +is$o##uni$ation between levels of an organi/ation will be #ini#i/ed. /pplyin% the principle o# leadership typically leads to % &onsidering the needs of all interested parties in$luding $usto#ers, owners, e#plo)ees, suppliers, finan$iers, lo$al $o##unities and so$iet) as a whole. Jstablishing a $lear vision of the organi/ation?s future. Setting $hallenging goals and targets. &reating and sustaining shared values, fairness and ethi$al role #odels at all levels of the organi/ation. Jstablishing trust and eli#inating fear. .roviding people with the re1uired resour$es, training and freedo# to a$t with responsibilit) and a$$ountabilit). Inspiring, en$ouraging and re$ogni/ing people?s $ontributions.

2rinciple 3, In$ol$ement o# people

2eople at all le$els are the essence o# an or%ani+ation and their #ull in$ol$ement ena"les their a"ilities to "e used #or the or%ani+ation<s "ene#it. Aey "ene#its, +otivated, $o##itted and involved people within the organi/ation. Innovation and $reativit) in furthering the organi/ation?s obIe$tives. .eople being a$$ountable for their own perfor#an$e. .eople eager to parti$ipate in and $ontribute to $ontinual i#prove#ent. /pplyin% the principle o# in$ol$ement o# people typically leads to, .eople understanding the i#portan$e of their $ontribution and role in the organi/ation. .eople identif)ing $onstraints to their perfor#an$e. .eople a$$epting ownership of proble#s and their responsibilit) for solving the#. .eople evaluating their perfor#an$e against their personal goals and obIe$tives. .eople a$tivel) see3ing opportunities to enhan$e their $o#peten$e, 3nowledge and e7perien$e. .eople freel) sharing 3nowledge and e7perien$e. .eople openl) dis$ussing proble#s and issues.

2rinciple !, 2rocess approach

/ desired result is achie$ed more e##iciently when acti$ities and related resources are mana%ed as a process. Aey "ene#its, Lower $osts and shorter $)$le ti#es through effe$tive use of resour$es. I#proved, $onsistent and predi$table results. 0o$used and prioriti/ed i#prove#ent opportunities.

/pplyin% the principle o# process approach typically leads to, S)ste#ati$all) defining the a$tivities ne$essar) to obtain a desired result. Jstablishing $lear responsibilit) and a$$ountabilit) for #anaging 3e) a$tivities. 2nal)sing and #easuring of the $apabilit) of 3e) a$tivities. Identif)ing the interfa$es of 3e) a$tivities within and between the fun$tions of the organi/ation. 0o$using on the fa$tors su$h as resour$es, #ethods, and #aterials that will i#prove 3e) a$tivities of the organi/ation. Jvaluating ris3s, $onse1uen$es and i#pa$ts of a$tivities on $usto#ers, suppliers and other interested parties.

2rinciple &, System approach to mana%ement

Identi#yin%, understandin% and mana%in% interrelated processes as a system contri"utes to the or%ani+ation<s e##ecti$eness and e##iciency in achie$in% its o"?ecti$es. Aey "ene#its, Integration and align#ent of the pro$esses that will best a$hieve the desired results. 2bilit) to fo$us effort on the 3e) pro$esses. .roviding $onfiden$e to interested parties as to the $onsisten$), effe$tiveness and effi$ien$) of the organi/ation.

/pplyin% the principle o# system approach to mana%ement typically leads to, Stru$turing a s)ste# to a$hieve the organi/ation?s obIe$tives in the #ost effe$tive and effi$ient wa). Anderstanding the interdependen$ies between the pro$esses of the s)ste#. Stru$tured approa$hes that har#oni/e and integrate pro$esses. .roviding a better understanding of the roles and responsibilities ne$essar) for a$hieving $o##on obIe$tives and thereb) redu$ing $ross8fun$tional barriers. Anderstanding organi/ational $apabilities and establishing resour$e $onstraints prior to a$tion. !argeting and defining how spe$ifi$ a$tivities within a s)ste# should operate. &ontinuall) i#proving the s)ste# through #easure#ent and evaluation.

2rinciple ', 1ontinual impro$ement

1ontinual impro$ement o# the or%ani+ation<s o$erall per#ormance should "e a permanent o"?ecti$e o# the or%ani+ation. Aey "ene#its, .erfor#an$e advantage through i#proved organi/ational $apabilities. 2lign#ent of i#prove#ent a$tivities at all levels to an organi/ation?s strategi$ intent. 0le7ibilit) to rea$t 1ui$3l) to opportunities. /pplyin% the principle o# continual impro$ement typically leads to, J#plo)ing a $onsistent organi/ation8wide approa$h to $ontinual i#prove#ent of the organi/ation?s perfor#an$e. .roviding people with training in the #ethods and tools of $ontinual i#prove#ent. +a3ing $ontinual i#prove#ent of produ$ts, pro$esses and s)ste#s an obIe$tive for ever) individual in the organi/ation. Jstablishing goals to guide, and #easures to tra$3, $ontinual i#prove#ent. -e$ogni/ing and a$3nowledging i#prove#ents.

2rinciple (, Dactual approach to decision ma9in%

@##ecti$e decisions are "ased on the analysis o# data and in#ormation Aey "ene#its, Infor#ed de$isions. 2n in$reased abilit) to de#onstrate the effe$tiveness of past de$isions through referen$e to fa$tual re$ords. In$reased abilit) to review, $hallenge and $hange opinions and de$isions.

/pplyin% the principle o# #actual approach to decision ma9in% typically leads to, Jnsuring that data and infor#ation are suffi$ientl) a$$urate and reliable. +a3ing data a$$essible to those who need it. 2nal)sing data and infor#ation using valid #ethods. +a3ing de$isions and ta3ing a$tion based on fa$tual anal)sis, balan$ed with e7perien$e and intuition.

2rinciple ), :utually "ene#icial supplier relationships

/n or%ani+ation and its suppliers are interdependent and a mutually "ene#icial relationship enhances the a"ility o# "oth to create $alue Aey "ene#its, In$reased abilit) to $reate value for both parties. 0le7ibilit) and speed of Ioint responses to $hanging #ar3et or $usto#er needs and e7pe$tations. Opti#i/ation of $osts and resour$es.

/pplyin% the principles o# mutually "ene#icial supplier relationships typically leads to, Jstablishing relationships that balan$e short8ter# gains with long8ter# $onsiderations. .ooling of e7pertise and resour$es with partners. Identif)ing and sele$ting 3e) suppliers. &lear and open $o##uni$ation. Sharing infor#ation and future plans. Jstablishing Ioint develop#ent and i#prove#ent a$tivities. Inspiring, en$ouraging and re$ogni/ing i#prove#ents and a$hieve#ents b) suppliers.

Anderstand the basi$s

Chis section e=plains what %eneric mana%ement system standards are. Eeneric Eeneric #eans that the sa#e standard can "e applied to any or%ani+ation, large or s#all, whatever its produ$t or servi$e, in any sector o# acti$ity, and whether it is a business enterprise, a publi$ ad#inistration, or a govern#ent depart#ent. :ana%ement system :ana%ement system refers to what the organi/ation does to #anage its pro$esses, or a$tivities, so that its produ$ts or servi$es #eet the obIe$tives it has set itself, su$h as%

satisf)ing the customer<s .uality re.uirements, $o#pl)ing with re%ulations, or #eeting en$ironmental o"?ecti$es.

:ana%ement system standards :ana%ement system standards provide a model to #ollow in setting up and operating a #anage#ent s)ste#. !his #odel in$orporates the features on whi$h e7perts in the field have rea$hed a $onsensus as being the international state o# the art. 2lan F 3o F 1hec9 F /ct !he .lan H @o H &he$3 H 2$t 4.@&25 $)$le is the operatin% principle of ISO?s #anage#ent s)ste# standards.

2lan H establish obIe$tives and #a3e plans 4anal)/e )our organi/ation?s situation, establish )our overall obIe$tives and set )our interi# targets, and develop plans to a$hieve the#5. 3o H i#ple#ent )our plans 4do what )ou planned to5.

1hec9 H #easure )our results 4#easure6#onitor how far )our a$tual a$hieve#ents #eet )our planned obIe$tives5. /ct H $orre$t and i#prove )our plans and how )ou put the# into pra$ti$e 4$orre$t and learn fro# )our #ista3es to i#prove )our plans in order to a$hieve better results ne7t ti#e5.

ISO 14000 essentials

Chis section concisely descri"es the essential #eatures o# the ISO 1! #amily. !he ISO 14000 fa#il) addresses various aspe$ts of environ#ental #anage#ent. !he ver) first two standards, ISO 1! 1,2 ! and ISO 1! !,2 ! deal with environ#ental #anage#ent s)ste#s 4J+S5. ISO 14001% 004 provides the re.uirements for an J+S and ISO 14004% 004 gives general J+S %uidelines. !he other standards and guidelines in the fa#il) address spe$ifi$ environ#ental aspe$ts, in$luding% labeling, perfor#an$e evaluation, life $)$le anal)sis, $o##uni$ation and auditing. /n ISO 1! 1,2 !-"ased @:S

2n J+S #eeting the re1uire#ents of ISO 14001% 004 is a #anage#ent tool enabling an organi/ation of an) si/e or t)pe to%

identif) and $ontrol the en$ironmental impact of its a$tivities, produ$ts or servi$es, and to impro$e its environ#ental perfor#an$e $ontinuall), and to i#ple#ent a systematic approach to setting environ#ental obIe$tives and targets, to a$hieving these and to de#onstrating that the) have been a$hieved.

*ow it wor9s ISO 14001% 004 does not spe$if) levels of environ#ental perfor#an$e. If it spe$ified levels of environ#ental perfor#an$e, the) would have to be spe$ifi$ to ea$h business a$tivit) and this would re1uire a spe$ifi$ J+S standard for ea$h business. !hat is not the intention. ISO has #an) other standards dealing with spe$ifi$ environ#ental issues. !he intention of ISO 14001% 004 is to provide a #ramewor9 #or a holistic, strate%ic approach to the organi/ation?s environ#ental poli$), plans and a$tions. ISO 14001% 004 gives the %eneric re.uirements for an environ#ental #anage#ent s)ste#. !he underl)ing philosoph) is that whatever the organi/ation?s a$tivit), the re1uire#ents of an effe$tive J+S are the sa#e.

!his has the effe$t of establishing a common re#erence for $o##uni$ating about environ#ental #anage#ent issues between organi/ations and their $usto#ers, regulators, the publi$ and other sta3eholders. ;e$ause ISO 14001% 004 does not la) down levels of environ#ental perfor#an$e, the standard $an to be i#ple#ented b) a wide $ariety o# or%ani+ations, whatever their $urrent level of environ#ental #aturit). <owever, a commitment to compliance with appli$able environ#ental legislation and regulations is re1uired, along with a $o##it#ent to continual impro$ement H for whi$h the J+S provides the fra#ewor3. Che @:S standards ISO 1! !,2 ! provides %uidelines on the ele#ents of an environ#ental #anage#ent s)ste#

and its i#ple#entation, and dis$usses prin$ipal issues involved. ISO 1! 1,2 ! spe$ifies the re.uirements for su$h an en$ironmental mana%ement system.

0ulfilling these re1uire#ents de#ands obIe$tive eviden$e whi$h $an be audited to de#onstrate that the environ#ental #anage#ent s)ste# is operating effe$tivel) in $onfor#it) to the standard. What can "e achie$ed ISO 14001% 004 is a tool that $an be used to #eet internal o"?ecti$es%

pro$ide assurance to mana%ement that it is in $ontrol of the organi/ational pro$esses and a$tivities having an i#pa$t on the environ#ent assure employees that the) are wor3ing for an environ#entall) responsible organi/ation. ISO 14001% 004 $an also be used to #eet e=ternal o"?ecti$es%

provide assuran$e on environ#ental issues to e=ternal sta9eholders H su$h as $usto#ers, the $o##unit) and regulator) agen$ies $o#pl) with environ#ental regulations support the organi/ation?s claims and communication about its own environ#ental poli$ies, plans and a$tions provides a fra#ewor3 for demonstratin% con#ormity via suppliers? de$larations of $onfor#it), assess#ent of $onfor#it) b) an e7ternal sta3eholder 8 su$h as a business $lient 8 and for $ertifi$ation of $onfor#it) b) an independent $ertifi$ation bod).

Introdu$tion and support pa$3age% :uidan$e on the !er#inolog) used in ISO 9001 and ISO 9004

Document ISO/TC )*+/SC ,/- .,+/, October ,001

1.

Introduction

:reat $are has been ta3en during the develop#ent of ISO 9001 and ISO 9004 to use the $orre$t Jnglish words and ter#s to des$ribe their $on$epts and re1uire#ents, to assist in their readabilit) and translation. !he obIe$tive is to use si#ple te$hni$all) a$$urate ter#s, and to the greatest e7tent possible, rel) on $o##on di$tionar) definitions. 2s with #ost te$hni$al subIe$ts, there are so#e ter#s that have a ver) spe$ifi$ #eaning different fro# the $o##on di$tionar) oneL in su$h $ases, the appropriate te$hni$al definition is provided in one of the following%

ISO 9000% 00*, $uality mana!ement systems 2 Fundamentals and 3ocabulary ISO6IJ& :uide % 004, Standardi4ation and related activities 5 General vocabulary ISO6IJ& @ire$tives 8 .art % 004, /ules for the Structure and draftin! of International Standards ISO6IJ& :uide 99% 007, International 3ocabulary of %etrolo!y 5 6asic and General Concepts and 7ssociated Terms 83I%9 In all other $ases, for the purpose of this guidan$e, definitions are sele$ted fro# the &on$ise O7ford @i$tionar). @efinitions in ISO 9000% 00* have nor#ative status, whi$h ta3es pre$eden$e over their $o##on di$tionar) definitions. !he table below provides the sele$ted di$tionar) definitions for $o##on words, whi$h should be applied when using the standards.

2.
9ord

Ca"le o# important words and terms used in the ISO 9

0or# noun noun noun noun +eaning

#amily o# Standards

a$$ordan$e a$tivit) ade1ua$) adIust#ent

4In a$$ordan$e with5 in a #anner $onfor#ing with so#ething done in pursuit of an obIe$tive suffi$ien$) to satisf) a re1uire#ent or #eet a need operation of bringing a #easuring instru#ent into a state of perfor#an$e suitable for its use QOI+R

anal)sis appropriate appli$able

noun adIe$tive adIe$tive

@etailed e7a#ination of the ele#ents or stru$ture of so#ething suitable 4for, to5 8 relevant 8 appropriate

assess

verb

8 evaluate 8 esti#ate the value of

assure

verb

s)non)#% ensure #a3e $ertain

authorit)

noun

8 right to $o##and or give a final de$ision 8 bod) that has legal powers and rights

available awareness $alibration

adIe$tive noun noun

able to be used or obtained 3nowledge or per$eption of a situation or fa$t 8 set of operations that establish, under spe$ified 8 $onditions, the relationship between values of 8 1uantities indi$ated b) a #easuring instru#ent 8 or #easuring s)ste#, or values represented b) 8 a #aterial #easure or a referen$e #aterial, and 8 the $orresponding values reali/ed b) standards 8 QOI+R

$an

verb

SO6IJ& @ire$tives .art 8 be able to

2nne7 :

8 there is a possibilit) of 8 it is possible to $annot verb ISO6IJ& @ire$tives .art 8 be unable to 8 there is no possibilit) of 8 it is not possible to state of being dedi$ated to a $ause or poli$) $o##it#ent $o##uni$ation $o#plain $o#pl) $o#pro#ise noun noun verb verb noun state of being dedi$ated to a $ause or poli$) a$tion of sharing or e7$hanging infor#ation ideas e7press dis$ontent, displeasure 4person or organi/ation5 #eet spe$ified standards support or establish the $ertaint) or validit) of 2nne7 :

$onfir# $onsistent $onsistentl) $ontrol

verb adIe$tive adverb noun

4ite#5 #eet spe$ified re1uire#ents 4$onsistent with5 $onfor#ing to or in agree#ent with un$hanging over ti#e 8 power to dire$t or to restrain so#ething 8 #eans of restraining or regulating

$ontrol

verb

8 dire$t or restrain so#ething 8 restrain or regulate

data

noun

8 fa$ts and6or statisti$s, used for referen$e or anal)sis 8 infor#ation based on fa$ts

defi$ien$) define de#onstrate deplo) deplo)#ent deter#ine distribution disposition do$u#entation

noun verb verb verb noun verb noun noun noun

la$3 or shortage state or des$ribe e7a$tl) the nature, s$ope or #eaning of show $learl) 4with obIe$tive eviden$e5 put into use or a$tion i#ple#entation establish or find out with $ertaint) b) resear$h, e7a#ination or $al$ulation a$t of allo$ating to re$ipients a$tion of dealing with things in a parti$ular wa) see "ote to ISO 9000% 00* $lause '.7.

2 set of do$u#ents, for e7a#ple spe$ifi$ations and re$ords, is fre1uentl) $alled Bdo$u#entationC. enhan$e ensure verb verb I#prove the 1ualit), value or e7tent of s)non)#% assure #a3e $ertain essential establish evaluate adIe$tive verb verb absolutel) ne$essar), funda#ental set up assess

e7$lusion

noun

8 pro$ess or state of 3eeping out or preventing the o$$urren$e of 8 ite# or eventualit) spe$ifi$all) not $overed

e7pe$tation

noun

8 belief about 4or #ental pi$ture of5 the future 8 wishing with $onfiden$e of fulfil#ent

e7perien$e fa$ilitate

noun verb

pra$ti$al $onta$t with and observation of fa$ts and events 8 #a3e eas) or easier 8 pro#ote, help forward 4an a$tion, result, et$.5

fa$ilit) feedba$3

noun noun

building, servi$e or pie$e of e1uip#ent provided for a parti$ular purpose infor#ation given in response to a produ$t, a personEs perfor#an$e of a tas3, et$., used as a basis for i#prove#ent

fo$us fra#ewor3 fun$tional hardware

noun noun adIe$tive noun

$entre of interest or a$tivit) essential supporting or underl)ing stru$ture designed to be pra$ti$al and useful rather than attra$tive see the definition of Bprodu$tC in ISO 9000% 00* $lause '.4.

identif) identit)

verb noun

establish the identit) of so#eone or so#ebod) the individual $hara$teristi$s b) whi$h a thing or person is re$ogni/ed or 3nown

identifiable i#partialit) i#ple#ent i#prove#ent

adIe$tive noun verb noun

re$ogni/able through a uni1ue $hara$teristi$ state of being without preIudi$e or bias put into effe$t a$tion or pro$ess of #a3ing or be$o#ing better, also see B$ontinual i#prove#entC and B1ualit) i#prove#entC in this table.

independent 4noun% independen$e5

adIe$tive

8 not $onne$ted with anotherL separate 8 not subIe$t to anotherEs authorit)

integrit)

noun

8 state of being wholeL the $ondition of being unified or sound in $onstru$tion 8 1ualit) of having strong #oral prin$iples

irrespe$tive Iustifi$ation learning organi/ation legible liaison #aintain #aintenan$e

adIe$tive noun noun

in spite of ever)thing eviden$e proving that so#ething is right or reasonable institution, pla$e, organi/ation, et$. where the $ognitive pro$ess of a$1uiring s3ill and 3nowledge is $arried out

adIe$tive noun verb noun

possible to be read b) a person or a #a$hine for intended use $o##uni$ation or $ooperation between people or organi/ations $ause or enable 4a $ondition or state of affairs5 to $ontinue pro$ess or state of 3eeping 4a s)ste#, building, #a$hine, et$5 in good $ondition b) $he$3ing or repairing it regularl)

#a)

verb

ISO6IJ& @ire$tives .art 8 is per#itted 8 is allowed 8 is per#issible

2nne7 :

#easurable #easure

adIe$tive verb

adIe$tiveable to be #easured as$ertain the si/e, a#ount, or degree of 4so#ething5 b) $o#parison with a standard unit or with an obIe$t of 3nown si/e

#ethodolog) #onitor

noun verb

s)ste# of #ethods used in a parti$ular field observe and $he$3 over a period of ti#eL #aintain regular $lose observation over

ne$essar) need obIe$tive obIe$tive

adIe$tive noun noun adIe$tive

re1uired to be done, a$hieved or present so#ething that is wanted or re1uired so#ething to be a$hieved not influen$ed b) personal feelings or opinions in $onsidering or representing fa$ts

obsolete origin outsour$e

adIe$tive noun verb

no longer produ$ed or usedL out of date point at whi$h so#ething begins or arises obtain goods or servi$es fro# an outside supplier

per$eption

noun

wa) of regarding, understanding or interpreting so#ething

perfor#an$e

noun

8 the abilit) to a$hieve so#ething 8 the a$hieve#ent itself

periodi$

adIe$tive

8 re$urring or reappearing at regular or an) intervals 4of ti#e or spa$e5 8 inter#ittent

per#issible

adIe$tive

8 that $an or ought to be per#itted 8 allowable

personal 1ualifi$ation ph)si$al plan

noun

attribute that #ust be #et or $o#plied with and that fits a person for so#ething

adIe$tive noun

tangible or $on$rete s$he#e, progra##e or #ethod wor3ed out beforehand for the a$$o#plish#ent of an obIe$tive

plan preservation prevention previous pro$ess approa$h

verb noun noun adIe$tive noun

de$ide on and arrange in advan$e a$tion or a$t of #aintaining so#ething in its original or e7isting state a$tion of 3eeping so#ething fro# happening or arising e7isting or o$$urring before so#ething else in ti#e or in order s)ste#ati$ identifi$ation and #anage#ent of the pro$esses e#plo)ed within an organi/ation and parti$ularl) the intera$tions between su$h pro$esses

pro#ote propert) prote$t 1uotation

verb noun verb noun

further the progress of, support or en$ourage thing or things belonging to a person, persons or organi/ation 3eep safe fro# da#age $ontra$torEs 4supplierEs5 esti#ate for a spe$ified

Iob, et$. rationale reali/ation re$ogni/e regulator) relevant re1uire resour$e responsibilit) noun noun verb adIe$tive adIe$tive verb noun noun e7position of prin$iples or reasons a$tion of a$hieving so#ething desired or anti$ipatedL fulfil#ent be full) aware of re1uired, per#itted or ena$ted b) a rule or dire$tive passed b) an authorit) $losel) $onne$ted or appropriate to the #atter in hand need be$ause it is essential to the fulfil#ent of so#ething sto$3 or suppl) of #aterials or assets so#ething whi$h a person or organi/ation is re1uired to do or $ontrol as part of a Iob, role or legal obligation responsible adIe$tive having an obligation to do so#ething or having $ontrol over or $are for so#eone retain retrievable safeguard s$ope verb adIe$tive verb noun 3eep possession ofL not abolish, dis$ard or alter $apable of being brought ba$3 prote$t or prevent so#ething undesirable 4fro# happening5 e7tent of the area or subIe$t #atter that so#ething deals with or to whi$h it is relevant se1uen$e shall noun verb a parti$ular order in whi$h related events, #ove#ents, et$, follow ea$h other ISO6IJ& @ire$tives .art 8 is to 8 is re1uired to 8 it is re1uired that 8 has to 8 onl) S is per#itted 8 it is ne$essar) shall not verb ISO6IJ& @ire$tives .art 2nne7 : 2nne7 :

8 is not allowed Qper#ittedR Qa$$eptableR Qper#issibleR 8 is re1uired to be not

8 is re1uired that S be not 8 is not to be should verb ISO6IJ& @ire$tives .art 2nne7 :

8 it is re$o##ended that 8 ought to should not verb ISO6IJ& @ire$tives .art 2nne7 :

8 it is not re$o##ended that 8 ought not to s3ill software noun noun abilit) to do so#ething well see definition of Bprodu$tC in ISO 9000% 00* $lause '.4. spe$ifi$ spe$if) statutor) adIe$tive verb adIe$tive of or relating to a parti$ular subIe$t state e7pli$itl), $learl) and definitel) re1uired, per#itted or ena$ted b) a written law passed b) a bod) having the power to #a3e laws strateg) suitabilit) suitable suppl) s)ste#ati$ training noun noun adIe$tive verb adIe$tive noun an elaborate and s)ste#ati$ plan of a$tion $hara$teristi$s that are right or appropriate for a parti$ular purpose right or appropriate for a parti$ular purpose #a3e available for use done or a$ting a$$ording to a fi7ed plan or s)ste#L #ethodi$al a$t of tea$hing a parti$ular s3ill or t)pe of behaviour through pra$ti$e and instru$tion una#biguous utilities validate validit) verif) adIe$tive noun verb noun verb having onl) one #eaning servi$es su$h as gas, water, ele$tri$it), tele$o##uni$ation, et$. $arr) out validation, see ISO 9000% 00* $lause '.8.* $onfor#it) to fa$t, a$$ura$) or pre$ision $arr) out verifi$ation, See ISO 9000% 00* $lause '.8.4

wor3spa$e

noun

area in whi$h wor3 is perfor#ed

Introdu$tion and support pa$3age% :uidan$e on the $on$ept and use of the pro$ess approa$h for #anage#ent s)ste#s
Document: ISO/TC )*+/SC ,/-.;;/< October ,001

1.

Introduction

!his guidan$e do$u#ent provides an understanding of the $on$epts, intent and the appli$ation of the Bpro$ess approa$hC to the ISO 9000 fa#il) of (ualit) +anage#ent S)ste# standards. !he guidan$e #a) also be used to appl) the pro$ess approa$h to an) #anage#ent s)ste# regardless the t)pe or the si/e of organi/ation. !his in$ludes but is not li#ited to #anage#ent s)ste#s for%

Jnviron#ent 4ISO 14000 fa#il)5, O$$upational <ealth and Safet), ;usiness -is3, So$ial -esponsibilit). !his guide also ai#s to pro#ote a $onsistent approa$h to the des$ription of pro$esses and use of pro$ess related ter#inolog). !he purpose of the pro$ess approa$h is to enhan$e an organi/ationEs effe$tiveness and effi$ien$) in a$hieving its defined obIe$tives. In relation to ISO 9001% 008 this #eans enhan$ing $usto#er satisfa$tion b) #eeting $usto#er re1uire#ents. ;enefits of the pro$ess approa$h are%

Integration and align#ent of pro$esses to enable a$hieve#ent of desired out$o#es 2bilit) to fo$us effort on pro$ess effe$tiveness and effi$ien$). .rovision of $onfiden$e to $usto#ers, and other interested parties, about the $onsistent perfor#an$e of the organi/ation. !ransparen$) of operations within the organi/ation. Lower $osts and $reation of shorter $)$le ti#es, through the effe$tive use of resour$es. I#proved, $onsistent and predi$table results. .rovision of opportunities for fo$used and prioriti/ed i#prove#ent initiatives. Jn$ourage#ent of the involve#ent of people and the $larifi$ation of their responsibilities.

2.

What is a process?

2 B.ro$essC $an be defined as a Bset of interrelated or intera$ting a$tivities, whi$h transfor#s inputs into outputsC. !hese a$tivities re1uire allo$ation of resour$es su$h as people and #aterials. Fi!ure ) shows a generi$ pro$ess. 2 #aIor advantage of the pro$ess approa$h, when $o#pared to other approa$hes, is in the #anage#ent and $ontrol of the intera$tions between these pro$esses and the interfa$es between the fun$tional hierar$hies of the organi/ation 4as further e7plained in se$tion 45.

Figure 1 - Generic process

Inputs and intended outputs #a) be tangible 4su$h as e1uip#ent, #aterials or $o#ponents5 or intangible 4su$h as energ) or infor#ation5. Outputs $an also be unintended, su$h as waste or pollution. Ja$h pro$ess has $usto#ers and other interested parties 4who #a) be either internal or e7ternal to the organi/ation5, with needs and e7pe$tations about the pro$ess, who define the re1uired outputs of the pro$ess. 2 s)ste# should be used to gather data to provide infor#ation about pro$ess perfor#an$e, whi$h should then be anal)/ed to deter#ine if there is an) need for $orre$tive a$tion or i#prove#ent. 2ll pro$esses should be aligned with the obIe$tives, s$ope and $o#ple7it) of the organi/ation, and should be designed to add value to the organi/ation.

.ro$ess effe$tiveness and effi$ien$) $an be assessed through internal or e7ternal review pro$esses.

3.
3.1

Cypes o# processes
Ge#erences to processes in ISO 9 1,2 ),

ISO 9001% 008 states% In sub $lause 0.1 :eneral% =The desi!n and implementation of an or!ani4ation>s (uality mana!ement system is influenced by: its business environment, chan!es in that environment, or ris?s associated ith that environment@ its varyin! needs@ its particular obAectives@ the products it provides@ the processes it employs@ its si4e and or!ani4ational structure' It is not the intent of this International Standard to imply uniformity in the structure of (uality mana!ement systems or uniformity of documentationB' In sub $lause 0. .ro$ess 2pproa$h% =The application of a system of processes ithin an or!ani4ation, to!ether ith the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the =process approach=' In sub $lause 4.1 :eneral re1uire#ents% =The or!ani4ation shall establish, document, implement and maintain a (uality mana!ement system and continually improve its effectiveness in accordance ith the re(uirements of this International Standard' The or!ani4ation shall: a9 determine the processes needed for the (uality mana!ement system and their application throu!hout the or!ani4ation 8see )',9, b9 determine the se(uence and interaction of these processes, c9 determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d9 ensure the availability of resources and information necessary to support the operation and monitorin! of these processes, e9 monitor, measure 8 here applicable9, and analyse these processes, and f9 implement actions necessary to achieve planned results and continual improvement of these processes' These processes shall be mana!ed by the or!ani4ation in accordance ith the re(uirements of this International StandardB' ;ased on the above, ea$h organi/ation should define the nu#ber and t)pe of pro$esses needed to fulfil its business obIe$tives. It is per#issible for a pro$ess that is re1uired b) ISO 9001% 008 to be part of a pro$ess 4or pro$esses5 that is alread) established b) the organi/ation, or to be defined b) the organi/ation in ter#s that are different to those in ISO 9001. 3.2 Cypical types o# processes that can "e identi#ied,

In a$$ordan$e with '.1 above, organi/ations have to define the nu#ber and t)pes of pro$esses needed to fulfil their business obIe$tives. 9hile these will be uni1ue to ea$h organi/ation, it is however possible to identif) t)pi$al pro$esses, su$h as%

&rocesses for the mana!ement of an or!ani4ation' !hese in$lude pro$esses relating to strategi$ planning, establishing poli$ies, setting obIe$tives, ensuring $o##uni$ation, ensuring availabilit) of resour$es for the other organi/ationEs 1ualit) obIe$tives and desired out$o#es and for #anage#ent reviews.

&rocesses for mana!in! resources' !hese in$lude all the pro$esses that are ne$essar) to provide the resour$es needed for the organi/ationEs 1ualit) obIe$tives and desired out$o#es. /eali4ation processes' !hese in$lude all pro$esses that provide the desired out$o#es of the organi/ation. %easurement, analysis and improvement processes' !hese in$lude the pro$esses needed to #easure and gather data for perfor#an$e anal)sis and i#prove#ent of effe$tiveness and effi$ien$). !he) in$lude #easuring, #onitoring, auditing, perfor#an$e anal)sis and i#prove#ent pro$esses 4e.g. for $orre$tive and preventive a$tions5. +easure#ent pro$esses are often do$u#ented as an integral part of the #anage#ent, resour$e and reali/ation pro$essesL whereas anal)sis and i#prove#ent pro$esses are treated fre1uentl) as autono#ous pro$esses that intera$t with other pro$esses, re$eive inputs fro# #easure#ent results, and send outputs for the i#prove#ent of those pro$esses.

!.

Hnderstandin% the process approach

2 pro$ess approa$h is a powerful wa) of organi/ing and #anaging a$tivities to $reate value for the $usto#er and other interested parties. Organi/ations are often stru$tured into a hierar$h) of fun$tional units. Organi/ations are usuall) #anaged verti$all), with responsibilit) for the intended outputs being divided a#ong fun$tional units. !he end $usto#er or other interested part) is not alwa)s visible to all involved. &onse1uentl), proble#s that o$$ur at the interfa$e boundaries are often given less priorit) than the short8ter# goals of the units. !his leads to little or no i#prove#ent to the interested part), as a$tions are usuall) fo$used on the fun$tions, rather than on the intended output. The process approach introduces horizontal management, crossing the barriers between different functional units and unifying their focus to the main goals of the organization. It also i#proves the #anage#ent of pro$ess interfa$es 4see Fi!ure ,5.

Figure 2 - E ample of !rocess lin"ages across departments in an organization.

!he perfor#an$e of an organi/ation $an be i#proved through the use of the pro$ess approa$h. !he pro$esses are #anaged as a s)ste#, b) $reating and understanding a networ3 of the pro$esses and their intera$tions. "ote% !he $onsistent operation of this networ3 is often referred to as the =s)ste# approa$h= to #anage#ent. !he outputs fro# one pro$ess #a) be inputs to other pro$esses and interlin3ed into the overall networ3 or s)ste# 4for generi$ e7a#ples, see Fi!ure < and Fi!ure ;5.

Figure # - E ample of a generic process se$uence

Figure % - E ample of a process se$uence and its interactions

&.

Implementin% the process approach

!he following i#ple#entation #ethodolog) $an be applied to an) t)pe of pro$ess. !he step se1uen$e is onl) one #ethod and is not intended to be pres$riptive. So#e steps #a) be $arried out si#ultaneousl). &.1. Identi#ication o# processes o# the or%ani+ation

Steps in the process approach &.1.1 @efine the purpose of the organi/ation

What to do?

Euidance

!he organi/ation should identif) its :ather, anal)/e and deter#ine $usto#er and other $usto#ers and other interested parties as well as their re1uire#ents, needs and e7pe$tations to define the organi/ation?s intended outputs. interested parties re1uire#ents, and other needs and e7pe$tations. &o##uni$ate fre1uentl) with $usto#ers and other interested parties to ensure $ontinual understanding of their re1uire#ents, needs and e7pe$tations. @eter#ine the re1uire#ents for 1ualit) #anage#ent, environ#ental #anage#ent, o$$upational health and safet), #anage#ent, business ris3, so$ial

responsibilities and other #anage#ent s)ste# dis$iplines that will be applied within the organi/ation. &.1.2 @efine the poli$ies and obIe$tives of the organi/ation ;ased on anal)ses of the re1uire#ents, needs and e7pe$tations, establish the organi/ation?s poli$ies and obIe$tives !op #anage#ent should de$ide whi$h #ar3ets the organi/ation should address and develop relevant poli$ies. ;ased on these poli$ies, #anage#ent should then establish obIe$tives for the intended outputs 4e.g. produ$ts, environ#ental perfor#an$e, o$$upational health and safet) perfor#an$e5 &.1.3 @eter#ine the pro$esses in the organi/ation @eter#ine all the pro$esses needed to produ$e the intended outputs. @@eter#ine the pro$esses needed for a$hieving the intended outputs. !hese pro$esses in$lude +anage#ent, -esour$es, -eali/ation and +easure#ent, 2nal)sis and I#prove#ent.

Identif) all pro$ess inputs and outputs, along with the suppliers, $usto#ers and other interested parties 4who #a) be internal or e7ternal5. &.1.! @eter#ine the se1uen$e of the pro$esses 8 !he $usto#er of ea$h pro$ess, 8 !he inputs and outputs of ea$h pro$ess, 8 9hi$h pro$esses are intera$ting, 8 Interfa$es and what are their $hara$teristi$s, 8 !i#ing and se1uen$e of the intera$ting pro$esses, 8 Jffe$tiveness and effi$ien$) of the se1uen$e. @eter#ine how the pro$esses flow in se1uen$e and intera$tion @efine and develop a des$ription of the networ3 of pro$esses and their intera$tion.&onsider the following%

"ote% 2s an e7a#ple, a reali/ation pro$ess that results in an output, su$h as produ$t delivered to a $usto#er, will intera$t with other pro$esses 4su$h as the #anage#ent, #easure#ent and #onitoring, and resour$e provision pro$esses5. +ethods and tools su$h as blo$3 diagra#s, #atri7 and flow$harts $an be used to support the develop#ent of pro$ess se1uen$es and their

intera$tions. &.1.& @efine pro$ess ownership 2ssign responsibilit) and authorit) for ea$h pro$ess +anage#ent should define individual roles and responsibilities for ensuring the i#ple#entation, #aintenan$e and i#prove#ent of ea$h pro$ess and its intera$tions. Su$h an individual is usuall) referred to as the =pro$ess owner=. !o #anage pro$ess intera$tions, it #a) be useful to establish a =pro$ess #anage#ent tea#=, that has an overview a$ross all the pro$esses, and whi$h in$ludes representatives fro# ea$h of the intera$ting pro$esses. &.1.' @efine pro$ess do$u#entation @eter#ine those pro$esses that are to be do$u#ented and how the) are to be do$u#ented. .ro$esses e7ist within the organi/ation and the initial approa$h should be li#ited to identif)ing and #anaging the# in the #ost appropriate wa). !here is no =$atalogue=, or list of pro$esses, that have to be do$u#ented. !he #ain purpose of do$u#entation is to enable the $onsistent and stable operation of the pro$esses.

!he organi/ation should deter#ine whi$h pro$esses are to be do$u#ented, on the basis of% 8 !he si/e of the organi/ation and its t)pe of a$tivities, 8 !he $o#ple7it) of its pro$esses and their intera$tions, 8 !he $riti$alit) of the pro$esses, andT 8 !he availabilit) of $o#petent personnel.

9hen it is ne$essar) to do$u#ent pro$esses, a nu#ber of different #ethods $an be used su$h as graphi$al representations, written instru$tions, $he$3lists, flow $harts, visual #edia, or ele$troni$ #ethods. "ote% 0or #ore guidan$e see the ISO 9000 Introdu$tion and Support .a$3age #odule :uidan$e

on the @o$u#entation -e1uire#ents of ISO 9001% 008

&.2

2lannin% o# a process

Steps in the process approach &.2.1 @efine the a$tivities within the pro$ess

What to do?

Euidance

@eter#ine the a$tivities needed to a$hieve the intended outputs of the pro$ess

@efine the re1uired inputs and outputs of the pro$ess. @eter#ine the a$tivities re1uired to transfor# the inputs into the re1uired outputs. @eter#ine and define the se1uen$e and intera$tion of the a$tivities within the pro$ess. @eter#ine how ea$h a$tivit) will be perfor#ed.

"ote% In so#e $ases, the $usto#er #a) spe$if) the wa) the pro$ess is to be perfor#ed. &.2.2 @efine the #onitoring and #easure#ent re1uire#ents @eter#ine where and how #onitoring and #easuring should be applied. !his should be both for $ontrol and i#prove#ent of the pro$esses and the intended Identif) the #easures and #onitoring $riteria for pro$ess $ontrol and pro$ess perfor#an$e,

pro$ess outputs. +onitoring is alwa)s appli$able but to deter#ine the effe$tiveness and #easure#ent #a) not be pra$ti$able or even possible. effi$ien$) of the pro$ess, ta3ing "evertheless #easure#ent gives #ore obIe$tive data on the perfor#an$e of the pro$ess and it is a powerful #anage#ent and i#prove#ent tool. into a$$ount fa$tors su$h as% 8 &onfor#it) with re1uire#ents, 8 &usto#er satisfa$tion, 8 Supplier perfor#an$e, @eter#ine the need for re$ording results. 8 On ti#e deliver), 8 Lead ti#es, 8 0ailure rates,

8 9aste, 8 .ro$ess $osts, 8 In$ident fre1uen$). &.2.3 @efine the resour$es needed @eter#ine the resour$es needed for the effe$tive operation of ea$h pro$ess J7a#ples of resour$es in$lude% 8 <u#an resour$es, 8 Infrastru$ture, 8 9or3 environ#ent, 8 Infor#ation, 8 "atural resour$es, 8 +aterials, 8 0inan$ial resour$es &.2.! Oerif) the pro$ess and its a$tivities against its planned obIe$tives &onfir# that the $hara$teristi$s of the pro$esses are $onsistent with the purpose of the organi/ation 4see *.1.15 Oerif) that all the re1uire#ents identified in *.1.1 are satisfied. If not, $onsider what additional pro$ess a$tivities are re1uired and return to *. .1 to i#prove the pro$ess.

&.3.

Implementation and measurement o# the process

I#ple#ent the pro$esses and their a$tivities as planned. !he organi/ation #a) develop a proIe$t for i#ple#entation that in$ludes, but is not li#ited to

&o##uni$ation, 2wareness, !raining, &hange #anage#ent, +anage#ent involve#ent, 2ppli$able review a$tivities. 2ppl) the $ontrols, and perfor# the #onitoring and #easure#ents as planned.

&.!.

/nalysis o# the process

2nal)/e and evaluate pro$ess infor#ation obtained fro# #onitoring and #easuring data, in order to 1uantif) pro$ess perfor#an$e. 9here appropriate, use statisti$al #ethods.

&o#pare the results of pro$ess perfor#an$e infor#ation with the defined re1uire#ents of the pro$ess, to $onfir# pro$ess effe$tiveness and effi$ien$) and to identif) an) need for $orre$tive a$tion. Identif) pro$ess i#prove#ent opportunities based on the results of the anal)sis of pro$ess infor#ation. -eport to top #anage#ent, and other relevant people in the organi/ation, on the perfor#an$e of the pro$ess, as appropriate. &.&. 1orrecti$e action and impro$ement o# the process

9henever $orre$tive a$tions are needed, the #ethod for i#ple#enting the# should be defined. !his should in$lude the identifi$ation and eli#ination of the root $auses of the proble#s 4e.g. errors, defe$ts, la$3 of ade1uate pro$ess $ontrols5. !he effe$tiveness of the a$tions ta3en should be reviewed. I#ple#ent the $orre$tive a$tions and verif) their effe$tiveness a$$ording to plan. 9hen planned pro$ess out$o#es are being a$hieved and re1uire#ents fulfilled, the organi/ation should fo$us its efforts on a$tions to i#prove pro$ess perfor#an$e to higher levels, on a $ontinual basis. !he #ethod for i#prove#ent should be defined and i#ple#ented 4e7a#ples of i#prove#ents in$lude% pro$ess si#plifi$ation, enhan$e#ent of effi$ien$), i#prove#ent of effe$tiveness, redu$tion of pro$ess $)$le ti#e5. Oerif) the effe$tiveness of the i#prove#ent. -is3 anal)sis tools #a) be e#plo)ed to identif) potential proble#s. !he root $ause4s5 of these potential proble#s should also be identified and eli#inated, preventing o$$urren$e in all pro$esses with si#ilarl) identified ris3s. !he .lan8@o8&he$382$t 4.@&25 #ethodolog) $an be a useful tool to define, i#ple#ent and $ontrol $orre$tive a$tions and i#prove#ents. J7tensive literature e7ists about the .@&2 $)$le in nu#erous languages.

!&'( )) Establish the obAectives and processes necessary to deliver results in accordance ith customer, statutory and re!ulatory re(uirements and the

or!ani4ationCs policies@ *+ )) Implement the processes@ ,-E,. )) %onitor and measure processes and product a!ainst policies, obAectives and re(uirements for the product and report the results@ ',T )) Ta?e actions to continually improve process performance@B !he .@&2 is a d)na#i$ #ethodolog) that $an be deplo)ed within ea$h of the organi/ationEs pro$esses and a$ross their intera$tions. It is inti#atel) asso$iated with planning, i#ple#entation, verifi$ation and i#prove#ent. +aintaining and i#proving pro$ess perfor#an$e $an be a$hieved b) appl)ing the .@&2 $on$ept at all levels within an organi/ation. !his applies e1uall) to all pro$esses, fro# high8level strategi$ pro$esses to si#ple operational a$tivities.

Introdu$tion and support pa$3age % :uidan$e on ?Outsour$ed pro$esses?

Document: ISO/TC )*+/SC ,/- +<0/< October ,001

1.

Introduction

!he ai# of this do$u#ent is to provide guidan$e on the intent of ISO 9001% 008 $lause 4.1, regarding the $ontrol of outsour$ed pro$esses. ISO 9001% 008 $lause 4.1 states% B9here an organi/ation $hooses to outsour$e an) pro$ess that affe$ts produ$t $onfor#it) to re1uire#ents, the organi/ation shall ensure $ontrol over su$h pro$esses. !he t)pe and e7tent of $ontrol to be applied to these outsour$ed pro$esses shall be defined within the 1ualit) #anage#ent s)ste#. -OTE ): &rocesses needed for the (uality mana!ement system referred to above include processes for mana!ement activities, provision of resources, product reali4ation and measurement, analysis and improvement' -OTE ,: 7n =outsourced processB is a process that the or!ani4ation needs for its (uality mana!ement system and hich the or!ani4ation chooses to have performed by an e"ternal party' -OTE <: Ensurin! control over outsourced processes does not absolve the or!ani4ation of the responsibility of conformity to all customer, statutory and re!ulatory re(uirements' The type and e"tent of control to be applied to the outsourced process may be influenced by factors such as: a9 the potential impact of the outsourced process on the or!ani4ationDs capability to provide product

that conforms to re(uirements@ b9 the de!ree to hich the control for the process is shared@ c9 the capability of achievin! the necessary control throu!h the application of clause *';'B

2.
2.1

Euidance
What is an 4outsourced process5?

!he O7ford Jnglish @i$tionar) defines the verb Boutsour$eC as =to obtainE'' by contract from a source outside the or!ani4ation or area@ to contract 8 or?9 outB 2s now defined in ISO 9001% 008 Sub $lause 4.1 "O!J , an Boutsour$ed pro$essC is a pro$ess that the organi/ation needs for its 1ualit) #anage#ent s)ste# and whi$h the organi/ation $hooses to have perfor#ed b) an e7ternal part). -ote: ISO 9000% 00* $lause '.4.1 defines Bpro$essC as =set of interrelated or interactin! activities hich transforms inputs into outputsB' 2n outsour$ed pro$ess $an be perfor#ed b) a supplier that is totall) independent fro# the organi/ation, or whi$h is part of the sa#e parent organi/ation 4e.g. a separate depart#ent or division that is not subIe$t to the sa#e 1ualit) #anage#ent s)ste#5. It #a) be provided within the ph)si$al pre#ises or wor3 environ#ent of the organi/ation, at an independent site, or in so#e other #anner. 2.2 Intent o# 1lause !.1

!he intent of &lause 4.1 of ISO 9001% 008 is to e#phasi/e that when an organi/ation $hooses to outsour$e 4either per#anentl) or te#poraril)5 a pro$ess that affe$ts produ$t $onfor#it) with re1uire#ents 4see ISO 9001% 008 $lause 7. .15, it $an not si#pl) ignore this pro$ess, nor e7$lude it fro# the 1ualit) #anage#ent s)ste#. !he organi/ation has to de#onstrate that it e7er$ises suffi$ient $ontrol to ensure that this process is perfor#ed a$$ording to the relevant re1uire#ents of ISO 9001% 008, and an) other re1uire#ents of the organi/ationEs 1ualit) #anage#ent s)ste#. !he nature of this $ontrol will depend on the i#portan$e of the outsour$ed pro$ess, the ris3 involved, and the $o#peten$e of the supplier to #eet the pro$ess re1uire#ents. ;ased on the nature of the $ontrol, it should $onsider the pro$esses referred to 1ualit) #anage#ent s)ste# for #anage#ent a$tivities, provision of resour$es, produ$t reali/ation and #easure#ent, anal)sis and i#prove#ent. !he outsour$ed organi/ation does not ne$essaril) have to have a $ertified (ualit) +anage#ent S)ste#, but it has to de#onstrate the $apabilit) of the previousl) #entioned pro$esses. Outsour$ed pro$esses will intera$t with other pro$esses fro# the organi/ation?s 1ualit) #anage#ent s)ste# 4these other pro$esses #a) be $arried out b) the organi/ation itself, or #a)

the#selves be outsour$ed pro$esses5. !hese intera$tions also need to be #anaged 4see ISO 9001% 008 $lause 4.1 4a5 and 4b55. 2.3 1ontrol o# outsourced processes !he a$1uisition of outsour$ed pro$esses will nor#all) be subIe$t to the $apabilit) of

2.3.1

a$hieving the ne$essar) $ontrol through the appli$ation of re1uire#ents of both ISO 9001% 008 $lause 7.4 4.ur$hasing5 and $lause 4.1 4:eneral -e1uire#ents5 2s #entioned in the "ote, in so#e situations, the organi/ation #ight not Bpur$haseC the outsour$ed pro$ess in the traditional senseL it #ight, for e7a#ple, re$eive the servi$e fro# a $orporate head offi$e or fro# another division within a group of organi/ations, without an) #onetar) transa$tion ta3ing pla$e 4see .1 above5. Ander these $ir$u#stan$es, however, ISO 9001% 008 &lauses 7.4 and 4.1 are still appli$able. 2.3.2 !here are two situations that fre1uentl) need to be $onsidered when de$iding the

appropriate level of $ontrol of an outsour$ed pro$ess%

9hen an organi/ation has the $o#peten$e and abilit) to $arr) out a pro$ess, but $hooses to outsour$e that pro$ess 4for $o##er$ial or other reasons5. In this situation the pro$ess $ontrol $riteria should alread) have been defined, and $an be transposed into re1uire#ents for the supplier of the outsour$ed pro$ess, if ne$essar).

9hen the organi/ation does not have the $o#peten$e to $arr) out the pro$ess itself, and $hooses to outsour$e it. In this situation the organi/ation has to ensure that the $ontrols proposed b) the supplier of the outsour$ed pro$ess are ade1uate. In so#e $ases it #a) be ne$essar) to involve e7ternal spe$ialists in #a3ing this evaluation. 2.3.3 It #a) be $onvenient, or even ne$essar), to define so#e or all of the #ethods to be used

for $ontrol of the outsour$ed pro$esses in a $ontra$t between the organi/ation and the supplier. !he potential i#pa$t of the outsour$ed pro$ess is based on the outsour$ingEs $apabilit) to provide produ$t that $onfor#s to re1uire#ents. &are should be ta3en, however, not to inhibit the supplier fro# proposing innovations to the outsour$ed pro$ess. !he organi/ationEs $ontrol of the outsour$ed pro$ess has to be based on the need for produ$t $onfor#it) to re1uire#ents. Jnsuring $ontrol over outsour$ed pro$esses does not absolve the organi/ation of the responsibilit) of $onfor#it) to all $usto#er, statutor) and regulator) re1uire#ents. 2.3.! In so#e situations it #ight not be possible to verif) the output fro# the outsour$ed pro$ess

b) subse1uent #onitoring or #easure#ent. In these $ases, the organi/ation needs to ensure that

the $ontrol over the outsour$ed pro$ess in$ludes pro$ess validation in a$$ordan$e with ISO 9001% 008 $lause 7.*. .

Introdu$tion and support pa$3age% I#ple#entation guidan$e for ISO 9001% 008
Document: ISO/TC )*+/SC ,/-1<+ October ,001

1.

Introduction

!his I#ple#entation :uidan$e has been developed to assist users in understanding the issues that need to be $onsidered during the $o8e7isten$e period between ISO 9001% 000 and ISO 9001% 008. 9hile the $hanges between ISO 9001% 000 and ISO 9001% 008 are e7pe$ted to have a li#ited i#pa$t on users, so#e arrange#ents regarding i#ple#entation are needed. -ote: To reflect the limited scope of the chan!es the term /implementation0 is no there ere si!nificant chan!es throu!hout the standard' bein! used to hen

ma?e a clear distinction ith the former =transitionB from ISO F00):)FF; to ISO F00):,000,

2 wide diffusion of this i#ple#entation guidan$e is re$o##ended, in parti$ular the $o#parison table between ISO 9001% 008 and ISO 9001% 000, given in 2nne7 ; to ISO 9001% 008. ISO 9001% 008 has been developed in order to introdu$e $larifi$ations to the e7isting re1uire#ents of ISO 9001% 000 and to i#prove $o#patibilit) with ISO 14001% 004. ISO 9001% 008 does not introdu$e additional re1uire#ents nor does it $hange the intent of the ISO 9001% 000 standard. &ertifi$ation to ISO 9001% 008 is not an BupgradeC, and organi/ations that are $ertified to ISO 9001% 000 should be afforded the sa#e status as those who have alread) re$eived a new $ertifi$ate to ISO 9001% 008 "o new re1uire#ents were introdu$ed in this edition but, in order to benefit fro# the $larifi$ations of ISO 9001% 008, users of the for#er version will need to ta3e into $onsideration whether the $larifi$ations introdu$ed have an i#pa$t on their $urrent interpretation of ISO 9001% 000, as $hanges #a) be ne$essar) to their (+S

2.

Bac9%round to the ISO 9

1,2

) re$ision process

In order to assist organi/ations to have a full understanding of the new ISO 9001% 008, it #a) be useful to have an insight on the revision pro$ess, how this revision refle$ts the inputs re$eived fro# users of the standard, and the $onsideration given to benefits and i#pa$ts during its develop#ent.

.rior to the $o##en$e#ent of a revision 4or a#end#ent5 to a #anage#ent s)ste# standard, ISO6:uide 7 % 001, Guidelines for the Austification and development of mana!ement system standards re$o##ends that a BFustifi$ation Stud)C is prepared to present a $ase for the proposed proIe$t and that it outlines details of the data and inputs used to support its argu#ents. In relation to the develop#ent of ISO 9001% 008 user needs were identified fro# the following%

the results of a for#al BS)ste#ati$ -eviewC on ISO 9001% 000 that was perfor#ed b) the #e#bers of ISO6!& 17,6S& during 00'8 004 feedba$3 fro# the ISO6!& 17,69or3ing :roup on BInterpretationsC the results of an e7tensive worldwide BAser 0eedba$3 Surve) on ISO 9001 and ISO 9004C b) ISO6!& 17,6S& 69: 18 and si#ilar national surve)s. !he Fustifi$ation Stud) identified the need for an a#end#ent, provided that the i#pa$t on users would be li#ited and that $hanges would onl) be introdu$ed when there were $lear benefits to users. !he 3e) fo$uses of the ISO 9001% 008 a#end#ent were to enhan$e the $larit) of ISO 9001% 000 and to enhan$e its $o#patibilit) with ISO 14001% 004. 2 tool for assessing the i#pa$ts versus benefits for proposed $hanges was $reated to assist the drafters of the a#end#ent in de$iding whi$h $hanges should be in$luded, and to assist in the verifi$ation of drafts against the identified user needs. !he following de$ision #a3ing prin$iples were applied% 1. . '. "o $hanges with high i#pa$t would be in$orporated into the standardL &hanges with #ediu# i#pa$t would onl) be in$orporated when the) provided a $orrespondingl) #ediu# or high benefit to users of the standardL Jven where a $hange was low i#pa$t, it had to be Iustified b) the benefits it delivered to users, before being in$orporated. !he $hanges in$orporated in this ISO 9001% 008 edition were $lassified in ter#s of i#pa$t into the following $ategories%

"o $hanges or #ini#u# $hanges on user do$u#ents, in$luding re$ords "o $hanges or #ini#u# $hanges to e7isting pro$esses of the organi/ation "o additional training re1uired or #ini#al training re1uired "o effe$ts on $urrent $ertifi$ations !he benefits identified for the ISO 9001% 008 edition fall into the following $ategories%

.rovides $larit) In$reases $o#patibilit) with ISO 14001. +aintains $onsisten$) with ISO 9000 fa#il) of standards.

I#proves translatabilit).

3.
3.1 a8

Hser %roups
Indi$idual or%ani+ations usin% ISO 9 1urrent Hsers o# ISO 9 1,2 1 7includin% industry associations8

!his user group is defined as having $o#pleted or being in the pro$ess of i#ple#enting ISO 9001% 000, regardless of whether the) are $ertified or not, or whether the) intend to be $ertified or not. "8 New Hsers

2 "ew Aser is defined as an organisation that is either beginning to use ISO 9001% 000 or ISO 9001% 008 for the first ti#e or is a potential user of the standard in the future. c8 Hsers o# Industry Sector Schemes, "ased on ISO 9 1,2

!his user group is defined as those using 1ualit) #anage#ent s)ste# progra##es based on ISO 9001% 000 that in$lude additional 1ualit) #anage#ent s)ste# re1uire#ents, that $an either be $ertified or a$$redited under the guidan$e of a parti$ular Industr) Se$tor S$he#e 4e.g. ISO6!S 1,949 (ualit) s)ste#s H 2uto#otive suppliers H .arti$ular re1uire#ents for the appli$ation of ISO 9001% 0005. 3.2 Other user %roups

!hese are defined as being% 1. . '. 4. "ational Standards ;odies 4"S;s5 2$$reditation ;odies 42;s5 &ertifi$ation6-egistration ;odies 4&;6-;s5 !rainers and &onsultants

!.
!.1

Implementation %uidance
Eeneric %uidance

2ll users groups are strongl) advised to note the Foint I208ISO $o##uni1uU for I#ple#entation of a$$redited $ertifi$ation to ISO 9001% 008, whi$h details the agreed i#ple#entation plan for a$$redited $ertifi$ation as follows%

/ccredited certi#ication to ISO 9 1,2

1,2

) shall not "e %ranted until the pu"lication o# ISO

) as an International Standard.

&ertifi$ation of $onfor#it) to ISO 9001% 008 and6or national e1uivalents shall onl) be issued after

offi$ial publi$ation of ISO 9001% 008 4whi$h should ta3e pla$e before the end of 0085 and after a routine surveillan$e or re8$ertifi$ation audit against ISO 9001% 008.

Ialidity o# certi#ications to ISO 9

1,2

One )ear after the publi$ation of ISO 9001% 008 all a$$redited $ertifi$ations issued 4new $ertifi$ations or re8$ertifi$ations5 shall be to ISO 9001% 008. !went) four #onths after publi$ation b) ISO of ISO 9001% 008, an) e7isting $ertifi$ation issued to ISO 9001% 000 shall not be valid.

Figure 1 - 1mplementation timetable for 12+ 344152446, for all user groups

!o benefit fro# the $larifi$ations introdu$ed into ISO 9001% 008, users 4fro# all user groups5 should note the re$o##endations given in the table below. -e$o##endations for spe$ifi$ user groups are given in se$tion 4. further down.

VV :et a$1uainted with the new edition of the standard. Ase 2nne7 ; in ISO 9001% 008 to fa$ilitate identifi$ation of the $larifi$ations VV 9as )our for#er interpretation of ISO 9001% 000 different fro# the $larifi$ations provided b) ISO 9001% 008 N VV If not, $o##uni$ate to both internal and e7ternal parties the $on$lusion and results of )our i#ple#entation of ISO 9001% 008. VV If )es, deter#ine the i#pa$t of the $larifi$ations of the new version on )our $urrent use of ISO 9001 and plan an) ne$essar) re#edial a$tions. VV Ase the .lan8@o8&he$382$t #ethodolog) to #anage the i#ple#entation of )our re#edial a$tions, but 3eep in #ind the ti#efra#e provided in Fi!ure ). "ote that the a$tions #a) need to var) a$$ording to )our user group 4see 4. below5. !.2 Euidance #or speci#ic user %roups

!hese re$o##endations $o#ple#ent the generi$ guidan$e to all user groups given in se$tion '.0 above. !.2.1 a8 Or%ani+ations usin% ISO 9 1urrent users 1,2

Organisations that are alread) $ertified to ISO 9001% 000 should $onta$t their $ertifi$ation6registration bodies 4&;6-;5 to agree a progra##e for anal)sing the $larifi$ations in ISO 9001% 008 in relation to their individual 1ualit) #anage#ent s)ste#s and for upgrading their $ertifi$ates. &ertified organi/ations should bear in #ind that ISO 9001% 000 $ertifi$ates have the sa#e status as new ISO 9001% 008 $ertifi$ates during the $o8e7isten$e period. Organi/ations in the pro$ess of $ertifi$ation to ISO 9001% 000 should $hange to using ISO 9001% 008 and appl) for $ertifi$ation to it. "8 New users

"ew users should start b) using ISO 9001% 008. c8 Industry Sector Schemes

Asers of spe$ifi$ se$tor s$he#es are re$o##ended to refer to the organi/ation that is responsible that se$tor s$he#eE, e.g. for%

ISO6!S 1, 949 refer to the I2!0, !L 9000 refer to the (uJS! 0oru# 2S 90006 J" 9100 refer to the I2(: !.2.2 National Standards Bodies

Infor#ation regarding the 008 edition of ISO 9001 should be $o##uni$ated to standard users, in a ti#el) #anner, b) the national standards bodies 4"S;s5. It is re$o##ended that "S; a$tions be s)n$hroni/ed with the infor#ation flows fro# ISO and ISO6!& 17,. "S;s are responsible, at a national level, for $o##uni$ating the issues regarding the $hanges fro# ISO 9001% 000 to ISO 9001% 008 to all interested parties and for providing translations of the new edition of the standard in their national languages. It is re$o##ended that the) $oordinate their $o##uni$ations regarding these issues with other lo$al interested parties 4for e7a#ple% 2;s, &;6-;s, professional 1ualit) asso$iations, et$.5. Cranslation Issues - If a re1uire#ent for translation of the new standards e7ists, the translation pro$ess should be started as earl) as possible, in order to provide the e1uivalent national edition as soon as possible. 2n "S; should anal)se if there are interpretation proble#s in the national ISO 9001% 000 version due to for#er translation proble#s. In affir#ative $ases the "S; should $arr) out an e7tensive translation of the standard. If interpretation divergen$es still re#ain, the "S; is re$o##ended to

appl) for $larifi$ation to the =ISO/TC )*+, Interpretations Gor?in! GroupB using the established BInterpretationsC pro$ess. If an "S; has no translation proble# with its version of ISO 9001% 000 it $an use 2nne7 ; to ISO 9001% 008 as a 1ui$3 guide for preparing its translation of the standard. !.2.! /ccreditation Bodies

2;s should refer to the Ioint I208ISO $o##uni1uU for the i#ple#entation of a$$redited $ertifi$ation to ISO 9001% 008 4see 4.1 above5. !.2.& 1erti#ication Bodies

&;s should refer to the Ioint I208ISO $o##uni1uU for the i#ple#entation of a$$redited $ertifi$ation to ISO 9001% 008 4see 4.1 above5. &;s should re#e#ber that $ertifi$ates of $onfor#it) to ISO 9001% 008 and6or its national e1uivalent adoptions $an onl) be issued after the offi$ial publi$ation of the a#ended standard. It is i#portant that a$$redited $ertifi$ation bodies ensure that their auditors are aware of the $larifi$ations introdu$ed in ISO 9001% 008, and their i#pli$ations, prior to $ondu$ting audits to that standard. !.2.' Crainin% Bodies and 1onsultants

2ll trainers and $onsultants should be aware of the $larifi$ations in ISO 9001% 008. 2ll training bodies and $onsultants are re$o##ended to deter#ine the need for updating training progra#s and do$u#entation, or an) other $hanges ne$essar), to the servi$es the) provide.

&.

Dre.uently as9ed .uestions

9hile this I#ple#entation :uidan$e provides re$o##endations on a nu#ber of issues fa$ing the different user groups during the $o8e7isten$e period, it does not address #ore general 1uestions about the ISO 9000 standards. Instead ISO6!& 17,6S& 1uestions 402(s5 to provide su$h advi$e. It is e7pe$ted that the 02(s will be updated on a #ore regular basis than this I#ple#entation :uidan$e. 0or the latest version of the 02(s, referen$e should be #ade to the open a$$ess web site at www.iso.org6t$17,6s$ has prepared a set of fre1uentl) as3ed

'.

/uthenticity o# in#ormation re%ardin% ISO 9

1,2

!he first point of $onta$t for infor#ation regarding the re1uire#ents of ISO 9001% 008 should be )our "ational Standards ;od) 4for a listing of ISOEs #e#ber "ational Standards ;odies, see www.iso.org6iso6about6isoP#e#bers.ht#5.

Other re$o##ended sour$es of infor#ation are%

ISOEs 9eb site provides general infor#ation regarding ISO 9001% 008 and the ISO 9004 revision progra##e 4as well as details of its #e#ber "ational Standards ;odies5. !he ISO6!&17, 9eb site www.t$17,.org provides #ore spe$ifi$ infor#ation on the stru$ture and wor3 progra##e of ISO6!&17,, and on the for#al BinterpretationsC issued on ISO 9001 !he ISO6!&17,6S& 9eb site, www.iso.org6t$17,6s$ provides detailed infor#ation on the ISO 900169004 revision progra#, updated on a regular basis