Quality Systems Manual

Quality Management Plan

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T*is Quality Systems Manual provides an overview o" t*e +uality system in operation at ,ompany and is an essential re"eren,e to t*e met*od in w*i,* t*e +uality system "un,tionsT*e Quality Management System "orms part o" ,ompany.s overar,*ing operational management system/ w*i,* in,orporates Quality/ $nvironment and 0ealt* 1 Sa"ety into an 'ntegrated Management SystemAs an overview manual t*is do,ument ,ontains re"eren,es to t*e detailed pro,edures and do,uments used to operate t*e Quality System2 3ut does not ,ontain ,opies o" t*ese itsel"%opies o" t*e pro,edures are ,ontrolled issue do,uments and are availa3le "rom t*e ,ompany on re+uestT*is do,ument *as 3een designed "or general distri3ution to employees/ suppliers and ,lients and is not a ,ontrolled do,ument-

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Introduction
,ompany is a ,onsultan,y spe,ialising in t*e delivery o" strategi, solutions and value added servi,es in t*e "ield o" environmental management to t*e mining and resour,es se,tor wit*in Australia and internationally "or t*e past !4 years'n order to assure +uality systems and servi,es to our ,lients/ ,ompany *as developed t*is Quality Management Plan in ,omplian,e wit* 'S& 00!52006T*is Quality Management Plan is not a stand7alone do,ument as it "orms part o" t*e ,ompany 'ntegrated Management System-

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2.1

Company
Quality Policy Quality servi,e is a ,ommitment to ex,ellen,e 3y ea,* ,ompany employee and is a,*ieved 3y teamwor8 and a pro,ess o" ,ontinuous improvement9e are dedi,ated to 3eing t*e leader in providing +uality produ,ts and servi,es/ w*i,* meet or ex,eed t*e expe,tations o" our ,lients$nsuring t*e timely ,ompletion o" pro:e,ts/ response to en+uiries and personal ,lient "o,us t*roug* well de"ined and ,learly ,ontrolled 3usiness pro,esses are t*e 8ey "a,tors ena3ling ,ompany to 3e one o" t*e leading $nvironmental solution providers-

2.2

Mission Assuring +uality is a multi7"un,tional e""ort ,overing many aspe,ts o" ,ompany.s operation't is a ,ontinuous pro,ess involving5 T*e identi"i,ation and do,umentation o" ,lient needs T*e development and delivery o" servi,es to meet t*ose needs ,onsistently ;eed3a,8 "rom t*e ,lient to assess t*e ,ompany.s per"orman,e A,tion on t*e ,lient.s "eed3a,8 to improve t*e ,ompany.s per"orman,e2 and &ngoing training and development o" sta"" at all levelsDeveloped and endorsed 3y management/ t*e ,ompany Quality Management System ensures t*at ,lients re,eive +uality/ relia3ility and integrity in t*e produ,ts and servi,es

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,ompany provides t*em/ and ,lients. needs and re+uirements are met- T*e system re+uires ad*eren,e to spe,i"i,ations/ as well as regulatory and +uality re+uirementsProdu,t +uality is maintained t*roug* t*e standardisation o" systems and pro,ess ,ontrols- Servi,e +uality ,overs all aspe,ts o" ,lient transa,tions and is assured 3y t*e sta"" providing t*e servi,e2.3 Company Processes T*e "ollowing pro,ess "low,*arts are in t*e appendi,es5 !- ,ompany organisation ,*art 2- Proposal development <- Proposal re+uest 4- Networ8 diagram #- %orre,tive A,tions Re+uest =- 'nternal Auditing 4- Data %olle,tion

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3.1

Scope and e clusions

Scope T*e QSM guides ,ompany sta"" in applying t*e +uality poli,y and in pursuing ,onsistent a,*ievement o" its +uality goals- ,ompany s*all esta3lis*/ do,ument/ implement and maintain t*e QSM and ,ontinually improve its e""e,tivenessT*e QSM ,omprises t*ree elements5 people/ pro,esses2 and SystemsT*e e""e,tiveness o" t*e QSM depends on *aving all t*ree elements in pla,e and alignedT*e initial "o,us o" t*e QSM is on t*e ,ore servi,es ,ompany provides to its ,lients- 't t*ere"ore in,ludes all t*e a,tivities t*at relate to t*ose servi,es/ 3ut initially ex,ludes some supporting a,tivities-

3.2

! clusions T*ere are nil ex,lusions at t*e time o" writing-

3.3

"e#erences Do,uments re"eren,ed in t*e development o" t*is Quality Management Plan in,lude5

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AS>N? 'S& 00!52006 Quality Management Systems @ Re+uirementsAS>N? 'S& ! 0!!5200< Auidelines "or +uality and>or environmental management systems auditing AS>N? 'S& 00452000 Quality management systems @ Auidelines "or per"orman,e improvements AS>N? 'S& !00!45200= Auidan,e on statisti,al te,*ni+ues "or 'S& 00!52000 B'S&>TR !00!4/ $d- 2-0 B200<C M&DC (S $PA Auidan,e "or developing +uality systems "or $nvironmental Pro:e,ts2 $PA QA>A! 'S& 000 Quality Management System @ ;undamentals and Do,a3ulary-

T*e "ollowing normative do,ument ,ontains provisions/ w*i,* t*roug* re"eren,e in t*is text/ ,onstitute provisions o" 'S& 00!- ;or dated re"eren,es/ su3se+uent amendments to/ or revisions o"/ any o" t*ese pu3li,ations do not apply- 0owever/ parties to agreements 3ased on 'S& 00! are en,ouraged to investigate t*e possi3ility o" applying t*e most re,ent edition o" t*e normative do,ument indi,ated 3elow- ;or undated re"eren,es/ t*e latest edition o" t*e normative do,ument re"erred to applies3.$ %erminology <-4-! &eaders'ip @ T*is term re"ers to all sta"" per"orming a leaders*ip role2 "rom Prin,iple ,onsultant t*roug* to graduate sta"" managing su3se,tions o" a pro:e,t<-4-2 Quality Control 7 T*e operational te,*ni+ues and a,tivities used to "ul"il re+uirements o" +uality<-4-< Quality Policy 7 A do,ument issued 3y ,ompany "ormalising t*e ,ompany.s ,ommitment to Quality Per"orman,e<-4-4 Speci#ications @ T*e pres,ri3ed re+uirements to w*i,* a produ,t or servi,e must ,on"orm<-4-# Product @ A set o" delivera3les esta3lis*ed 3y t*e ,lient addressing t*e ,lients provided s,ope o" wor8<-4-= Service @ T*e provision o" ,apa3ility 3y ,ompany and its sta""<-4-4 Controlled documentation @ Due to t*e nature o" ,ompany as a ,onsultan,y and t*e nature o" t*e produ,t presented to a ,lient t*is term en,ompasses most "orms o" do,umentation developed/ in,luding 3ut not limited to all do,uments developed to support t*e 'ntegrated Management System @ in,luding "orms/ poli,ies/ pro,edures/ templates- All reports and assessments *aving t*e potential to 3e delivered to a ,lient or user outside ,ompany sta"" in,luding dra"t reports and assessments<-4-6 Peer revie( @ t*e review o" do,umentation to 3e provided to a ,lient 3y anot*er ,ompany sta"" mem3er<-4Quality C'ampion @,ompany sta"" mem3er responsi3le "or all Quality ,ontrol measures and w*o gives "inal approval "or ,ontrolled do,uments to 3e delivered to t*e end user<-4-!0 Documented procedure 7 an esta3lis*ed/ do,umented/ implemented and maintained pro,edure-

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<-4-!! "ecord ) *orm @ 9*ile t*e de"initions di""er/ t*e two words are synonymously t*roug* out t*e Quality do,umentation-

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4-!

Quality Management System

+eneral "e,uirements! ,ompany do,uments/ implements and maintains a +uality management system and ,ontinually improves its e""e,tiveness in a,,ordan,e wit* t*e re+uirements o" t*e 'S& 00! 'nternational Standard,ompany5 identi"ies t*e pro,esses needed "or t*e +uality management system and t*eir appli,ation t*roug*out t*e organisation/ determines t*e se+uen,e and intera,tion o" t*ese pro,esses/ determines ,riteria and met*ods needed to ensure t*at 3ot* t*e operation and ,ontrol o" t*ese pro,esses are e""e,tive/ ensures t*e availa3ility o" resour,es and in"ormation ne,essary to support t*e operation and monitoring o" t*ese pro,esses/ and Monitors/ measures and analyses t*ese pro,esses/ and implements a,tions ne,essary to a,*ieve planned results and ,ontinual improvement o" t*ese pro,essesT*e organisation manages t*ese pro,esses in a,,ordan,e wit* t*e re+uirements o" t*e 'S& 00! 'nternational Standard9*ere t*e organisation ,*ooses to outsour,e any pro,ess t*at a""e,ts produ,t ,on"ormity/ ,ompany ensures ,ontrol over su,* pro,esses-

4-2 Documentation "e,uirements 4-2-! +eneral2 T*e Quality Management System do,umentation in,ludes5 do,umented statements o" a +uality poli,y and +uality o3:e,tives/ a +uality manual/ do,umented pro,edures re+uired 3y t*e 'S& 00! 'nternational Standard/ do,uments needed 3y ,ompany to ensure t*e e""e,tive planning/ operation and ,ontrol o" its pro,esses/ and Re,ords re+uired 3y t*e 'S& 00! 'nternational Standard$.2.2 Quality Manual ,ompany *as esta3lis*ed and maintains a +uality manual/ w*i,*/ in,ludes5 t*e s,ope o" t*e +uality management system/ in,luding details o" and :usti"i,ation "or any ex,lusions/
!

Pro,esses needed "or t*e +uality management system re"erred to a3ove/ in,lude pro,esses "or management a,tivities/ provision o" resour,es/ produ,t realisation and measurementDo,umentation ,an 3e in any "orm or type o" medium-

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t*e do,umented pro,edures esta3lis*ed "or t*e +uality management system/ or re"eren,e to t*em/ and a des,ription o" t*e intera,tion 3etween t*e pro,esses o" t*e +uality management system-

Supporting Do,umentation Quality System Overview flowchart $.2.3 Control o# Documents Do,uments re+uired 3y t*e +uality management system are ,ontrolled a,,ording to t*e re+uirements given in 4-2-4A do,umented pro,edure is esta3lis*ed to de"ine t*e ,ontrols needed5 to approve do,uments "or ade+ua,y prior to issue/ to review and update as ne,essary and re7approve do,uments/ to ensure t*at ,*anges and t*e ,urrent revision status o" do,uments are identi"ied/ to ensure t*at relevant versions o" appli,a3le do,uments are availa3le at points o" use/ to ensure t*at do,uments remain legi3le and readily identi"ia3le/ to ensure t*at do,uments o" external origin are identi"ied and t*eir distri3ution ,ontrolled/ and to prevent t*e unintended use o" o3solete do,uments/ and to apply suita3le identi"i,ation to t*em i" t*ey are retained "or any purposeSupporting Do,umentation Document Synchronisation Procedure Document Control Procedure $.2.$ Control o# records Re,ords are esta3lis*ed and maintained to provide eviden,e o" ,on"ormity to re+uirements and or t*e e""e,tive operation o" t*e +uality management systemRe,ords remain legi3le/ readily identi"ia3le and retrieva3le- A do,umented pro,edure is esta3lis*ed to de"ine t*e ,ontrols needed "or t*e identi"i,ation/ storage/ prote,tion/ retrieval/ retention time and disposition o" re,ordsSupporting Do,umentation Quality Record Control Procedure

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Management "esponsibility
Management Commitment

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,ompany leaders*ip is ,ommitted to t*e development and implementation o" t*e +uality management system and ,ontinually improves its e""e,tiveness 3y5 -.2 esta3lis*ing a +uality poli,y/ ,ommuni,ating to sta"" t*e importan,e o" meeting ,lient as well as statutory and regulatory re+uirements/ esta3lis*ing +uality o3:e,tives/ ,ondu,ting management reviews/ and $nsuring t*e availa3ility o" resour,esClient #ocus All sta"" ensures t*at ,lient re+uirements are determined and are met/ wit* t*e aim o" en*an,ing ,lient satis"a,tion- Bsee 4-2-! and 6-2-!C -.3 Planning -.3.1 Quality ob.ectives T*e Quality ,*ampion toget*er wit* ,ompany )eaders*ip ensures t*at +uality o3:e,tives/ in,luding t*ose needed to meet re+uirements "or produ,t delivery Esee 4-!F are esta3lis*ed at relevant "un,tions wit*in ,ompanyT*e +uality o3:e,tives are measura3le and ,onsistent wit* t*e +uality poli,y Meet or ex,eed ,lient expe,tations 3y e""e,tive ,ommuni,ation and review o" ,lient re+uirements Provide our ,lients *ig* +uality produ,ts and servi,es/ on time delivery at a reasona3le ,ost $""e,tively manage our produ,ts/ pro,esses/ and servi,es to provide superior ,lient satis"a,tion Promote t*e sa"ety/ awareness/ and well 3eing o" employees t*roug* training and edu,ation-.3.2 Quality management system planning T*e Quality ,*ampion ensures t*at5 t*e planning o" t*e +uality management system is ,arried out in order to meet t*e re+uirements given in 4-!/ as well as t*e +uality o3:e,tives/ and t*e integrity o" t*e +uality management system is maintained w*en ,*anges to t*e +uality management system are planned and implemented-

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"esponsibility/ Aut'ority and Communication

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"esponsibility and Aut'ority ,ompany leaders*ip ensures t*at responsi3ilities and aut*orities are de"ined and ,ommuni,ated wit*in t*e organisation in order to promote e""e,tive management o" t*e +uality system- T*e Quality ,*ampion *as 3een given t*e relative aut*ority to manage/ per"orm/ and veri"y t*e a,tivities a""e,ting t*e QMSAll sta"" *ave 3een appointed to evaluate and implement re+uirements o"/ as well as improvements to/ t*e 'S& 00! Quality Management SystemSupporting Do,umentation company organisational chart

#-4-2

Management "epresentative< ,ompany leaders*ip *as appointed a Quality ,*ampion w*o/ irrespe,tive o" ot*er responsi3ilities/ *as t*e responsi3ility and aut*ority t*at in,ludes ensuring t*at pro,esses needed "or t*e +uality management system are esta3lis*ed/ implemented and maintained/ reporting to ,ompany leaders*ip on t*e per"orman,e o" t*e +uality management system and any need "or improvement ensuring t*e promotion o" awareness o" ,lient re+uirements t*roug*out t*e organisation/ and liaison wit* external parties on matters relating to t*e +uality management system -.$.3 Internal Communication T*e Quality ,*ampion ensures t*at appropriate ,ommuni,ation pro,esses are esta3lis*ed wit*in t*e organisation and ,ommuni,ation ta8es pla,e regarding t*e e""e,tiveness o" t*e +uality management system-

-.-.-.1

Management "evie( +eneral ,ompany sta"" reviews t*e organisationGs +uality management system/ at planned intervals/ to ensure its ,ontinued suita3ility/ ade+ua,y and e""e,tiveness- T*e review in,ludes assessing opportunities "or improvement and t*e need "or ,*anges to t*e +uality management system/ in,luding t*e +uality poli,y and +uality o3:e,tives- Re,ords "rom management reviews are maintained Bsee 4-2-4CSupporting Do,umentation Management Review Procedure

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T*e responsi3ility o" a management representative ,an in,lude liaison wit* external parties on matters relating to t*e +uality management system-

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"evie( input T*e input to management review in,ludes in"ormation on5 results o" audits/ ,lient "eed3a,8/ pro,ess per"orman,e and produ,t ,on"ormity/ status o" preventive and ,orre,tive a,tions/ "ollow7up a,tions "rom previous management reviews/ ,*anges t*at ,ould a""e,t t*e +uality management system/ and Re,ommendations "or improvement-.-.3 "evie( 0utput T*e output "rom t*e management review in,ludes any de,isions and a,tions related to5 improvement o" t*e e""e,tiveness o" t*e +uality management system and its pro,esses/ improvement o" produ,t related to ,lient re+uirements/ and Resour,e needs-

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1.1

"esource Management
Provision o# "esources ,ompany determines and provides t*e resour,es needed to implement and maintain t*e +uality management system and ,ontinually improve its e""e,tiveness/ and To en*an,e ,lient satis"a,tion 3y meeting ,lient re+uirements

1.2 2uman "esources 1.2.1 +eneral T*e personnel/ per"orming wor8 a""e,ting produ,t +uality are ,ompetent 3ased upon appropriate edu,ation/ training/ s8ills and experien,e1.2.2 Competence/ %raining and A(areness ,ompany 5 determines t*e ne,essary ,ompeten,e "or personnel per"orming wor8 a""e,ting produ,t +uality/ provides training or ta8es ot*er a,tions to satis"y t*ese needs/ evaluates t*e e""e,tiveness o" t*e a,tions ta8en/ ensures t*at its personnel are aware o" t*e relevan,e and importan,e o" t*eir a,tivities and *ow t*ey ,ontri3ute to t*e a,*ievement o" t*e +uality o3:e,tives/ and Maintains appropriate re,ords o" edu,ation/ training/ s8ills and experien,e Bsee 4-2-4C-

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Supporting Do,umentation Training Procedure 1.3 In#rastructure ,ompany determines/ provides "or/ and maintains t*e in"rastru,ture needed to a,*ieve ,on"ormity to produ,t re+uirements- 'n"rastru,ture in,ludes/ as appli,a3le5 3uildings/ wor8spa,e and asso,iated utilities/ Pro,ess e+uipment B3ot* *ardware and so"twareC/ and Supporting servi,es Bsu,* as transport or ,ommuni,ationC3or4 !nvironment %ooperatively/ ,ompany sta"" determines and manages t*e wor8 environment needed to a,*ieve +uality out,omes-

1.$

Product "ealisation

,ompany )eaders*ip strives to ensure t*e e""e,tive and e""i,ient delivery o" pro:e,t management pro,esses to t*e 3ene"it o" satis"ying ,lient re+uirements9or8 pro,esses "orm t*e ,ornerstone o" ,ompanyGs a3ility to ,onvert ,lient input into output/ as demonstrated 3y our wide 7 ranging servi,e provisioning4-! Planning o# product "ealisation41# ,ompany *as planed and developed t*e pro,esses needed "or produ,t realisationPlanning o" produ,t realisation is ,onsistent wit* t*e re+uirements o" t*e ot*er pro,esses o" t*e +uality management system Bsee 4-!C'n planning produ,t realisation/ ,ompany *as determined t*e "ollowing/ as appropriate5 +uality o3:e,tives and re+uirements "or t*e produ,t/ t*e need to esta3lis* pro,esses/ do,uments/ and provide resour,es spe,i"i, to t*e produ,t/ re+uired veri"i,ation/ validation/ monitoring/ inspe,tion and test a,tivities spe,i"i, to t*e produ,t and t*e ,riteria "or produ,t a,,eptan,e/ and Re,ords needed to provide eviden,e t*at t*e realisation pro,esses and resulting produ,t meet re+uirements Bsee 4-2-4C T*e output o" t*e planning is in a "orm suita3le "or ,ompanyGsG met*od o" operations-

A do,ument spe,i"ying t*e pro,esses o" t*e +uality management system Bin,luding t*e produ,t realisation pro,essesC and t*e resour,es to 3e applied to a spe,i"i, produ,t/ pro:e,t or ,ontra,t/ is re"erred to as t*e +uality plan# ,ompany also applies t*e re+uirements given in 4-< to t*e development o" produ,t realisation pro,esses-

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5.2 Client related processes 5.2.1 Determination o# "e,uirements related to t'e product ,ompany determines ,lient re+uirements 3e"ore a,,eptan,e o" an order,lient re+uirements in,lude t*ose5 Re+uested 3y t*e ,lient Re+uired "or delivery and post7delivery a,tivities Not stated 3y t*e ,lient 3ut ne,essary "or spe,i"ied use or 8nown and intended use Statutory and regulatory re+uirements appli,a3le to t*e produ,t / and Additional re+uirements determined 3y ,ompany Supporting Do,umentation Quotation Procedure Confirmation of Scope Procedure Change of Scope Procedure 4-2-2 "evie( o# re,uirements related to t'e product= ,ompany reviews t*e re+uirements related to t*e produ,t- T*is review is ,ondu,ted prior to ,ompanyGs ,ommitment to supply a produ,t to t*e ,lient Be-gsu3mission o" tenders/ a,,eptan,e o" ,ontra,ts/ a,,eptan,e o" ,*anges to ,ontra,tsC and ensures t*at5 Produ,t re+uirements are de"ined %ontra,t or order re+uirements di""ering "rom t*ose previously expressed are resolved ,ompany *as t*e a3ility to meet t*e de"ined re+uirements Re,ords are maintained s*owing t*e results o" t*e review and any a,tions arising "rom t*e review 9*ere a ,lient does not provide a do,umented statement o" re+uirement/ t*e ,lient re+uirements are ,on"irmed 3e"ore a,,eptan,e 2 and 9*en produ,t re+uirements are ,*anged/ ,ompany ,ommuni,ates ,*anges to relevant personnel and amends relevant do,umentsRe,ords o" t*e results o" t*e review and a,tions arising "rom t*e review are maintained Bsee 4-2-4C9*ere t*e ,lient provides no do,umented statement o" re+uirement/ t*e ,lient re+uirements are ,on"irmed 3y ,ompany 3e"ore a,,eptan,e9*ere produ,t re+uirements are ,*anged/ ,ompany ensures t*at relevant do,uments are amended and t*at relevant personnel are made aware o" t*e ,*anged re+uirements-

'n some situations/ a "ormal review is impra,ti,al "or ea,* S,ope o" 9or8- 'nstead t*e review ,an ,over relevant produ,t in"ormation su,* as ,atalogues or advertising material-

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Supporting Do,umentation Quotation Procedure Confirmation of Scope Procedure Change of Scope Procedure 5.2.3 Client communication ,ompany determines and implements e""e,tive arrangements "or ,ommuni,ating wit* ,lients in relation to5 produ,t in"ormation/ en+uiries/ ,ontra,ts or order *andling/ in,luding amendments/ and ,lient "eed3a,8/ in,luding ,lient ,omplaintsSupporting Do,umentation Quotation Procedure Confirmation of Scope Procedure Change of Scope Procedure 5.3 Design and development

5.3.1 Design and development Planning ,ompany plans and ,ontrols t*e design and development o" a produ,t- During t*e design and development planning/ ,ompany determines5 t*e design and development stages/ t*e review/ veri"i,ation and validation t*at are appropriate to ea,* design and development stage/ and t*e responsi3ilities and aut*orities "or design and development,ompany manages t*e inter"a,es 3etween di""erent groups involved in design and development to ensure e""e,tive ,ommuni,ation and ,lear assignment o" responsi3ility- Planning output is updated/ as appropriate/ as t*e design and development progressesSupporting Do,umentation Data Collection Procedure Proposal Request lowchart Pro!ect Development lowchart 5.3.2 Design and development Inputs 'nputs relating to produ,t re+uirements are determined and re,ords maintained Bsee 4-2-4CT*ese inputs in,lude5 "un,tional and per"orman,e re+uirements/ appli,a3le statutory and regulatory re+uirements/

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w*ere appli,a3le/ in"ormation derived "rom previous similar pro:e,ts/ and ot*er re+uirements essential "or design and development-

T*ese inputs are reviewed "or ade+ua,y- Re+uirements are ,omplete/ unam3iguous and do not ,on"li,t wit* ea,* ot*erSupporting Do,umentation Data Collection Procedure Proposal Request lowchart Pro!ect Development lowchart 5.3.3 Design and development 0utputs T*e outputs o" design and development are provided in a "orm t*at ena3les veri"i,ation against t*e design and development input and are approved prior to releaseDesign and development outputs5 Meet t*e input re+uirements Provide appropriate in"ormation "or pur,*asing/ produ,tion and "or servi,e provision %ontain or re"eren,e produ,t a,,eptan,e ,riteria Spe,i"y t*e ,*ara,teristi,s o" t*e produ,t t*at are essential "or its sa"e and proper useSupporting Do,umentation Data Collection Procedure Proposal Request lowchart Pro!ect Development lowchart "a#oratory Request procedure 5.3.$ Design and development "evie( At suita3le stages/ systemati, reviews o" design and development are per"ormed in a,,ordan,e wit* planned arrangements Bsee 4-<-!C to evaluate t*e a3ility o" t*e results o" design and development to meet re+uirements/ and to identi"y any pro3lems and propose ne,essary a,tionsParti,ipants in su,* reviews in,lude representatives o" "un,tions ,on,erned wit* t*e design and development stageBsC 3eing reviewed- Re,ords o" t*e results o" t*e reviews and any ne,essary a,tions are maintained Bsee 4-2-4CSupporting Do,umentation Data Collection Procedure Proposal Request lowchart Pro!ect Development lowchart

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5.3.-

Design and development 6eri#ication Deri"i,ation is per"ormed in a,,ordan,e wit* planned arrangements Bsee 4-<-!C to ensure t*at t*e design and development outputs *ave met t*e design and development input re+uirements- Re,ords o" t*e results o" t*e veri"i,ation and any ne,essary a,tions are maintained Bsee 4-2-4CSupporting Do,umentation Data Collection Procedure Proposal Request lowchart Pro!ect Development lowchart

5.3.1

Design and development 6alidation Design and development validation is per"ormed in a,,ordan,e wit* planned arrangements Bsee 4-<-!C to ensure t*at t*e resulting produ,t is ,apa3le o" meeting t*e re+uirements "or t*e spe,i"ied appli,ation or intended use/ w*ere 8nown- 9*erever pra,ti,a3le/ validation is ,ompleted prior to t*e delivery or implementation o" t*e produ,t- Re,ords o" t*e results o" validation and any ne,essary a,tions is maintained Bsee 4-2-4CSupporting Do,umentation Data Collection Procedure Proposal Request lowchart Pro!ect Development lowchart "a#oratory Request procedure

5.3.5

Control o# design and development c'anges Design and development ,*anges are identi"ied and re,ords maintained- T*e ,*anges are reviewed/ veri"ied and validated as appropriate/ and approved 3e"ore implementationT*e reviews o" design and development ,*anges in,lude evaluation o" t*e e""e,t o" t*e ,*anges on ,onstituent parts and produ,t already delivered- Re,ords o" t*e results o" t*e review o" ,*anges and any ne,essary a,tions are maintained Bsee 4-2-4CSupporting Do,umentation Change of Scope procedure

5.$ Purc'asing 5.$.1 Purc'asing process ,ompany ensures t*at pur,*ased produ,ts ,on"orm to spe,i"ied pur,*ase re+uirements- T*e type and extent o" ,ontrol applied to t*e supplier and t*e pur,*ased produ,t is dependent upon t*e e""e,t o" t*e pur,*ased produ,t on

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su3se+uent produ,t realisation or t*e "inal produ,t9*en re+uired/ ,ompany evaluates and sele,ts suppliers 3ased on t*eir a3ility to supply produ,t in a,,ordan,e wit* pro:e,t re+uirements- %riteria "or sele,tion/ evaluation and re7 evaluation are esta3lis*ed- Re,ords o" t*e results o" evaluations and any ne,essary a,tions arising "rom t*e evaluation is maintained Bsee 4-2-4CSupporting Do,umentation Purchasing Control procedure Supplier $pproval procedure 5.$.2 Purc'asing In#ormation Pur,*asing in"ormation des,ri3es t*e produ,t to 3e pur,*ased/ in,luding w*ere appropriate5 Re+uirements "or approval o" produ,t/ pro,esses and e+uipment Re+uirements "or +uali"i,ation o" personnel Quality management system re+uirements ,ompany ensures t*e ade+ua,y o" spe,i"ied pur,*ase re+uirements prior to ,ommuni,ation to t*e supplier5.$.3 6eri#ication o# purc'ased product ,ompany esta3lis*es and implements t*e inspe,tion or ot*er a,tivities ne,essary "or ensuring t*at a pur,*ased produ,t meets spe,i"ied pur,*ase re+uirements- 9*ere ,ompany or its ,lient intends to per"orm veri"i,ation at t*e supplier.s premises/ ,ompany will state t*e intended veri"i,ation arrangements and met*od o" produ,t release in t*e pur,*asing in"ormationSupporting Do,umentation Data Collection Procedure Pro!ect Development lowchart "a#oratory Request procedure 5.- Production and Service provision 5.-.1 Control o# Production and Service Provision As appli,a3le/ ,ompany plans and ,arries out produ,tion and servi,e provisions under ,ontrolled ,onditions%ontrolled ,onditions in,lude5 t*e availa3ility o" in"ormation t*at des,ri3es t*e ,*ara,teristi,s o" t*e produ,t/ t*e availa3ility o" wor8 instru,tions/ as ne,essary/ t*e use o" suita3le e+uipment/ t*e availa3ility and use o" monitoring and measuring devi,es/

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suita3le environmental ,onditions/ t*e implementation o" monitoring and measurement a,tivities/ and t*e implementation o" produ,t release/ delivery and post7delivery a,tivities-

Supporting Do,umentation %quipment Maintenance Procedure Control of &on'conformance Product Procedure Document Control Procedure Control of Monitoring and Measuring Devices Procedure Data Security Procedure Chemical (andling and Storage Procedure Data Collection Procedure 5.-.2 6alidation o# process #or Production and Service provision ,ompany validates any pro,esses "or produ,tion and servi,e provisions w*ere t*e resulting output ,annot 3e veri"ied 3y su3se+uent monitoring or measurement- T*is in,ludes any pro,esses w*ere de"i,ien,ies 3e,ome apparent only a"ter t*e produ,t is in use or t*e servi,e *as 3een delivered- Dalidation demonstrates t*e a3ility o" t*ese pro,esses to a,*ieve planned resultsAs appli,a3le/ ,ompany esta3lis*es arrangements "or t*ese pro,esses in,luding5 de"ined ,riteria "or review and approval o" t*e pro,esses/ approval o" e+uipment and +uali"i,ation o" personnel/ use o" spe,i"i, met*ods and pro,edures/ re+uirements "or re,ords Bsee 4-2-4C/ and revalidation5.-.3 Identi#ication and %raceability 9*ere appropriate/ ,ompany identi"ies t*e produ,t 3y suita3le means t*roug*out produ,t realisation- ,ompany identi"ies t*e produ,t status wit* respe,t to monitoring and measurement re+uirements- 9*ere tra,ea3ility is a re+uirement/ ,ompany ,ontrols and re,ords t*e uni+ue identi"i,ation o" t*e produ,t B4-2-4CSupporting Do,umentation Control of &on'conformance Product Procedure Document Control Procedure Control of Monitoring and Measuring Devices Procedure Data Security Procedure Chemical (andling and Storage Procedure Data Collection Procedure 4-#-4
4

Client Property5

%ustomer property ,an in,lude intelle,tual property-

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,ompany exer,ises ,are wit* ,lient property w*ile it is under ,ompanyGs ,ontrol or 3eing used 3y ,ompany sta""- ,ompany identi"ies/ veri"ies/ prote,ts and sa"eguards ,lient property provided "or use or in,orporation into t*e produ,t- '" any ,lient property is lost/ damaged or ot*erwise "ound to 3e unsuita3le "or use/ it.s reported to t*e ,lient and re,ords maintained Bsee 4-2-4CSupporting Do,umentation Data Security Procedure Document Control Procedure Document Synchronisation procedure Quality Record Control Procedure )nternal $uditing Procedure 5.-.- Preservation o# Product ,ompany preserves t*e ,on"ormity o" produ,t during internal pro,essing and delivery to t*e intended destination- T*is preservation in,ludes identi"i,ation/ *andling/ pa,8aging/ storage and prote,tion- Preservation also applies to t*e ,onstituent parts o" a produ,tSupporting Do,umentation Data Security Procedure Document Control Procedure Document Synchronisation procedure Quality Record Control Procedure )nternal $uditing Procedure 5.1 Control o# Monitoring and Measuring !,uipment ,ompany determines t*e monitoring and measurement to 3e underta8en and t*e monitoring and measuring devi,es needed to provide eviden,e o" ,on"ormity o" produ,t to determined re+uirements Bsee 4-2-!C,ompany esta3lis*es pro,esses to ensure t*at monitoring and measurement ,an 3e ,arried out/ and is ,arried out in a manner t*at is ,onsistent wit* t*e monitoring and measurement re+uirements- 9*ere ne,essary to ensure valid results measuring e+uipment is5 ,ali3rated or veri"ied at spe,i"ied intervals/ or prior to use/ against measurement standards tra,ea3le to international or national measurement standards2 w*ere no su,* standards exist/ t*e 3asis used "or ,ali3ration or veri"i,ation s*all 3e re,orded/ ad:usted or re7ad:usted as ne,essary/ identi"ied to ena3le t*e ,ali3ration status to 3e determined/ sa"eguarded "rom ad:ustments t*at would invalidate t*e measurement result/ and prote,ted "rom damage and deterioration during *andling/ maintenan,e and storage'n addition/ ,ompany assesses and re,ords t*e validity o" t*e previous measuring results w*en t*e e+uipment *as 3een "ound not to ,on"orm to re+uirements- ,ompany ta8es

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appropriate a,tion on t*e e+uipment and any produ,t a""e,ted- Re,ords o" t*e results o" ,ali3ration and veri"i,ation are maintained Bsee 4-2-4C9*en used in t*e monitoring and measurement o" spe,i"ied re+uirements/ t*e a3ility o" ,omputer so"tware to satis"y t*e intended appli,ation is ,on"irmed- T*is is underta8en prior to initial use and re,on"irmed as ne,essarySupporting Do,umentation Control of Monitoring and Measuring Devices Procedure )nternal $uditing Procedure 7 7.1 Measurement/ Analysis and Improvement +eneral ,ompany plans and implements t*e monitoring/ measurement/ analysis and improvement pro,esses needed5 to demonstrate ,on"ormity o" t*e produ,t/ to ensure ,on"ormity o" t*e +uality management system/ and to ,ontinually improve t*e e""e,tiveness o" t*e +uality management systemT*is in,ludes determination o" appli,a3le met*ods/ in,luding statisti,al te,*ni+ues/ and t*e extent o" t*eir useSupporting Do,umentation Data Collection Procedure 7.2 Monitoring and Measurement 7.2.1 Client Satis#action As one o" t*e measurements o" t*e per"orman,e o" t*e +uality management system/ ,ompany monitors in"ormation relating to ,lient per,eption as to w*et*er t*e organisation *as met ,lient re+uirements- T*e met*ods "or o3taining and using t*is in"ormation are determinedSupporting Do,umentation Control of &on'Conforming Product Procedure Corrective $ction Request procedure 7.2.2 Internal Audit ,ompany ,ondu,ts internal audits at planned intervals to determine w*et*er t*e +uality management system5 ,on"orms to t*e planned arrangements Bsee 4-!C/ to t*e re+uirements o" 'S& 00! and to t*e +uality management system re+uirements esta3lis*ed 3y t*e organisation/ and is e""e,tively implemented and maintained-

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A planned audit program ta8es into ,onsideration t*e status and importan,e o" t*e pro,esses and areas audited/ as well as t*e results o" previous audits- T*e audit ,riteria/ s,ope/ "re+uen,y and met*ods are de"ined- Auditors do not audit t*eir own wor8- T*e responsi3ilities and re+uirements "or planning and ,ondu,ting audits/ and "or reporting results and maintaining re,ords Bsee 4-2-4C is de"ined in a do,umented pro,edureT*e Quality ,*ampion ensures t*at a,tions are ta8en wit*out undue delay to eliminate dete,ted non,on"ormities and t*eir ,auses- ;ollow7up a,tivities in,lude t*e veri"i,ation o" t*e a,tions ta8en and t*e reporting o" veri"i,ation results Bsee 6-#-2CSupporting Do,umentation )nternal $udit Procedure 7.2.3 Monitoring and Measurement o# Process ,ompany applies suita3le met*ods "or monitoring and w*ere appli,a3le/ measurement o" t*e +uality management system pro,esses- T*ese met*ods demonstrate t*e a3ility o" t*e pro,esses to a,*ieve planned results- 9*en planned results are not a,*ieved/ ,orre,tion and ,orre,tive a,tion is ta8en/ as appropriate/ to ensure ,on"ormity o" t*e produ,tMonitoring and Measurement o# Product ,ompany monitors and measures t*e ,*ara,teristi,s o" t*e produ,t to veri"y t*at produ,t re+uirements *ave 3een met- T*is is ,arried out at appropriate stages o" t*e produ,t realisation pro,ess in a,,ordan,e wit* t*e planned arrangements Bsee 4-!C$viden,e o" ,on"ormity wit* t*e a,,eptan,e ,riteria is maintained- Re,ords indi,ate t*e Quality ,*ampions release o" produ,t Bsee 4-2-4C- Produ,t release and servi,e delivery does not pro,eed until t*e planned arrangements Bsee 4-!C are satis"a,torily ,ompleted/ unless ot*erwise approved 3y t*e Prin,iple %onsultantSupporting Do,umentation Document Control Procedure Pro!ect Development lowchart 7.3 Control o# 8on9con#orming product ,ompany ensures t*at produ,t w*i,* does not ,on"orm to produ,t re+uirements is identi"ied and ,ontrolled to prevent its unintended use or delivery- T*e ,ontrols and related responsi3ilities and aut*orities "or dealing wit* non7,on"orming produ,ts are de"ined in a do,umented pro,edureT*e organisation deals wit* a non7,on"orming produ,t 3y one or more o" t*e "ollowing ways5

7.2.$

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3y ta8ing a,tion to eliminate t*e dete,ted non7,on"ormity/ 3y aut*orising its use/ release or a,,eptan,e under ,on,ession 3y a relevant aut*ority and/ w*ere appli,a3le/ 3y t*e ,lient/ and 3y ta8ing a,tion to pre,lude its original intended use or appli,ation-

Re,ords o" t*e nature o" non7,on"ormities and any su3se+uent a,tions ta8en/ in,luding ,on,essions o3tained/ are maintained Bsee 4-2-4C- 9*en a non7,on"orming produ,t is ,orre,ted t*e produ,t is su3:e,t to re7veri"i,ation to demonstrate ,on"ormity to t*e re+uirements- 9*en a non7,on"orming produ,t is dete,ted a"ter delivery/ ,ompany ta8es a,tion appropriate to t*e e""e,ts/ or potential e""e,ts/ o" t*e non,on"ormitySupporting Do,umentation Control of &on'conforming Product Procedure Corrective $ction Request Procedure Document Control Procedure Quality Record Control Procedure )nternal $uditing Procedure 7.$ Analysis o# Data ,ompany determines/ ,olle,ts and analyses appropriate data to demonstrate t*e suita3ility and e""e,tiveness o" t*e +uality management system and to evaluate w*ere ,ontinual improvement o" t*e e""e,tiveness o" t*e +uality management system ,an 3e made- T*is in,ludes data generated as a result o" monitoring and measurement and "rom ot*er relevant sour,esT*e analysis o" data provides in"ormation relating to5 ,ustomer satis"a,tion Bsee 6-2-!C/ ,on"ormity to produ,t re+uirements Bsee 4-2-!C/ ,*ara,teristi,s and trends o" pro,esses and produ,ts in,luding opportunities "or preventive a,tion/ and suppliersSupporting Do,umentation Client eed#ac* Procedure )nternal $udit Procedure Corrective $ction Request Procedure Control of &on'conforming Product Procedure 7.Improvement 7.-.1 Continual Improvement ,ompany ,ontinually improves t*e e""e,tiveness o" its +uality management system t*roug* t*e use o" t*e +uality poli,y/ +uality o3:e,tives/ audit results/ analysis o" data/ ,orre,tive and preventive a,tions and management reviews7.-.2 Corrective Action

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,ompany ta8es a,tion to eliminate t*e ,ause o" non,on"ormities in order to prevent re,urren,e- %orre,tive a,tions are appropriate to t*e e""e,ts o" t*e non,on"ormities en,ounteredA do,umented pro,edure is esta3lis*ed to de"ine re+uirements "or5 reviewing non,on"ormities Bin,luding ,ustomer ,omplaintsC/ determining t*e ,auses o" non,on"ormities/ evaluating t*e need "or a,tion to ensure t*at non,on"ormities do not re,ur/ determining and implementing a,tion needed/ re,ords o" t*e results o" a,tion ta8en Bsee 4-2-4C/ and reviewing ,orre,tive a,tion ta8enSupporting Do,umentation )nternal $udit Procedure Corrective $ction Request Procedure Control of &on'conforming Product Procedure 7.-.3 Preventative action ,ompany determines a,tions to eliminate t*e ,auses o" potential non,on"ormities in order to prevent t*eir o,,urren,e- Preventive a,tions are appropriate to t*e e""e,ts o" t*e potential pro3lemsA do,umented pro,edure is esta3lis*ed to de"ine re+uirements "or5 determining potential non,on"ormities and t*eir ,auses/ evaluating t*e need "or a,tion to prevent o,,urren,e o" non,on"ormities/ determining and implementing a,tion needed/ re,ords o" results o" a,tion ta8en Bsee 4-2-4C/ and reviewing preventive a,tion ta8enSupporting Do,umentation )nternal $udit Procedure Corrective $ction Request Procedure Control of &on'conforming Product Procedure

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Appendices
company 0rganisational C'art

:.2

company Pro.ect proposal #lo( c'art

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company pro.ect development #lo(c'art

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