Transcript
XYZ COMPANY COMPANY
IATF 16949 QUALITY MANUAL Order Quality Manual
DATE: REVISION 01
UNCONTROLLED COPY CONTROLLED COPY Serial # _________ Issued To: To: ___________________________ Date: ___________
SAMPLE Note: This sam!e ma"#a! o" o"!$ !$ %o"tai"s a&tia! te't the&e(o&e) the "#m*e&i"+ is "ot %o"se%#ti,e-
XYZ COMPANY
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Ta*!e o( Co"te"ts
I"t&o.#%tio"----------------------------------------------------------------------------------------------------------------------------------------------------------------- --- /
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SCOPE-------------------------------------------------------------------------------------------------------------------------------------9
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P&o.#%ts a". se&,i%es-------------------------------------------------------------------------------------------------------------------------------------- 9
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A!i%a*i!it$------------------------------------------------------------------------------------------------------------------------------------------------------- 9
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Q#a!it$ o!i%$ stateme"t--------------------------------------------------------------------------------------------------------------------------------- 10
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COMPANY 3ISTOY AN5 CONTACT INFOMATION-------------------------------------------------------11
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TEMS AN5 5EFINITIONS--------------------------------------------------------------------------------------------------11
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CONTEXT OF T3E OANIZATION-----------------------------------------------------------------------------------1
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U".e&sta".i"+ the o&+a"i7atio" a". its %o"te't------------------------------------------------------------------------------------------ 1
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U".e&sta".i"+ the "ee.s a". e'e%tatio"s o( i"te&este. a&ties-------------------------------------------------------------- 1
4-2 5ete&mi"i"+ the s%oe o( the 8#a!it$ ma"a+eme"t s$stem------------------------------------------------------------------------ 12 4.3.1 Determining the scope of the quality management system - supplemental..................................................13 4.3.2 Customer-specific requirements....................................................................................................................13 4-4 Q#a!it$ ma"a+eme"t s$stem a". its &o%esses-------------------------------------------------------------------------------------------12 4.4.1.1 Conformance of products and processes.................................................................................................1 4.4.1.2 !roduct safety........................................................................................................................................... 1
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LEA5ES3IP------------------------------------------------------------------------------------------------------------------------1
-1 Lea.e&shi a". %ommitme"t--------------------------------------------------------------------------------------------------------------------------1 ".1.1 #eneral..................................................................................................................................................... .... 1 ".1.1.1 Corporate responsi$ility............................................................................................................................ 1% ".1.1.2 !rocess effecti&eness and efficiency........................................................................................................1% ".1.1.3 !rocess o'ners........................................................................................................................................1( ".1.2 Customer focus............................................................................................................................................. 1( - Po!i%$---------------------------------------------------------------------------------------------------------------------------------------------------------------- 19 ".2.1 )sta$lishing the quality policy....................................................................................................................... 1( ".2.2 Communicating the quality policy.................................................................................................................. 2*
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-2 O&+a"i7atio"a! &o!es) &eso"si*i!ities a". a#tho&ities--------------------------------------------------------------------------------- 0 ".3.1 Organi+ational roles, responsi$ilities, and authorities supplemental..........................................................22 ".3.2 esponsi$ility and authority for product requirements and correcti&e actions...............................................22 -4
Ma"a+eme"t &eso"si*i!ities-------------------------------------------------------------------------------------------------------------------------
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Ma"a+eme"t &e&ese"tati,e--------------------------------------------------------------------------------------------------------------------------- 2
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PLANNIN-----------------------------------------------------------------------------------------------------------------------------4
6-1 A%tio"s to a..&ess &is; a". oo&t#"ities----------------------------------------------------------------------------------------------------4 /.1.1........................................................................................................................................................................... 24 /.1.2........................................................................................................................................................................... 24 /.1.2.1 is0 analysis............................................................................................................................................. 2" /.1.2.2 !re&enti&e action......................................................................................................................................2" /.1.2.3 Contingency plans....................................................................................................................................2" 6- Q#a!it$ o*ype and e7tent of control............................................................................................................................. " %.4.2.1 >ype and e7tent of control supplemental..............................................................................................."% %.4.2.2 5tatutory and regulatory requirements......................................................................................................"%
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%.4.2.3 5upplier quality management system de&elopment.................................................................................."% %.4.2.4 5upplier monitoring................................................................................................................................... "( %.4.2." ?erification of purchased product........................................................................................................./1 %.4.3 nformation for e7ternal pro&iders................................................................................................................../1 %.4.3.1 !urchasing information........................................................................................................................./1 %.4.3.2 nformation for e7ternal pro&iders supplemental..................................................................................../2 /- P&o.#%tio" a". se&,i%e &o,isio"------------------------------------------------------------------------------------------------------------------ 6 %.".1 Control of production and ser&ice pro&ision................................................................................................../2 %.".1.1 Control plan.............................................................................................................................................. /3 %.".1.2 5tandardi+ed 'or0 operator instructions and &isual standards............................................................../4 %.".1.3 ?erification of o$ set-ups........................................................................................................................../4 %.".1.4 ?erification after shutdo'n........................................................................................................................ /4 %.".1." >otal producti&e maintenance.................................................................................................................../4 %.".1./ Management of production tooling and manufacturing, test, inspection tooling and equipment.............../" %.".1. !roduction scheduling...............................................................................................................................// %.".1.% ?alidation of processes for production and ser&ice pro&ision...............................................................// %.".2 dentification and tracea$ility......................................................................................................................... / %.".2.1 dentification and tracea$ility 8 supplemental........................................................................................../ %.".3 !roperty $elonging to customers or e7ternal pro&iders................................................................................./% %.".4 !reser&ation.................................................................................................................................................. /% %.".4.1 !reser&ation supplemental..................................................................................................................../% %."." !ost-deli&ery acti&ities.................................................................................................................................../ ( %.".".1 @eed$ac0 of information from ser&ice......................................................................................................./( %.".".2 5er&ice agreement 'ith customer............................................................................................................./( %."./ Control of changes........................................................................................................................................ * %."./.1 Control of changes supplemental..........................................................................................................* /-6 e!ease o( &o.#%ts a". se&,i%es--------------------------------------------------------------------------------------------------------------- -- 1 %./.1 elease of products and ser&ices 8 supplemental......................................................................................1 %./.2 ayout inspection and functional testing.......................................................................................................2 %./.3 6ppearance items......................................................................................................................................... 2 %./.4 ?erification and acceptance of conformity of e7ternally pro&ided products and ser&ices..............................2 %./." 5tatutory and regulatory conformity.............................................................................................................. 3 %././ 6cceptance criteria........................................................................................................................................ 3 /- Co"t&o! o( "o"%o"(o&mi"+ o#t#ts---------------------------------------------------------------------------------------------------------------- 2 %..1.1 Customer authori+ation for concession.....................................................................................................4 %..1.2 Control of nonconforming product customer specified process.............................................................4 %..1.3 Control of suspect product........................................................................................................................4 %..1.4 Control of re'or0ed product......................................................................................................................4 %..1." Control of repaired product......................................................................................................................." %..1./ Customer notification................................................................................................................................" %..1. Aonconforming product disposition..........................................................................................................."
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PEFOMANCE E>ALUATION-------------------------------------------------------------------------------------------
9-1 Mo"ito&i"+) meas#&eme"t) a"a!$sis) a". e,a!#atio"------------------------------------------------------------------------------------6 (.1.1 #eneral..................................................................................................................................................... .... /
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(.1.1.1 Monitoring and measurement of manufacturing processes................................................................../ (.1.1.2 dentification of statistical tools................................................................................................................. (.1.1.3 6pplication of statistical concepts............................................................................................................. (.1.2 Customer satisfaction.................................................................................................................................... (.1.2.1 Customer satisfaction supplemental......................................................................................................% (.1.3 6nalysis and e&aluation................................................................................................................................ % (.1.3.1 !rioriti+ation.............................................................................................................................................. ( 9- I"te&"a! a#.it---------------------------------------------------------------------------------------------------------------------------------------------------- 9 (.2.1.1 nternal audit program............................................................................................................................... %* (.2.1.2 Quality management system audit............................................................................................................%* (.2.1.3 Manufacturing process audit.....................................................................................................................%1 (.2.1.4 !roduct audit............................................................................................................................................. %1 9-2 Ma"a+eme"t &e,ie=---------------------------------------------------------------------------------------------------------------------------------------- /1 (.3.1 #eneral..................................................................................................................................................... .... %1 (.3.1.1 Management re&ie' supplemental........................................................................................................%1 (.3.2 Management re&ie' inputs........................................................................................................................... %1 (.3.2.1 Management re&ie' inputs supplemental..............................................................................................%2 (.3.3 Management re&ie' outputs......................................................................................................................... %2 (.3.3.1 Management re&ie' outputs supplemental............................................................................................%3
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IMPO>EMENT---------------------------------------------------------------------------------------------------------------------/2
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10- No"%o"(o&mit$ a". %o&&e%ti,e a%tio"------------------------------------------------------------------------------------------------------------ /2 1*.2.1......................................................................................................................................................................... %4 1*.2.2......................................................................................................................................................................... %4 1*.2.3 !ro$lem sol&ing........................................................................................................................................%4 1*.2.4 )rror-proofing............................................................................................................................................ %" 1*.2." Barranty management systems...............................................................................................................%" 1*.2./ Customer complaints and field failure test analysis..................................................................................%/ 10-2 Co"ti"#a! im&o,eme"t---------------------------------------------------------------------------------------------------------------------------------- /6 1*.3.1 Continual impro&ement supplemental....................................................................................................%/ I"se%tio" a". Test P&o%e.#&e----------------------------------------------------------------------------------------------------------------------------------- // Correcti&e and !re&enti&e 6ction !rocedure..................................................................................................................( 2
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I"t&o.#%tio" E Company recogni+es its responsi$ility as a manufacturer of quality productsFpro&ider of quality ser&ices. >o this end, E Company has de&eloped and documented a quality management system. >he quality management system complies 'ith the international standard 6>@ 1/(4(G2*1/, 6utomoti&e Quality Management 5ystem 5tandard. >he quality management system is commonly referred to as the quality system or QM5. >his Quality Manual applies to sites of the organi+ation 'here customer-specified parts, for production andFor ser&ice, are manufactured, supporting functions, 'hether on-site or remote and throughout the entire automoti&e supply chain. >he purpose of this manual is to pro&ide comprehensi&e e&idence to all customers, suppliers and employees of 'hat specific controls are implemented to ensure productFser&ice quality. >his manual also go&erns the creation of quality related documented information. t 'ill $e re&ised, as necessary, to reflect the quality system currently in use. t is issued on a controlled copy $asis to all internal functions affected $y the quality management system and on an uncontrolled copy $asis to customers and suppliers. t may $e issued to customers on a controlled copy $asis upon customer request. >his manual is di&ided into ten main sections. 5ections 4-1* are modeled on the sectional organi+ation of the 6>@ 1/(4(G2*1/ standard. 5ections are further su$di&ided into se&eral su$sections representing main quality system elements or acti&ities.
HHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHH 9Aame:, !resident
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4-4-1-1 Co"(o&ma"%e o( &o.#%ts a". &o%esses E Company ensures that all products and processes conform to all applica$le customer, regulatory, statutory requirements, and e7pectations of all interested parties. >his includes outsourced processes and parts for ser&ices. @or details, refer to the is0 Management !rocedure, !rocess Control !rocedure, nspection and >est !rocedure, !urchasing !rocedure, 5er&icing !rocedure, nternal 6udits !rocedure, and Management e&ie' !rocedure.
4-4-1- P&o.#%t sa(et$ E CompanyIs has de&eloped and implemented a !roduct 5afety Management !rocedure to manage product safety. Design, manufacturing, and ser&icing processes further support product safety initiati&es.
-1-1-1 Co&o&ate &eso"si*i!it$ E Company promotes an ethical $usiness culture and focuses on maintaining integrity in all of its $usiness acti&ities. >o this end, E Company has de&eloped and enforces documented corporate responsi$ility policies. @or details, refer to the 6nti-he effecti&eness of these actions is e&aluated, and actions are integrated in to E CompanyIs quality management system. @or details, refer to the is0 Management !rocedure.
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6--4 ?e$ i"itiati,es >he management of E Company esta$lishes annual 0ey initiati&es, 'hich include quality o$ecti&es. >he o$ecti&es are esta$lished &ia the Management e&ie' !rocedure and communicated to all le&els of the organi+ation for use in esta$lishing each functionIs and employeeIs annual 0ey o$ecti&es. Quality o$ecti&es are measura$le, include $usiness performance indicators reflecting requirements for productsFser&ices, and are consistent 'ith the quality policy including the commitment to continuous impro&ement. >he use of quality o$ecti&es for facilitating continual impro&ement is e7plained in the Continual mpro&ement !rocedure.
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Oe&atio"
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Oe&atio"a! !a""i"+ a". %o"t&o!
/-1-1 P!a""i"+ o( &o.#%t a". se&,i%e &ea!i7atio" E Company has esta$lished and maintains a documented !roduct and 5er&ice eali+ation !lanning !rocedure to ensure that processes and su$-processes are conducted under controlled conditions. !lanning of the reali+ation processes is consistent 'ith the other requirements of the organi+ationIs quality management system.
/-2--2 5e,e!ome"t o( &o.#%ts =ith em*e..e. so(t=a&e E Company maintains and follo's a documented a soft'are quality assurance process for products 'ith internally de&eloped em$edded soft'are. E Company uses an appropriate assessment methodology to assess its soft'are de&elopment process.
/-4-1 e"e&a! E Company ensures that the purchasing process is controlled such that purchased products and su$contracted ser&ices, 'hich affect productFser&ice quality, conform to specified requirements.
/-4--2-1 A#tomoti,e &o.#%t@&e!ate. so(t=a&e o& a#tomoti,e &o.#%ts =ith em*e..e. so(t=a&e
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E Company require suppliers of soft'are-related products, or products 'ith em$edded soft'are to maintain soft'are quality assurance process for its products, this includes a soft'are de&elopment assessment methodology. >he requirements 'ithin 5ection %.3.2.3 of this manual also apply to E Company suppliers. @or details refer to 5ection %.3.2.3.
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I"se%tio" a". Test P&o%e.#&e 1.*
ecei&ing nspection and >est 1.1
6ll purchased material 'hich influences the manufacture of, or is intended for use as part of, deli&era$le products is su$ect to inspection andFor testing $y ecei&ing nspection. Jpon receipt of products, recei&ing personnel &erify the quantity of deli&ered units, chec0 mar0ing and identification of pac0ages, and inspect all pac0ages for any signs of tampering or damage. f all these chec0s and inspections are satisfactory, recei&ing personnel signs the deli&ery receipt. f not, any shortages or damages are noted on all copies of the deli&ery receipts.
1.2
>he recei&ed containers are then mo&ed to the designated inspection area, a copy of the purchase order is retrie&ed, and the pac0ing slips are remo&ed from the containers. Jpon opening the containers, the goods are &erified against the purchase order and the pac0ing slip, and are e7amined &isually for any signs of damage. >he purchase order is stamped ;)C)?)D= and is signed and dated $y the recei&ing inspector. 6ll recei&ing inspections are logged in the ecei&ing nspection og.
1.3
On critical parts and components, as determined $y the Quality Manager, a precision inspectionFtest is performed. >his type of inspection includes one or more of the follo'ingG
re&ie' of material certificates, supplier inspection records, compliance certificates, and any other rele&ant documentation deli&ered 'ith the product
receipt of, and e&aluation of, statistical data
random sampling $ased on statistical technique specified
1**K nspectionFtesting if necessary
&isual inspection to detect any damage or other &isi$le pro$lems
performing measurements and testing against specified requirements
second or third party assessments or audits of supplier sites, 'hen com$ined 'ith records of accepta$le deli&ered product quality
part e&aluation $y a designated la$oratory
another method agreed 'ith the customer
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esults of such inspectionFtest, including recording the sample si+e and actual measurements are recorded on the nspectionF>est L 6udit eport
2.*
3.*
1.4
Bhere it is not practical to perform recei&ing inspection upon receipt, pro&isions are made to perform source inspection at the supplierIs facility.
1."
>he Quality Manager determines the e7tent and scope of recei&ing inspection $ased on the importance of the item and the suppliersI control methods and performance. >he Quality Manager may request that suppliers pro&ide o$ecti&e e&idence of conformance 9i.e., material certifications, certificates of conformance, test data, first article inspection and 5!C data:. O$ecti&e e&idence pro&ided $y suppliers may $e used as the $asis for reducingF'ai&ing recei&ing and source inspection.
1./
Jpon acceptance, products are identified 'ith an ;6CC)!>= tag green stic0erN and mo&ed to stoc0. n the e&ent that product 'hich is designated for recei&ing inspection is released to production due to urgency, it shall $e positi&ely identified and recorded in recei&ing inspection records.
n-process nspection and >est 2.1
n-process inspectionFtesting is conducted to ensure that the productFprocess conforms to specified requirements. >he inspectionFtesting is normally carried out $y production personnel. andom audits of the in-process inspectionFtesting process are conducted $y quality control personnel.
2.2
>he Quality Manager determines the e7tent and scope of in-process inspectionFtesting $ased on the importance of the item, control methods, and pre&ious performance.
@inal nspection and >est 3.1
@or acceptance of completed products, final inspectionFtesting is utili+ed. >his includes a &erification of satisfactory recei&ing and in-process inspectionsFtests, as 'ell as completion of the remaining inspectionsFtests to assure that the finished productsFprocesses conform to specified requirements. !roducts are not released, processes are not appro&ed until all inspectionFtest acti&ities ha&e $een satisfactorily completed and the appropriate documentation is a&aila$le and authori+ed. 6ll final inspections are logged in the @inal nspection og. On critical parts and components, as determined $y the Quality Manager, a @inal nspectionF>est L 6udit eport is completed.
3.2
E Company ensures the planned arrangement, to &erify that the products and ser&ice requirements ha&e $een satisfied, are aligned 'ith the control plan and are documented as specifies in the control plan.
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3.3
E Company ensures that the planned arrangements for initial release of products and ser&ices encompass product or ser&ices appro&al.
3.4
Bhen changes occur after initial release, E Company ensures that product or ser&ices appro&als are o$tained in accordance 'ith section %."./.
3."
6 layout inspection and a functional &erification to applica$le customer engineering material and performance standards is performed for each product as specified in the control plans. >he frequency of layout inspections is determined $y the customer. esults are a&aila$le for customer re&ie'.
3./
>he Quality Manager determines the e7tent and scope of final inspectionFtesting $ased on the importance of the item, control methods, and pre&ious performance.
nspection and >est ecords 4.1
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nspectionFtest records, 'hich sho' clearly 'hether the productFprocess has passed or failed the defined acceptance criteria, are esta$lished and maintained.
Aonconforming MaterialF!roducts ".1
6ll materialFproducts that are found to $e nonconforming are identified and segregated andFor quarantined, and appropriately dispositioned per the Control of Aonconforming !roduct !rocedure.
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Co&&e%ti,e a". P&e,e"ti,e A%tio" P&o%e.#&e 1.*
2.*
3.*
nitiation of Correcti&eF!re&enti&e 6ctions 1.1
Correcti&e actions may $e requested 'hen a condition, 'hich is ad&erse to quality or 'hich has the potential for productFprocess impro&ement is identified. >his includes nonconforming material recei&ed from a supplier.
1.2
!re&enti&e actions may $e requested 'hen potential productFprocess pro$lems are identified.
1.3
6ny employee of the company can initiate a correcti&eFpre&enti&e action request $y completing the top portion of the Correcti&e 6ction equest 9C6: form, $ut only the Quality Manager can issue a 5upplier Correcti&e 6ction equest 95C6:. >he Quality Manager records all C6s in the Correcti&e 6ction 5tatus og and 5C6s in the 5upplier Correcti&e 6ction 5tatus og.
Customer Complaints 2.1
Mar0etingF5ales is responsi$le for recei&ing, processing, and responding to customer complaints. 6ll recei&ed customer complaints are recorded in the Customer Complaints 5tatus og.
2.2
>he Quality Manager e&aluates e&ery complaint and 'hen rele&ant, requests implementation of correcti&e actions from the responsi$le function. >he Quality Manager, in conunction 'ith the !resident and 5ales, determines the appropriate customer response.
2.3
@ield failures are handled as descri$ed in the 5er&icing !rocedure.
6nalysis and 6ppro&als 3.1
6 thorough analysis of all related processes, operations, quality records and specifications, 'hich may ha&e contri$uted to the deficiency, is conducted $y the responsi$le function. >he in&estigation and analysis of the root cause and pre&enti&e measures shall $e fully documented $y the group or indi&idual assigned to the pro$lem. >he analysis shall include re&ie' of all applica$le data and e7amination of product scrapped or re'or0ed to determine the e7tent and cause of the pro$lem and analysis of trends in processes or performance of 'or0 to pre&ent nonconformances.
3.2
6nalysis of correcti&e action and pre&enti&e action is used as input into management re&ie's.
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6t a minimum, the follo'ing pro$lem-sol&ing methods are usedG
pro$lem identification
containment
root cause identification
&erification of effecti&eness of correcti&e action
6dditionally, the follo'ing methods may $e usedG
analysis of failure mode
capa$ility studies
correlation diagrams
data collection
fish $one diagram 9ishi0a'a diagram:
@M)6 re&ie'
histograms
pareto analysis
pro$a$ility charts
recording 'ith corresponding graphic representations
stratification 9separation of data and di&isions into categories:
3.4
f a customer-prescri$ed pro$lem-sol&ing format e7ists, E Company uses the prescri$ed format.
3."
6ll pro$lems are e&aluated in terms of potential impact on production costs, quality costs, performance, relia$ility, safety, and customer satisfaction. 6ll pro$lems are classified either minor or maor. esolutions to all correcti&e and pre&enti&e actions are re&ie'ed and appro&ed $y the Quality Manager. Bhere the response is unsatisfactory, the correcti&e action request is re-issued. >he Quality Manager conducts periodic re&ie'sFfollo' up to determine if the correcti&e and pre&enti&e actions ha&e $een implemented and are effecti&e.
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6ll department managers handle correcti&e Fpre&enti&e actions in priority order. >he Quality Manager ensures that all action plans are carried out in a reasona$le timeframe relati&e to the se&erity of the pro$lem.
!re&enti&e 6ctions 4.1
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Bhen correcti&e actions are implemented or 'hen a potentially serious nonconformance is identified, similar parts, products, and processes are analy+ed to determine the required steps for effecti&e implementation of pre&enti&e actions.
ecords ".1
6ll C6s, 5C6s, customer complaints, soft'are pro$lem reports, sur&eys, returned product and post-production records, incident reports, ad&isory notices, recall records, and their resolution including their &erification, are filed and maintained.
".2
>he ris0 management files are updated as appropriate.
QUALITY SYSTEMS INNOVATIONS, INC. www.qsinnovations.com Phone !"#$%!#$&'%" Emai( qsiinc)*t+.net