iso 9001-2008 gap assessment

8/18/2019 ISO 9001-2008 Gap Assessment

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Gap Analysis Report Summary

s reference is a quick clause-by-clause summary of the ISO 9001:2008 requirements.

e: See the actual stan!ar! alon" #ith the $a% &nalysis 'hecklist for a com%lete !escri%tion of the requirements.

9001:2008 Summary of Requirements

$eneral )equirements Im%lement quality system an! continually im%ro*e it

+ocumentation )equirements

1 $eneral Inclu!e the require! !ocuments an! recor!s

2 ,uality anual stablish an! maintain a quality manual

/ 'ontrol of +ocuments nsure !ocuments are at ri"ht status in ri"ht %laces

( 'ontrol of )ecor!s I!entify recor!s an! kee% as e*i!ence of conformity

ana"ement 'ommitment Sho# e*i!ence of to% mana"ement commitment

'ustomer ocus eet the requirements an! satisfy your customers

,uality olicy 3a*e to% mana"ement e4%ress quality intentions

lannin"

1 ,uality Ob5ecti*es Set measurable tar"ets for %ro!ucts an! %rocesses

2 ,uality ana"ement System lannin" 'arry out %lans for quality system an! its %rocesses

)es%onsibility6 &uthority6 an! 'ommunication

1 )es%onsibility an! &uthority ake sure e*eryone kno#s their !uties an! roles

2 ana"ement )e%resentati*e &%%oint a mana"er as focal %oint for quality system

/ Internal 'ommunications 7ee% e*eryone informe! of system effecti*eness

ana"ement )e*ie#

1 $eneral )e*ie# the quality system at %lanne! inter*als

2 )e*ie# In%ut nsure the require! a"en!a to%ics are co*ere!

/ )e*ie# Out%ut )ecor! the !ecisions an! actions from re*ie#s

ro*ision of )esources ro*i!e necessary resources to meet requirements

3uman )esources

1 $eneral nsure e*eryone #orkin" in system is com%etent

2 'om%etence6 Trainin"6 an! areness Train %ersonnel an! reco"nie their contributions

Infrastructure ro*i!e facilities6 equi%ment6 an! su%%ort ser*ices

ork n*ironment ana"e combination of human an! %hysical factors

lannin" of ro!uct )ealiation lan an! !e*elo% %rocesses for %ro!uct realiation

'ustomer-)elate! rocesses

1 +etermination of ro!uct )equirements +efine customer6 re"ulatory6 an! o#n requirements

2 )e*ie# of ro!uct )equirements )e*ie# requirements before committin" to customer

/ 'ustomer 'ommunication Talk to customers about %ro!ucts an! com%laints+esi"n an! +e*elo%ment

Quality Management System

Management Resonsi!ility

Resour#e Management

ro&u#t Reali'ation


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9001:2008 Summary of Requirements

1 +esi"n an! +e*elo%ment lannin" lan !esi"n sta"es6 acti*ities6 an! res%onsibilities

2 +esi"n an! +e*elo%ment In%uts I!entify an! re*ie# in%ut requirements for !esi"n

/ +esi"n an! +e*elo%ment Out%uts re%are !esi"n out%uts an! a%%ro*e before release

( +esi"n an! +e*elo%ment )e*ie# )e*ie# ability of !esi"n results to meet requirements

+esi"n an! +e*elo%ment


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ult+O!ser*ations


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ult+O!ser*ations


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ISO/TS 16949:2009 Gap Analysis Che!list

GAP ANALYSIS PAGE 5 OF 115

R,Q-IR,M,/S

Q-)I/ M)),M,/ SS/,M

eneral Requirements

?ook for !ocumentation of the %rocesses inclu!e! in the ,S

Is there any information on the effecti*eness of %rocesses@

3o# are im%ro*ements ma!e to %rocesses@

ISO 9001:2008S,3/IO

3-RR,/ I %)3,ist &o#uments or e*i&en#e

This clause asks you to i!entify ho# mana"ement a%%lies the%rocess a%%roach to achie*e the effecti*e an! efficient controlof %rocesses6 resultin" in %erformance im%ro*ement.S%ecifically this section is lookin" for an o*erall %rocesse*aluation of all quality relate! %rocesses an! theirinterrelationshi%s. ?ook to see that your or"aniational%rocesses are !efine! an! that consi!eration is "i*en to theitems !escribe! belo#.

Is there a ,uality ana"ement System in %lace that has beenestablishe! an! !ocumente! to meet the requirements of theISOATS 19(9:2009 Technical S%ecification@

?ook for information on the relationshi% an! sequence of the,S %rocesses.

&sk ana"ement if o%eration an! control of %rocesses iseffecti*e. 3o# !o they kno# if it is effecti*e@

&sk ho# they are able to kno# if resources an! informationnee!e! to su%%ort %rocesses ha*e been %ro*i!e!.


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R,Q-IR,M,/SISO 9001:2008

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ist &o#uments or e*i&en#e

6o#umentation Requirements

.1 eneral

1

1

1

1

1

1 & quality manual@

1

Is there im%lementation of %rocess measure6 monitorin" an!analysis@

hat %rocesses !oes your or"aniation outsource@3o# are the %rocess controlle!@

This section a!!resses ho# you use !ocuments an! recor!sto su%%ort effecti*e an! efficient o%eration of youror"aniation. & re*ie# of your %rocesses6 %roce!ures6 #orkinstructions6 an! recor!s #ill !etermine if the stan!ar!requirements are met.

+oes your quality system !ocumentation inclu!e the!ocumentation require! by the technical s%ecification ISOATS19(9@

Is the !ocumentation sufficient to ensure a!equate o%erationof the ,S@

Is the !ocumentation sufficient to ensure a!equacy for thesie an! ty%e or or"aniation6 com%le4ity an! interaction of%rocesses an! com%etency of %ersonnel@

+oes the quality mana"ement system !ocumentation inclu!ethe follo#in":

+ocumente! statements of a quality %olicy an! qualityob5ecti*es@

+ocumente! %roce!ures require! by ISOATS 19(9:2009@Bthere are se*enC


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1

1 )ecor!s require! by ISOATS 19(9:2009@

1

1 +oes the ,S !ocumentation inclu!e ,uality )ecor!s@

.2 Quality Manual

2 )e*ie# the ,uality anual if a*ailable:

2 hat is the sco%e of your ,S@

2 hat %rocesses ha*e been e4clu!e!@ Is this a%%ro%riate@

2

2 +oes the ,uality anual inclu!e a sco%e@

2 +oes the ,uality anual a!equately !escribe the ,S@

2

.7 3ontrol of 6o#uments

/ & !ocumente! %roce!ure is require!.

+ocuments nee!e! by the or"aniation to ensure theeffecti*e %lannin"6 o%eration an! control of its %rocesses@

Is there a list or other means of i!entifyin" other!ocumentation require! by your ,S@ &re the require! !ocuments a*ailable@

Is a !escri%tion or illustration of the interrelation of the%rocesses inclu!e!@

+oes the ,uality anual !ocument or reference the require!!ocumente! %roce!ures@


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/

/ &re !ocuments a%%ro*e! %rior to release@

/ &re !ocuments u%!ate! an! re-a%%ro*e! %rior to release@

/ 3o# are chan"es i!entifie!@

/

/

/

/

/

.4 3ontrol of Quality Re#or&s

(

+o you ha*e a formal %roce!ure re"ar!in" the control of!ocuments for your or"aniation@

&re !ocuments a*ailable to those that nee! to use them@3o# is the most current *ersion ke%t in the correct locations@

'an users easily i!entify !ocuments@ 'an users easily rea!the !ocuments@ &re the !ocuments easy an! accessible forthe em%loyees use@

If !ocuments such as reference books6 user>s manuals an!other outsi!e !ocuments are use!6 ho# are they controlle!@

3o# are ol! !ocuments han!le!@ &re they remo*e! fromuse@ &re they labele!@Is a co%y maintaine! for reference@Is there any chance that an ol! !ocument coul! be use! byacci!ent@

+oes the or"aniation a!equately !ocument Bre*ision le*el6!ate6 etc.C the re*ision le*el6 !ate6 etc.@

& !ocumente! %roce!ure is require! by this clause of thestan!ar!.


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( Is there a !ocumente! %roce!ure in %lace for recor!s control@

(

(

(

( 'an they be retrie*e!@

( 3o# lon" !oes it take@

( &re recor!s !is%ose! of accor!in" to the retention times@

(

(

M)),M,/ R,S%OSIII/

Management 3ommitment

here are recor!s ke%t@Is this i!entifie! some#here so users can easily fin! recor!s@'an users i!entify the recor!s@ &re the recor!s le"ible@

3o# are the retention times6 stora"e requirements6 an! their!is%osition i!entifie!@

&re they store! in areas an! locations are suitable to %re*entloss6 !ama"e or !eterioration@

If the !ocuments an! or recor!s are in the net#ork or

Internet6 can they be chan"e!@

&re recor!s a*ailable on !eman!@ Is there e*i!ence thatrecor!s are easily retrie*able for the or"aniation@


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This section asks you to i!entify ho# your to% mana"ement!emonstrates its lea!ershi%6 commitment an! in*ol*ement. Is

mana"ement communicatin" the im%ortance of meetin"customer requirements@


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3ustomer o#us

Is the or"aniation hea!e! in the ri"ht !irection6 !o themana"ement re*ie# minutes sho# %ositi*e tren!s for keymeasurables such as customer satisfaction6 customer

returns6 !eli*ery6 an! other key customer e4%ectationsi!entifie! in .2 'ustomer ocus@

+oes mana"ement sho# in*ol*ement an! take action #henthin"s are not "oin" in the ri"ht !irection@

This is a requirement that may be !efine! in a !ocument!escribin" ho# your or"aniation a!!resses this clause. If no!ocument is a*ailable inter*ie# to% mana"ement forcom%liance. To% mana"ement an! other %ersonnel shoul! bein*ol*e! in this section.

Is there a %rocess in %lace to i!entify your customerrequirements@3o# is To% ana"ement in*ol*e!@

3o# !oes To% ana"ement kno# if customer requirementsare bein" met@

Is your or"aniation aime! at achie*in" customersatisfaction@3o#@

&re all ty%es of customers: consumer6 client6 en! user6retailer6 an! beneficiary i!entifie!@


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3o# !o e4%ectations translate into requirements@

3o# are customer requirements %rioritie!@

Quality %oli#y

+oes the or"aniation "ather the ty%e of information thatcoul! be translate! into %hysical B!imensionalC6 sensoryBsmell6 touch6 tasteC6 beha*ioral Bcourtesy6 honestyC6 tem%oral

B%unctuality6 reliabilityC6 er"onomic Blin"uistic6 %hysiolo"ical6human safetyC6 an! functional terms@

+o you inclu!e the follo#in" e4%ectations:satisfactionA!issatisfaction6 customer com%laintsAre5ects6%ro!uct requirements inclu!in" re"ulatory an! le"al an!%ro!uct failure information@

3o# is the or"aniation !istin"uishin" bet#een %ro!uct an!business requirements@

&re customer e4%ectations "athere! at least once a year #iththe business %lannin" cycle@

Is the information "athere! suitable for con*ertin" intorequirements6 settin" ob5ecti*es6 i!entifyin" %rocesses6 an!for im%ro*ement@

+oes the %rocess %ro*i!e confi!ence that fulfillin" therequirements #ill achie*e customer satisfaction@

Is the %rocess con!ucte! from a narro# com%liance *ie#%ointor is it con!ucte! #ith the i!ea that customer satisfaction isthe "oal@


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+oes the quality %olicy ins%ire an! lea! or"aniation for#ar!@

%lanning

.1 Quality O!e#ti*es

)e*ie# the quality %olicy6 mana"ement6 %ersonnel6mana"ement re*ie# meetin" minutes an! other !ocumentsthat mi"ht a%%ly to this clause for com%liance. *aluate ho#

the quality %olicy lea!s to im%ro*ements.

Is the quality %olicy a%%ro%riate for the or"aniation an!ali"ne! #ith customer e4%ectations6 business en*ironment6an! mana"ement "oals@

+oes the quality %olicy inclu!e a Dcommitment to meetin"requirements an! to continual im%ro*ementE@

3o# !oes the quality %olicy %ro*i!e a frame#ork forestablishin" an! re*ie#in" quality ob5ecti*es@

hat is the relationshi% bet#een the quality %olicy an! theob5ecti*es that are set@

3o# is it communicate! an! !e%loye! to be un!erstoo! atDa%%ro%riateE le*els of the or"aniation@

Is the quality %olicy re*ie#e! at a minimum once a year an!!o the mana"ement re*ie#s e*aluate the nee! for chan"e tothe quality %olicy reference@


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1

1 )e*ie# ,uality Ob5ecti*es:

1

1

1

1 3o# are the ob5ecti*es !e%loye!@

1

1

.2 Quality Management System %lanning

)e*ie# your !efine! quality ob5ecti*es. +o your qualityob5ecti*es translate your quality %olicy into measurable "oals@ &re they !ocumente! so all %ersonnel kno#s #hat they are

an! ho# the ob5ecti*es a%%ly to their %rocesses@ &re thequality ob5ecti*es bein" re*ie#e!@ &re they measurable@ +othe ob5ecti*es contain commitment to the continualim%ro*ement of the ,S@

here are ob5ecti*es !efine! for meetin" %ro!uctrequirements@

&t #hat le*els ha*e quality ob5ecti*es been establishe!@+e%artment@ rocess@

3o# are ob5ecti*es measure!@3o# !o they contribute to meetin" the quality %olicy@

+o the quality ob5ecti*es sho# continual im%ro*ement@If not6 #hy not@

+o the or"aniation>s ob5ecti*es tar"et the areas that areim%ortant to the customer Brefer to .2 'ustomer ocusC@


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2

2 hat quality %lannin" %rocess is in %lace@

2

2

2

2 Is there &nalysis for each %rocess@

2

2

2

2

2

)e*ie# the !ocuments or e*i!ence in the ,S com%lyin"#ith this clause.


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2

2

Resonsi!ility( )ut;ority an& 3ommuni#ation

.1 Resonsi!ility an& )ut;ority

1

1

1

.2 Management Reresentati*e

2

2

&re the im%ro*ement tar"ets a%%ro%riate to achie*e customersatisfaction@

ill the %lan accom%lish the task of meetin" the customers>

nee!s an! e4%ectations e4%resse! in .2 'ustomer ocus@


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2

2

2

2

2

2

.7 Internal 3ommuni#ation

/

/ 3as the or"aniation establishe! communication %rocesses@

/

/

Is the mana"ement re%resentati*e acti*ely in*ol*e! in theim%lementation an! maintenance of the ,S@

+oes heAshe ensure that the %rocesses of the ,S areestablishe! an! maintaine!@

Is the ana"ement )e%resentati*e kno#le!"eable of the,S@

+oes heAshe re%ort to to% mana"ement on the %erformanceof the ,S an! the nee! for im%ro*ement@

+oes heAshe %romote a#areness of customer requirementsthrou"hout the or"aniation@ &re there meetin" minutes6 meetin" notices6 bulletins6 an! Aor ne#sletters@

Is heAshe %romotin" the correctAim%ortant customerrequirements@


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/

/ hat %rocesses are they communicatin"@

/

/

Management Re*ie<

.1 eneral

1

1 Is there a sche!ule for mana"ement re*ie#@

1

+oes the communication communicate both %rocessinformation an! its effecti*eness@

3o# are they communicatin" effecti*eness of %rocesses@ Is ita%%ro%riate@

+o em%loyees un!erstan! the status an! effecti*eness of the,S6 #here the or"aniation is hea!e!6 an! their role an!contribution@

)e*ie# your mana"ement re*ie# recor!s for conformance.The requirements for mana"ement re*ie# in%ut coul! be%resente! in an a"en!a or #ritten in a !ocument. s suitability6a!equacy6 an! effecti*eness@


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1 &re there recor!s or mana"ement re*ie#s@

1

1

.2 Re*ie< Inut

2

2 aC )esults of au!its

2 bC 'ustomer fee!back

2 cC rocess %erformance an! %ro!uct conformity

2 !C Status of %re*entati*e an! correcti*e actions

2 eC ollo#-u% actions from %re*ious mana"ement re*ie#s

2 fC 'han"es that coul! affect the quality mana"ement system

2 "C )ecommen!ations for im%ro*ements

.7 Re*ie< Outut

/

+o the or"aniation>s mana"ement re*ie#s inclu!e assessin"o%%ortunities for im%ro*ement an! the nee! for chan"es to

the quality mana"ement system6 inclu!in" the quality %olicyan! quality ob5ecti*es@

&re the or"aniation>s recor!s from mana"ement re*ie#smaintaine!@

+oes the ana"ement )e*ie# rocess a!!ress all therequire! In%uts@

+oes the out%ut of mana"ement re*ie# inclu!e actionsrelate! to im%ro*ement of the ,S@


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/

/

/ 3o# are resources allocate!@

/

/

R,SO-R3, M)),M,/

%ro*ision of Resour#es

&re resources sufficient to meet customer requirements@

+oes the out%ut of mana"ement re*ie# inclu!e %rocesses6im%ro*ement of %ro!uct relate! to customer requirements6an! resource nee!s@

Is there e*i!ence that resources are allocate! to meetcustomer satisfaction an! ,S ob5ecti*es@

&re mana"ement re*ie# in%uts %resente! in such a fashionthat mana"ement can easily i!entify the current %erformancean! im%ro*ement o%%ortunities of each of the items%resente!@

If the current %erformance is ina!equate6 are actionsi!entifie! in the out%ut to a!!ress im%ro*ements nee!e!@


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=uman Resour#es

.1 eneral

1

1 *aluate the com%etence of %ersonnel:

1

.2 3ometen#e( /raining an& )


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2 3as the !etermine! trainin" been %ro*i!e!@

2

2

2

2

2

2

2

2 Is there ne# em%loyee orientation an! trainin"@

2

2

Is there on-"oin" continual e!ucation trainin"@ &n! is this trainin" !ocumente! in the em%loyees> trainin"

recor!s@

Is the effecti*eness of the trainin" e*aluate!@3o#@Is there sufficient e*i!ence@

&re %ersonnel a#are of the rele*ance an! im%ortance of theiracti*ities an! ho# they contribute to the achie*ement of thequality ob5ecti*es@

&re a%%ro%riate recor!s maintaine! !escribin" em%loyees>e!ucation6 trainin"6 skills an! e4%erience@

&re there com%etency requirements !efine! for all ty%es of 5obs@ake sure all ty%es of em%loyees are sam%le!

3a*e the com%etency nee!s of em%loyees affectin" quality

been i!entifie!@

Is there a trainin" %lan to satisfy these nee!s@Is it follo#e!@

+oes it co*er rele*ance an! im%ortance of em%loyeeacti*ities6 an! ho# they relate to the quality ob5ecti*es@

&re there recor!s for all em%loyees in!icatin" their trainin"6skills e!ucation an! e4%erience@


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2

Infrastru#ture

hat is your infrastructure@

>or? ,n*ironment

&re com%etent %ersonnel Deffecti*elyE carryin" out acti*itiesan! %ro*i!in" results for the or"aniation throu"him%ro*ement@ &re there #eaknesses@

This clause a!!resses ho# your or"aniation ensures thatthe infrastructure is a%%ro%riate for the achie*ement of yourob5ecti*es.


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3as this #ork en*ironment been %ro*i!e!@

%RO6-3/ R,)I@)/IO

%lanning or %ro&u#t Reali'ation

4am%les to look at for com%liance #oul! be #ork metho!s6safety6 er"onomics6 an! tem%erature an! humi!ity controls.lements that may also be inclu!e! in #ork en*ironment are

information6 su%%liers an! %artnershi%s6 natural an! financialresources.

hat #ork en*ironment is nee!e! to meet %ro!uct or ser*icerequirements@

3as the or"aniation i!entifie! the human an! %hysicalfactors of their #ork en*ironment@hysical factors inclu!e heat6 noise6 li"ht6 hy"iene6 humi!ity6cleanliness6 *ibration6 %ollution6 an! airflo#.

3as the or"aniation i!entifie! #ork rules for %eo%lein*ol*ement6 safety rules6 an! er"onomics@

hat %rocess !o they use to mana"e the human an! %hysicalfactors@

+o recor!s sho# #ork en*ironment as a root cause for non-conformances@

hile #alkin" throu"h the facility6 monitor the le*el ofhousekee%in". Is there oil on the floor6 chi%s = !irt6 ci"arettebutts6 etc@

hat is the "eneral #ork en*ironment as it relates to noise6air quality6 etc@


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Is there a quality %lan for the %rocess@

+oes the %lan inclu!e a%%ro%riate quality ob5ecti*es@

Is the %lan out%ut a%%ro%riate to the o%eration@

3ustomerARelate& %ro#esses

.1

This section may be a!!resse! in a !ocumente! %roce!ureor in the quality manual. +oes your or"aniation un!erstan!the %rocesses nee!e! to meet %ro!uct requirements@ The

%lannin" acti*ity for the %rocesses relate! to %ro!uctrealiation must a!!ress the requirements in section (.1.

or each %ro!uctA%ro5ect or contract sam%le! stu!y the%lannin" of the realiation %rocess:

+o the ob5ecti*es relate to customer requirements an! thebusiness "oals establishe! in .( lannin"@

as the nee! to establish ne# %rocesses an!Aor chan"ee4istin" %ro!uct realiation %rocess6 !ocumentation6resources6 an! facilities for %ro!uct i!entifie!@

+oes the %lan s%ecify *erification an! *ali!ation an! criteria ofacce%tability of the %ro!uct as it "oes throu"h each %rocess@

+oes the %lan i!entify the recor!s necessary for %rocess an!%ro!uct conformance@

6etermination of Requirements Relate& to t;e%ro&u#t


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1

1 3o# are customer requirements !etermine!@

1

1

1

1 &re a!!itional requirements !etermine! by the or"aniation@

1 &re these requirements in%ut into .2 'ustomer ocus@

1

If customer requirements are not un!erstoo! there is the%ossibility of not meetin" the customer nee!s. & re*ie# ofcustomer com%laints6 sur*eys6 an! re%orts #ill !enote any

%roblems. &lso look at any contract6 lo"s6 or or!ers to see ifany amen!ments ha*e been ma!e. If so6 is the reason forthe amen!ment !ocumente!@ This requirement also inclu!esrecyclin"6 en*ironmental im%act an! characteristics i!entifie!as a result of the or"aniation>s kno#le!"e of the %ro!uct an!manufacturin" %rocesses.

&re %ro!uct requirements B%hysical6 functional6 er"onomic6etc.C i!entifie! from the customer inclu!in" !eli*ery an! %ost-!eli*ery acti*ities !etermine!@

+oes the or"aniation a!! requirements that they i!entifie!that #ere not s%ecifie! by the customer6 but necessary for

inten!e! or s%ecifie! use@Is there a %rocess for this to ha%%en@

&re obli"ations relate! to the %ro!uct6 inclu!in" re"ulatoryan! le"al6 i!entifie!@

&re %ro!uct requirements "athere! only !urin" contractsta"es@


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S,3/IO3-RR,/ I %)3,


1

.2 Re*ie< of Requirements Relate& to t;e %ro&u#t

2

2 3o# !oes your or"aniation re*ie# customer requirements@

2 hat information is re*ie#e!@

2 hat recor!s are maintaine!@

2 3o# are customer requirements confirme! on a *erbal or!er@

2 3o# is your ability to meet or!er requirements confirme!@

2 3o# are chan"es to or!ers han!le!@

2

2

2 &re !ifferin" requirements resol*e!@

+oes the or"aniation try to analye A summarie %ro!uctrequirements "athere! bet#een customers6 by %ro!uct family6etcF as to in%ut the %lannin" %rocess@

hen lookin" at the !ocuments Brecor!s6 %roce!ure6 an!#ork instructionsC consi!er require! !eli*ery !ates6 a%%licablestan!ar!s6 an! any or"aniational requirements. Is the same%rocess bein" follo#e! for *erbal or!ers@

+oes the or"aniation re*ie# %ro!uct requirements for the%ro!ucts sam%le! from ;.2.1@

&re the %ro!uct requirements from ;.2.1 re*ie#e! before thecommitment to %ro!uce is ma!e@


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S,3/IO3-RR,/ I %)3,


2

2 Is the re*ie# an! subsequent actions !ocumente!@

2

2

2

.7 3ustomer 3ommuni#ation

/

/ 3o# !o you communicate %ro!uct information to customers@

/

/

+oes the re*ie# make sure that they ha*e the ability to meetall requirements before commitment to su%%ly@

hen customer requirements or %ro!uct requirements arechan"e!6 are rele*ant %ersonnel ma!e a#are of the chan"e@

Is each or!er re*ie#e!6 !ocumente! an! a%%ro*e! %rior tocommitment to the customer@

hen the customer %ro*i!es little to no !ocumente!requirements6 !oes the or"aniation re*ie# the requirementsfrom ;.2.1 #ith the customer@

If there is no !ocument a*ailable re"ar!in" customercommunication then the questions belo# shoul! be aske! to

!etermine com%liance to this clause. 'ustomer requirementsare im%ortant an! usually in*ol*e !ifferent le*els in theor"aniation. &sk !ifferent le*els to see if the ans#ers areconsistent an! !o they a"ree #ith the or"aniations %olicyan! ob5ecti*es.

hat %rocess is use! for customer enquiries6 contracts oror!er han!lin"6 inclu!in" amen!ments@

hat mechanism is in %lace to collect customer fee!back6inclu!in" com%laints@


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S,3/IO3-RR,/ I %)3,


/

6esign an& 6e*eloment

.1 6esign an& 6e*eloment %lanning

1

1

1

1

Is the lan"ua"e s%ecifie! by the customer use! forcommunications@

+oes %ro!uct an! manufacturin" %rocess !esi"n focus onerror %re*ention rather than !etection@

If your organi'ation &oes not ;a*e a %RO6-3/ 6,SIan& 6,B,O%M,/ fun#tion( t;e elements asso#iate&


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1 ere the sta"es of !esi"n an! or !e*elo%ment !etermine!@

1

1

1

1

.2 6esign an& 6e*eloment Inuts

2

2

2

2 +i! they inclu!e functional an! %erformance requirements@

2

2

2

ere re*ie#s6 *erification6 an! *ali!ation acti*ities con!ucte!for each sta"e@

ere the res%onsibilities an! authorities for these acti*itiesi!entifie!@

3o# #as the interface bet#een the !ifferent "rou%s mana"e!for effecti*e communication an! clarity of res%onsibilities@

as the out%ut of the %lan u%!ate! as the !esi"n or!e*elo%ment %ro"resses@

&lthou"h the stan!ar! !oes not s%ecifically require it6consi!er %re%arin" a !ocument to a!!ress the in%utrequirements in or!er to a*oi! any misun!erstan!in"s.)e*ie# any !ocument or %a%er#ork that a!!resses thisclause.

'ontinue the same %ro!uct sam%les from;./.1 +esi"n an!Aor +e*elo%ment lannin":

ere in%uts relatin" to %ro!uct requirements !efine! an!!ocumente!@

+i! they inclu!e a%%licable re"ulatory an! le"alrequirements@

+i! they inclu!e a%%licable information !eri*e! from %re*ioussimilar !esi"ns@

+i! they inclu!e other requirements essential for !esi"nan! Aor !e*elo%ment@


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S,3/IO3-RR,/ I %)3,


2

2

.7 6esign an& 6e*eloment Oututs

/

/

/

/ as the out%ut re*ie#e! %rior to release@

/ +i! the out%uts meet the in%ut requirements@

/

/ +i! it contain or reference %ro!uct acce%tance criteria@

/

.4 6esign an& 6e*eloment Re*ie<

Is there e*i!ence that the in%uts #ere re*ie#e! fora!equacy@

Is there e*i!ence that incom%lete6 ambi"uous6 or conflictin"requirements #ere resol*e!@


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S,3/IO3-RR,/ I %)3,


(

(

( hat is co*ere! in !esi"n re*ie#@

(

( ere !esi"n re*ie#s con!ucte! at suitable frequencies@

( ere they con!ucte! as %er the D%lanne!E sche!ule@

(

( &re they accom%lishin" #hat is require! at the sta"e@

( +i! they i!entify %roblems an! %ro%ose action@

(

( as the re*ie# #ell !ocumente! inclu!in" follo#-u% actions@

.5 6esign an& 6e*eloment Berifi#ation


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S,3/IO3-RR,/ I %)3,


3o# is *erification %lanne!@

hat !oes *erification inclu!e@

." 6esign an& 6e*eloment Bali&ation


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.$ 3ontrol of 6esign an& 6e*eloment 3;anges

3o# is *ali!ation %lanne!@hat is inclu!e! in *ali!ation@

as the out%ut of !esi"n or !e*elo%ment *ali!ate! to test

#hether the %ro!uct is Dca%able of meetin" the requirementsfor the s%ecifie! or inten!e! use or a%%licationE@

Note: the validation should be testing the product as close toreal use as possible. It should be testing the product underthe various conditions or worst conditions that it will be put touse by the customer.

as the *ali!ation com%lete! before !eli*ery orim%lementation of the %ro!uct #hene*er D%racticableE@

If full *ali!ation #as im%ractical %rior to !eli*ery orim%lementation6 #as %artial *ali!ation %erforme! to the e4tenta%%licable@

ere the results of the *ali!ation an! any subsequent follo#-u% actions recor!e!@

+oes the *ali!ation %rocess inclu!e an analysis of fiel!re%orts for similar %ro!ucts@

+oes *erification an! *ali!ation e*i!ent for both %ro!uct an!manufacturin" %rocesses@


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S,3/IO3-RR,/ I %)3,


;

; 3o# are chan"es to the !esi"n recor!e! an! im%lemente!@

;

;

;

;

%ur#;asing

.1 %ur#;asing ro#ess

1

1

Some of chan"es that may take %lace are omissions6 errorsor inconsistencies in the !esi"n or requirements6 chan"es instatutory or re"ulatory requirements6 or issues raise! !urin"re*ie#s. It is im%ortant that chan"es be !ocumente! an!actions taken to %re*ent any %ossible effect on the %ro!uct. &ssess the !esi"nA!e*elo%ment recor!s for com%liance an!*erify that chan"es ha*e been communicate! to all %arties.

&re the chan"es *erifie!6 *ali!ate! an! a%%ro*e! %rior toim%lementation@

&re the chan"es e*aluate! for the effect on constituent %artsan! !eli*ere! %ro!ucts@

&re the results of the re*ie# of chan"es an! any necessaryactions recor!e!@

+o !esi"n an! !e*elo%ment chan"es inclu!e all chan"es!urin" the %ro!uct %ro"ram life@

This clause asks your or"aniation to base the ty%e an!e4tent of control of su%%liers on the effect of the %urchase!material on both the %ro!uct realiation %rocesses an!%ro!ucts %ro!uce!. &ssess the recor!s of su%%liere*aluations an! follo# u% actions.

Is there a %rocess in %lace to ensure that %urchase! %ro!uctconforms to requirements@


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S,3/IO3-RR,/ I %)3,


1

1 Is there a metho! of controllin" the su%%liers@

1 3o# are su%%liers selecte!@

1 hat criteria are there for e*aluatin" su%%liers@

1 &re e*aluation an! any necessary actions bein" recor!e!@

1 Is there a list of a%%ro*e! su%%liers@

1 +oes the list inclu!e all the a%%ro%riate ty%es of su%%liers@

1

1 as there a criteria for their selection@

1 ere the su%%liers %erio!ically e*aluate!@

1 ere their criteria for their %erio!ic e*aluation@

1

1 &re there recor!s of su%%lier selection an! e*aluation@

1

Is the control a%%ro%riate to effect the %urchase! %ro!uct hason the subsequent or final %ro!uct@

ere the su%%liers e*aluate! an! selecte! base! u%on theirability to su%%ly %ro!uct in accor!ance #ith requirements@

+i! they base their %urchasin" commitments on su%%liere*aluation@

+oes the or"aniation>s %urchasin" %rocess inclu!e all%ro!ucts an! ser*ices that affect customer requirements suchas sub-assembly6 sequencin"6 sortin"6 re#ork an! calibrationser*ices@


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S,3/IO3-RR,/ I %)3,


1

.2 %ur#;asing Information

2

2 hat !oes %urchasin" information inclu!e@

2

2

2

2

2

.7 Berifi#ation of %ur#;ase& %ro&u#t

hen there are mer"ers6 acquisitions or affiliationsassociate! #ith su%%liers6 the or"aniation shoul! *erify thecontinuity of the su%%lier>s quality mana"ement system an!its effecti*eness.

&ssess ho# the or"aniation !escribes the %ro!ucts6materials or ser*ices that are %urchase!.

3o# !o your %urchasin" %ersonnel confirm that the %urchaserequirements are com%lete an! correct before the or!er is%lace!@

+oes the or"aniation use %urchase or!ers@+o the %urchase or!ers inclu!e information !escribin" the%ro!uct@

+o the .O.>s inclu!e requirements for a%%ro*al orqualifications Bas a%%ro%riateC for a%%ro*al of %ro!ucts6

%roce!ures6 equi%ment an! %ersonnel@+o the .O.>s inclu!e quality mana"ement systemrequirements@

+oes the %urchasin" %rocess inclu!e an e*aluation to ensurethe a!equacy of s%ecifie! requirements %rior to release@


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S,3/IO3-RR,/ I %)3,


/

/

/

/

/

%ro&u#tion an& Ser*i#e %ro*ision

.1 3ontrol of %ro&u#tion an& Ser*i#e %ro*ision

1

1 3o# are %ro!uction an! ser*ice %ro*ision controlle!@

1 here are the %ro!uct characteristics !ocumente!@

&ssess ho# the or"aniation has !efine! the ins%ection%rocess for com%liance an! *erify e*i!ence of %ro!uctacce%tance. s %remises is sel!om use!. If bein" !one assessthe %rocess for com%liance.

Is ins%ection use! to *erify that %urchase! %ro!uct meetsrequirements@hat other metho!s are use! in a!!ition to ins%ection@

&re the acti*ities for *erification of %urchase! %ro!ucti!entifie! an! im%lemente!@

If the customer %erforms *erification acti*ities on thesu%%lier>s %remises6 are the metho!s of *erification an!release s%ecifie!@

Is there e*i!ence that %urchase! %ro!uct quality6 !eli*ery6 orcost is affectin" in- %rocess6 !eli*ere! %ro!uct6 an! Aor

customer satisfactionAcustomer !issatisfaction@

The requirements note! belo# co*er %rocess control6ins%ection an! testin"6 ins%ection an! test status6 an!ser*icin" an! requirements for the release6 !eli*ery6 an! %ost-!eli*ery of the %ro!uct.


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1

1

1

1

1

1 Is the equi%ment suitable for the #ork

1

1

1

1

1

3o# !o %ersonnel kno# #hat equi%ment to use for a%rocess@

+oes !ocumentation i!entify #hat monitorin" an! measurin"equi%ment shoul! be use!6 an! #hen@

Select a re%resentati*e sam%le of the %rocesses of theor"aniation.Is there a quality %lan or other !ocument that i!entifies thecharacteristics controlle! in each ste% of the %rocess@

Is enou"h information a*ailable to s%ecify the characteristicsof the %ro!uct@

&re #ork instructions a*ailable for each %rocess ste% or areo%erators able to e4%lain ho# to %erform that ste% of the%rocess@

%erforme! an! !o recor!s sho# that maintenance is %lanne!an! bein" carrie! out@

+o they ha*e the necessary "au"e an!Aor monitorin"equi%ment for %rocess an! %ro!uct monitorin"@

+o recor!s in!icate that the monitorin" acti*ities are %ro%erlyim%lemente! an! that all %ersons o%eratin" the %rocess arefollo#in" it@

+o they ha*e !efine! %rocesses for release6 !eli*ery an!%ost-!eli*ery acti*ities@

+oes the or"aniation control the %ro*ision of %ro!uct an!ser*ice so that it is meetin" or e4cee!in" customere4%ectations@


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1

.2

2

2

2 3o# is *ali!ation %erforme!@

2

2

2

2 +oes the *ali!ation %rocess inclu!e *ali!ation of %rocesses@

2

2

2

+oes monitorin" an! measurement !ata sho# that theor"aniation is meetin" ob5ecti*es set for the %ro!uct@

Bali&ation of %ro#esses for %ro&u#tion an& Ser*i#e%ro*ision

If s%ecial %rocesses are %art of your or"aniation>s sco%e theabo*e requirements #ill be assesse! for com%liance. +efinecon!itions an! the criteria for re*ali!ation. If you ha*e nos%ecial %rocesses6 i!entify that in the quality manual.

+oes your or"aniation ha*e any %rocesses for %ro!uctionan! ser*ice #here the out%ut cannot be *erifie! by monitorin"or measurement@+o you *ali!ate these %rocesses@

If the %rocess bein" au!ite! is a s%ecial %rocess6 ho# is*ali!ation %erforme!@

+oes *ali!ation !emonstrate the ability to achie*e %lanne!results@

+oes the *ali!ation %rocess inclu!e !efine! criteria for re*ie#an! a%%ro*al of the %rocess@

+oes the *ali!ation %rocess inclu!e *ali!ation of equi%mentan! %ersonnel@

+oes the *ali!ation %rocess inclu!e use of !efine!metho!olo"ies an! %roce!ures@

+oes the *ali!ation %rocess inclu!e requirements forrecor!s@


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R,Q-IR,M,/SISO 9001:2008

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2 +oes the *ali!ation %rocess inclu!e )e-*ali!ation@

2

.7 I&entifi#ation an& /ra#ea!ility

/

/ 3o# is %ro!uct i!entifie!@

/ 3o# is measurin" an! monitorin" status i!entifie!@

/

/

/

/

/

/ To #hat le*el is traceability require!@

/

.4 3ustomer %roerty

+oes the or"aniation *ali!ate all of its %rocesses for all its%ro!uction an! ser*ice %ro*ision #here the resultin" out%ut

cannot be *erifie! by subsequent monitorin" ormeasurement@

ro!uct nee! to be i!entifie! in such a #ay as to kno# itsstatus6 that is6 is "oo!6 ba!6 or !on>t kno#@

+oes your or"aniation control an! recor! the uniquei!entification of the %ro!uct6 #here traceability is require!@

Is the %ro!uct i!entifie! throu"hout the %rocess until it is

shi%%e!@Is the i!entification clear an! le"ible@ Is each form or ta" tobe fille! out com%letely@

Is the status of the %ro!uct in relationshi% to measurementan! monitorin" clearly !iscernible@

3o# !oes the o%erator kno# #hat has an! has not beenchecke!@

3o# !o they track the %ro!uct to the traceability le*elrequire!@


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S,3/IO3-RR,/ I %)3,


(

( Is there any customer %ro%erty use! in the %rocess@

(

(

( Is there e*i!ence that this is ha%%enin"@

.5 %reser*ation of %ro&u#t

Is any %ro!uct on the floor6 mis%lace!6 mishan!le!@

&re there o%%ortunities #here somethin" may "o #ron"@

ro%erty %ro*i!e! by the customer can inclu!e intellectual%ro%erty6 as #ell as toolin"6 information6 soft#are6 containers6or materials. )emember to inclu!e all these items in the

re*ie# of customer %ro%erty.

3o# is the customer %ro%erty i!entifie!6 *erifie!6 %rotecte!an! maintaine!@

+o they ha*e a %rocess of recor!in" an! re%ortin" to thecustomer any lost6 !ama"e!6 or other#ise unsuitable%ro!uct@

ro!ucts nee! to be %rotecte! in or!er to %reser*e conformityto requirements

3o# !o you make sure that %ro!uct quality is maintaine!!urin" %rocessin" an! !eli*ery@

&re %acka"in" s%ecs !efine! an! un!erstoo!@ &re they bein" follo#e!@

&re there customer com%laints relate! to im%ro%er%acka"in"@

&re there customer com%laints for !ama"e %ro!ucts !urin"trans%ort@


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R,Q-IR,M,/SISO 9001:2008

S,3/IO3-RR,/ I %)3,


3ontrol of Monitoring an& Measuring ,quiment

hat recor!s are maintaine!@

. )e*ie# %roce!ures6 #ork instructions an! recor!s forcom%liance.

3as your or"aniation establishe! a mechanism to ensuremonitorin" an! measurin" is %erforme! consistent #ithrequirements@

hat action is taken if equi%ment is foun! to be out ofcalibration@

+oes your or"aniation take a%%ro%riate action on theequi%ment an! any %ro!uct affecte! abo*e@

3o# is soft#are use! for measurin" an! monitorin" *erifie!%rior to use an! reconfirme! as necessary@

3as the or"aniation i!entifie! measurements to be ma!ean! the measurement an! monitorin" equi%ment require! for

conformity of %ro!uct@ &u!it the "a"es: Bcheck quality6 manufacturin" %rototy%e laban! maintenance !e%artment "a"esC &ccuracy6 %recision@ 3o# chosen@I!entification@


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R,Q-IR,M,/SISO 9001:2008

S,3/IO3-RR,/ I %)3,


&re they calibrate! to International or ational Stan!ar!s@

&re results recor!e!@

&re they a!5uste! %erio!ically or before use@

Is calibration status i!entifie!@

&cce%tance criteria@3an!lin"6 stora"e an! %reser*ation of ins%ection6 measurin"an! test equi%ment@n*ironmental con!itions@ ?ocation@'orrecti*e actions@ requency of checks@ &u!it the calibration %ro"ram.NOTE: Monitoring and measuring equipment should betrailed from processes audited in roduction and !ervicerovision "#.$%

Sam%le se*eral %ieces of equi%ment use! in the or"aniationfor the follo#in":

+ailyA#eekly masterin" of "a"es before use Busually !urin"%lant au!itC@

here no International Stan!ar! e4ists6 is the basis of the

calibration recor!e!@

&re they safe"uar!e! from a!5ustment that #oul! in*ali!atethe calibration@

&re they %rotecte! from !ama"e an! !eterioration !urin"han!lin"6 maintenance6 an! stora"e@

+oes the or"aniation ha*e a %rocess to re-assess %re*iousresults if equi%ment is foun! to be out of calibration an! ha*ecorrecti*e action taken@


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R,Q-IR,M,/SISO 9001:2008

S,3/IO3-RR,/ I %)3,


&u!it backtrackin" of %ro!uct #hen "a"e is foun! to be ba!@

3a*e they recor!e! the results of calibration@

M,)S-R,M,/( ))SIS )6 IM%ROB,M,/

eneral

hat action is taken #hen equi%ment is foun! to be out ofcalibration@


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R,Q-IR,M,/SISO 9001:2008

S,3/IO3-RR,/ I %)3,


3a*e measurement acti*ities been im%lemente!@

+o they em%loy a%%licable metho!olo"ies@

Monitoring an& Measurement

.1 3ustomer Satisfa#tion

1

1

1

1 &re all the ty%es of customers sur*eye! A inter*ie#e!@

1

1

3a*e measurement an! monitorin" acti*ities been %lanne!@3o#@

This clause !oes not !efine ho# your or"aniation is tomonitor information on customer %erce%tions. or com%lianceto this clause6 *erify ho# your or"aniation monitors thecustomer information6 follo# throu"h on the metho!s bein"use!. &re the metho!s bein" use! consistent #ith the quality%olicy an! quality ob5ecti*es@

hat metho!s !oes your or"aniation use to monitorinformation on customer %erce%tion re"ar!in" fulfillin"customer requirements@

Is there a !efine! %rocess #ith !ocumente! metho!olo"iesfor obtainin" customer satisfaction an! !issatisfaction@

Is the number of customers sur*eye!Ainter*ie#e! enou"h to%ro*i!e "oo! information6 i.e. statistically *ali!@

&re they sur*eyin"Ainter*ie#in" !ifferent !e%artments #ithinthe customer #ho affect the buyin" !ecision@


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R,Q-IR,M,/SISO 9001:2008

S,3/IO3-RR,/ I %)3,


1

1

1

1

1

1

1

1

.2 Internal )u&it

3o# is this information use! #hen !eterminin" customere4%ectations@

hat is the quality of the information "athere!@ Is the

information "athere! useful in im%ro*in" the or"aniation@

'an they %ro*i!e e*i!ence of usin" this information forcontinual im%ro*ement@

+oes the customer satisfaction %rocess %ro*i!e a true %ictureof the %erce%tion Bo%inionC of the or"aniation>s customers@ Isthe information "athere! useful in im%ro*in" the or"aniation@

&re the %erformance in!icators hea!e! in the ri"ht !irection@+oes it sho# correlation to customer satisfaction@

Is the information "athere! bein" use! to im%ro*e customersatisfaction@

Is there an e*aluation of the realiation %rocess in!icators6 in

or!er to better un!erstan! the correlation bet#een customersatisfaction an! the %ro!uct realiation %erformancein!icators@

Is the manufacturin" %rocess %erformance monitore!@+o tren!s sho# conformity #ith customer requirements@


48/115


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R,Q-IR,M,/SISO 9001:2008

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2 +o the recor!s sho# that the sche!ule is bein" follo#e!@

2

2

2

2 &re the au!itors in!e%en!ent of the area au!ite!@

2

2

2

2 &re there non-conformances i!entifie! in the au!it re%orts@

2

2

+oes the internal au!it co*er the full sco%e of the stan!ar! as

#ell as any customer s%ecific requirements@

+o the au!it sche!ule an! the au!it %rocess in!icate that thecurrent au!itin" %rocess au!its effecti*e im%lementation an!maintenance of the system@

3a*e au!its6 sco%e an! frequency6 an! metho!olo"ies been!efine!@

&re au!it questions com%rehensi*e@ &re they focuse! on the %erformance of the %rocess meetin"%lanne! ob5ecti*es@

Is the ob5ecti*e e*i!ence recor!e! for each question@There should be ob&ective evidence for both conformance andnon' conformances.

+o the questions an! the e*i!ence in!icate that the au!it ischeckin" #hether the ,S is effecti*ely im%lemente! an!maintaine!@

&re the non-conformances #ell #ritten6 that is6 arerequirement cite! Bis it correctCG is there ob5ecti*e e*i!ence6an! the nature of the non-conformance@

&re all the elements au!ite!@If not6 check to see that all the elements are au!ite! by acombination of the entire year>s au!its@


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2 &re the nonconformities close! out in a timely manner@

2 +oes the or"aniation "o back an! au!it the %roblem@

2 Is there ob5ecti*e e*i!ence of *erification results@

2

2 &re the %roblems #ell !ocumente!@

2

2

2 &re the %roblems re%eatin"@

2 &re the number an! ty%e of %roblems "oin" !o#n@

2

.7 Monitoring an& Measurement of %ro#esses

/

Is the internal au!it "enerally fin!in" the same ty%e of%roblems as the current au!it@

Is there ob5ecti*e e*i!ence for areas of conformance an!nonconformity@

&re the non-conformances close! out on a timely basisBthree-month #in!o# at the mostC@

&re the summary results of the au!its communicate! to theirres%ecti*e %rocess o#ners an! ana"ement@


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/

/

/

/

/

/

/ &re the metho!s suitable@

/

/ 3o# are the %rocesses measure!6 monitore! an! analye!@

/

/

/

/

3o# are ,S %rocesses monitore!@ here are a%%ro%riatemeasurements i!entifie!@

&re results e*aluate! to !etermine if the ,S %rocesses areachie*in" the %lanne! results@

hen the results are not achie*e!6 are correcti*e actionstaken to confirm conformity of the %ro!uct@

&re the %olicies6 %roce!ures or requirements Bi.e. %rocesscharacteristicsC clearly i!entifie!@

&re the characteristics relate! to customer or %ro!uctrequirements for the %rocesses i!entifie!@

hat are the criteria an! metho!s use! to control the%rocesses@

3o# !o they ensure that the %rocess is o%eratin" effecti*elyan! that the necessary resources an! information area*ailable to su%%ort o%eration an! measurement of%rocesses@

Is there e*i!ence to sho# that the measurement an!monitorin" of the %rocess is satisfactory in meetin" customerrequirements@

&re actions taken to achie*e %rocess "oals an! for continualim%ro*ement@

+o the criteria an! metho!s use! effecti*ely control the%rocess@

&re the %rocess metrics relate! to customer requirementsan! or"aniational ob5ecti*es@


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/ Is the %rocess im%ro*in" an! is it benefitin" the customer@

.4 Monitoring an& Measurement of %ro&u#t

(

(

(

(

( here are %lanne! measurements i!entifie!@

(

(

(

(

This section inclu!es all measurement acti*ities fromrecei*in" ins%ection to %ro!uct !eli*ery. &ssess #orkinstructions6 %roce!ures6 an! recor!s to *erify com%liance.


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hat recor!s are maintaine!@

Is the or"aniation follo#in" the %roce!ure@

+oes the %roce!ure i!entify the #ays that nonconformin"%ro!uct can be han!le!@

Is nonconformin" %ro!uct re-*erifie! after correction to!emonstrate conformity to requirements@

hat action !oes your or"aniation take #hen anonconformity is !etecte! after !eli*ery or use has starte!@

Is there a !ocumente! %roce!ure for !ealin" #ithnonconformin" %ro!uct@

Is non-conformin" %ro!uct Binclu!in" %ro!uct thou"ht to benon-conformin"C store! se%arately so that it !oes not "etmi4e! #ith conformin" %ro!uct@

+oes the or"aniation %rom%tly !is%ose of %ro!uct that%re*ents a lar"e accumulation of non-conformin" %ro!uct@ Is

there e*i!ence of this@

3o# !oes the or"aniation !eal #ith non- conformin"%ro!uct@ 'heck lo" or file for !e*iation or concessionrecor!s

&re recor!s maintaine! of the nature of nonconformities an!subsequent action@

hat actions are taken if %ro!uct non-conformance is!isco*ere! after shi%%in"@

&re there customer com%laints or re5ects !ue to non-conformin" %ro!uct bein" shi%%e! to customers@


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)nalysis of 6ata

Hase! on internal an! e4ternal re5ect an! re#ork !ata6 arethere %roblems in!icate! relate! to han!lin"6 %acka"in"6stora"e an! !eli*ery@

&ssess the metho!s use! to collect an! analye the !atarequire! belo#. 'onfirm the analysis of the !ata is use! to!emonstrate the suitability an! effecti*eness of the ,S an!the system continues to im%ro*e.

3o# is !ata from measurin" an! monitorin" acti*ities use! to!emonstrate suitability an! effecti*eness of the ,S@3o# is it use! to continually im%ro*e the ,S@

+oes the or"aniation analye !ata for im%ro*ement@3o# often@

+oes the !ata %ro*i!e information on customer satisfactionan!Aor !issatisfaction@

+oes the !ata %resente! clearly in!icate the tren! incustomer satisfaction@

Is the !ata analye! to un!erstan! thin"s "one ri"ht or thin"s"one #ron"@

+oes the or"aniation trace success or failure to %ro5ects%erformin" #ell or %oorly@

+oes the or"aniation stu!y o%%ortunities for im%ro*ementan! use techniques such as areto analysis or criticalrequests from customers to !eci!e on ne# o%%ortunities@


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Is %rocess an! %ro!uct !ata tracke! an! tren!e!@

Is this !ata use! for selectin" an! e*aluatin" su%%liers@

3o# is the information use! to i!entify im%ro*ement@

+oes the !ata %oint to im%ro*ement o%%ortunities@

+oes the or"aniation analye non- conformance !ata6customer com%laints an! customer returns@+ata analye! shoul! be collecte! to allo# analysis of allcustomer requirements.

Is the !ata a*ailable in a form to allo# analysis an!i!entification of %ro5ects@

Is information on characteristics of %rocesses6 %ro!uct an!their tren!s analye!@

hat is the %rocess #hen a %rocess or %ro!uct is foun! notmeetin" customer requirements@

+oes the or"aniation i!entify im%ro*ement o%%ortunities forthe characteristics@

+oes the or"aniation "ather an! analyin" information onsu%%liers@

+oes the or"aniation track su%%lier !ata as it relates to!eli*eries an! recei*in" ins%ection@

+oes the !ata analysis clearly sho# #hat is ha%%enin" tocustomer satisfaction6 conformance to customerrequirements6 characteristics of %rocesses6 %ro!uct an! theirtren!s6 an! su%%liers@


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Is !ata com%are! to com%etitors or benchmarks@

Imro*ement

.1 3ontinual Imro*ement

1

1

1

.2 3orre#ti*e )#tion

2

+oes the or"aniation !etermine6 collect an! analyea%%ro%riate !ata to !emonstrate the suitability an!effecti*eness of the quality mana"ement system an! to

e*aluate #here continual im%ro*ement of the effecti*eness ofthe quality mana"ement system can be ma!e@

+oes the or"aniation>s !ata analysis inclu!e !ata "enerate!as a result of monitorin" an! measurement an! from otherrele*ant sources@

This clause contains many of the requirements alrea!ys%ecifie! in %re*ious clauses.


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2 hat is i!entifie! as correcti*e action@

2

2

2 Sam%le se*eral correcti*e actions:

2 as the non-conformity Bi.e. %roblemC i!entifie!@

2 as the cause of non-conformity !etermine!@

2

2 as correcti*e action im%lemente!@

2 ere results of the correcti*e action recor!e!@

2 as the correcti*e action taken@

2 +oes the !ata sho# that the correcti*e action is effecti*e@

2 +o %roblems re%eat@

2

.7 %re*enti*e )#tion

/

&re the actions taken a%%ro%riate to the im%act of the%roblems encountere!@

Is there a !ocumente! %roce!ure for correcti*e action6 an! isthere ob5ecti*e e*i!ence that they follo# it@

as the nee! for actions to ensure %roblem !o not re%eate*aluate!@

&re correcti*e action %erformance tren!s monitore!6 analye!an! im%ro*e!@

& !ocumente! %roce!ure is require! by this clause. )e*ie#recor!s to confirm conformance.


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/

/ hat !oes the or"aniation i!entify as %re*enti*e action@

/

/ Sam%le %re*enti*e actions:

/ as a %otential non-conformity Bi.e. %roblemC i!entifie!@

/ as it !etermine! that %re*enti*e action #as nee!e!@

/ ere the results of action taken recor!e!@

/ as %re*enti*e action taken re*ie#e!@

/ +oes the !ata sho# that the %re*entati*e action is effecti*e@

/ &re %roblems eliminate! before they occur@

3as your or"aniation establishe! a %roce!ure to eliminatethe cause of %otential nonconformities to %re*ent theiroccurrence@Is there ob5ecti*e e*i!ence it is follo#e!@

&re the actions taken a%%ro%riate to the im%act of the%roblems encountere!@


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iso 9001-2008 gap assessment

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