ISO 9001:2008 Interview Checklist

ISO 9001:2008 Interview Checklist

Interviewee: Interviewer: Date: Instructions on Use: 1. e!uire" organisational in#or$ation inclu"e: a% &a$e o# organisation: '% (e) 'usiness activities: c% &u$'er o# sta##: "% O##ice a""ress: e% #% g% 2. &a$e o# ke) contact sta##: Contact nu$'er * e$ail a""ress: Co$+an) we',site -where a++lica'le%: ____________________ ____________________ ____________________ Designation: ____________________

.he +ur+oses #or this interview checklist are to: a% /auge the level o# co$+liance to ISO 9001:2008 re!uire$ents ') )our grou+ 0 "ivision 0 tea$ '% 1acilitate the +rovision o# in#or$ation necessar) #or ISO 9001:2008 i$+le$entation c% Serve as a training $aterials #or un"erstan"ing the ISO 9001:2008 re!uire$ents 3lease s+en" a'out 2 hours going through the checklists4 answering the !uestions to the 'est o# )our knowle"ge. .he Interviewer will go through the !uestions with )ou to hel+ )ou to answer so$e o# the !uestions "uring the interview session. 3lease also +rovi"e a co+) -where availa'le% o# the #ollowing: a% Organisation6s $ission state$ent4 long4 $i" an" short ter$ work o'7ectives '% Organisation chart 0 structure #or )our grou+ 0 "ivision 0 tea$ c% (e) reason-s% #or the ISO 9001:2008 i$+le$entation 0 certi#ication "% Overview in#or$ation #or various ke) activities +er#or$e" ') )our grou+ 0 "ivision 0 tea$ e% 8n) +roce"ures4 work instructions4 checklists4 "ocu$ent te$+lates4 #low,charts4 training $aterials that are use" to #acilitate various work +rocesses #% 1or$s co$$onl) use" ') )our grou+ 0 "ivision 0 tea$ g% 9o' res+onsi'ilit) 0 "escri+tion #or various sta## h% :onthl) re+orts #or the +ast #ew $onths where a++lica'le. 3lease list out the to+ ;,< ke) activities +er#or$e" ') )our grou+ 0 "ivision 0 tea$ that covers at least 80= o# all the work "one ') )our grou+ 0 "ivision 0 tea$: a% '%

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ISO 9001:2008 Interview Checklist c% "% e% #% g% >. .

I"enti#) )our ke) custo$er-s%: a% '% c% . I"enti#) )our ke) su++lier-s% a% '% c% . ?hat are the ke) o'7ective-s% 0 goals #or )our tea$@ a% '% c% . ?hat are the ke) in+uts re!uire" ') )our tea$ to +er#or$ various activities@ a% '% c% . ?hat are the ke) out+uts generate" ') )our tea$ to +er#or$ various activities@ a% '% c% . Aow "o )ou $onitor i# )our esta'lishe" o'7ective-s% 0 goals are $et@ a% '% c% . ?ill an) activities 'e eBclu"e" #ro$ the sco+e o# the ISO 9001:2008 i$+le$entation@ a% '% c% . Are there any statutory or regulatory requirements applicable for your organisation or team? a% '% 3age 2 o# 1>

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ISO 9001:2008 Interview Checklist c% 15. .

8re there an) visi'le eBa$+les o# $g$t co$$it$ent to !ualit) relate" issues@ a% '% c% . Is there an) evi"ence that $g$t sta## are custo$er,#ocus@ a% '% c% . 8re there an) evi"ence o# internal co$$unication ') to+ $g$t sta## on the i$+ortance o# !ualit)@ a% '% c% . ?hat custo$er satis#action in"icators "o )ou have@ a% '% c% . ?hat are the eBa$+les o# continual i$+rove$ents $a"e "uring the +ast 1 )ear@ a% '% c% . ISO 9001 Clauses Ces &o 3artial &.8.

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1<.

18.

Quality Mgmt System QMS! "e#uirements

5.1 /eneral Dualit) :g$t S)ste$ -D:S% e!uire$ents a% Is a !ualit) $g$t s)ste$ esta'lishe"4 "ocu$ente"4 i$+le$ente" an" $aintaine" accor"ing to the ISO 9001 stan"ar"@ '% 8re +rocesses nee"e" #or the !ualit) $g$t s)ste$ i"enti#ie"@ c% 8re the #ollowing "eter$ine" #or these +rocesses: 1. .he se!uence an" interaction 2. .he criteria * $etho"s to ensure e##ective o+eration * control@ "% 8re in#or$ation necessar) to su++ort o+eration an" $onitoring o# these +rocesses availa'le@ e% 8re there $easure$ent4 $onitoring an" anal)sis o# these +rocesses to achieve +lanne" results an" continual i$+rove$ent@ #% 8re the type and extend of control of out-sourced processes defined in the !ualit) $g$t s)ste$@ 209512;1;."oc -Dec 2008% 3age 2 o# 1>

ISO 9001:2008 Interview Checklist ISO 9001 Clauses e$arks -i# an)%: 5.2 /eneral D:S Docu$entation e!uire$ents a% Dualit) :anual: Is there a !ualit) $anual that "ocu$ents the 2. Dualit) +olic) an" o'7ectives 5. Sco+e o# the D:S * "etails o# an" 7usti#ications #or an) eBclusions ;. 3roce"ure #or control o# "ocu$ents >. 3roce"ure #or control o# !ualit) recor"s <. 3roce"ure #or con"uct o# internal au"its 8. 3roce"ure #or control o# non,con#or$it) 9. 3roce"ure #or corrective action 10. 3roce"ure #or +reventive action@ '% Control o# Docu$ents: 8re "ocu$ents re!uire" ') the D:S un"er "ocu$ent control@ 8re the #ollowing controls "ocu$ente": 11. 8++rove "ocu$ents #or a"e!uac) 'e#ore issue 12. eview4 u+"ate an" re,a++rove "ocu$ents 12. Changes * current revision status are i"enti#ie" 15. elevant versions are availa'le at +oint o# use 1;. Docu$ents are legi'le an" rea"il) i"enti#ia'le 1>. Docu$ents o# eBternal origin are i"enti#ie" an" "istri'ution controlle" 1<. O'solete "ocu$ents are suita'l) i"enti#ie"4 i# the) are to 'e retaine" c% Control o# ecor"s: 8re recor"s $aintaine" to +rovi"e evi"ence o# con#or$ance to D:S@ 18. 8re the) legi'le4 rea"il) i"enti#ia'le * retrieva'le 19. 8re there "ocu$ente" +roce"ures #or the i"enti#ication4 storage4 +rotection4 retrieval4 retention ti$e an" "is+osal o# recor"s@ "% 8re the #ollowing recor"s $aintaine": 20. :g$t review recor"s 21. ecor"s o# e"ucation4 training4 !uali#ication0skill an" eB+erience 22. ecor"s to +rovi"e 209512;1;."oc -Dec 2008% 3age 5 o# 1> Ces &o 3artial &.8.

ISO 9001:2008 Interview Checklist ISO 9001 Clauses evi"ence o# con#or$it) to esta'lishe" +rocesses * +ro"uct re!uire$ents 22. 3ro"uct re!uire$ents0contract * review recor"s 25. Design an" "evelo+$ent review recor"s 2;. Eeri#ication * vali"ation recor"s 2>. ecor"s #or "esign * "evelo+$ent changes 2<. 3urchase evaluation recor"s 28. Eali"ation recor"s #or s+ecial +rocesses 29. ecor" #or uni!ue i"enti#ication o# +ro"uct 0 service 20. ecor"s o# custo$er, su++lie" ite$s 21. ecor"s #or e!ui+$ent cali'rations * veri#ication 22. ecor"s o# +erson authorising release o# +ro"uct 22. ecor"s o# non, con#or$ities * actions taken 25. ecor"s o# +reventive actions taken@ e$arks -i# an)%: Ces &o 3artial &.8.

Management "es%&nsi'ility

;.1 :anage$ent Co$$it$ent a% 8re there evi"ence o# to+ $g$t co$$it$ent to the "evelo+$ent4 i$+le$entation * i$+rove$ent o# the D:S through: 2;. Co$$unicating to the organisation the i$+ortance o# $eeting custo$er4 statutor) * regulator) re!uire$ents 2>. Fsta'lishing the !ualit) +olic) 2<. Fnsuring the !ualit) o'7ectives are $et 28. Con"ucting $g$t review o# the D:S 29. Fnsuring the availa'ilit) o# resources #or D:S i$+le$entation * i$+rove$ent@ e$arks -i# an)%:

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ISO 9001:2008 Interview Checklist ISO 9001 Clauses ;.2 Custo$er 1ocus a% Does to+ $g$t ensure custo$er re!uire$ents are: 50. Deter$ine" 51. 1ul#ille" with the ai$ o# enhancing custo$er satis#action@ e$arks -i# an)%: Ces &o 3artial &.8.

;.2 Dualit) 3olic) a% Does to+ $g$t ensure that the !ualit) +olic): 52. Is a++ro+riate to the +ur+ose o# the organisation 52. Inclu"e a co$$it$ent to $eeting custo$er re!uire$ents 55. Inclu"e a co$$it$ent to continual i$+rove$ent 5;. 3rovi"e a #ra$ework #or esta'lishing an" reviewing !ualit) o'7ectives 5>. Is co$$unicate" an" un"erstoo" within the organisation 5<. Is reviewe" #or continuing suita'ilit)@ e$arks -i# an)%: ?hat is the $ission state$ent #or )our grou+ 0 "ivision 0 tea$@

;.5 Dualit) O'7ectives0D:S 3lanning a% Dualit) O'7ectives: Does to+ $g$t ensure that !ualit) o'7ectives are esta'lishe" at relevant #unctions an" levels with the organisation@ '% 8re the !ualit) o'7ectives $easurea'le an" consistent with the !ualit) +olic)@ c% 8re !ualit) o'7ectives esta'lishe" to ensure that +ro"uct re!uire$ents $et@ "% D:S 3lanning: Does the to+ $g$t ensure that 58. D:S +lanning is carrie" out in or"er to $eet re!uire$ents given in section 5.14 as well as the !ualit) o'7ectives 59. .he integrit) o# the D:S is $aintaine" when changes to the D:S are +lanne" * i$+le$ente"@ e% Is the out+ut o# this +lanning "ocu$ente"@ e$arks -i# an)%: ?hat are the !ualit) o'7ectives an" targets set #or )our grou+ 0 "ivision 0 tea$@

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ISO 9001:2008 Interview Checklist ISO 9001 Clauses ;.; es+onsi'ilit)4 8uthorit) an" Co$$unication a% es+onsi'ilities * 8uthorit): Does to+ $g$t ensure that the res+onsi'ilities * authorit) #or various #unctions "e#ine" * co$$unicate" to #acilitate e##ective !ualit) $g$t@ '% :g$t e+resentative: Is a $g$t re+resentative a++ointe" ') to+ $g$t to ;0. Fnsure the +rocesses o# the D:S are esta'lishe"4 i$+le$ente" an" $aintaine" ;1. e+ort to to+ $g$t o# the +er#or$ance o# the D:S4 inclu"ing nee"s #or i$+rove$ent ;2. 3ro$ote awareness o# custo$er re!uire$ents throughout the organisation ;2. Giaise with eBternal +arties on $atters relating to the D:S@ c% Is the mgmt representative a member of the organisations management team@ "% Internal Co$$unication: Does to+ $g$t ensure that the +rocesses o# the D:S an" their e##ectiveness co$$unicate" 'etween various levels an" #unctions within the organisation@ e$arks -i# an)%: Ces &o 3artial &.8.

;.> :g$t eview o# D:S a% Is there a review o# the D:S ') to+ $g$t at +lanne" intervals to ensure its continuing suita'ilit)4 a"e!uac) an" e##ectiveness@ '% Does the review inclu"e: ;5. 8ssessing o++ortunities 0 reco$$en"ations #or i$+rove$ents H0 I$+rove$ent o# the D:S * its +rocesses H1 I$+rove$ent o# +ro"uct relate" to custo$er re!uire$ents ;;. 8ssessing nee" to change the D:S4 inclu"ing !ualit) +olic) * o'7ectives ;>. eview o# au"it results * custo$er #ee"'ack ;<. 3rocess +er#or$ance * +ro"uct con#or$ance ;8. Status o# corrective * +reventive actions ;9. 1ollow,u+ actions #ro$ earlier review $eetings >0. Changes that coul" a##ect the D:S >1. esource nee"s #or 209512;1;."oc -Dec 2008% 3age < o# 1>

ISO 9001:2008 Interview Checklist ISO 9001 Clauses D:S i$+le$entation * i$+rove$ent@ c% 8re the results o# the $g$t review recor"e"@ e$arks -i# an)%: Ces &o 3artial &.8.

"es&urce Management

>.1 3rovision o# esources a% 8re resources "eter$ine" an" +rovi"e" #or: >2. I$+le$enting4 $aintaining an" i$+roving the +rocesses o# the !ualit) $g$t s)ste$ >2. Fnhancing custo$er satis#action ') $eeting custo$er re!uire$ents@ e$arks -i# an)%: >.2 Au$an esources a% 8re +ersonnel assigne" res+onsi'ilities "e#ine" in the D:S co$+etent on the 'asis o# a++lica'le e"ucation4 training4 skills0!uali#ications an" eB+erience@ '% Co$+etence4 8wareness * .raining: 8re co$+etenc) nee"s #or +ersonnel +er#or$ing activities a##ecting !ualit) i"enti#ie"@ c% 8re training +rovi"e" to satis#) the co$+etenc) nee"s@ "% Is e##ectiveness o# training +rovi"e" evaluate"@ e% 8re e$+lo)ees aware o# the relevance an" i$+ortance o# their activities an" how the) contri'ute to the achieve$ent o# the !ualit) o'7ectives@ #% 8re a++ro+riate recor"s o# e"ucation4 eB+erience4 skills0!uali#ications an" training $aintaine"@ e$arks -i# an)%: >.2 In#rastructure 0 1acilities a% 8re in#rastructure 0 #acilities nee"e" to achieve con#or$it) o# +ro"ucts i"enti#ie"4 +rovi"e" an" $aintaine"@ '% Do the) inclu"e: >5. Iuil"ing4 works+ace an" associate" utilities >;. 3rocess e!ui+$ent4 har"ware an" so#tware >>. Su++orting services -e.g. trans+ort or co$$unication%@ e$arks -i# an)%:

>.5 ?ork Fnviron$ent a% 8re the hu$an an" +h)sical #actors 209512;1;."oc -Dec 2008%

e.g. noise! 3age 8 o# 1>

ISO 9001:2008 Interview Checklist ISO 9001 Clauses lighting! temperature! humidity and "eather! etc.# o# the work environ$ent nee"e" to achieve con#or$it) o# +ro"uct i"enti#ie" an" $anage"@ e$arks -i# an)%: Ces &o 3artial &.8.

*r&+uct "ealisati&n

<.1 3lanning o# the 3ro"uct ealisation 3rocesses a% 8re the +rocesses nee"e" #or +ro"uct realiJation +lanne"4 "evelo+e" * "ocu$ente" in a !ualit) +lan@ '% 8re the #ollowing "eter$ine" in the !ualit) +lan4 as a++ro+riate: ><. Dualit) o'7ectives #or +ro"uct4 +ro7ect or contract >8. &ee" to esta'lish +rocesses 0 "ocu$ents >9. &ee" to +rovi"e resources 0 #acilities <0. e!uire" veri#ication4 vali"ation4 $onitoring4 ins+ection4 test activities * criteria #or acce+tance <1. ecor"s to +rovi"e evi"ence o# con#or$it) to esta'lishe" +rocesses * +ro"uct re!uire$ents@ e$arks -i# an)%:

<.2 Custo$er elate" 3rocesses a% Deter$ination o# 3ro"uct e!uire$ents: <2. e!uire$ents s+eci#ie" ') the custo$er4 inclu"ing "eliver) * +ost,"eliver) activities <2. e!uire$ents not s+eci#ie" ') the custo$er 'ut necessar) #or inten"e" or s+eci#ie" use <5. Statutor)4 regulator) re!uire$ents an" an) other re!uire$ents "eter$ine" ') the organisation. b# $o the post-delivery activities cover actions under "arranty provisions! contractual obligations such as maintenance activities and supplementary services such as recycling or final disposal? c% 3ro"uct e!uire$ent0Contract eview: <;. 3ro"uct re!uire$ents are a"e!uatel) "e#ine" * "ocu$ente" <>. Contract or or"er re!uire$ents that "i##er #ro$ those +reviousl) eB+resse" are resolve" <<. .he organisation has 209512;1;."oc -Dec 2008% 3age 9 o# 1>

ISO 9001:2008 Interview Checklist ISO 9001 Clauses the a'ilit) to $eet the "e#ine" re!uire$ents. "% 8re the results o# the +ro"uct0contract review an" su'se!uent #ollow,u+ actions recor"e"@ e% &ote: 1or internet sales4 #or$al review is not +ractical #or each or"er. Instea" the review can cover the relevant +ro"uct catalogue or a"vertising $aterial. #% 8re custo$er re!uire$ents con#ir$e"4 i# the custo$er +rovi"e no "ocu$ente" re!uire$ents@ g% ?here +ro"uct0contract re!uire$ents are change"4 "oes the organisation ensure <8. .hat relevant "ocu$entation is a$en"e" <9. elevant +ersonnel are $a"e aware o# the change" re!uire$ents@ h% Custo$er Co$$unication: Does the organisation i"enti#) * i$+le$ent arrange$ent #or co$$unication with the custo$ers relating to: 80. 3ro"uct in#or$ation 81. Fn!uiries4 contract or or"er han"ling4 inclu"ing a$en"$ents 82. Custo$er #ee"'ack4 inclu"ing custo$er co$+laints. e$arks -i# an)%: Ces &o 3artial &.8.

<.2 3ro"uct Design an" Develo+$ent a% Design an" Develo+$ent 3lanning: 8re the #ollowing "eter$ine": 82. Design an" "evelo+$ent stages 85. eview4 veri#ication an" vali"ation activities 8;. es+onsi'ilities * authorit) #or "esign an"0or "evelo+$ent activities@ '% 8re the inter#aces 'etween "i##erent grou+s $anage" to ensure e##ective co$$unication * clarit) o# res+onsi'ilities@ c% 8re +lanning out+ut ke+t u+,to,"ate@ d# Are the follo"ing conducted and recorded separately or in any combination! as suitable for the product and the organisation? %&. $esign and $evelopment 'evie" %(. )erification %%. )alidation e% Design an" Develo+$ent In+uts: 8re these "e#ine"4 "ocu$ente" an" "o the) inclu"e: 209512;1;."oc -Dec 2008% 3age 10 o# 1>

ISO 9001:2008 Interview Checklist ISO 9001 Clauses 89. 90. 91. 92. +er#or$ance re!uire$ents * regulator) re!uire$ents "erive" #ro$ si$ilar "esign 1unctional 8++lica'le 8++lica'le * statutor) in#o. Ces &o 3artial &.8.

8n) other essential re!uire$ents@ #% Design an" Develo+$ent Out+uts: 8re these "ocu$ente"4 a++rove" 'e#ore issue an" "o the) *3. +xist in a form suitable for verification against the design and development inputs 95. 3rovi"e a++ro+riate in#or$ation #or +ro"uction * service o+erations 9;. Contain or re#erence +ro"uct acce+tance criteria 9>. De#ine the characteristics o# the +ro"uct that are essential to its sa#e an" +ro+er use@ g% Design an" Develo+$ent eview: 8t suita'le stages4 are s)ste$atic reviews o# "esign 0 "ev. con"ucte" to: 9<. Fvaluate a'ilit) to #ul#il re!uire$ents 98. I"enti#) +ro'le$s * +ro+ose #ollow,u+ actions@ h% Design an" Develo+$ent Eeri#ication: Is this +er#or$e" to ensure that the "esign0"evelo+$ent out+uts $eets its in+uts@ 99. 8re the results o# the veri#ication an" resulting #ollow,u+ actions recor"e"@ i% Design an" Develo+$ent Eali"ation: Is this +er#or$e" to con#ir$ that the resulting +ro"uct is ca+a'le o# $eeting the re!uire$ents #or inten"e" use@ 100. ?herever a++lica'le4 is vali"ation co$+lete" 'e#ore "eliver) or i$+le$entation o# the +ro"uct@ 101. 8re results o# vali"ation * su'se!uent #ollow,u+ actions recor"e"@ 7% Design an" Develo+$ent Changes: 8re these i"enti#ie"4 "ocu$ente"4 reviewe"4 veri#ie" an" vali"ate"4 as a++ro+riate 'e#ore i$+le$entation@ 102. 8re there evaluation o# the e##ect o# changes on constituent +arts an" +ro"ucts alrea") "elivere"@ e$arks -i# an)%:

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ISO 9001:2008 Interview Checklist ISO 9001 Clauses <.5 3urchasing a% 3urchasing 3rocess0Control: 8re t)+e * eBten" o# control to 'e a++lie" to the su++lier an" +urchase" +ro"uct "e+en"ent on the e##ects on su'se!uent +ro"uct realisation +rocess or the #inal +ro"uct@ 102. 8re criteria #or selection * +erio"ic evaluation "e#ine"@ 105. 8re results o# su++lier evaluations * #ollow,u+ actions shall 'e recor"e"@ '% 3urchasing In#or$ation: Do +urchasing "ocu$ents contain in#or$ation "escri'ing the +ro"uct to 'e +urchase"4 inclu"ing where a++ro+riate: 10;. e!uire$ents #or +ro"uct a++roval4 +roce"ures4 +rocesses an" e!ui+$ent 10>. e!uire$ents #or !uali#ication o# sta## 10<. D:S re!uire$ents@ c% Eeri#ication o# 3urchase" 3ro"ucts : 8re activities necessar) #or veri#ication o# +urchase" +ro"ucts esta'lishe" an" i$+le$ente"@ "% ?here veri#ication nee"s to 'e +er#or$e" at the su++lier6s +re$ises4 are inten"e" veri#ication arrange, $ent * $etho" o# +ro"uct release "ocu$ente"@ e$arks -i# an)%: Ces &o 3artial &.8.

<.; 3ro"uction * Service O+erations a% O+erations * Service Control: 8re +ro"uction * service o+erations controlle" through4 as a++lica'le: 108. 8vaila'ilit) o# in#o on characteristics o# +ro"uct 109. 8vaila'ilit) o# work instructions 110. Use * $aintenance o# suita'le e!ui+$ent 111. 8vaila'ilit) * use o# $easuring * $onitoring "evices 112. I$+le$entation o# $onitoring activities 112. I$+le$entation o# "e#ine" +rocesses #or release4 "eliver) an" +ost, "eliver) activities@ '% 3ro"uction * Service O+eration Eali"ation 0 S+ecial 3rocesses: ?here resulting out+ut cannot 'e veri#ie" ') su'se!uent $onitoring or $easure$ent4 are the +ro"uction an" service +rocesses vali"ate" through -e.g. #or +acking o# +arachutes%4 as a++lica'le: 115. De#ine" criteria #or 209512;1;."oc -Dec 2008% 3age 12 o# 1>

ISO 9001:2008 Interview Checklist ISO 9001 Clauses review an" a++roval Ces &o 3artial &.8.

8++roval o# e!ui+$ent an" !uali#ication o# +ersonnel 11>. Use o# s+eci#ic $etho"s an" +roce"ures 11<. e!uire$ents #or recor"s an" re,vali"ations@ c% I"enti#ication * .racea'ilit): 8re various +ro"ucts suita'l) i"enti#ie" throughout +ro"uction an" service o+erations@ 118. 8re the +ro"uct status i"enti#ie" w.r.t. $easure$ent * $onitoring re!uire$ents@ 119. ?here tracea'ilit) is a re!uire$ent4 are uni!ue i"enti#ication o# +ro"uct controlle" an" recor"e". "% Custo$er 3ro+ert): 8re custo$er +ro+ert) +rovi"e" #or use or incor+oration into the +ro"uct i"enti#ie"4 veri#ie"4 +rotecte" * sa#eguar"e"@ 120. I# the custo$er +ro+ert) that is lost4 "a$age" or otherwise unsuita'le #or use4 is this re+orte" to the custo$er an" recor"e"@ -Custo$er +ro+ert) $a) inclu"e intellectual +ro+ert) and personal data4 e.g. in#or$ation +rovi"e" in con#i"ence%. e% 3reservation o# 3ro"uct : 8re the con#or$it) o# +ro"uct "uring internal +rocessing an" "eliver) to inten"e" "estination +reserve"@ 121. Does this inclu"e i"enti#ication4 han"ling4 +ackaging4 storage an" +rotection o# the +ro"uct an" constituent +arts@ e$arks -i# an)%:

11;.

<.> Control o# :easuring an" :onitoring Devices a% 8re the #ollowing "eter$ine"@ 122. :onitoring an" $easure$ent to 'e un"ertaken 122. :onitoring an" $easure$ent "evices nee"e" to +rovi"e evi"ence o# con#or$it) o# +ro"uct to "eter$ine" re!uire$ents '% 8re +rocesses to ensure that $onitoring * $easure, $ents can 'e carrie" out "eter$ine"@ c% Is the $easuring e!ui+$ent: 125. Cali'rate" or veri#ie" at s+eci#ie" intervals 12;. 8"7uste" or re, a"7uste" as necessar) 12>. I"enti#ie" to ena'le 209512;1;."oc -Dec 2008% 3age 12 o# 1>

ISO 9001:2008 Interview Checklist ISO 9001 Clauses the cali'ration status to 'e "eter$ine" 12<. Sa#eguar"e" #ro$ a"7ust$ents that woul" invali"ate the $easure$ent result 128. 3rotecte" #ro$ "a$age * "eterioration "uring han"ling4 $aintenance * storage@ "% ?hen a $easuring e!ui+$ent is #oun" not to con#or$ to re!uire$ents: 129. Is the vali"it) o# the +revious $easuring results assesse" an" recor"e"@ 120. 8re a++ro+riate actions taken on the e!ui+$ent an" an) a##ecte" +ro"ucts@ e% 8re recor"s o# e!ui+$ent cali'ration * veri#ication $aintaine"@ #% ?hen use" #or $onitoring or $easure$ent4 is the a'ilit) o# the co$+uter so#tware to satis#) the inten"e" a++lication con#ir$e" 'e#ore initial use@ e$arks -i# an)%: Ces &o 3artial &.8.

Measurement, -nalysis . Im%r&vement

8.1 :easure$ent * :onitoring 3lanning a% 8re $easure$ent * $onitoring activities +lanne" an" i$+le$ente" to 121. De$onstrate con#or$it) o# the +ro"uct 122. Fnsure the con#or$it) to D:S 122. Continuall) i$+rove the e##ectiveness o# the D:S '% 8re a++lica'le $etho"s4 inclu"ing statistical techni!ues an" the eBtent o# their use "eter$ine"@ e$arks -i# an)%:

8.2 :easure$ent an" :onitoring a% Custo$er Satis#action: 8re the $etho"s #or o'taining an" using this in#or$ation "eter$ine"@ b# $oes the input source include customer satisfaction surveys! customer data on delivered product quality! user opinion surveys! lost business analysis! compliments! "arranty claims and dealer reports? c% Internal 8u"it: 8re internal au"its con"ucte" at +lanne" intervals to "eter$ine whether the D:S 125. Con#or$s to the ISO 209512;1;."oc -Dec 2008% 3age 15 o# 1>

ISO 9001:2008 Interview Checklist ISO 9001 Clauses 9001 re!uire$ents Ces &o 3artial &.8.

Is e##ectivel) i$+le$ente" * $aintaine"@ "% Is au"it +rogra$ +lanne"4 taking into consi"eration the status0i$+ortance o# the activities0areas to 'e au"ite" an" the results o# +revious au"its@ e% 8re the au"it sco+e4 #re!uenc) * $etho"olog) "e#ine"@ 12>. 8re au"its con"ucte" ') +ersonnel other than those who +er#or$ the activit) 'eing au"ite"@ #% 8re the #ollowing "ocu$ente" in a +roce"ure: 12<. es+onsi'ilit) 0 re!uire$ent #or +lanning * con"ucting au"it 128. e+orting results an" $aintaining recor"s@ g% Does $g$t ensure that ti$el) actions are taken to eli$inate "etecte" non,con#or$ities an" their causes@ 129. 8re #ollow,u+ actions veri#ie" * veri#ication results re+orte"@ h% :easure$ent * :onitoring o# 3rocesses: 8re suita'le $etho"s #or $onitoring an"4 where a++lica'le $easure$ent o# D:S +rocesses a++lie"@ 150. Do these $etho"s "e$onstrate the a'ilit) o# the +rocesses to +lanne" results@ 151. ?hen +lanne" results are not achieve"4 are a++ro+riate corrective action taken4 to ensure con#or$it) o# the +ro"uct@ i# $o such measurement and monitoring assist the organisation to meet the product requirements and improve the effectiveness of the quality mgmt system? 7% :easure$ent * :onitoring o# 3ro"uct : 8re the characteristics o# the +ro"ucts $onitore" * $easure" to veri#) that re!uire$ents o# +ro"uct have 'een $et@ 152. 8re these carrie" out at a++ro+riate stages o# the +ro"uct realisation +rocess in accor"ance with +lanne" arrange$ents@ 152. 8re the evi"ences o# con#or$it) with acce+tance criteria $aintaine"@ 155. 8re recor"s in"icating the +erson authorising the release o# the +ro"uct $aintaine"@ 15;. 8re +ro"uct release an" service "eliver) hel" 'ack until the +lanne" arrange$ents have 'een satis#actoril) co$+lete"4 unless otherwise a++rove" ') the custo$er or relevant authorit)@ e$arks -i# an)%:

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ISO 9001:2008 Interview Checklist ISO 9001 Clauses 8.2 Control o# &on,Con#or$it) a% 8re +ro"ucts which "o not $eet re!uire$ents i"enti#ie" * controlle" to +revent uninten"e" use or "eliver)@ '% 8re the controls4 res+onsi'ilit) an" authorit) #or "ealing with non,con#or$ing +ro"ucts "e#ine" in a "ocu$ente" +roce"ure@ 15>. 8re actions taken to eli$inate the "etecte" non,con#or$it) or concessions +rovi"e" ') relevant authorit) or the custo$er #or use4 release or acce+tance@ c% 8re recor"s on the nature o# the non,con#or$it) an" #ollow,u+ actions inclu"ing concessions4 $aintaine"@ "% ?here the non,con#or$ing +ro"uct is correcte"4 is it su'7ecte" to re,veri#ication@ e% ?here the non,con#or$ing +ro"uct is "etecte" a#ter "eliver) or use4 are actions a++ro+riate to the e##ects or +otential e##ects4 taken@ e$arks -i# an)%: 8.5 8nal)sis o# Data a% 8re a++ro+riate "ata to "eter$ine suita'ilit) * e##ectiveness o# the D:S -an" to i"enti#) i$+rove$ents% "eter$ine"4 collecte" an" anal)se"@ '% 8re "ata relating to the #ollowing anal)se": 15<. Custo$er satis#action0"is,satis#action 158. Con#or$ance to custo$er re!uire$ents 159. Characteristics * tren"s o# +rocess * +ro"ucts 1;0. Su++liers@ e$arks -i# an)%: ?hat eBisting $easures are collecte" an" anal)se"@ Ces &o 3artial &.8.

8.; D:S I$+rove$ent4 Corrective * 3reventive 8ctions a% Continual I$+rove$ent: 8re the e##ectiveness o# the D:S continuall) i$+rove" through the use o#: 1;1. Dualit) +olic) * o'7ectives 1;2. 8u"it results4 anal)sis o# "ata 1;2. Corrective * +reventive actions 1;5. :anage$ent review@ 209512;1;."oc -Dec 2008% 3age 1> o# 1>

ISO 9001:2008 Interview Checklist ISO 9001 Clauses '% Corrective 8ction: 8re corrective action taken to eli$inate the cause o# the non,con#or$ities to +revent recurrence@ 1;;. Corrective action shall 'e a++ro+riate to the i$+act o# the +ro'le$s encountere". c% Do the "ocu$ente" +roce"ures "e#ine re!uire$ents #or: 1;>. I"enti#)ing * reviewing non,con#or$ities -inclu"ing custo$er co$+laints% 1;<. Deter$ining the cause-s% o# the non,con#or$it) 1;8. Fvaluate nee" #or actions 1;9. Deter$ining4 i$+le$enting4 recor"ing * veri#)ing the corrective action-s%@ "% 3reventive 8ction: 8re a++ro+riate actions taken to eli$inate cause-s% o# +otential non,con#or$ities in or"er to +revent their occurrence@ 1>0. 3reventive action shall 'e a++ro+riate to the i$+act o# the +otential +ro'le$s. e% Do the "ocu$ente" +roce"ures "e#ine re!uire$ents #or: 1>1. I"enti#)ing +otential non,con#or$ities * their causes 1>2. Fvaluating the nee" #or action 1>2. Deter$ining4 i$+le$enting4 recor"ing an" veri#)ing the +reventive action-s%@ e$arks -i# an)%: Ces &o 3artial &.8.

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