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8/17/2019 ISO 9000 Awareness Presentation 8-27-15
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Awareness and Use ofISO 9000:2015
“Quality Management
Systems —Fundamentals and
Vocabulary”Normative Reference for ISO
9!"#!$ 1Compliments of US TAG to ISO TC 17 !"2"2015
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#$rpose and S%ope
• T&e p$rpose of t&is presentation is to stress t&eimportan%e of $sin' ISO 9000:2015 for t&ea$ditin' and implementation of ISO 9001:2015
• T&e presentation is intended to (e $sed fortrainin' () t&e p$(li%
!"2"2015Compliments of US TAG to ISO TC17
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“+ormati,e -eferen%es.
As /$oted dire%tl) from ISO 9001:2015
“T&e followin' referen%ed
do%$ments are indis%ensablefor t&e appli%ation of t&is
do%$ment:.
“ISO 9000:2015 Qualitymanagement systems —
Fundamentals and vocabulary”
*Compliments of US TAG to ISO TC 17 !"2"2015
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&indis%ensable”
• adjective indispensa(le 6in8di8spent;8s
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ISO 9000 Series• ISO 9 , / Quality management systems
— Fundamentals and vocabulary o ISO 9000 pro,ides an essential (a%'ro$nd for t&e
proper $nderstandin' and implementation of t&e ISO9001 International Standard
•
ISO 9! 0 Quality Management Systems -Requirement o ISO 9001 spe%iHes re/$irements aimed primaril) at
'i,in' %onHden%e in t&e prod$%ts and ser,i%es pro,ided() an or'aniation and t&ere() impro,in' %$stomer
satisfa%tion• ISO 91 , Managing for the sustained
success of an organization - 2 3ualitymanagement a%%roac)o ISO 9003 #ro,ides '$idan%e for or'aniations t&at
%&oose to pro'ress (e)ond t&e re/$irements of t&e ISO 5!"2"2015Compliments of US TAG to ISO TC 17
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5ommon 6roundStandards 7)ic) Normative referenceISO 9! also re3uire t)e use of ISO98Some %rime e.am%les are s)o7n )ere"
• S2 2S 9!5"#9 0 2eros%ace ,-e/$irements
• ISO :S !;919"#9 , 2utomotive,-e/$irements
•
ISO !
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5ontents
Fore7ord M Introduction
! Sco%e
# Fundamental conce%ts and 3uality
management %rinci%les
#?! 6eneral
#?# Fundamental conce%ts
221 K$alit)
222 K$alit) mana'ement s)stem
22* Conte=t of an or'aniation223 Interested parties
225 S$pport
Compliments of US TAG to ISO TC 17 !"2"2015
Nes%ripti,e
lan'$a'e wit&nore/$irements
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5ontents 5ontinued
#?< Quality management%rinci%les
2*1 C$stomer fo%$s
2*2 eaders&ip2** n'a'ement of people2*3 #ro%ess approa%&2*5 Impro,ement
2* ,iden%e8(ased de%ision main'2*7 -elations&ip mana'ement
Compliments of US TAG to ISO TC 17 !"2"2015
+ore/$irementsPideas $sef$lin '$idin'or'aniationsQa%tions Used
as a (asis forde,elopin'ISO 9001
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#?1 *evelo%ing t)e QMS usingfundamental conce%ts and%rinci%les
231 KFS model 232 Ne,elopment of a KFS
23* KFS standards ot&er
mana'ement s)stems and e=%ellen%emodels
9!"2"2015Compliments of US TAG to ISO TC 17
5ontents 5ontinued
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< :erms and de+nitions , Terms related
to *! data informationand do%$ment
*9 %$stomer
*10 %&ara%teristi%*11 determination
*12 a%tion
*1* a$dit
*1 person or people
*2 or'aniation
** a%ti,it)
*3 pro%ess
*5 s)stem
* re/$irement
*7 res$lt
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-e/$ired deHnitions of terms $sedin re/$irements standards s$%& as
ISO 9001
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5ontents 5ontinued
2nne. 25once%t relations)i%s andt)eir gra%)ical re%resentation
@ibliogra%)y 2l%)abetical inde. of
terms
!"2"2015Compliments of US TAG to ISO TC17
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Con%ept dia'ramsaid in $nderstandin'of interrelations&ipsamon' terms and
%on%epts
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e o o roper ) s n'9000
Tain' ISO 9001:2015 %la$se 1021dP for e=ample:
•“T&e Or'aniation s&all revie7 t)eeectiveness of any corrective action taAen.
R) s$(stit$tin' “eBe%ti,eness. and “%orre%ti,ea%tion. wit& t&eir deHnitions from ISO 9000 t&is
statement (e%omes:
• T&e Or'aniation s&all revie7 t)e “etent to!hich "lanned activities are realized and
"lanned results are achieved# for any “action
taAen to eliminate the cause of anonconformity and to "revent recurrence#
12!"2"2015Compliments of US TAG to ISO TC 17
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1*
Bnderstanding t)e de$nitions andfundamental conce"ts in ISO9!"#!$
• Interested%arty
• RisA
•RisA,based
t)inAing
• 4rovider
• *ocumented
information• Cectiveness
1*
• 5om%etence
•Out%ut
• Information
• Informationsystem
• Veri+cation• Validation
• 5orrectiveaction
• 4reventive
:)e Follo7ing are e.am%les of some of t)eNe78 Revised or Removed :erms of ISO
9!Ne7
Ne7
Ne7
Ne7
Ne7
Revised
Revised
Revised
Revised Revised
Revised
Revised
Revised
Removed
!"2"2015Compliments of US TAG to ISO TC 17
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+ew “Terms. in t&e Hrst Cla$ses of ISO9001:2015
1 S%ope of standard2 +ormati,e referen%es
* Terms and deHnitions
1? &5onte.t of t)e organiDation”
31 Understandin' t&e or'aniation and its “conte.t”32 Understandin' t&e needs and e=pe%tations of
“interested %arties”
3* Neterminin' t&e s%ope of t&e /$alit) mana'ements)stem 8 (; t&e re/$irements of rele,ant “interested%arties”
33 K$alit) mana'ement s)stem and its pro%esses 8 f;address t&e &risAs &
$? &>eaders)i%”
;? &4lanning”“ ”
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Understandin' “Conte=t.
5onte.t of an organiDation• Understandin' t&e %onte=t of t&e or'aniation is a
pro%ess T&is pro%ess determines fa%tors w&i%&
in$en%e t&e or'aniationQs p$rpose o(>e%ti,es ands$staina(ilit)
5onte.t of t)e organiDation• Com(ination of internal M e=ternal iss$es t&at %an
&a,e an eBe%t on an or'aniationQs approa%& tode,elopin' and a%&ie,in' its o(>e%ti,es
15!"2"2015Compliments of US TAG to ISO TC 17
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Understandin' “Interested #arties.
&en determinin' t&e s%ope of t&e or'aniation we s&all%onsider t&e e=pe%tations of rele,ant interested parties
2ll of t)e follo7ing can be Einterested %artiesE• person &a,in' an interest in t&e s$%%ess of an or'aniation
• person t&at %an aBe%t an a%ti,it)
• or'aniation t&at per%ei,es itself to (e aBe%ted () a de%ision• stae&older
• person &a,in' an interest in t&e performan%e of anor'aniation
•
pro,iders re'$lators• %ompetitors
• opposin' press$re 'ro$p
• T&ere are more
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Understandin' “-is. T&e term “-is. &as (een added to ISO 9001:2015
and is noted in man) pla%es t&ro$'&o$t t&estandard
“-is. 8 eBe%t of $n%ertaint) positi,e or ne'ati,e
%onse/$en%e or lieli&ood referen%e topotential e,ents t&e %onse/$en%es of an e,ent
T&is ma) appl) for e=ample toP a prod$%tser,i%e pro%ess pro,ider %$stomer %ons$meren,ironment emplo)ee M t&e %ompetition
17!"2"2015Compliments of US TAG to ISO TC 17
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Assistin' Or'aniations
• :)e 4rice of ISO 9 is !(< t)e cost ofot)er ISO standards of similar siDe
• ISO 9000 terms are (roen down ()
%ate'or) to promote international$nderstandin' and in%rease %onHden%e int&e 'lo(al maret
• T&e ele%troni% Ado(e ,ersion of ISO 9000
in%l$des %li%8on n$meri%al lins for deHnedterms
• ASK oBers standard ($ndle pa%a'es topromote t&e $se of +ormati,e -eferen%eNo%$ments 1!!"2"2015Compliments of US TAG to ISO TC 17
-e eren%e n s or a t ona
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-e eren%e n s or a t onaInformation
• #a$l #almes arti%le L “&atQs +ormati,eAn)wa).o &ttp:""wwwinsidestandards%om"iso8900020158w&ats8normati,e8
an)wa)"
• ASKor' Standards Conne%tiono &ttp:""as/or'"standards%onne%tion"
• ASKor' Standards Centralo &ttp:""as/or'"nowled'e8%enter"standards8iso8900182015&tml
• ASK Standards C&annelo &ttp:"",ideosas/or'"as/8standards8%&annel
• ISO"VNIS 9000:2015 +OT G$idan%e on someadditional fre/$entl)8$sed words in t&e KFS standardsde,eloped () ISO"TC 17 and w&i%& &a,e anidentiHed di%tionar) meanin' is pro,ided in a 'lossar)a,aila(le at:o
&ttp:""wwwisoor'"iso"0*Wterminolo')W$sedWinWisoW9000Wfamil)pdf
19!"2"2015Compliments of US TAG to ISO TC 17
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