ISO 9001:2008 AUDIT CHECKLIST UNIVERSITI MALAYSIA SABAH

No. Ques !o" +. QUALITY MANA,EMENT SYSTEM +.1 ,e"e-$# Re.u!-e'e" 1. Has the organization established, documented, implemented and maintained a quality management system in accordance with the requirements of !" #$$1% s the effecti&eness of the quality management system &o" !"u$##) !'/-o0e1% Has the organization ' a. dentified the processes needed for the quality management system including their applications throughout the organization. (etermined the sequence and interaction of these processes. (etermine the criteria and methods needed to ensure that both the operation and control of these processes are effecti&e. )nsure the a&ailability of resources and information is necessary to support the operation and monitoring of these processes. Me$su-e12 'o"! o-e1 $"1 $"$#)3e1 4ese /-o&esses I'/#e'e" e1 $& !o"s "ee1e1 o $&4!e0e /#$""e1 -esu# s $"1 &o" !"u$# !'/-o0e'e" * C#$use%Do&. No Yes Co''e" s No I( $")*

2. 3.

b. c.

d.

e. 4. 5. (.

(oes the organization manage the processes in arcordance with the requirement of !" #$$1% 54e-e /-o&esses 4$ $((e& /-o1u& &o"(o-'! ) 6! 4 -e.u!-e'e" s $-e ou sou-&e12 $-e 4e &o" -o#s (o- 4ese /-o&esses !1e" !(!e1 6! 4!" 4e .u$#! ) '$"$7e'e" s)s e'* +.2 +.2.1 *. Do&u'e" $ !o" Re.u!-e'e" s ,e"e-$# system

(oes the quality management documentation include ' a. b. c. d.

documented statements of quality policy and .u$#! ) o89e& !0es* +uality ,anual% (ocumented /-o&e1u-es $"1 -e&o-1s required by !" #$$1% (ocuments and records needed by the organization to ensure the effecti&e

No.

Ques !o" planning, operation and control of its processes% +.2.2 Qu$#! ) M$"u$#

C#$use%Do&. No Yes

Co''e" s No

I( $")*

-.

Has a quality manual been established and maintained that includes ' a. b. &. the scope of the quality management system !"&#u1!"7 1e $!#s o( $"1 9us !(!&$ !o" (o- $") e:&#us!o"s% (ocumented procedures established for the quality management system system, or reference to them% Des&-!/ !o" o( 4e !" e-$& !o" 8e 6ee" 4e /-o&esses o( 4e .u$#! ) '$"$7e'e" s)s e'* Co" -o# o( 1o&u'e" s the quality

+.2.; .. #.

/re documents required for management system controlled%

Has documented procedure been establish identifying the following controls needed% a. b. c. d. e. f. g. /ppro&al of documents for a adequacy prior to issue% 0e&iew, update as necessary and re1 appro&al of documents% )nsure that changes and the current re&ision status of documents are identified% )nsure that rele&ant &ersion of applicable documents are a&ailable at points of use% E"su-e 4$ 1o&u'e" s -e'$!" #e7!8#e $"1 -e$1!#) !1e" !(!$8#e* )nsure that documents of e2ternal origin are identified and their distribution controlled% 3re&enting the unintended use of obsolete documents, and to apply suitable identification to them if they are retained% Co" -o# o( Re&o-1s

+.2.+ 1$.

Ha&e records been establish and maintained to pro&ide e&idence of conformity to requirements and of the effecti&e operation of the quality management system% Has a documented procedure been established to define the following controls needed% a. b. c. d. e. dentification% !torage% 0etrie&al% 3rotection% 0etention 4ime%

11.

No. f.

Ques !o" (isposition%

C#$use%Do&. No Yes

Co''e" s No

I( $")*

<. MANA,EMENT RES=ONSIBILITY <.1 M$"$7e'e" Co''! 'e" 1. Has top management pro&ide e&idence of its commitments to the de&elopment and implementation of the quality management system and for the continual impro&ement of its effecti&eness by ' a. 5ommunicating to the organization the importance of meeting customer as well as regularly and legal requirements% )stablishing the quality policy% )nsuring that quality ob6ecti&es are established% 5onducting management re&iews% )nsuring the a&ailability of resources%

b. c. d. e.

<.2 Cus o'e- >o&us 2. H$s o/ '$"$7e'e" e"su-e1 4$ &us o'e- -e.u!-e'e" s $-e 1e e-'!"e1 $"1 'e 6! 4 4e $!' o( e"4$"&!"7 &us o'e- s$ !s($& !o". <.; Qu$#! ) =o#!&) 3. Has top management ensured that the quality policy 7 a. b. is appropriate to the purpose of the organization. ncludes a commitment to comply with requirements and o &o" !"u$##) !'/-o0e 4e e((e& !0e"ess o( 4e .u$#! ) '$"$7e'e" s)s e'. 3ro&ides a framewor8 for establishing and re&iewing quality ob6ecti&es. s communicated and understood within the organization% Is -e0!e6e1 (o&o" !"u!"7 su! $8!#! )%

c. d. e.

<.+ =#$""!"7 <.+.1 Qu$#! ) O89e& !0es 4. Has top management ensured that quality ob6ecti&es are established at rele&ant functions and le&els within the organization. Ha&e quality ob6ecti&es needed to meet the requirements of the product been established% /re quality ob6ecti&es measurable and consistent with the quality policy%

5. *.

No. 5.4.2 -.

Ques !o" +uality ,anagement !ystem 3lanning

C#$use%Do&. No Yes

Co''e" s No

I( $")*

Has top management ensured that the resources needed to $&4!e0e 4e .u$#! ) o89e& !0es are identified and planned% s the output of the planning documented% 9e.g 7 quality manual, procedures, wor8s instructions, quality plans, etc.: Does o/ '$"$7e'e" e"su-e 4$ 4e !" e7-! ) o( 4e .u$#! ) '$"$7e'e" s)s e' !s '$!" $!"e1 64e" &4$"7es $-e /#$""e1 $"1 !'/#e'e" e1% <.< Res/o"s!8!#! )2 Au 4o-! ) Co''u"!&$ !o" <.<.1 Res/o"s!8!#! ) $"1 Au 4o-! ) $"1

..

#.

1$.

Has top management ensured that responsibilities, authorities are defined and &o''u"!&$ e1 within the organization% <.<.2 M$"$7e'e" Re/-ese" $ !0e

11

Has top management appointed member9s: of management who ha&e responsibility and authority for 7 a. b. )nsuring that processes are established, implemented and maintained% 0eporting to top management on the performance of the quality management system, including needs for impro&ement% 3romoting awareness of customer requirements throughout the organization.

c.

12

<.<.; I" e-"$# Co''u"!&$ !o" Has top management ensured that appropriate communication processes ha&e been established within the organization% (oes communication ta8e place regarding the effecti&eness of the quality management system% <.? M$"$7e'e" Re0!e6 <.?.1 ,e"e-$#

13

14

(oes the top management re&iew the quality management system, at planned inter&als, to ensure its continuing suitability, adequacy and effecti&eness% /re opportunities for impro&ement and the need for changes to the quality management system,

15

No.

Ques !o" including quality policy and ob6ecti&es, re&iewed during the re&iew% /re records of management re&iews maintained as quality records% <.?.2 Re0!e6 I"/u (o the inputs to management re&iew include information on7 a. 0esults of audits% b. 5ustomer feedbac8% c. 3rocess performance and product conformity% d. !tatus of pre&enti&e and correcti&e actions% e. ;ollow1up actions from pre&ious managements re&iews% f. 3lanned changes that could affect the quality management system% g. 0ecommendations for impro&ement% <.?.; Re0!e6 Ou /u (o the outputs from management re&iew include the decisions and actions related to7 a. mpro&ement of the effecti&eness of the quality management system and its processes% b. mpro&ement of the product related to customer requirements% c. 0esources needed% * Resou-&e M$"$7e'e" *. Resou-&e M$"$7e'e" ?.1 =-o0!s!o" o( Resou-&es Ha&e the resources been determined and pro&ided for7 a. mplementing and maintaining quality management system and continually impro&ing its effecti&eness% b. )nhancing customer satisfaction by meeting customer requirements% *.2 Hu'$" Resou-&es ?.2.1 ,e"e-$# s competency for personnel who perform wor8 affecting product quality based on appropriate education, training, s8ills, and e2perience% *.2.2 Co'/e e"&)2 $6$-e"ess $"1 -$!"!"7 Has the organization 7 a. (etermined the necessary competency for personnel performing wor8 affecting product quality% b. 3ro&ided training or ta8e other actions to satisfy these needs% c. )&aluated the effecti&eness of the actions ta8en% d. )nsured that employees are aware of the rele&ance and importance of their acti&ities and how they contribute to the achie&ement of the quality ob6ecti&es e. ,aintained appropriate records of

C#$use%Do&. No Yes

Co''e" s No

I( $")*

1*

1-

1.

No.

Ques !o" education, training, s8ills and e2perience. *.3 I"(-$s -u& u-e

C#$use%Do&. No Yes

Co''e" s No

I( $")*

4o achie&e conformity of product, does the organization identity, pro&ide, and maintain the facilities including 7 a. b. c. <uilding, wor8shops and associated utilities% 3rocess equipment, hardware and software% !upporting ser&ices%

*.4 5o-@ E"0!-o"'e" 5 Has the en&ironment needed to achie&e conformity of product requirements been determined and managed% -. =-o1u& Re$#!3$ !o" -. 3roduct 0ealization -.1 3lanning of 0ealization 3rocess s planning of the organization=s product realization consistent with the requirements of the other processes of the quality management system% /re the following being determined when planning the product realization7 +uality ob6ecti&es and requirements for the product% b. 4he need to establish processes, documents, and pro&ide resources specific to the product% c. 0equired &erification, &alidation, monitoring, inspection and test acti&ities specific to the product and criteria for product acceptance% d. 0ecords needed to pro&ide e&idence that the realization processes and resulting product fulfil requirements% s the planning output in a form that is suitable for the organization=s method of operation% -.2. Cus o'e-ARe#$ e1 =-o&esses B.2.1 De e-'!"$ !o" o( Re.u!-e'e" s Re#$ e1 o 4e =-o1u& Has the organization determined 7 a. 0equirements specified by the customer, including the requirements for deli&ery and post deli&ery acti&ities% b. 0equirements not stated by the customer but necessary for specified or intended use, where 8nown% c. !tatutory and regulatory requirements related to the product% d. /ny additional requirements determined by the organization% a.

No.

Ques !o"

C#$use%Do&. No Yes

Co''e" s No

I( $")*

-.2.2 Re0!e6 o( Re.u!-e'e" s Re#$ e1 o 4e =-o1u& 3rior to the commitment to the customer 9e.g. submission of tenders, acceptance of contracts or orders or acceptance of change orders: are requirements re&iewed to ensure that7 a. b. 3roduct requirements are defined% 5ontract or order requirements differing from those pre&iously e2pressed or resol&ed% c. 4he organization has the ability to meet defined requirements% /re the results of re&iews and actions arising from these re&iews recorded and maintained as records% >here the customer has not pro&ided a documented statement of requirements, are customer requirements confirmed by the organization before acceptance% >here product requirements are changed, does the organization ensure that rele&ant documentation is amended and rele&ant personnel are made aware of the changed requirements% B.2.; Cus o'e- Co''u"!&$ !o" Has the organization determined and implemented effecti&e arrangements for communicating with customers relating to7 a. 3roduct information% b. nquiries, contracts, amendments or order handling% c. 5ustomer feedbac8, including customer complaints% B.; Des!7" $"1 De0e#o/'e" B.;.1 Des!7" $"1 De0e#o/'e" =#$""!"7

1$ 11

/re product design and de&elopment acti&ities planned and controlled% (uring design and de&elopment planning has the organization determined7 a. !tages of design and de&elopment% b. 0e&iew, &erification and &alidation that are appropriate to each design and de&elopment stage% c. 0esponsibilities and authorities for design and de&elopment% /re interfaces between different groups in&ol&ed in design and de&elopment managed to ensure effecti&e communication and clear assignment of responsibilities% s planning output updated as the design and de&elopment progresses%

12

13

No.

Ques !o"

C#$use%Do&. No Yes

Co''e" s No

I( $")*

B.;.2 Des!7" $"1 De0e#o/'e" I"/u s 14 /re inputs relating to product requirements defined, documented and maintained as a record% (oes design and de&elopment input include7 a. ;unctional and performance requirements% b. /pplicable statutory and regulatory requirements% c. /pplicable information deri&ed from pre&ious similar designs% d. "ther requirements essentials for designs and de&elopment% /re design and de&elopment inputs re&iewed for adequacy% /re incomplete, unambiguous or conflicting requirements resol&ed% B.;.; Des!7" $"1 De0e#o/'e" Ou /u s /re outputs of the design and de&elopment pro&ided in a form that enables &erification against the design and de&elopment inputs% /re design outputs appro&ed prior release% (oes the design and de&elopment output7 ,eet the design and de&elopment input requirements% b. 3ro&ide appropriate information for purchasing, production and for ser&ice pro&ision% c. 5ontain or reference product acceptance criteria% d. !pecify the product characteristics that are essential to its safe and proper use% B.;.+ Des!7" $"1 De0e#o/'e" Re0!e6 21 /re systematic re&iews performed in accordance with planned arrangements at suitable stages of the design and de&elopment% (o design and de&elopments re&iew7 a. )&aluate the ability of the results of design and de&elopment to meet requirements% b. dentify problems and propose necessary actions% (o re&iew participants include representati&es of functions concerned with the design and de&elopment stage9s: being re&iewed% /re results of re&iews and any actions necessary maintained as records% a.

15

1* 1-

1.

1# 2$

22

23

24

No.

Ques !o"

C#$use%Do&. No Yes

Co''e" s No

I( $")*

B.;.< Des!7" $"1 1e0e#o/'e" Ve-!(!&$ !o" 25 s design and de&elopment &erification performed in accordance with planned arrangements to ensure that the design outputs ha&e met the design and de&elopment input requirements% /re results of the &erification and actions maintained as records% B.;.? Des!7" $"1 De0e#o/'e" V$#!1$ !o" s design and de&elopment &alidation performed in accordance with planned arrangements% s design and de&elopment &alidation performed to confirm that the product is capable of meeting the requirements for the specified application or intended use, where 8nown% s &alidation completed prior to deli&ery or implementation of the product where&er applicable% /re results of the &alidation and actions maintained as records% B.;.B Co" -o# o( Des!7" $"1 De0e#o/'e" C4$"7es /re design and? or de&elopment changes identified and recorded% (o re&iews of design and de&elopment changes include e&aluation of the effect of the changes on constituent parts and product already deli&ered% /re design and de&elopment changes re&iewed, &erified, &alidated as appropriate and appro&ed before implementation% /re results of the re&iew of changes and necessary actions maintained as records% B.+ =u-&4$s!"7 B.+.1 =u-&4$s!"7 &o" -o# /re the purchasing processes controlled to ensure purchased product 9or ser&ice: conforms to requirements% s the type and e2tent of control applied to the supplier and purchased product dependent upon the effect of the purchased product on subsequent product realization or the final product. /re supplies selected and e&aluated based on their ability to supply product in accordance with the organization=s requirements%

2*

22.

2#

3$

31 32

33

34

35

3*

3-

No. 3.

Ques !o" Has the organization established criteria for selection e&aluation and re1e&aluation of suppliers% /re results of the e&aluations and any necessary actions maintained as records% B.+.2 =u-&4$s!"7 I"(o-'$ !o" (oes purchasing information describe the product to be purchased% ncluding are appropriate7 a. 0equirements for appro&al of product, procedures, processes and equipment% b. 0equirements for qualification of personnel% c. +uality management system requirements% s the adequacy of specified purchased requirements ensured prior to their communication to the supplier% B.+.; Ve-!(!&$ !o" o( =u-&4$se1 =-o1u& Ha&e the inspection or other acti&ities necessary for ensuring that purchased product meets specified purchase requirements been established and implemented% /re &erification arrangements and method of product release specified in the purchasing information where the organization or its customer intends to perform &erification at supplier=s premises% B.< =-o1u& $"1 Se-0!&e =-o0!s!o" B.<.1 Co" -o# o( =-o1u& !o" $"1 Se-0!&e =-o0!s!o"

C#$use%Do&. No Yes

Co''e" s No

I( $")*

3#

4$

41

42

43

44

/re the production and ser&ice pro&ision planned and carried out under controlled conditions including 7 a. /&ailability of information that describes the product characteristics% b. /&ailability of wor8 instructions, as necessary% c. @se of suitable equipment% d. /&ailability and use of monitoring and measuring de&ices% e. mplementation of monitoring and measurement% f. mplementation of release, deli&ery and post deli&ery acti&ities% B.<.2 V$#!1$ !o" o( =-o&esses (o- =-o1u& !o" $"1 Se-0!&e =-o0!s!o"

45

Ha&e processes where deficiencies may become apparent only after the product is in use or the ser&ice has been deli&ered been &alidated%

10

No. 4*

Ques !o" (o the results of &alidation demonstrate the ability of the processes to achie&e planned results% >here applicable, ha&e the arrangements been established for7 (efining criteria for re&iew appro&al of processes% b. /ppro&al of equipment qualification of personnel% c. @se of specific methods procedures% d. 0equirements for records% e. 0e1 &alidation% B.<.; I1e" !(!&$ !o" $"1 T-$&e$8!#! ) a. and and and

C#$use%Do&. No Yes

Co''e" s No

I( $")*

4-

4. 4# 5$ 51

s the product identified by suitable means throughout product realization% s the product status identified with respect to monitoring and measurement requirements% >hen traceability is a requirement, is the product uniquely identified and controlled% s the unique identification maintained as a record% B.<.+ Cus o'e- =-o/e- ) (oes the organization e2ercise care with customer property while it is under the organization=s control or being used by the organization% s customer property identified, protected, and safeguard% &erified,

52

53 54

f lost, damaged or otherwise found to be unsuitable for use, is condition recorded, reported to the customer and maintained as a record% B.<.< =-ese-0$ !o" o( =-o1u& s conformity of product preser&ed during internal processing and deli&ery to the intended destination% (oes preser&ation acti&ities include7 a. dentification% b. Handling% c. 3ac8aging% d. !torage% e. 3rotection% /re preser&ation acti&ities applied to constituent parts of a product% B.? Co" -o# o( Me$su-!"7 $"1 Mo"! o-!"7 De0!&es

55

5*

5-

5.

Has the organization determined the monitoring

11

No.

Ques !o" and measurement to be underta8en and the monitoring and measurement de&ices needed to pro&ide e&idence of conformity of product to determined requirements%

C#$use%Do&. No Yes

Co''e" s No

I( $")*

5#

Ha&e processes been established to ensure that monitoring and measurement can be carried out in a manner consistent with the monitoring and measurement requirements% >here necessary to ensure &alid results, are measuring equipment7 a. 5alibrated or &erified at specified inter&als, or prior to use, against measurements standards traceable to international or national measurements standards' where no such standards e2ist, is the basis used for calibration or &erification recorded% b. /d6usted or re1ad6usted as necessary% c. dentified to enable the calibration status to be determined% d. !afeguarded from ad6ustments that would in&alidate the measurement result% e. 3rotected from damage and deterioration during handling, maintenance and storage% Has the organization assessed and recorded the &alidity of the pre&ious measuring results when the equipment is found not to conform to requirements%, and ta8en the appropriate action on the equipment and any product affected% /re records of the calibration and &erification results maintained% >here computer software is used in the monitoring and measurement of specified requirements is the ability of the computer software to satisfy the intended application confirmed prior to initial use% s the ability of computer software to satisfy the intended application reconfirmed as necessary% 8 Me$su-e'e" 2 A"$#)s!s $"1 I'/-o0e'e" 8 Me$su-e'e" 2 $"$#)s!s $"1 !'/-o0e'e" 8.1 ,e"e-$#

*$

*1

*2 *3

*4

Ha&e the monitoring, measurement, analysis and impro&ement processes been planned, and implement to7 a. (emonstrate conformity of the product% b. )nsure conformity of the quality management system% c. 5ontinually impro&e the effecti&eness of the quality management system%

12

No. 2

Ques !o" Ha&e the applicable methods including statistical techniques and their e2tent to use been determined% 8.2 Mo"! o-!"7 $"1 Me$su-e'e" 8.2.1 Cus o'e- s$ !s($& !o"

C#$use%Do&. No Yes

Co''e" s No

I( $")*

s information relating to customer perception monitored by the organization as to whether customer requirements ha&e been met% Ha&e the methodologies for obtaining and using information related to customer perception been determined% 8.2.2 I" e-"$# Au1!

/re internal audits conducted at planned inter&als to determine whether the quality management system7 a. 5onforms to planned arrangements, requirements of !" #$$1 and the quality management system% b. s effecti&ely implemented and maintained% /re the audit programs planned ta8ing into consideration the status and importance of the processes and areas to be audited, as well as the results of pre&ious audits% s the audit criteria, scope, frequency and method defined% (o auditor selection and conduct of audits ensure ob6ecti&ity and impartiality of the audit process% s it ensured that auditors do not audit their own wor8% Has a documented procedure been established to define responsibilities and requirements for planning and conducting audits, reporting results, and maintaining records% Ha&e management responsibilities for the area being audited ensured that actions ha&e been ta8en without undue delay to eliminate detected nonconformities and their causes% (o follow1up acti&ities include the &erification of the actions ta8en, and the reporting of the &erification results% 8.2.; Mo"! o-!"7 $"1 Me$su-e'e" =-o&esses o(

# 1$

11

12

13

/re suitable methods applied for monitoring and where applicable, measurement of the quality

13

No.

Ques !o" management system processes necessary to meet customer requirements% (o these methods demonstrate the ability of the processes to achie&e planned results% /re correction and correcti&e actions ta8en when planned results are not achie&ed%

C#$use%Do&. No Yes

Co''e" s No

I( $")*

14 15

8.2.+ 1*

Mo"! o-!"7 $"1 Me$su-e'e" =-o1u&

o(

/re the product characteristics monitored and measured to &erify that product requirements are met% s monitoring and measurement of product characteristics carried out at appropriate stages of the product realization process in accordance with the planned arrangements% s e&idence of conformity with the acceptance criteria documented and maintained% /re records maintained to indicate the person9s: authorizing release of product% @nless otherwise appro&ed by a rele&ant authority or where applicable, the customer, are all planned arrangements satisfactory completed prior to proceeding with release% 8.; Co" -o# o( No"&o"(o-'!"7 =-o1u&

1-

1. 1# 2$

21 22

s nonconforming product identified and controlled to pre&ent unintended use or deli&ery% Has a documented procedure been established to define controls and related responsibilities and authorities for dealing with nonconforming product% /re nonconforming product dealt with by one or more of the following ways7 /ction ta8en to eliminate the detected nonconformity% b. /uthorized use, release or acceptance under concession by a rele&ant authority and, where applicable, by the customer. c. /ction ta8en to preclude its original intended use or application. /re records maintained identifying the nature of nonconformities and any subsequent actions ta8en, including any concessions% >hen nonconforming product is corrected, is it sub6ect to re1&erification to demonstrate a.

23

24

25

14

No.

Ques !o" conformity to the requirements%

C#$use%Do&. No Yes

Co''e" s No

I( $")*

2*

>hen nonconforming product is detected after deli&ery, or use has started, is appropriate action ta8en by the organization to the effect or potential effect% 8.+ A"$#)s!s o( D$ $

2-

s appropriate data determined, collected and analyzed to demonstrate the suitability and effecti&eness of the quality management system and to e&aluate where continual impro&ement of the effecti&eness of the quality management system can be made% (oes this data included data generated from monitoring, measurement and other rele&ant sources% (oes the analysis of this data pro&ide information related to7 a. b. c. d. 5ustomer satisfaction% 5onformance to product requirement% 5haracteristics and trends of processes and product including, opportunities for pre&enti&e action% !uppliers%

2.

2#

8.< I'/-o0e'e" 8.<.1 Co" !"u$# I'/-o0e'e" 3$ (oes the organization continually impro&e the effecti&eness of the quality managements system% /re results of audits, analysis of data, correcti&e and pre&enti&e actions, management re&iews, quality 3olicy and quality ob6ecti&es used for continual impro&ement% 8.<.2 Co--e& !0e A& !o" 32 /re correcti&e actions ta8en to eliminate the cause of nonconformities and to pre&ent recurrence% /re correcti&e actions appropriate to the effects of the nonconformities encountered% Has documented procedure been established to define the requirements for7 a. 0e&iewing nonconformities, including customer complaints% b. (etermining the causes of nonconformity% c. )&aluating the need for action to ensure that nonconformities do not recur% d. (etermining and implementing action

31

33 34

15

No. e. f.

Ques !o" needed% 0ecording and maintaining the results of action ta8en% 0e&iewing correcti&e action ta8en%

C#$use%Do&. No Yes

Co''e" s No

I( $")*

8.<.; =-e0e" !0e A& !o" 35 Has the organization determined actions to eliminate the causes of potential nonconformities in order to pre&ent occurrence% /re pre&enti&e actions appropriate to the effects of the potential problems% Has documented procedure been established to define the requirements for7 a. (etermining potential nonconformities and their causes% b. )&aluating the need for action to pre&ent occurrence of nonconformities% c. (etermining and implementing actions needed% d. 0ecording and maintain the results of action ta8en% e. 0e&iewing of pre&enti&e action%

3* 3-

16