Context of the Organization

Context of the Organization-ISO 9001:2015 Clause 4 Definition  As per ISO 9000, the definitio definition n of Context of the Organiz Organization ation is “ business “, “combination of internal and external factors and conditions that can have environment “, an effect on an organization’s approach to its products, services and investments and  interested intere sted Parti Parties es“. The note states that this concept of Context of Organization is equa eq uall ll app applic lica! a!le le to "o "ott fo forr pro profit fit or organ ganiz izati ation on,, pu pu!li !lic c se ser#i r#ice ce org organ aniza izatio tion n an and d go#e go #ern$ rn$ent ental al or orga ganiz nizat ation ion.. Also in nor nor$al $al lan langu guag age e thi this s co conc ncept ept is als also o %no %no&n &n as !usiness en#iron$ent, organizational en#iron$ent or ecosste$ of an organization.

Introduction: The i$ple$entation i$ple$entation of '(S should !e the strategic strategic decision of the organization organization and is influenced ! the context of the organisation and the changes in that context. The changes in the context can !e &ith respect to its specific o!)ecti#es, the ris%s associated &ith its context and o!)ecti#es, the needs and expectations of its custo$ers and other  rele#an rele #antt inte interest rested ed part parties, ies, the prod products ucts and ser ser#ice #ices s it pro# pro#ides ides,, the co$p co$plexi lexit t of  proce pro cess sses es it e$p e$plo los s an and d the their ir int inter eract action ions, s, th the e co co$pe $pete tenc nce e of pe pers rsons ons &i &ithi thin n or  &or%ing &or %ing on !eh !ehalf alf of the organizatio organization n and its size and orga organiza nization tional al stru structur cture.T e.The he context of of an organization organization &ill &ill include internal factors factors such such as organizationa organizationall culture, and external factors such as the socio*econo$ic conditions under &hich it operates.The scope of ISO +IS 900-0/ states that organization organization needs to de$onstrate de$onstrate its a!ilit to consistentl consist entl pro#ide products and ser#ices that $eet custo$er and applica applica!le !le statutor and regulator require$ents and ai$s to enhance custo$er satisfaction.  An interested part &hich is not rele#ant to the qualit $anage$ent sste$ need not !e considered and si$ilarl an require$ent of the interested part not rele#ant to the qualit $anage$ent sste$ need not !e considered. +eter$ining &hat is rele#ant or  not rele#ant is dependent on &hether or not it has an i$pact on the organizations a!ilit to co cons nsist isten entl tl pro pro#i #ide de pro produc ducts ts an and d se ser#i r#ice ces s tha thatt $ee $eett cu cust sto$e o$err an and d ap appli plica ca!le !le statutor and regulator require$ents or the organizations ai$ to enhance custo$er  sati sa tisf sfac acti tion on.. Th The e or orga gani niza zati tion on ca can n de deci cide de to de dete ter$ r$in ine e ad addi diti tion onal al ne need eds s an and d expectations that &ill $eet its qualit o!)ecti#es. 1o&e#er, it is at the organizations discretion &hether or not to accept additional require$ents to satisf interested parties !eond &hat &hat is required ! this Standard.

 here are a ne! clause relating to the context of the organization"

Clause 4 Context of the organization This clauses require the organization to deter$ine the issues and require$ents that can i$pact on the planning of the qualit $anage$ent sste$. Interested parties cannot go !eond the scope of ISO 900.There 900.There is no require$ent to go !eond interested interested parties that th at ar are e re rele le#a #ant nt to th the e qu qual alit it  $a $ana nage ge$e $ent nt s sst ste$ e$.. Co Cons nsid ider er i$ i$pa pact ct on th the e organizations a!ilit to consistentl pro#ide products and ser#ices that $eet custo$er  and appl applica! ica!le le stat statutor utor  and regu regulato lator r requ require$e ire$ents nts or the org organiz anizati ations ons ai$ to enha en hanc nce e cu cust sto$ o$er er sa sati tisf sfac acti tion on.. Or Orga gani niza zati tion ons s ca can n go !e !e on ond d th the e $i $ini ni$u $u$ $ require$ents require $ents to deter$in deter$ine e additional needs and expect expectations ations for interested parties that &ould not !e “rele#ant2 at the discretion of organization and should !e clear in qualit $anage$ent sste$. The “Context of Organization2 clause has four su! clauses ie 

Clause 4#1 $nderstanding the Organization and its context

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Clause 4#2 $nderstanding the needs and ex%ectations of interested %arties

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Clause 4#& Deter'ining the sco%e of the (ualit) (ualit) 'anage'ent s)ste'

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Clause 4#4 *ualit) 'anage'ent s)ste' s)ste ' and its %roces %rocesses ses

Clause 4#1 $nderstanding the Organization and its context The or The orga gani niza zati tion on sh shou ould ld de dete term rmin ine e ex exte tern rnal al an and d in inte tern rnal al is issu sues es fo forr th the e organi org anizati zation on rel relevan evantt to its pur purpos pose, e, stra strategi tegic c pla planni nning ng and whi which ch aff affect ect the organization’s ability to achieve its objectives . The Organization should monitor  and rev review iew the inf inform ormati ation on abo about ut exte externa rnall and int intern ernal al iss issues ues.. Man Manage agemen ment  t  eview re!uired the monitoring of external and internal issues. The organization must consider issues related to values, culture "nowledge and performance of  the org organi anizat zation ion for und underst erstand anding ing of int interna ernall iss issues. ues. The org organi anizati zation on mus must  t  consider issues related to arising from legal, technological, competitive, mar"et, cultura cul tural, l, soc social ial,, and eco econom nomic ic env enviro ironme nments nts,, whe whether ther int interna ernatio tional nal,, nati nationa onal, l, regional or local for understanding of external context. #or considering internal  context as well as external factors both positive as well as negative factors must  be considered.

 An organizations context in#ol#es its “operating en#iron$ent.2 The context $ust !e deter$ined !oth &ithin the organization and external to the organization. It is i$portant to understand the unique context of an organization !efore starting the strategic planning.To esta!lish the context $eans to define the external and internal factors that the organizations $ust consider &hen the $anage ris%s. An organizations external context includes its outside sta%eholders, its local operating en#iron$ent, as &ell as an external factors that influence the selection of its o!)ecti#es 3goals and targets4 or its a!ilit to $eet its goals. An organizations internal context includes its interested parties, its approach to go#ernance, its contractual relationships &ith its custo$ers, and its capa!ilities and culture.An organizations internal context is the internal en#iron$ent &ithin &hich the organization see%s to achie#e its sustaina!ilit goals. The internal context $a include, 

5roduct and ser#ice offerings

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6o#ernance, organizational structure, roles, and accounta!ilit

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7egulator require$ents

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5olicies and goals, and the strategies that are in place to achie#e the$,

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 Assets 3e.g., facilities, propert, equip$ent and technolog4 Capa!ilities, understood in ter$s of resources and %no&ledge 3e.g., capital, ti$e, people, processes, sste$s, and technologies4 Infor$ation sste$s, infor$ation flo&s, and decision*$a%ing processes 3!oth for$al and infor$al4 7elationships of the staff8#olunteers8$e$!ers and the perceptions and #alues of  their internal sta%eholders including suppliers and partners

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Organizations culture

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Standards, guidelines, and $odels adopted ! the organization and

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or$ and extent of the organizations contractual relationships.

Internal context can also !e defined as anthing &ithin the organization that $a influence the &a in &hich the organization $anages its internal ris%s. Once the internal context is understood, one can conduct the $acro*en#iron$ental external analsis using “5:ST2 3political, econo$ic, social and technological4 analsis.This   analsis deter$ines &hich factors are can influence ho& the organization operates. The organization cannot control these factors, !ut the $ust see% to adapt to the$. The 5:ST factors can !e classified as opportunities and threats in a S;OT 3strengths,

&ea%nesses, opportunities and threats4 analsis. Alternati#el, so$e organizations $ight use 5orters “i#e orces (odel.2 These $ethods are used to re#ie& a strateg or  position or direction of an organization. Co$pleting a pest analsis is si$ple and helps the indi#iduals in#ol#ed in the organization to understand and find &as to deal &ith the context. Political Factors

Economic Factors

 Ecological/Environmental Issues

National economies and trends

 Current legislation

General taxation issues

 Anticipated future legislation

Taxation to activities, products, services

 International legislation (global influences)

easonalit! or ot"er #eat"er issues

 $egulator! bodies and processes

%ar&et and trade c!cles

 Government policies, terms and c"ange

pecific sector factors

 'unding, grants, and initiatives

Customer/enduser drivers

 %ar&et lobb!ing groups

Interest and exc"ange rates

 ars and conflicts

International trade and monetar! issues

 Social Factors

Technology Factors

 *ifest!le trends

Competing tec"nolog! development

+emograp"ics

Associated/+ependent tec"nologies

 Consumer attitudes and opinions

$eplacement tec"nolog!/olutions

 %edia vie#s

%aturit! of Tec"nolog!

*a# c"anges affecting social be"aviors

Information and communications

 Image of t"e organiation

Consumer bu!ing mec"anisms

 Consumer bu!ing patterns

Tec"nolog! legislation

 'as"ion and role models

Innovation potential

 %a-or events and influences

Tec"nolog! access, licensing, patents

 .u!ing access and trends

Intellectual propert! issues

 Et"nic/$eligious factors

Global communication

 Advertising and publicit!

ocial media use

 Et"ical issues

%aturit! of organiations products/ services

+xa'%le of ,+S nal)sis

+xa'%le ,orter.s /ie orces odel#3

 Although organizations cannot control $acro*en#iron$ent factors the need to $anage the$ to their ad#antage. The also need to protect the$sel#es fro$ 5:ST factors &hich $a increase operational costs or affect their reputation. The external contexts $icro* en#iron$ent consists of the organizations i$$ediate operations and ho& the affect its perfor$ance and decision*$a%ing. These factors ha#e a direct i$pact on the success of  the organization. It is i$portant to ha#e a full analsis of the $icor*en#iron$ent !efore $o#ing to strateg de#elop$ent. 1ere are so$e of the $icro*en#iron$ental context factors. 

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Custo'ers: Organizations $ust attract and retain custo$ers ! offering products ser#ices that $eet their needs along &ith pro#iding excellent custo$er ser#ice +'%lo)ees: There $ust !e a#aila!ilit of people &ith the $oti#ation to re$ain as contri!uting $e$!ers of the organization and de#elop the s%ills necessar to pro#ide a co$petiti#e edge Su%%liers: Suppliers pro#ide organizations &ith the resources the need to carr out their 

acti#ities. If a supplier pro#ides !ad ser#ice, this affects the &a the organization operates. Close supplier relationships are an effecti#e &a to re$ain co$petiti#e and secure the resources needed 

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Inestors:  All organizations require in#est$ent to gro&. The $a !orro& the $one fro$ a !an% or ha#e people in#est in their &or%. 7elationships &ith in#estors need to !e $anaged carefull as pro!le$s can detri$entall affect the long*ter$ success of  the organization edia: 5ositi#e $edia attention can !ring success to the organization ! $aintaining its reputational strength. (anaging the $edia 3including the presence in social $edia4 is a challenge. Co'%etitors:

(e$!ers of the organization need to ha#e a sense of !elonging. Can the organization offer !enefits that are !etter than those offered ! the co$petitors< Is there a strong #alue proposition< Co$petitor analsis and $onitoring is crucial if  an organization is to $aintain or i$pro#e its position in the co$petiti#e landscape of the co$$unit. The organization $ust al&as !e a&are of its co$petitors acti#ities. The landscape can change quic%l.  As in the case of the $acro*en#iron$ental context, the organization cannot al&as control its $icro*en#iron$ent factors. =ut the $ust !e carefull $anaged together and &ith the internal context understanding. =oth internal and external context can ha#e influence o#er the organization. Custo$er pressures and co$plaints can force organizations to change #arious policies such as product returns and custo$er and technical support. Technological changes can pro#ide ne& and $ore effecti#e &as to handle co$$unications, operations, shipping and logistics. Cultural and religious differences $a hinder product or ser#ice entr into certain countries. 6o#ern$ents regulator and trade policies can pla a significant role in deter$ining ho& !usinesses operate, especiall in regard to international trade, taxation, and regulations. The $edia, including social $edia, can ha#e a huge i$pact on a co$pans i$age and pu!lic relations. A !ad ne&s #ideo or ne&s report can go #iral prett fast, and if our  organization doesnt pro#ide an accepta!le response, the negati#e pu!licit and effects can last a long ti$e. Sociological forces often dri#e &hat, &here and ho& consu$ers !u product and ser#ices. There is an increasing trend in the nu$!er of consu$ers purchasing products online and reading re#ie&s !efore $a%ing a purchase. The $ultinational and $ulticultural trend in &or%force co$position can cause significant changes in hiring and retention of co$petent hu$an resources. If the response to these situations is unplanned, &ea% or unti$el, it $ight ha#e a dra$atic i$pact on the future of the !usiness > loss of custo$ers, serious production interruption or disruption, per$anent loss of organizational %no&ledge, e#en loss or !an%ruptc of the !usiness. Contextual issues can ha#e a positi#e i$pact, as it $a present opportunities

such as ne&, i$pro#ed or increased a#aila!ilit of pre#iousl scarce resources, opening up of or access to ne& $ar%ets, a#aila!ilit of ne& technologies leading to reduced costs, i$pro#ed product qualit, ser#ices and operational efficienc. (an of these contextual issues can !e #ie&ed as #aria!les so$e changing faster, others slo&er, depending on &hether the organization is fast paced and leading edge or in a sta!le or  $ature industr. Therefore #aria!ilit in these issues depicts uncertaint a!out their  future !eha#iour. Such uncertaint can !e quite di#erse, co$plex and at ti$es highl unpredicta!le. This presents a dile$$a to organizations in ter$s of trac%ing and adapting to changes in these issues. This uncertaint introduces the need for  understanding and use of ris% e#aluation, $itigation and $anage$ent. Thus each organizational contextual issue &ill ha#e its o&n specific set of uncertainties &ith different le#els of co$plexit and ris% and the need for specific controls to $itigate or  eli$inate the ris%. +xa'%le internal issues could include" ut are not li'ited to: 

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Structure of the organization  ? li$ited flexi!ilit &hen dealing &ith #aring de$ands oles !ithin the organization  ? 7igid, personnel &illing to adopt to de$ands< ailailit) of reliale (ualified and co'%etent !or6 force  ? #er good 3positi#e4

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Stailit) of !or6force  > ;age !ench$ar%ing is not consistent &ith co$petitors

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Staff retention ? #er high 3positi#e4

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I'%act of unionization > @ncordial

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Staff co'%etenc) leels > high3positi#e4

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Contractual arrange'ents !ith custo'er *!eneficial

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,a)'ent ter's fro' custo'ers- high credit

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Solenc) of custo'ers *etc

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+x%ansion of custo'er ase-etc

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Oerall strength of usiness to su%%ort funding needs *etc

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elationshi% !ith inestors # *etc

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Credit ter's aailale # *etc

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Serice leel agree'ents !ith custo'ers *etc

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Culture !ithin the organization *etc

+xa'%le external issues could include" ut are not li'ited to: 

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,olitical" econo'ic" social" technological" legal and regulator) ? a&s changing ,affecting product confor$it, $ini$u$ &age changing, e#olutions in $ore efficient $achiner affecting price O%erating ,er'its eco'ing tighter on e'ission leels ? technolog de$ands

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Oerall econo'ic %erfor'ance in the countr)  ? a!o#e :@ nor$ 3positi#e4

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Co'%etitie eniron'ent  ? o#erall lo&*cost of entr in to the $ar%et

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+cono'ic %lans for future  *etc

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he nature and i'%act of econo') on 'ar6et *etc

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Custo'er de'ogra%hic *etc

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7eneral leels of consu'er confidence *etc

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Custo'er ex%ectation *etc

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Standardization and certification !ithin the industr) *etc

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egulation !ithin the industr) generall) *etc

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rade associations and lo)ing %o!ers *etc

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I'%act on neighors# *etc

Clause 4#2 $nderstanding the needs and ex%ectations of  interested %arties The organization shall determine relevant interested parties and relevant  re!uirements of relevant interested parties. elevant interested parties to be considered are those that could affect or potentially affect the organization’s ability to constantly provide products and services that meet customer and  applicable statutory and regulatory re!uirements. Monitor and review information related to interested parties and relevant re!uirements.

 irstl, the organization &ill need to deter$ine external and internal issues that are rele#ant to its purpose, i.e. &hat are the rele#ant issues, !oth inside and out, that ha#e an i$pact on &hat the organization does, that &ould affect its a!ilit to achie#e the intended outco$e3s4 of its $anage$ent sste$. It should !e noted that the ter$ Bissue co#ers not onl pro!le$s, &hich &ould ha#e !een the su!)ect of pre#enti#e action in pre#ious standards, !ut also i$portant topics for the $anage$ent sste$ to address, such as an $ar%et assurance and go#ernance goals that the organization $ight set for  its $anage$ent sste$. "ext the organization has to deter$ine rele#ant interested parties and rele#ant require$ents of rele#ant interested parties.  An interested part is a person or organization that can affect, !e affected !, or  percei#e the$sel#es to !e affected ! a decision or acti#it thats &ithin the scope of  the $anage$ent sste$. There &ill !e those external interested parties that i$pose specific legal, regulator or contractual require$ents in an organization. There $a also !e require$ents specified ! internal interested parties, for exa$ple $anage$ent and staff 3per$anent and te$porar4. Tpicall these &ould include

Shareholders

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O&ners

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(anage$ent

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:$ploees

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Trade unions

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Suppliers

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5artners

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Client

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6o#ern$ent agencies

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(edia

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Societ

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an other person or organization interested in the organization

There is no require$ent in this International Standard for the organization to consider interested parties &hich ha#e !een deter$ined ! the organization not to !e rele#ant to its qualit $anage$ent sste$. Si$ilarl, there is no require$ent to address a particular require$ent of a rele#ant interested part if the organization considers that

the require$ent is not rele#ant. +eter$ining &hat is rele#ant or not rele#ant is dependent on &hether or not it has an i$pact on the organizations a!ilit to consistentl pro#ide products and ser#ices that $eet custo$er and applica!le statutor and regulator require$ents or the organizations ai$ to enhance custo$er  satisfaction. The organization can decide to deter$ine additional needs and expectations that &ill assist it to $eet its qualit o!)ecti#es. 1o&e#er, it is at the organizations discretion &hether or not to accept additional require$ents to satisf interested parties !eond &hat is required ! this International Standard. INTERESTED PARTIES

REQUIREMENTS

Executive .oard

Good financial performance, legal compliance/avoidance of fines

*ocal residents

 No complaints relating to 0 noise, par&ing, "ealt" and safet!, pollution, #aste, emplo!ment

*a# enforcers/ $egulators

Identification of applicable statutor! and regulator! re1uirements for t"e products and services provided, understanding of t"e re1uirements, application #it"in t"e 2%, and update/ maintenance of t"em

Customers

3alue for mone!, "ig" 1ualit!, expectations for design innovation, on time, lo#cost, 1uic& response, installation expertise, "ealt" and safet!/E%

.an&/'inance

Good financial performance

Emplo!ees

4rofessional development, prompt pa!ment "ealt" and safet!, #or&/ life balance, emplo!ment securit!

Insurers

No claims/prompt pa!ment/ris& management

External providers

4rompt pa!ment, "ealt" and safet!, #or& relations"ip

Trade 5nions

Compliance (emplo!ment la#)

One tool &hich can !e used for deter$ining the rele#ant require$ent of rele#ant interested parties is Sta%eholder analsis

Example of ta&e"older anal!sis

Clause 4#& Deter'ining the sco%e of the (ualit) 'anage'ent  s)ste' The organization must establish scope of the !uality management system by  determining the boundaries and applicability of the !uality management system. $hile determining the scope the organization must consider the internal and  external issues determined in %.&.,the re!uirements of relevant interested parties in %.'. and the products and services of the organization. e!uirements from this (nternational standards that can be applied by the organization shall be applied  within the scope of the )M*. e!uirements from this (nternational standards that  cannot be applied by the organization and which does not affect the organization’s ability or responsibility to provide product and services that meet  the conformity of its product and services and enhancement of the customer  satisfaction. The organization must ma"e available the scope and must maintain scope as documented information stating the +roducts and services covered by  the )M* and any ustification where a re!uirement of this (nternational standard  cannot be applied.

n exa'%le of ho! a sco%e could e deried Organization.s %ur%ose and strategic direction ,ur%ose:

“ As one of India’s leading Data Communications manufacturers, installers and onsite managed service providers of fiber optic cabling for Information !echnolog"  connectivit"#$ as %ell as installer and on-site managed service provider of copper  cabling and I! cabinets& our reason for 'being’ is a combination of our vision, mission, and values(“ 8hat is our ision

“!o become the most trusted manufacturer, installer and service provider of fiber  optic)copper cabling I! cabling# and I! cabinets %ithin India and *urope( “ 8hat is our 'ission

“!o expand our operations b" Consistentl" meeting customers expectations, and our  legal re+uirements, %hich includes the enhancement of customer satisfaction through the effective application of our processes for continual improvement( “ 8hat are our alues

“ustainable business practices including$ corporate social responsibilit"  social, economical and environmental#, responsible governance, and e+ual opportunit" are all  expected values %ithin our organization( !hese are reenforced through sustainable ethics and %or.force integrit" throughout all business operations( Co-operation and  collaboration are expected norms %ithin the organization’s management, %ith recognition provided for all through regular appraisals( /e encourage and embrace an" values %hich enforce the behaviors that emplo"ees cherish( “ Strategic Direction:

“!o open t%o ne% offices in India, and one ne% office in 0erman", and pain this "ear( !o implement and gain accredited certification to I1 2334 and I1 45334 in these ne%  offices, %ithin a "ear of the offices opening( !o emplo" a motivated %or.force that %ill  embrace the organization’s values, and complement the co-operation and collaboration needed to achieve the effective application of our processes for continual improvement( “

2# Organization.s intended results; of its *S 

ro' the Sco%e of the Standard: 

!o demonstrate its abilit" to consistentl" provide products and services that meet customer and applicable regulator" re+uirements !o enhance customer satisfaction through the$

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*ffective application of the 67

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Processes for continual improvement of the 67

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 Assurance of conformit" to customer and applicable statutor" and  regulator" re+uirements

S%eci trac%ing against process para$eters, goals and o!)ecti#es, using tools and records such as process chec%* sheetsD product acceptance criteriaD S5C recordsD production recordsD $aintenance recordsD la!or records, etc. (ore details on $onitoring and $easuring controls are co#ered in clause 9.. @nder ..d, resources for '(S processes $a include facilit, $aterial, equip$ent, la!or, supplies, utilities etc. :#er '(S process &ill require a different co$!ination of  resources. 7esource details $a !e identified in specifications,production schedules, !ill of $aterials, production tra#elers or routers, &or% instructions, etc. Infor$ation for  '(S processes &ill #ar fro$ process to process and $a include *production schedules, !ill of $aterials, product acceptance and process perfor$ance criteria, production tra#eler or router, &or% instructions etc. @se clause F./ and other rele#ant clauses to control process infor$ation. @nder .. e the organization shall has to ensure that adequate responsi!ilities and authorities are assigned as per as the require$ents gi#en in the clause /.G. This pro$otes the use of ris% !ased thin%ing. 7is% is defined as the “effect of  uncertaint.2 "otes in the definition further descri!e ris% as a “de#iation fro$ the expected,2 either positi#e or negati#e. The ter$ “uncertaint2 is defined as a lac% of  infor$ation or %no&ledge a!out a potential e#ent that can !e expressed as a result of  the li%elihood and consequence of such an e#ent. A positi#e de#iation arising fro$ a ris% can pro#ide an opportunit, !ut not all positi#e effects of ris% result in opportunities.  Actions to address opportunities can also include consideration of associated ris%s. Clause .. f requires that &hen planning its '(S, the top $anage$ent $ust i$ple$ent and pro$ote a culture of ris%*!ased thin%ing throughout the organization to deter$ine and address the ris%s and opportunities associated &ith pro#iding assurance that the '(S can achie#e its intended result3s4D pro#ide confor$ing products and

ser#ices, enhance custo$er satisfactionD pro$ote desira!le effects and i$pro#e$entD and pre#ent, or $itigate, undesired effects. Clause .. g requires e#aluate of '(S processes as per the require$ent gi#en in clause 9..G and e#aluation $a !e done through a re#ie& of $easure$ent and $onitoring records and perfor$ance indicators for each process. These re#ie&s $ust identif opportunities to i$pro#e '(S processes, use of resources and product qualit. Clause .. h calls for i$pro#e$ent in process as per as the require$ent gi#en in clause 0. ;hen process nonconfor$ities occur, then correcti#e action is required to !ring the '(S process under control. 7e$e$!er, the correcti#e action process is not  )ust for product related nonconfor$ities. 5rocesses $ust !e continuall i$pro#ed through setting of incre$entall realistic, $easura!le o!)ecti#es. 5lanning for continual i$pro#e$ent requires a re#ie& of process data, resources and controls to !ring a!out the desired change. Clause ..a > ..h $ust !e applied to all '(S processes. "ote also that $an ISO 900 clauses 3e.g. clause H.D H.D H.D etc.4, require specific processes to !e esta!lished &ithin our '(S, These processes $ust also !e identified and controlled in our '(S.