Ref. No.

CNCA-08C-038:2001
IMPLEMENTATION RULES FOR COMPULSORY
CERTIFICATION OF MEDICAL DEVICE

Artificial Heart-Lung Machine Roller Pum
Announce! on "ec #$ 2001 %mlemente! on Ma& 12002
Certification and Accreditation Administration
Of Peope!s Rep"#ic of C$ina
1
CONTENTS
%& SCOPE&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&'
(& CERTIFICATION MODEL&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&'
'& )ENERAL RE*UIREMENTS FOR CERTIFICATION&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&'
3.1APPL%CA'%(N )(R C*R'%)%CA'%(N.......................................................................................3
3.2 '+P* '*,'%N-.....................................................................................................................
3.3%N%'%AL %N,P*C'%(N () 'H* )AC'(R+................................................................................./
3..*0AL1A'%(N () 'H* C*R'%)%CA'%(N R*,1L', AN" APPR(0AL () C*R'%)%CA'%(N.............2
3./ )(LL(3 1P ,1R0*%LLANC*...............................................................................................#
+& MAINTENANCE AND MODIFICATION OF T,E CERTIFICATES&&&&&&&&&&&&&&&&&&&&&&&&%-
..1 MA%N'*NANC* () 'H* C*R'%)%CA'*................................................................................10
..2M("%)%CA'%(N )(R C(0*R%N- PR("1C' () C*R'%)%CA'*................................................10
.& USE OF COMPULSORY CERTIFICATION MAR/&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&%-
/.1 "*R%0A'%(N, () C*R'%)%CA'%(N MAR4...........................................................................10
/.2 "*,%-N () 'H* MAR4 'HA' ALL(3*" '( 1,*................................................................11
/.3 APPL%CA'%(N () 'H* MAR4.............................................................................................11
/.. L(CA'%(N () 'H* MAR4,................................................................................................11
0& SUSPENSION1 CANCELLATION AND 2IT,DRA2AL OF T,E CERTIFICATES
&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&%%
3& C,AR)E&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&%%
APPENDI4 %&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&%(
APPENDI4 (&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&%'
2
%& Scope
'hi5 !ocument alie5 to artificial heart-lung machineroller um6hich i5 u5e! !uring
oen heart 5urger& in5tea! of the li7ing heart in e8tracororeal 9loo! circulation.
(& Certification Mode
'&e 'e5ting : %nitial )actor& %n5ection : )ollo6 u ,ur7eillance
'& )enera Re5"irements for Certification
3.1Alication for certification
3.1.1 "efining alication for certification
Princiall&$ 5ame ro!uct5 of a 5ame factor& 9ut !ifferent ro!ucing 5ite 5hall 9e alie!
5earatel& 6hen ma;ing alication for certification.
3.1.2 Alication !ocument5
Alicant 5hall 5u9mit formal alication an! relate! !ocument5 inclu!ing:
1< %n5truction for u5e$ technical !e5crition an! 5er7ice manual in Chine5e=
2< A55em9l& !ra6ing of ro!uct$ electrical !iagram$ electrical 6iring !ra6ing an!
in5tallation !iagram of comonent5=
3< 'e5t reort of 5afet& te5t for ro!uct >inclu!ing te5t 5tan!ar! an! te5t metho!<=
.< Hi5tor& of factor&$ ro!ucti7e caacit& of al&ing ro!uct=
/< Li5t of main 5afet& comonent5 6ith name$ t&e$ 5ecification$ 5ulier an! in5ection
item5 9efore 5toc;ing.
3.2 '&e te5ting
3.2.1,amle !eli7er& for t&e te5ting
3.2.1.1 'he rincile5 of 5ul&ing 5amle5 for t&e te5ting
3
'he 5amle5 5ulie! for t&e te5ting 5hall 9e 5electe! from rere5entati7e 5amle5.
3.2.1.2 ,amle5 ?uantit&
'he alicant5 5hall ta;e re5on5i9ilit& of 5amle !eli7er& for t&e te5ting in accor!ance 6ith
the re?uirement5 of the certification 9o!& an! 9e re5on5i9le for them.
'he ?uantit& of 5amle5 5hall 9e 1 an! comonent5 te5te! accoman&ing the aliance5 5hall
9e accor!ing to the re?uirement5 of aen!i8 1.
3.2.1.3 Han!le of 5amle5 an! relating !ocument5 after t&e te5ting
'he 5amle5 te5te! an!@or the relating !ocument5 5houl! 9e han!le! in aroriate 6a&5 after
t&e te5ting.
3.2.2 ,tan!ar!5$ item5 an! metho!5 of the t&e te5ting
3.2.2.1 'e5t 5tan!ar!5
-A 12220 Artificial heart-lung machine-Roller um
-AB#02.1 Me!ical electrical e?uiment-Part 1: -eneral re?uirement5 for 5afet&
3.2.2.2 'e5t item5
'he t&e te5ting 5hall 9e carrie! out accor!ing to total item5 5ecifie! -A B#02.1.
3.2.2.3 'e5t metho!5
'he t&e te5ting for comul5or& 5afet& certification for artificial heart-lung machine-roller
um 5hall 9e carrie! out accor!ing to -A B#02.1.
3.3%nitial in5ection of the factor&
3.3.1 Content5 of the in5ection
3.3.1.1 A55e55ment of factor& ?ualit& a55urance a9ilit&
'he in5ector a55igne! 9& the certification 9o!& 5hall carr& out the factor& ?ualit& a55urance
caa9ilit& a55e55ment accor!ing to the Comul5or& Pro!uct Certification Re?uirement5 for
)actor&C5 Dualit& A55urance A9ilit& >5ee aen!i8 2< an! the a!!itional in5ection
re?uirement5 5tiulate! 9& CNCA.
3.3.1.2 Chec; of con5i5tenc& of the ro!uct
.
'he in5ection for con5i5tenc& of the ro!uct5 al&ing for certification 5hall 9e imlemente!
on the 5ite of ro!uction !uring the factor& in5ection .
%f the certification referre! to the 7arie! t&e @mo!el of ro!uct5$ each t&e 5hall 9e 5amle! 1.
4e& item5 to 9e chec;e! are a5 follo65:
1<'he namelate5 an! mar;5 of ro!uct5 to 9e certifie! 5hall 9e i!entical 6ith tho5e in!icate!
in the t&e te5t reort5.
2<'he ro!uct>5< con5truction referre! to 5afet& function 5hall 9e i!entical to tho5e of the
5amle5 for the t&e te5t reort5.
3<'he 5afet& critical art5 5hall 9e i!entical 6ith tho5e !eclare! in t&e te5t an! confirme! 9&
certification 9o!&.
'he certifie! ro!uct 5hall 9e 5amle! for te5t 9& in5ector$ if there i5 a ?ue5tion in the
in5ection re5ult5. 'he 5amle 5hall 9e cho5en from the ?ualifie! ro!uct. 'he 5amle$
!etermine! 9& in5ector accor!ing to the actual 5ituation$ 6oul! 9e a comlete unit. )or
ro!uct$ ?uantit& i5 1= for 5afet& comonent5$ 5ee aen!i8 1. ,amle5 5hall 9e te5te! 9& the
!e5ignate! in5ection 9o!&. No in5ection organiEation un!er the factor& 5hall 9e entru5te! to
!o the te5t. 'he te5t item5 5hall 9e !etermine! 9& the certification 9o!& accor!ing to actual
5ituation.
3.3.2 %n5ection 5coe
All the ro!uct5 to 9e certifie! an! roce55ing remi5e5 5hall 9e co7ere! for in5ection of
factor& ?ualit& a55urance a9ilit& an! of con5i5tenc& of the ro!uct5.
3.3.3 'ime for initial factor& in5ection
Normall&$ the initial in5ection 5houl! 9e imlemente! after the 5amle ha5 a55e! the t&e
te5ting. 'he t&e te5ting an! factor& in5ection can 9e imlemente! at the 5ame time in
5ecial ca5e5.
'he !uration of factor& in5ection 5hall 9e !etermine! 9& the amount5 of alication unit5 of
ro!uct5 to 9e certifie! an! 6ith the con5i!eration of the 5cale of the factor&. %t 6ill normall&
ta;e a9out . to 2 man-!a& for each roce55ing remi5e5.
/
3..*7aluation of the certification re5ult5 an! aro7al of certification
3...1 *7aluation of the certification re5ult5
3...1.1 *7aluation of the t&e te5ting re5ult5
%f there are 5ome item5 un?ualifie! 9ut ea5& to correct$ the correcti7e action are allo6e!.
3hen all the te5t item5 conform to the 5tan!ar!$ the re5ult i5 Fa55G.
Certification 5hall 9e terminate! if the 5afet& te5t re5ult i5 FfailG.
3...1.2 *7aluation for the %nitial factor& in5ection.
'he re5ult5 can 9e !i7i!e! into 3 le7el5:
1< %f no nonconformit& i5 foun! !uring the in5ection$ certificate i5 recommen!e! to a6ar! to
the manufacturer 9& the certification 9o!&.
2< %f 5light nonconformit& i5 foun! an! the nonconformit& ha5 no a!7er5el& influence on the
ro!uct to conform to the 5afet& 5tan!ar!$ the manufacturer 5houl! ta;e correcti7e action
6ithin 3 month5 a5 5ecifie!. (nl& after 9eing confirme! 9& the in5ection grou$ certificate
i5 recommen!e! to i55ue to the manufacturer 9& the certification 9o!&.
3< %f 5e7ere nonconformit& i5 foun! or the manufacturer !oe5nCt ha7e the ?ualit& a55urance
a9ilit& to meet the certification re?uirement5$ in5ection can 9e terminate!.
3...2 Aro7al of the certification re5ult5

3hen the re5ult5 of t&e te5ting an! factor& in5ection for the ro!uct5 are ?ualifie! an!
ro7e! 9& the certification 9o!& $ certification can 9e i55ue!.
'he alication of the certificate5 5hall coml& 6ith the re?uirement5 of Administration of
Compulsory Products Certification.
3...3 'ime frame for certification
'he time frame for certification i5 the 6or;ing !a&5 occurring from the accetance of
2
comlete alication till i55uing certificate5$ 6hich inclu!e5 the time of t&e te5ting factor&
in5ection$ e7aluation of certification re5ult5 an! aro7al of certificate5 an! rearing the
certificate5.
'he time frame for t&e te5ting>inclu!ing ma;ing te5t reort5< of aliance normall& 5houl!
ta;e ./ 6or;ing !a&5 .
'he time frame for 5u9mitting the te5t reort 5hall 9e 6ithin / 6or;ing !a&5.
'he time frame for e7aluating on certification re5ult5$ aro7ing an! t&ing certificate5 5houl!
not e8cee! / 6or;ing !a&5.
3./ )ollo6 u 5ur7eillance
3./.1 'he fre?uenc& of the follo6 u 5ur7eillance
3./.1.1 'he follo6 u 5ur7eillance 5hall 9e imlemente! once at lea5t e7er& &ear after getting
the certificate5 for 12 month5.
3./.1.2 'he fre?uenc& of 5ur7eillance 5houl! 9e increa5e! if occurring an& of the follo6ing
ca5e:
1< 'he ?ualit& of the certifie! ro!uct ha5 5eriou5l& ro9lem5$ or recei7ing the aeal from
the client an! chec;ing conclu!e5 that the hol!er of the certificate 5hall 9e re5on5i9le for
it.
2< 'he certification 9o!& ?uerie5 the conformit& of the certifie! ro!uct again5t the
re?uirement5 of 5afet& 5tan!ar!5 6ith 5ufficient rea5on5.
3< 'here i5 5ufficient information that the conformit& or the con5i5tenc& of the certifie!
ro!uct5 6oul! 9e affecte! 5ince the change5 of organiEation 5&5tem$ ro!uction con!ition
an! the ?ualit& 5&5tem of the manufacturer5.
3./.2 Content5 of the follo6 u in5ection
3./.2.1 Mo!el of the in5ection
Routine factor& in5ection : con5i5tenc& in5ection
3./.2.2 Routine factor& in5ection for the ?ualit& a55urance caa9ilit& of the factor&
#
'he routine in5ection for factor& ?ualit& a55urance caa9ilit& 5hall 9e imlemente! 6ithin .
&ear5 after attaining the certificate an! the 5coe 5hall co7er the !ocument of Requirements of
Factory Quality Assurance Capability. 'he time frame for the routine in5ection 5houl! ta;e
1 to 2 er5on@!a& for each factor&@roce55ing remi5e.
'here 5hall 9e an o7erall in5ection to the factor& in the /
th
&ear of attaining the certificate
accor!ing to the !ocument of Requirements of Factory Quality Assurance Capability . 'he
5coe an! time 5hall 9e in con5i5tent 6ith the initial factor& in5ection.
'he 5an for an o7erall in5ection erio! 5hall 9e of . &ear5.
3./.2.3 Chec; of con5i5tenc& of the ro!uct5
'he con5i5tenc& in5ection for the al&ing certifie! ro!uct 5hall 9e imlemente! on the 5ite
of ro!uction 6ithin . &ear5 after getting the certificate.
'he in5ection or te5ting on the 5ite 5hall 9e carrie! out a5 the follo6ing li5t 9e5i!e5 the 5coe
of in5ection in thi5 ro7i5ion of 3.3.1.2 of the %mlementation Rule5.
a .'he item5 refer to the !ou9t a9out the 5tructure con5i5tenc& in5ection.
9.'he item5 refer to critical art5 i5 unconformit& to the critical art5 u5e! for
certifie! te5ting.
c. 'he 5afet& item5 !ifficult to Hu!ge 6ithout te5ting or mainl& an! ea5il& change! 5uch a5:
1<Mar;ing >accor!ing to Clau5e 2.1 of -AB#02.1<
2< Protecti7e earthling >accor!ing to Chater 18 of -AB#02.1$ if alica9le<
3<Lea;age current >accor!ing to Chater 1B of -AB#02.1. inclu!e5 *arth lea;age current$
*nclo5ure lea;age current an! Con!ition Patient lea;age current.<
.<"ielectric 5trength >accor!ing to Chater 20 of -AB#02.1<
%n5ector ma& imlement 5amle te5t on the ro!uct if 5u5ect of the con5i5tenc& an! 5afet&
of the ro!uct after in5ection.
,amle5 5hall 9e ro7i!e! accor!ing to the unit in the /
th
&ear of certification. Princiall& one
unit 5hall 9e 5amle! 1 for te5t. an! the te5t 5hall 9e imlemente! 9& aointe! te5ting 9o!ie5
accor!ing to the re?uirement5 of 3.2 in thi5 !ocument. %f no change on the ro!uct the
certification 9o!& 5hall ha7e 5amle te5t or information in5ection accor!ing to 5ecific
5ituation.
3./.3 ,amling te5t for follo6 u 5ur7eillance
,amling te5t 5hall 9e imlemente! to the certifie! ro!uct5 9& the aointe! te5ting 9o!ie5
8
6hen nece55ar&. *ach certifie! ro!uct 5hall 9e 5amle! 1 for te5t .Concrete te5t item5 can 9e
carrie! out accor!ing to 3.2.2.1 of thi5 !ocument.
Critical te5ting item5 are a5 follo65 accor!ing to -AB#02.1:
1< %!entificationmar;ing an! !ocument
2< Limitation of 7oltage an!@or energ&
3< *nclo5ure5 an! rotecti7e co7er5
.< Protecti7e earthing
/< Continuou5 lea;age current
2< "ielectric 5trength
#< Mechanical 5trength
8< ,urfacecorner5 an! e!ge5
B< Protecti7e earth terminal an! connection
'he certification 9o!& ma& carr& out the te5t5 9& choo5ing te5t item5 accor!ing to 5ecific
5ituation.
3./... *7aluation of follo6-u in5ection re5ult5
'he certificate5 can 9e retaine! an! the certification mar;5 can 9e continuou5l& u5e! uon
fa7ora9le in5ection re5ult5. %f there i5 an& non-conformitie5 foun! in the follo6-u
in5ection$ the correcti7e action5 5hall 9e ta;en 6ithin three month5. (ther6i5e$ the
certificate5 6ill 9e 6ith!ra6n$ the certification mar;5 6ill 9e 5toe! u5ing$ an! the rele7ant
re5ult5 6ill 9e announce!.
+& Maintenance and modification of t$e certificates
..1 Maintenance of the certificate
'he %mlementation Rule5 5ecifie5 the conformit& certificate5 6ithout co7ering the clo5ing
!ate of the certificate5. 'he term of 7ali!it& of the certificate5 !een!5 on the 5ur7eillance
in5ection 9& the certification 9o!& at regular inter7al5 for maintenance of it.
B
..2Mo!ification for co7ering ro!uct of certificate
..2.1 Proce!ure for change
%f the hol!er5 of the certificate5 re?uire changing the 5cale of the ro!uct5 6hich are of the
5ame unite a5 the certifie! one5$ the& 5hall ma;e alication fir5t. 'he certification 9o!& 5hall
chec; the con5i5tenc& of the ne6l& alie! ro!uct5 again5t the certifie! one5 an! confirm the
7ali!it& of the original certification again5t the ne6l& alie! ro!uct5 an! carr& out
5ulementar& te5t5 or in5ection for the !ifference5 . After 9eing confirme! that the
e8ten5ion ?ualifie! 9& the certification 9o!&$ ne6 certification or 5ulement of the
certification can 9e i55ue! to the hol!er. (r maintain the original certification or ;ee a5
technical information.
..2.2 'he re?uirement5 of 5amle ro!uct

'he hol!er5 of the certificate5 5hall fir5tl& 5u9mit the technical material5 relate! to the
e8ten!ing ro!uct5 an!$ a5 nece55ar&$ 5ul& 1 5amle accor!ing to the re?uirement5 of
ro7i5ion of 3.2 of the %mlementation Rule5 for chec;ing 9& the certification 9o!&. 'he
item5 for chec;ing 5hall 9e 5ecifie! 9& the certification 9o!& for the 5amle5 re?uire! te5ting
a5 chec;.
.& Use of comp"sor6 certification mar7
'he certificate hol!er 5hall follo6 the Regulation for Compulsory Product Certification Mark.
/.1 "eri7ation5 of Certification mar;
'he ro!uct5 li5te! in the Rule 5hall not 9e allo6e! to u5e an& !eri7ation of certification.
/.2 "e5ign of the mar; that allo6e! to u5e
3hen certification concern5 6ith 5afet& onl&the mar; 5hall 9e:
10
/.3 Alication of the mar;
,tan!ar! 5ecification mar; 5hall 9e u5e!.
/.. Location of the mar;5
'he certification mar;5 5hall 9e u5e! on the ro!uct5 near the namelate.
0& S"spension1 canceation and 8it$dra8a of t$e certificates
,houl! the hol!er>5< of the certificate>5< 7iolate the ,ecial Rule5 an! other re?uirement5 of
comul5or& ro!uct certification$ the certificate5 5hall 9e 5u5en!e!$ cancelle! an! 6ith!ra6n
in accor!ance 6ith the re?uirement5 of the !ocument Administration of Compulsory Product
Certification .
3& C$ar9e
'he certification 5hall 9e charge! 9& the certification 9o!& accor!ing to the national 5tatutor&
5tructural fee chart.
11
Appendi: %
List of Critica Components and *"antit6 of t$e Sampes
No. Name of comonent5 National 5tan!ar! *?ui7alent %*C
,tan!ar!
,amle5
Duantit&
1 Plugo6er 5ul& cor!5
an! a!ator5
-AB#02.1 3 5et5
2 Main 5ul& tran5former
-AB#02.1
3 c5$ one of
them i5 not
ac;age!.
3 ,ul& fu5e5 -AB#02.1 B c5$ of each
t&e
. ,ul& 56itche5 -AB#02.1 3 c5
12
APPENDI4 (
Comp"sor6 Prod"ct Certification Re5"irements
for Factor6!s *"ait6 Ass"rance A#iit6
Manufacturer 5hall meet the re?uirement5 for factor&!s ?ualit& a55urance a9ilit& 5ecifie! in
thi5 !ocument$ in or!er to en5ure that all certifie! ro!uct5 are i!entical 6ith the 5amle>5<
again5t 6hich the t&e te5t 6a5 aro7e!.
%& Responsi#iities and Reso"rces
1.1 Re5on5i9ilit&
Manufacturer 5hall !efine the re5on5i9ilitie5 an! inter-relation5 of all the er5onnel in7ol7e!
in ?ualit& acti7itie5. An! manufacture 5houl! aoint a management rere5entati7e for ?ualit&$
6ho$ irre5ecti7e of other re5on5i9ilitie5$ 5hall 9e re5on5i9le to:
a< en5uring that ?ualit& 5&5tem$ 6hich meet5 the re?uirement5 of thi5 !ocument$ i5
e5ta9li5he!$ imlemente! an! maintaine!.
9< en5uring that the ro!uct5 6ith the comul5or& certification mar; are ro!uce! in
conformit& 6ith the 5tan!ar!5 to 6hich the& 6ere certifie!.
c< e5ta9li5hing !ocumente! roce!ure5 to en5ure that comul5or& certification mar;5 are
;et an! u5e! aroriatel&.
!< e5ta9li5hing !ocumente! roce!ure to en5ure that the comul5or& certification mar; i5 not
affi8e! on an& non-conforming ro!uct or change! ro!uct that 6a5 not notifie! to
certification 9o!&.
'he management rere5entati7e for ?ualit& 5hall 9e cometent to erform the 6or;.
1.2 Re5ource5
)actor& 5hall 9e e?uie! 6ith nece55ar& ro!uction facilit& an! te5ting e?uiment in or!er to
con5i5tentl& manufacture the ro!uct5 in conformit& 6ith rele7ant 5tan!ar!5. %n a!!ition$ an!
factor& 5hall ro7i!e rele7ant human re5ource5$ to en5ure that er5onnel erforming 6or;
affecting ro!uct ?ualit& i5 cometent$ an! 5hall e5ta9li5h an! maintain nece55ar&
13
en7ironment 5uita9le for manufacturing$ te5ting an! in5ection$ 5torage etc.
(& Doc"ments and Records
2.1 Manufacturer 5hall e5ta9li5h an! maintain !ocumente! ?ualit& lan or rele7ant !ocument5
for certifie! ro!uct5$ an! the !ocument5 nee! to en5ure that relate! roce55e5 to ro!uct
?ualit& are oerate! an! controlle! effecti7el&. Dualit& lan 5hall !efine the o9Hecti7e of
ro!uct !e5ign$ realiEation roce55$ te5t an! relate! re5ource$ a5 6ell a5 the re?uirement5 for
change5 >i.e. 5ecification$ roce55ing$ critical comonent5 etc.< to certifie! ro!uct5$ u5e an!
management of mar;5.
,tan!ar! or 5ecification 6hich the !e5ign i5 9a5e! on$ a5 one e55ential art of ?ualit& lan$
5hall 9e more 5trict than the re?uirement5 5ecifie! in thi5 Rule5.
2.2 Manufacturer 5hall e5ta9li5h an! maintain !ocumente! roce!ure to control the
!ocument5 re?uire! in thi5 !ocument$ to en5ure that
a< all !ocument5 i55ue! an! change! 5hall 9e aro7e! 9& authoriEe! er5onnel rior to i55ue
an! change.
9< change5 an! current re7i5ion 5tatu5 of !ocument5 are i!entifie! to re7ent uninten!e! u5e
of o95olete !ocument5.
c< rele7ant 7ali! 7er5ion5 of alica9le !ocument5 are a7aila9le at oint5 of u5e.
2.3 Manufacturer 5hall e5ta9li5h an! maintain !ocumente! roce!ure5 to !efine the control5
for the i!entification$ 5torage$ rotection an! !i5o5ition of recor!5. Recor!5 5hall 9e legi9le$
integral to ro7i!e e7i!ence of ro!uct conformit& to re?uirement5.
Recor!5 5hall 9e retaine! for an aroriate erio!.
'& P"rc$asin9 and Recei;in9 Inspection
3.1 Control of ,ulier
Manufacturer 5hall e5ta9li5h the roce!ure5 that !efine the criteria for 5election$ e7aluation
an! routine 5uer7i5ion of 5ulier$ 6hich ro7i!e critical comonent5 an! material$ to en5ure
the 5ulier ha5 a9ilit& to ro7i!e the critical comonent5 an! material in accor!ance 6ith
re?uirement5.
Recor!5 of the e7aluation5 an! routine 5uer7i5ion 5hall 9e maintaine!.
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3.2 %n5ection@0erification for Critical Comonent5 an! Material
)actor& 5hall e5ta9li5h an! maintain roce!ure5 of in5ection or 7erification for urcha5e!
critical comonent5 an! material$ an! roce!ure of erio!ic 7erification in5ection$ to en5ure
that critical comonent5 an! material meet 5ecifie! certification re?uirement5.
%n5ection for urcha5e! critical comonent5 an! material ma& 9e carrie! out at the factor& or
5ulierC5 remi5e5. 3here in5ection i5 erforme! at 5ulierC5 remi5e$ Manufacturer 5hall
5ecif& the inten!e! in5ection re?uirement5 to 5ulier.
Manufacturer 5hall maintain recor!5 of in5ection or 7erification of critical comonent5$
7erification in5ection recor!5$ e7i!ence of conformit& an! rele7ant in5ection !ata$ etc.
.. Proce55 Control an! %n5ection
..1 Manufacturer 5hall i!entif& critical ro!uction roce55e5 an! arrange oerator5 6ith
aroriate ?ualification at the roce55e5. 3here ro!uct ?ualit& can not 9e guarantee! 6hen
no oerating !ocument$ aroriate oerating in5truction5 5hall 9e reare! to ma;e
ro!uction roce55e5 un!er control.
..2 3here en7ironment con!ition i5 re?uire!$ factor& 5hall meet the re?uirement5.
..3 Manufacturer 5hall monitor an! control aroriate roce55 arameter5 an! ro!uct
characteri5tic5$ a5 alica9le.
... Manufacturer 5hall e5ta9li5h an! maintain maintenance roce!ure for the manufacturing
e?uiment.
../ Pro!uction 5hall 9e in5ecte! at aroriate 5tage5 of manufacture to en5ure that ro!uct5$
comonent5 an! art5 are in accor!ance 6ith the certification aro7e! 5amle.
.& Ro"tine Tests and Verification Tests
)actor& 5hall e5ta9li5h an! maintain !ocumente! routine te5t5 an! 7erification te5t5
roce!ure5 to 7erif& an! !emon5trate that ro!uct5 are in comliance 6ith rele7ant
re?uirement5. 'he roce!ure5 5hall inclu!e te5t item5$ content5$ metho!$ accetance criteria
etc. 'e5t recor!5 5hall 9e maintaine!. Routine te5t5 an! 7erification te5t5 5hall meet the
re?uirement5 5ecifie! in rele7ant ro!uct certification imlementation rule.
Routine te5t5 are erforme! on 100I of ro!uction an! are normall& carrie! out at the final
5tage of ro!uction. Normall& no further oeration5$ e8cet for la9eling an! ac;ing$ ma& 9e
carrie! out after the5e te5t5.
0erification te5t5 are te5t5 on 5amle5 ta;en ran!oml& in or!er to 7erif& an! !emon5trate that
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ro!uct5 con5i5tentl& meet 5tan!ar! re?uirement5.
0& Inspection and Test E5"ipment
'he e?uiment u5e! for in5ection an! te5t mu5t 9e regularl& cali9rate! an! chec;e! for
correct oeration$ an! meet in5ection an! te5t caacit& re?uirement5.
Manufacture 5houl! 5tiulate the oeration rule5 of the in5ection an! te5t e?uiment. 'e5ting
er5onnel 5houl! follo6 the rule5 an! u5e the e?uiment correctl&.
2.1 Cali9ration
%n5ection an! te5t e?uiment u5e! for !etermining the conformit& of the ro!uct5 9eing
manufacture! 5hall 9e cali9rate! on a regular 9a5i5. All cali9ration5 un!erta;en on 5uch
e?uiment mu5t 9e tracea9le to national or international 5tan!ar!5. )or in-hou5e cali9ration$
the metho!$ accetance criteria$ cali9ration inter7al etc. 5hall 9e !ocumente!. Cali9ration
5tatu5 of the e?uiment 5hall 9e ea5il& i!entifie! 9& oerator an! er5onnel in-charge.
Cali9ration recor!5 5hall 9e maintaine! aroriatel&.
2.2 )unctional Chec;
'he )unctional chec; to the e?uiment u5e! for routine te5t5 an! 7erification te5t5 5hall 9e
un!erta;en on a !ail& 9a5i5. 3hen functional chec; i5 foun! to 9e not 5ati5fie! 6ith 5ecifie!
re?uirement5$ arrangements shall allow previous product to be traced$ retrie7e! an! re-te5te!
if nece55ar&. (erator 5hall 9e in5tructe! on 6hat action i5 to 9e ta;en if a functional te5t i5
foun! to 9e un5ati5factor&.
'he re5ult5 of functional chec; an! all 5u95e?uent correcti7e action ta;en mu5t 9e recor!e!.
3& Contro of Non<conformin9 Prod"ct
Manufacturer 5hall e5ta9li5h roce!ure of control of non-conforming ro!uct$ 6hich 5hall
inclu!e5 i!entification metho!$ 5egregation$ !i5o5al$ correcti7e action an! re7enti7e action.
Reaire! an! re6or;e! ro!uct 5hall 9e re-te5te!. Recor!5 of reairing for critical
comonent5 an! art5 an! !i5o5al of non-conforming ro!uct 5hall 9e maintaine!.
=& Interna A"dit
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%nternal au!it roce!ure5 5hall 9e e5ta9li5he! an! !ocumente! to en5ure that ?ualit& 5&5tem i5
imlemente! effecti7el& an! certifie! ro!uct5 are comlie! 6ith 5ecific re?uirement5. 'he
re5ult5 of internal au!it 5hall 9e maintaine!.
)actor& 5hall ;ee recor!5 of all comlaint5$ e5eciall& to a ro!uctC5 non-comliance 6ith
re?uirement5 of rele7ant 5tan!ar!$ an! ma;e the5e comlaint5 a5 one of inut of internal au!it.
Correcti7e an! re7enti7e action 5hall 9e ta;en to non-conformitie5 an! recor!5 5hall 9e
maintaine!.
>& C$an9es to Certified Prod"ct
An& con5tructional Change5 from original 5amle for '&e 'e5ting 5houl! 9e controlle! 5o a5
to ma;e certifie! ro!uct5 con5i5tentl& 9e in conformit& 6ith rele7ant 5tan!ar!.
Manufacturer 5hall e5ta9li5h roce!ure5 to monitor change5 of the critical comonent$
material$ con5truction an! factor5 that ma& affect comliance 6ith rele7ant 5tan!ar!. 'he
change5 on certifie! ro!uct5 mu5t 9e notifie! to the certification 9o!& for authoriEation$ rior
to their imlementation.
%-& Pac7in91 ,andin9 and Stora9e
)ini5he! ro!uct5 5hall 9e ac;age!$ 5tore! an! han!le! in 5uch a 6a& a5 to en5ure that the&
6ill continue to coml& 6ith the alica9le 5tan!ar!5.
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