Iso9001 2000 Key Changes Jjd

8102019 Iso9001 2000 Key Changes Jjd

httpslidepdfcomreaderfulliso9001-2000-key-changes-jjd 165



2

ISO9001 amp ISO9004 (a consistent pair)

bullISO9001 Requirements

bull ISO9004 Guidelines for performance

improvements

ISO9002 amp ISO9003 are no osolete



3

Start Date 1 May 2002

PRamesh PandyaShamete

R$omashMMMaampanaARontadaPDesai

D( othari

PShahAMDesaiS)haudhary

PShu+aAMistryP)hattoadhyay ( ( Da-e



4

Philosophy

Requirements built round business processes

Forward looking and pro-active Emphasis on improvement

Greater focus on meeting the needs ofcustomers



5

Principle 1 Customer focus

Principle 2 Leadership

Principle 3 Involvement of people

Principle 4 Process approach

Principle 5 System approach to management

Principle 6 Continual improvement Principle actual approach to decision maing

Principle $utually eneficial supplier relationships

ampuality $anagement Principles



6



Organizations depend on their customers and therefore should

understand current and future customer needs should meet

customer requirements and strive to exceed customer expectations


Leaders estalish unit of purpose and direction of the

organization he should create and maintain the internal

environment in hich people can ecome full involved in

achieving the organizations o$ectives





ampeople at all levels are the essence of an organization and their full

involvement enales their ailities to e used for the organizations

enefit


( desired result is achieved more efficientl hen activities and

related resources are managed as a process



)



dentifing understanding and managing interrelated processes as

a sstem contriutes to the organizations effectiveness and

efficienc in achieving its o$ectives

Principle 6 Continual improvement

+ontinual improvement of the organizations overall

performance should e a permanent o$ective of the

organization




Principle actual approach to decision maing

-ffective decisions are ased on the analsis of data and

information


(n organization and its suppliers are interdependent and a

mutuall eneficial relationship enhances the ailit of oth tocreate value



he 02 element0 structure of 1O 4 has een

replaced this processased qualit management

sstem hich is shon schematicall in igure elo



he amp+( +cle and the process approach

0he eming +cle0



2

1chematic representation of a amprocess



3

Documentation

here is a stated reuirement or on+y documented rocedures

)ontro+ o documents )ontro+ o records

Interna+ audits

)ontro+ o nonconormity

)orrectie action Preentie action



4

op management shall ensure

$anagement Commitment

Customer ocus

(stalish a ampuality Policy

(stalish and plan to realise ampuality o)ectives

ppoint a memer of management

(stalish internal communication processes

+evie the amp$S



5

ampuality Policy - )ectives

Policy to include a Commitment to meeting reuirements

and continual improvement

ampuality o)ectives to e measurale and defined

consistent ith the ampP

)ectives to e estalished for all relevant functions and

levels of the organisation

)ectives to include those needed to meet product

reuirements



16

SMMARIS3D A4A$SIS O5 3

34A4)3M34S 36334ISO 90011997 8 ISO 90012000



ISO90011994 20 elements

ISO 90012000

ISO l$ Ref$

4 ualit ana(ement Sstem

) ana(ement Responsiilit

Resource ana(ement

+ roduct Reali-ation

easurement nalsis amp Improvement

he )hanes - enera+



)

Summary o 4eamp )+auses

12 - enera+ Descrition aout the a+ication o the

standard

2 - )ustomer 5ocuslt o Manaement ensures that customer reuirements are

determined and u+=++ed - ampith the aim o customer satisaction

gt - Interna+ communicationlt o manaement to ensure that aroriate communication

rocesses are esta+ished ampithin the oraniation and thatcommunication taes +ace reardin the eectieness o theua+ity manaement system




21 Determination o reuirements re+ated to the roductlt gt neamp reuirements hae een added in the rocess o determinin

customers needs hey areaB reuirements not stated y the customer ut necessary or seci=edor intended use amphere noampnCB statutory and reu+atory reuirements re+ated to the roductcB any additiona+ reuirements determined y the oraniation

2gt )ustomer )ommunicationlt Oraniation is reuired to determine and im+ement eectie

arranements or communicatin ampith customers

21 )ustomer satisactionlt - emhasies that the oraniation sha++ monitor inormation re+atin

to customerEs ercetion as to amphether the oraniation has u+=++ed

customer reuirements



2

ISO Manua+ and Procedures

1O +lauses

7ualit 1stem 8anual Operational amprocedures

Based on Process Approach

bull Cross reference to Operational Procedres

bull he anal sections are in seence

follo$ed y ISO Standard

esined alon a Process

bull nctions and responsiility of ore than

one departent shall for a part of the

procedre

bull Cross reference to anal Sections and

other Operational Procedres



2

71 FMS enera+

Reuirements

3sta+ish document im+ement

maintain and continua++y imroethe eectieness o a ua+itymanaement system



22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s

ualit olic and Oectives ocumented

ualit anual ocumentedScope of Sstem incl eclusions5ocumented

rocedures or Reference to t6emocumented

escription of sequence7interaction of

processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents

Approve Review Update

dentif urrent Revision tatus and

changes Ensure availabilit

$egible dentiable Retrievable

ontrol Eampternal ocuments ontrol (bsolete ocuments

Records are a special tpe of document



24

)ontro+ o Fua+ity Records

)o provide evidence of conformit

to requirements and sstem

$egible identiable retrievable

Retention time specied

isposition specied

Requires a documented procedure 0 o c u m e n

t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25

72 enera+ Documentation

Reuirements FMS sha++ inc+ude

lt documented ua+ity o+icy andoGectie

lt documented ua+ity manua+

lt documented rocedures reuired y9001

lt documents reuired y theoranisation to ensure eectie+annin oeration and contro+ o

rocesses



26

3sta+ishin the System

determine rocesses needed

seuence and interaction

criteria and methods or oeration andcontro+

inormation aai+a+e or oeration andmonitorin

measure monitor and ana+yse im+ement action to achiee +anned

resu+ts and continua+ imroement



2

1 Manaement

)ommitment emonstrate ommitment to evelopment

mplementation ontinuall mprovingthe e+ectiveness of stem ncluding

statutor and regulator requirements ommunicating mportance of eeting

ustomer Requirements

Establishing ualit 0olic (b1ectives

onducting anagement Reviews

0roviding 2ecessar Resources



2)

2 )ustomer 5ocus

Requirements replaces needs and

epectations5

im of en6ancin( ustomer

Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy

Appropriate to purpose fororganisation

ommitment to ontinuallmprove the e+ectiveness ofthe sstem

Framework for setting andreviewing ualit (b1ectives



3

7 P+annin

)$4$1 ualit Oectives

easurale

onsistent it6 olic

86e oectives include t6ose needed to

meet requirements for product



3

7 P+annin

34546 ualit 0lanning

0rocesses of the stem Resources needed

ontinual mprovement

hange management



R ii+it A th it



33

Resonsii+ity Authorityand )ommunication

34346 anagement Representative

(nl one member of management

0rocesses Established implemented

aintained

Report to )op anagement

0romote Awareness of ustomer Reuirements

R ii+it A th it



34


34348 nternal ommunications

)op management shall ensure

communication between various

levels and functions regarding

e+ectiveness of sstem



35

Manaement Reieamp

HInutsB urrent 0erformance and mprovement

(pportunities

Audit Results ustomer Feedback

0rocess90roduct onformance

0reventive9orrective Actions

Actions from previous reviews 0lanned changes

Recommendations for improvement



36

Manaement Reieamp

HOututsB Actions related to

improvement of the and its

processes improvement of product related

to customer requirements

resource needs



3

1 Resource Manaement

etermine 0rovide in )imelanner to

lt mplement aintain ontinuall mprove 0rocesses

lt Enhance ustomer atisfaction



3)

2 uman Resources

4647 General

0ersons competent to perform work a+ectingqualit

4646 ompetence Awareness )raining determine competenc needslt

provide training or other actionslt

evaluate e+ectiveness of traininglt

ensure awareness of relevance and importanceof activitieslt

maintain records



3

gt Inrastructure

etermine provide aintain

lt =uildingsgtorkspace and Utilities

lt Equipment hardware software

lt upporting ervices transport orcommunication



4

7 6or 3nironment

dentif aintain conditionsto achieve conformit ofproduct



4

Product Rea+iation

47 0lanning of Realiation 0rocesses

ualit (b1ectives

0rocessesocumentationResources

Facilities

erication9alidation and riteria forAcceptance

Records

0lanning should be suitable for organisationsoperations



42

2 )ustomer Re+ated

Processes dentif Requirements

Review Requirements not stated

but necessar

An other requirement of

organisation



43

21 Identi=cation o)ustomer Reuirements

pecied b the customer

2ot specied b the customer

(bligations



44

22 Reieamp o

Reuirements enders and )ontracts

Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed

Amendments contro++ed

Internet sa+es addressed

9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer

)ommunication roduct inormation

enuiries contracts or order hand+in

inc+udin amendmentsC

customer eedac inc+udin customercom+aints



46

gt Desin and8or

Dee+oment gt1 P+annin

gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin

71 Purchasin )ontro+

72 Purchasin Inormation

7gt eri=cation o Purchased Product

9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production and Serice

Proision 1 )ontro+ o roduction and serice roision

Aai+ai+ity o inormation

6or Instructions amphere necessary

se Maintenance o suita+e euiment

Aai+ai+ity se o Monitorin Measurineuiment

Im+ement Monitorin Actiities Processes or Re+ease De+iery Post De+iery

Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice

Proision 2 a+idation o Processes

gt Identi=cation raceai+ity

7 )ustomer Proerty

Preseration o Product

)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt

)ontro+ o Monitorin Measurin Deices

Determine Measurements

Identiy Deices Reuired

se )ontro+

6here a+ica+e

)a+irate or eri=ed Saeuard Protect

etc

inc+udes sotampare

Measurement Ana+ysis



5

Measurement Ana+ysis Imroement

1 P+annin

De=neP+anIm+ement

Measurement Monitorin Actiities

)onormity o roduct and system Imroe

eectieness o system

A+ica+e Methodo+oies Hinc Statistica+ echniuesB

2 M it i



52

21 )ustomer Satisaction Hmonitor customer

ercetion to reuirementEs u+=+mentB

22 Interna+ Audits

Monitorin8Measurement

2gt Processes Hcorrection correctie actionB

27 Product

2 Monitorin Measurement





54

22 Interna+ Audit Fua+ity System

3ectie+y Im+emented

3ectie+y Maintained )onorms to ISO9001

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55

2gt Monitorin Measurement o Processes

Suita+e Methods

Rea+isation Processes

Demonstrate Ai+ity

Achiee +anned resu+ts

)orrection and )orrectie action

4 onitorin amp



56

++4 onitorin ampeasreent of Prodct

Measure and monitor characteristicso the roduct to eriy that

reuirements are met Aroriate Staes

3idence o conormity HrecordsB

4o re+ease8de+iery unti+ a++ OHaroed y re+eant authorityB



5

Re+ated to Product

Identi=ed and )ontro++ed

Preent nintended se or De+iery

)orrected and re-eri=ed

A+ies to ost de+iery ro+ems amphich ampi++

reuire aroriate action

gt )ontro+ o 4onconormin

Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data

)ustomer Satisaction

)onormance to Product Reuirements)haracteristics and rends o

Processes Products

Su+iers



5

1 P+annin or )ontinua+1 P+annin or )ontinua+ImroementImroement

Imroement

P+an and Manae the rocessesnecessary or continua+

imroement Hua+ity o+icy ua+ity oGecties

audit resu+ts data

correctie8reentie actionB

)ontinua+ Imroement



6

)ontinua+ Imroement

De=nin measurin and ana+ysin eJistinsituationC

3sta+ishin oGecties or imroementC

Searchin or ossi+e so+utionsC

3a+uatin so+utionsC Im+ementin se+ected so+utionC

Measurin eriyin and ana+ysin resu+ts

o im+ementationC 5orma+isin chanes



6

Reieamp 4onconormities Hinc+)om+aintsB

Determine )ause

3a+uate 4eed or Action

Determine Im+ement Actioninc+udin reention o recurrence

Record Resu+ts

Reieamp )orrectie action

2 )orrectie Action2 )orrectie Action

Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action

Im+ement Action Record Resu+ts

Reieamp Preentie actionIdenti=cation

Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

gt Preentie Actiongt Preentie Action

Imroement

8ampL-8-9(O9 1-amp1 at azira



63


Stes )om+etion Date

Manua+ Procedure Prearation )om+eted

Interna+ Fua+ity auditors trainin1st atch 11112002

2nd atch 2112002

D4 Document Sumission 20112002

Orientation and Aampareness 2-gt0112002trainin at K6

Preassesment y D4 0gt122002

Interna+ Fua+ity Audit HIFAB 2-10122002

Manaement reieamp HMRMB 17122002

Reistration audit 2gt-27122002



64

8=gtOand is6in( ou a (rand success

durin( t6e audits and maintainin(

ontinual Improvement of ualit



EAUREE2) A2A$B A2 0R(EE2) ( CDD76DDD - lause 47 General

his c+ause reuires that monitorin measurement ana+ysis andimroement rocesses needed to demonstrate conormity o theroduct ensure conormity o the ua+ity manaement system andcontinua++y imroe the eectieness o the ua+ity manaementsystem sha++ e +anned and im+emented

This shall include the determination of applicable methodsincluding statistical techniques and the extent of their use

ISO 9001199 lause 10 and 0 correspond



2

ISO9001 amp ISO9004 (a consistent pair)

bullISO9001 Requirements

bull ISO9004 Guidelines for performance

improvements

ISO9002 amp ISO9003 are no osolete



3




D( othari





4

Philosophy






5











6

















enefit






)









organization






information












0he eming +cle0



2




3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

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22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












3




D( othari





4

Philosophy






5











6

















enefit






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organization






information












0he eming +cle0



2




3

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4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

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R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












4

Philosophy






5











6

















enefit






)









organization






information












0he eming +cle0



2




3

Documentation



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4



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5









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16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

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22

0 o c u m

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0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












5











6

















enefit






)









organization






information












0he eming +cle0



2




3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












6

















enefit






)









organization






information












0he eming +cle0



2




3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64
















enefit






)









organization






information












0he eming +cle0



2




3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












)









organization






information












0he eming +cle0



2




3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64















information












0he eming +cle0



2




3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64


















0he eming +cle0



2




3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64













0he eming +cle0



2




3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












2




3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












3

Documentation



Interna+ audits





4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












4



Customer ocus





+evie the amp$S



5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












5









reuirements



16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












16


34A4)3M34S 36334ISO 90011997 8 ISO 90012000




ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64













ISO 90012000

ISO l$ Ref$



Resource ana(ement



he )hanes - enera+



)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












)



standard

















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64






















2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












2


1O +lauses









procedre





2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












2

71 FMS enera+

Reuirements





22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












22

0 o c u m

e n t e d

0 o c u m

e n t e d

P r o c e d u r

e s

P r o c e d u r

e s





processes ocumented

yes o Documents



23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












23

0 o c u m

e n t e

d

0 o c u m

e n t e

d

P r o c e d u r e s

P r o c e d u r e s

)ontro+ o Documents









24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












24






isposition specied


t e d

0 o c u m e n

t e d

P r o c e d u r e s

P r o c e d u r e s



25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












25







rocesses



26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












26










2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












2

1 Manaement










2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












2)

2 )ustomer 5ocus


epectations5


Satisfaction



2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












2

0 o c u m e n

t e d

0 o c u m e n

t e d

gt Fua+ity Po+icy






3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












3

7 P+annin


easurale

onsistent it6 olic





3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












3

7 P+annin



ontinual mprovement

hange management



R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












R ii+it A th it



33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












33





aintained



R ii+it A th it



34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












34









35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












35

Manaement Reieamp


(pportunities








36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












36

Manaement Reieamp





resource needs



3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












3







3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












3)

2 uman Resources

4647 General






maintain records



3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












3

gt Inrastructure







4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












4

7 6or 3nironment




4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












4

Product Rea+iation


ualit (b1ectives


Facilities


Records




42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












42

2 )ustomer Re+ated



but necessar


organisation



43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












43




(bligations



44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












44

22 Reieamp o


Reuirements de=ned

Anoma+ies reso+ed

Ai+ity con=rmed



9

O S

I G 9 I I 0

9 8 0 9 G lt



45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












45

2gt )ustomer







46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












46

gt Desin and8or


gt2 Inuts

gtgt Oututs

gt7 Reieamp

gt eri=cation

gt a+idation

gt )hanes

9

O S

I G 9 I I 0

9 8 0 9 G lt



4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












4

7 Purchasin




9

O S

I G 9 I I 0

9 8 0 9 G lt



4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












4)

9

O S

I G 9 I I 0

9 8 0 9 G lt








Actiities



4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












4

9

O S

I G 9 I I 0

9 8 0 9 G lt

Production Serice



7 )ustomer Proerty


)ontro+ o Monitorin



5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












5

9

O S

I G 9 I I 0

9 8 0 9 G lt




se )ontro+

6here a+ica+e


etc

inc+udes sotampare




5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












5


1 P+annin

De=neP+anIm+ement



eectieness o system


2 M it i



52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












52



22 Interna+ Audits



27 Product






54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64














54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












54


3ectie+y Im+emented


0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s

2 gt Monitorin



55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












55


Suita+e Methods


Demonstrate Ai+ity



4 onitorin amp



56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












56








5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












5

Re+ated to Product







Product

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












5)

7 Ana+ysis o Data



Processes Products

Su+iers



5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












5


Imroement



audit resu+ts data


)ontinua+ Imroement



6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












6

)ontinua+ Imroement









6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












6


Determine )ause



Record Resu+ts



Imroement

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s



62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












62

Action



Determine )ause

Determine

0 o c u m e

n t e d

0 o c u m e

n t e d

P r o

c e d u r e s

P r o c e d u r e s


Imroement




63


Stes )om+etion Date



2nd atch 2112002









64












63


Stes )om+etion Date



2nd atch 2112002









64












64














