CFR Part 820 Hev.

05

21 CPR Part 820

Quality System Regulation

(2005

o¥ 4 A

13 i;f(~TJl&)

§
§ 820.

;fA.

1 13~

§ 820.3 § 820.5 § 820.20

Jt.

Subpar 1 A - illiJ!1J [Genera I Prov is ions] : [Scope]:

[Definition]

1f1J:l'l:~,7,7".b. [Quality System]

Subpart B &b~~,7,7

.b.~**l1i:

[Qualit~, System Requirements]

7;f-£J;>t;....-HJ).{f:

[Management

Responsibility]

§ 820.22
§ 820.25 § 820.30 § 820.40 § 820.50

&W~:1It
AA

[Quality Audit]

[Personnel] Subparl C

$:W+1fJ!!! Jt~lfrm
"M:~1f~

[Design Controls]

1t9:W+f[ff!Yl Jt1tfflill UM:~tfm!

[Design Controls] [Document Controls]

Subpart D

[Document Controls] [Purchasing Controls]

Subpart E

[Purchasing Controls]

Subpart F

fi'&IT~',& Vliib'JJJ;'~f.

[Identification and Traceability]

§ 820.60 § 820.65

lit~, [ldentiflcation]
~Ujlj,t'£ [Traceability] Subpart G

illl!~, B: V7"o-e-,7,'ifm!
[Inspection,

[Production

and Process Controls]

§ 820. 70 ~~,

JJ.. V7"O-eArg;@

[Production and Process Controls] Measuring, and Test Equipment]

§ 820.72 § 820.75 § 820.80 § 820.86

M!1!t, mljlE, &.V~D~~*S:

7"pt,7,o/{!J7-~3:"-iJt)...,

[Process Validation] Activities] In-process, and Finished

Subpart H il";f./}~JlE [Acceptance

4:,,--o7"O-e-.7.. &'If;IH~'H:lr.JO)*-Mt~:1It [Receiving,

Device Acceptance]

il";jlg.0):jftffi, [Acceptance Status]

Subpart I

/Ffl'*Jb

[NonconForming Product]

§ 820.90
§ 820.100

~*.fJH1

[Nonconforming Product]

Subpart

J {@;IE, &U:71VJ7~~3;""[Corrective

[Corrective

and Preventive Action] Action]

f@;IE, &a71l.157~~3~

and Preventive

CPH Part 820 Rev.05

Subpart K *jf-,

lk LJ§~O)1f~

[Labeling and Packaging Control]

§ 820.120 § 820.130

~1JlHm~0)3Vf.:

[Device Labeling] [Device Packaging]

~URl1Il~O)§~
Subpart L

IIM&v', {;~~. ffl':'~. &. tH1i'!ift

and Installation]

[Handling, Storage, Distribution,

§ 820.140 § 820.150 § 820.160 § 820.170 § 820.180 § 820.181 § 820.184 § 820.186 § 820.198 § 820.200 § 820.250

1&t& [Handling]

f*=1f lJiSM

[Storage]

ili[l.JlS- [Distribution]
(Installation]

itC.~~ [Records] -1GA'.]~:1t.lJi: [General Requirements]

Subpart !vi

~~m.t$:'""7:A?'-~~
pl'lp'tti-:';:AT Are~ *tfif77

[Device Master Record] History Record]

12Hj~,llIH*:0)1l.it~(i-JllC~ [Device -1Iv

[Complaint Files]

[Quality System Record]

Subpart N -!T-t":A

[Servicing]

-!T-t':A

[Servicing]

Subpart 0

~~'I'a{_j=Fr~ [Statistical
Techniques]

Techniques]

~ilNt'-J-=Fr!: [Statistical

CFR Part 820 Rev.05

21 CFR Part 820 Quality System Regulation

(2005

if 4 f.I

1 r:l

&UJt&)

Subpart A - itfttl [General Provisions]: § 820. 1 EI P9 [Scope]: (a) JiJfHliij lID

(I) CGMP[Currenl Good Manufacturing -? '"(mlE~,tt,.:;,o Practice](/) !I-;Jt$ JjjJi, ;;$:lfIlW~AT .b.mP,IJ[quality ;;$::Wt[this part]O)~>It*rjHi, device]O) 1t9:NHdesignJ, .{t[installationllk.. alfmuracilities system regulationJleJ: CT Q ~""( (/)~

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used in],

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O)fJlJJ.\t[components],

X j"j:1m b [parlsJ~~~T &'

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A. f**.JHn21[humancell],

s.rJfi:lUJI&,

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ifH:m(/)~~O)M~c Health Service Act] § *ilI[Part]O)

I'fI ~~ffl:I±li'1f.7i-O)to),

351 f::J::IJ~#-J~tf.J!WJ*IJ[biological product license]0)~fPJ:a:-r~lf'JI1~O)to)I"j:,

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procedures],

j:3J:. V Part

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good tissue practice]

.:p.lllJ{(1)M~ctftOo t,tJ.1UliJ.:. ff*~:hQo I

(2)

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CPR Part 820 Rev.05

[1996.10.7 {t'g¥~ 61 F~R2654 ~;::J:.Qm.IE"j:,2000.3.31

N 65 FR

17136, 2000.11.7

65 FR

66636, § 820.3
(a) ~

lkr.J

2005.5.25

f'I 69PI\29829 t.:..J::.fJi;R"Ji:J

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[Definitions]

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mlE:O) rdl ~[defined interval], lk a+:0't,ttmlt [sufficient frequencY]1:~:IifiIL, &itV.A7 A mllilJ [activit ies], B: a:tO)m<:.*O)fi!ii*n~~'ft~
[independent examination]~~T?':'}:1:ib,?,

707 A.=p.)I~(procedures]a-~~L,

.:t.tLn~Xh;!'ldf.J[ellectively](;:~1illi2:fl., 'Q':'c, -Cv

lk V-'to)

CFR Part 820 Rev.05

-FJm7.llJ1IlW~A7 A(J) F-l11!J[objecLivesJ(J)JlIi.U::.imitT.I-c"Ji>~::'l::~r.m~[determineJTQ':'t:~

It';,,
(u) rfh'llt*'!Jv-

,~~I.:.~L -Cf;.ll.fT1Hf:~f-fTQ~fk~Jmanagement with executive authority]~.:.J:I'J,,?-Cj7{JL1L~tLt.:., tJikllcL -CO)M§..g.~{_Jt~;lf.I2l[overall intention], B:

[Quality po][cy]e:fJ:, '?o [Quality system]tfi, VJJ~t[direction]~v

(v) ~ «~;t.7A

JH(.,.,-

*-:;j~r~~jiillT9t:.~(J)~f~*.liM&
-¥Jliit "j'P-E'A, &. 'UJJJ.fHresources]
changes]~bt.:.c:,i""7P-eA,

[organlzatlonal structure], ~f931Hit[responsibiliLiesl

a-v';c
(w)

¥}il!~~ [Remanufaclurer]tl-i, 12Hj'm~:I!l~!M8h\;:0~, -t:"(J)f.f:1iE;, :Z1J:*:3;:f.l:m~,

use] I.:.y;.J" L -cm~i~~9![significant .f!f.f*11HrestoreJ,:z Ii i:"(J)fill.(J)1T ~ rt1Jl~I;:1iti""Q[release for

:zri~[gjTQm~[jnlended [other actla'1T?~:a-v '?" (x) -¥Ii![L [Rework)tfi, 1T?mdiri:[actionJ-t-1t '50 (y)

lim1m [conditions], ~1~[renovates], flf.§~[repackage],

~.g.~ct.t"?t.:.[nonconformingJ!lllI:&~,
A~ -

distribution]Aiit.:. ~mt.m:~.,.,-

~f51<[DMR](J)

m7E(J)~*$lJ{ ,.:.i!&,g. ~-1:t Q[fulfill]t:.:.1lb I.:.

1t- 1:::" .:A

m~

[Specification] C l±,

1m! 61[product},

7" PtA,

[service},

)z Ii

it!! (J)!IIb {~

[activities] I.:.ML -Cll~T"~[must (z) /-t!JT'-~3~ [Validation]tf±, ~*$lJ:~1ltf':'Y~ilE:

conform]~*~i=!j[requirement]~lt

'50
&. am:iE[provision]f.:.

mJ:E[specific]O)f!J!fflEIi¥-JI.:.ML -cm:iE~tt.t.:.[particular] '?o

T Q[consistently fullill]':'.!::~~~[examinationl evidencejz L -clit~.gTQ':'c~v

J:1?~.tf.Jt.t~[J~[objective
(1) 7"P-E';t.o/'t!JT'-Y3/'

(Process validation].!::f±,7"ptA7.l~'Mf':'[cpnsistentlYlT1:I)JEbi)
3(

;;ht::[predeterminedJmmf:..g.j(i""9t:F.i*, [objective evidencejz L -rlim3'rTQ'::c~v '?o

1J:~Jb~li!i:tLQ':'c~,

~rdi(f.Jt.tmEW

(2)T"!f"'(;;-'/~!JT'-V3/'

[Design validation]tl±,

~~#,!~(J)m~n~.:;:L-"-(J)~**
$Ml1!Ji.tmEOO[objective
~~[examinationl '?o &.

l]i[user needs], .& Vf~ffl ~ 1l~!.:..g.itTQ[conformJ::'c~, evidencejz l,-cft'(~.lz:i""Q':'c~" '?o (aa) ~tiE

[Verificationjz; fi., mAEO)JIi*.lJ:;¢~1iMI)E~;f1, -c It 'o::'c-t-,

v:mJ:E[provision]I.:J::'J, ~.(J{_Jt.t~iEW[objective evidencejz l;-cm.~.gTQ':'c~v § 820.5 Jl)Jf!l~ATA [Quality System]

~~~~*Ij:,

m:iE[specific](7)~~~$:~,

~n, RliW~;¢liHl!WJ'':'[appropriatel

*jjf(J)

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,,!i.tSt~v '0
Subpart B £J(VATAJ!;}t$lj [Quality System Requirements] § 820.20 .,.,.*-~j~r(J)Jt1:f:: [Management Responsibility]

CFR Part 820 Rev.05

(a) Jhil{*'!J:"--- [Quality policy]. fM'f.ff:~1fTiS'?-*~~}/-'H;;I:, V~;tf,J[commitment].a-b·Mt*,!J:"---.!::L--C~lIL-ft~t:hf:;fftl?tt~'o nG:',!:: ;fr1;\f;mE[ensureJ Lftlt;h,l:fitl?ftv (b)
-,

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Q iii~J It [adequate]fJl~~ilHl,,¢J![organizational

[designed],
(1)

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and

structure]:a:-lI{llll.L., rfl.I<!f[maintainJL/t'tnlfttGft~ *

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( ii ) ¥AIT.ff:~

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I:: "'?v \-cu~ I~HreviewJLitlt.n.l:ftt;ftv

'0

rfIlWV.ATAO)P~~o) 13ft, lk 'U~MHi, (d) & 1t~tii!ii [Quality planning]. rfnJ.t ~

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m [quality

4HW!~~1!t1;;1:, wi-, lk a!1t!l3i!~nQ12H~·t~U~~.: TiS ~ r~H*

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eFR Part 820 Rev.05

§ 820.22 Jl~/I{~1!t [Quality Audit] ~!t!ij[~~I'J:, ~'b1li~ttO)~Jm[procedure]:a:-~'fflIz:l_" :.O)~:~n:.tt)&JtVAT AtJ\r«11Iz:~:h t':'&~VAT A~*~J.Jf:a:-~~L fiti~:e,l_,tl!ttLr~UlGt.tl,

-n \G:.~:a:-lImtJ~6b, ~'~~VAT
£,,:IDJi.t:tJ.lfr,:fjG~t.t$lJi:[deficient actionJ~J.&Gt.lltttr::/tl,

A o).f-fXM!I:[efl'ectiveness]:a:matter] (;: MT Q~~1t

'0

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'c

[reaudit].:a-~tt>, ~~1E7 :1~3~[corrective

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13 {t, fJ.i!tH'i)(iIf{1::

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n!t~[reviewJO)t:Jl) (;:flJ:tll~tLtlr'ftlGi.i:l, [documcnted]~tLillt:h'·iilGt.i:l, § 820.25 AA [PersonneIJ

'0

JI/j[Ifi~, .&lFilt~~O)

(a) -tlltF.l~.ll[Generul]. +)ttl[sufficient]AA

:6- !w'!~~1'§.'j:, *_ f;:m.JE~nt.:~""(

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s.lH:!M!~ff-tQ

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(1) f;1rJ 4t-R
0) -$

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-c ,

A ~ Ii ijf:tEO) ~

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'0

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Subpart § 820.30 ~~Ijf~

(1)

e IDt~HfJ:!l!

[Design Controls]

[Design Controls] .&G*rn:(a)(2)0)!JAH;:fiC.~~tLt::~7A [O)I~Jj#.i.~:a:-~~T Q[ensure]t::~~;:, Gtllt 'G ~

(a) -~9:'(f..r$ll[GeneralJ.

7:7Am, Xfi77AII,

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m~[specified]O)~iH- ~*$=ll1;:..g.jcT9=~~(*jfiET

~mt$:O)~ffH:'~m!i"Q[conlrol

the design]=FJllfi~lim.ll.L, *t1Jij: Lttlt:hl'itt

.j:j!t~;

I 0)~1i~$:1'i, 1tltft'I-1fJ!1!O)xt~~::tJ:o: J:kV:

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868.6810 878.4460

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#:~ :f:.

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71- f4 =¥Ufffl :1'0-:1[Gloves, surgeon's]

eFR Part 820 Rev.OS

880.6760 892.5650 892.5740

~ .tJ:.(I~[(~estraint}", ~71i1J1¥J[Preventive}" ... ~ AT A, .,. 77"!J 7~?'-, .. 'I&M,t1:ttHlI![Radionuclidel ~WJJ... .. ·mIDil[Sourcel . "1.&Mf:EttH!lL l!~1.&!ttK*mr~[Telelherapy]o·'

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-, ':'O)~I'@j"'Cti, in],

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10

CFR Part 820 Rev.05

[design historv liIe(DHF)J~L.. -C)(i!'fftL.tt~thlift'=>ttv

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:6- ~lt~~

1:1:, I!H~H~~O)

[production spec[ficationsJI':lEL..<.ti4!a~h"LIt 'Q,:_~.-a:-(*rtiETot;:~ O)=FlIIfla-fll'lf:lz: L, *ffi~L.. ftlttLrittGt,tv'o (i) T-!f1/'0)~!I![Design changes]. *!ll!I~~~rj:, B&~W:~O)T-if-{/c1)~9!1.l~~:Mi!~ho ~tiE, ~,*, &V*W1.l~frtt;b

iVH':, -to)P'i~1L ::icii{t, /~!JT'-~3/,

;h,Q:'c~(~fduETQt=~0)-¥11~~f11IfliL,

xrj:~,~ttm-.g., *tE#iL..f.tltn(·itt~f.tv

'0
-17".:.".!:: t.:~*J&:OOk

(j) ~~·I·JW:~7T1 )v(Design history Iile]. *t!X§:~1\flt,

[§.~~~0)4§.?,

771 JI-{DHF]a-fi'{EliL, *IH~t-L..tt~t;h,~"itt;ttlt'o ;h,t=riltfitilI' il!TI[design plan], .&.

U*_O) !I!~*lj

~1frmVJt7711v(':li, T-f-1/n~jJI;l1f,~
f.: tiE"'? -C6~~~;h.,t=tO)'1:';bQ:,.!::a-tiEijI':j

[demonslrale]i".Qt=~ t.:~,~ftm:~7.l~g*;h" Subpart 0 § 820.40

Xli § &~h "Lv '7tlthr:;fttr:,ftv

'0

Jt.1flID [Document Controls]

}!.--r.Q-¥II~a-Tlrn'z:L,K;IIi~ LJ.t~ttJ., *:l'!jt0)~*

Jt~If~

[Document Controls] *~""('~*~tJ.,Q~-CO) j(.~;:J~J'I:2-

*!m!~~~(;t, Itf.t~t.tv \

'::0)¥ll[JH.:(·t.b!.O)*J1t1.l~tml;;tGnhl±ftGttv': r

(a) Jt:jfO)iJl(~" &. UliC:fIi[Document approval and distribution]. *~ii!i:~.:f't, *!Jl:\:~-a-TQt=/I)r.:·lim:lz:-r.Q::icl!fn~j§WJ-e;b.Q':_~~~~L.., '.:*Wi"Q#[individual]-a:-t~~ ~O)!i:t a-~ 1-;., Jtlilt~n ~;h,t:::::iCifli, Lt,tlt;h,'"iftGft~'~

.:t;h,a-~WJ[issuanceJTQM I':$:lz:

:.O)*~~,(.:'t,J;~,0) f:l N, &V*~~, j

~-cO)mjfrl.:rm;;t~tL, L..,!OCv 'Iis~

-Cit'ttltnl"!ft~f.tv
JU;l:&:,~tt,

'., *.O)~**lji].:j@rTi".Qt=/I)

m:.t~tJ." f~Jfli-Q,

~-Co)II3It&X#
1':'&L -C1!1!ffl

[obsolete documentslkt, ~-cO)f!l!ff-J~m]j~G~~]j~I:IEI~~ Q[unintended use]:'c~ ~Jj L..t.t{ttLl:ff.,t ~ft" '. 11: (b) )(ilfO)~!1![Document changes]. Jt.O)~J!'j:,

~n

Wi (J) Jt ilfa-lItt

'*

~IJifi3'.:¥.f,.:m;Q::~ht.:~.g--a:~~,

~J!

L.., i¥.~, L.. r: II~ ~ [PI- (/)

m. fj'l§ [same

function], X It*Jit1l! (.: 1m T Q

[individual]I.:J:-?'""(B~~~h,

if-.;rr.:e,~tLtlJft.t~t.tv '<. *ff~,2:nt;:~~J;J:,

-7-1A!J-t.:~,~tJ:

11

CPR Part 820 Rev.05

[appropriate]A~I:xtL. L.t~ft.nf1ttl:>tJ':~
jJ;~~(l)~~,

""(iffi%l~;h..bJ;fl,tl:>tJ':~ *!Mi~1Ji€-*I:t, ::tilO)W2!1!O)~~~*lf!:F '0 W2!1!(l)WC~1d:f:t, J!fkJ$l: ~ rnlTo

a N, lk V~J!tJ~~tJJ~tJ':Q[become
[Purchasing Controls] ~'"((/)ll1~A[purchasedl

'0

nc.Ji&, ~~~

&(·!T::ti§:(l)~lt£,
\0

effective] ~ ;6'~*tLtll-;ftJ':Gt.t:v

Subpart E RIfRtgl!(! [Purchasing Controls]

§ 820.50 lIf4':~fjlfJ.!l!. *l!~~;g-I'j:,

3l.1'j:-t(/)ftl!(l)~It AtLilll!,~Mreceived product],

l:f!. V

~-l:::' ;7..;6~,Jfi1:O)M:jt~JnJ!i[specified requirements] ':-fr3.&T Q':'c!:::~f*~iETQt;:~O)~]I[J[:a: f

pt.rrl" t:1E~L.tt't;!1Ait.t:l:>tJ':v'0
(a) -1j-7"74i"-, consultants], ::I:..-'1'7:7?'-, ::I/'"JTJv?'/'''O)~'ffilfi[Evaluation of suppliers, contractors, and

*!.1.~ii!r~1lt'i, -l}-774-t-'"-,

::1/'''7:77'-,

'&'"(f::l/''if'Jv7'/'''i)'::~,*l,tJ':~t

;!1.littl:>tJ':~-. .:I1K~*~rJt[quality IttJ':l:>ttJ..0 *i'lfii!r~1f(:t: '

(1) 'if'7"74i"-,

requirementsH:"2itr,

~*~P1Hril{nLl" *,lfr#fL.ttft:.n.
\""(, .:I1itJ!*.!Ji~"Ei
\0

::1/'''7:77'-,

::I/'~ Jv?'/'H~tffi[potential]I:"'Jv 'ttttnl:fttGttlt

tr, Bf:lE(/)Ji:*$rJ.H:~-g.Tongt.J[abi1ity ':'O)~¥{!ffi ::ti!fft~:.n. {i,

""(It

]~: "'J~~ij1{IlliL., ~:Q::[selecl]L.tttttL!:UJ':Gttlt

\0

(2) ~f.fffliO)~~:!¥H:£.rj~, !.Wl8h[products],-IT-l:::';7..,-!T77-1-\"-, ?,;..--H:ML. ""(~j?::I:"--"P-JvO)?' 47,

(3)

::I;"--r7:7?'-,

::l ;"---l}-Iv

Jk V$fiI1lj[extent)~~i1:L.tt'ttLf;ft.t:l:>ttv
:::J;"--r7:7?'-, ':&'V:::1;"--'~)v?';"--H:0"''"(, rp.~**ri~"2itr,

'0
~~

"*~~~ntdacceptable]-l}-77-1i"~, :a:flmliL..,*,lfr-M'L..ttfttLI';fttl:>ttv -,

(b)

Rf4:J\ T-?'-[Purchasing

data]' ~fHI!~~ti:~':t,

X r:t..:eO)ft!!O)~tt .i\hi'lfJMreceived ttm-fr,:;t, 'if'77-1-\"-, fj?~.g.I±, oJ:?I:illi~[notify]TQ :::J;"--r7:7?'-,

product),,&, V-l)-- ~';q:

0" vr. fiJf:Q::O)~**rJi:=a:nI¢AXill:(-i,

nM:J\[purchased],

IY1fllH:~eJR1t, XI:;tij[ ml,t;:T-7-~i&ftL., *4E~L..ttlttLltttl?t.tJ..'o

m~

::I;"--~Jv7'~r;6~ • ..:eO)!.W!tli'l, X'i~-~'AO)~J!=a:R/1tAT-?' -Ii, § 820.40 1:1;(E0

!ll:!~~-tf;6~[!t:jjJHf!!~~~~~O)~i(I':'~W~Jkr£T~!JI-CibQ1.l~~*IjJE-e~

\§,0)~k;~iM~;*hhf1t.tGt.tv'o

""(*liif,~tLt~J!t.t:Gt.t:~ \0
Subpart F

~im, &. lfiHWliit

(/)~.i\n[recejptl

[Identification and Traceability] ~~[produclion], t'ii:!j![distribution] , &. 'OWN

§ 820.60 $~ [Identification]
~Ir[l

Dnstallation]O):i;'"( 0);7.. 7-:; I:jo I·tQ?if: 1m i,rftlj <·t:.ih M&8rJ [identifying]O)E¥lrm=a:--litli f.t¥.f L., L..ttlttL!:fttGtt~ § 820.65
\0

*!1W~~*f::t,

iHfIF-ffi: [Traceability]
[surgical implant]t
0),

{;$: I*I(.:.;r~fi..:p.f,fi-C..t.m~ ~ *nQ

X Ii

~-fri O)f~d~, X liMtlHsupport or

12

CFR Part 820 Rev.05

sustain life]~;l:I@T.Q'bCl),

B: 'U£;t ff.; O)}!§' ;;F(instruct

ions for use]iffi IJ~ 4J.J I:. fil:!

m ~ nt,t7.P0t:
Xf;t/<v =FJI~~~liL-.

[failure to perform]JjHfl.::.f!1.!ffj:tI':1!j\:t,tft!;~[significant ~tL.Q[reasonably expected]12H~~.$0)45-':!3~~:tI;t,

injuryJ~Ed£T':'.!::7'.liiS-Jma9I:'T}JlIJ JI:~!I!!!&'IO)45-.::z.':=-VI-. vl-, o

T~ml\\53IJT-31f.f!l!im=%~{'Ht, k4EfifL-t,t'tnl;ft,tGt,t~ Itnlft,tE:Jttlt

\0

~'!lt,tm*-t(J)*JlIiX[components]I'::''bft:ffl:TQ, action]:a:-$~

'0 ':'CI)=FjllHl:t, ft~IE7 :7~3~[corrective

I.:-r Q'b OJ ""C't,t

:.O),t ?t~MltW1(identiJication]Ij:,

~~-I1!!~kffiJJlliiiefQ<[DJ-[R]

l.:xil}{I::~nt.ltf

ttGttlr\
Subpart G

m'.!~,"&

V7"o-eAifm! [Production

[Production

and Process Controls]

§ 820.70

jg!)!, &. V7'p-e?/fm!

A[production

and Process Controls]

(a) -A~l¥J~JJ.[GeneralJ.

*!M~~*I:j:, ~~.mt~7'.l~m#H.:*J.&TQ,:,.!::a-{*#iETot;:~ I':,

process]~~H ~[develop], $M1'[conduct], i'Jm[control].lk

~~7"p-e

V.:t-.:=-

?7-Ltt~tnlfttl::>ttlr
l±l*t:.~*I:'fj:,

\ !lW:i1!r7"ptA(1)~*.!::L-

-c, mt!a-~Il5t(deviations]Lt:.~~:¥,l.s7'.l~
7"o-e A1fmll'::'fj:, W. rOJ.Jj7'.l~~~
tl'{ ~

!l!!!i1!r~~Ij:,

m..mI:'~*TQ':'.!::~*li1ETQt:.~I:.~.~t,t.Jja-tc.t\:L-t:.

:70 t?·Jilfl!l!.=prlifla-liiftLntlffttGttlt
(1) )( procedure:

, *ft¥.fL-t,tftnl:!'ttl::>ttl.-'~

':
instructions],

11 it ~ tz: Hl [2l (documented h

?7 -,

t~ {1' =F JIIW [standard

f,=lillT Qjj7RT

operation

SOP], B: 'U!W.!~J]r;Mmanner

of production]~~~L.

(2) 7' p -e A • .I~ 7 j. [characteristicsjjr, (4) /P-eA.

B: V!,ll!! n!i: 9:! 0)

standards]'

*Jllix (component],

o:.c;

B: V ~ ~ #til ~K:OJ '1'1:.:fj\

=e-;::'?7-, : 'U~:@-rQ':'c; B
x.1j:::x-r[codes]0Jll'<fT-3':'.!::: equipment]-a:-jf(~f.[approvaJ]TQ':'c; standards]I:.~ffl.~nt.:,

(3) FJr:Q:O)$r.tUi!i~[r(!ference
(5) ::t.fl::~.ht.:£$[documented ~nt.:{-t~~~7"lv[representative m!f!!o (b) !WUR,7PtAO)~!J![Production tA,

&'V7"ptAm1~[process

"&V
J( ,j:7J\~

J(J;tT!li)~!li)6.nt:.,

sampJesJt.:.J:i?~!li)~.tLt:.,

ttflfi[workmanship]O)*,J;iE

and process

changes].

*!lW:~~%'tt,

m-m, )jYR,

'70

;Z'j:=FIJlf;tCl)~J!('::'''?lr \""(/';):, .:f-JI~-a:-1il.rrL, *,!~~L-ttltnl;ft,tl::>ttl.-'" :'(1)J:;t,t~J!'j:,

~~[verified]~.tL, O)fiS!flIJ[activities]li,

~-'';}:~,Mt~§*.

~1iill:iW';: § 820.75

O)m:Q:I.:J:IJ.I{!JT-j..~tL,

:.tLG

)ci!ift~n"(It \ttlttLf'Ittl::>ttlt
control],

'0 ~£Ij:.

§ 820.40

1.:t1E0-C*~~tt..
eifect]-a:-'&

tHittGttlt

'0
t1IHIl ~ftj: iJ~,.!M tf~OJ I~'b~
expectedJm--g.Ij:. (;:!!!Hl~~~[adverse @!!~m1!tIj:.

(c) m:%'iJlJ![EnvironmenLal

!tT .:.'!::iJ~..g.ml(r\":..:rID'] ~tLQ[reasonably

t:.!flIDTQ-¥IIIJi1i:flnIlrL.

!li'H~~f*a-~~

~~jt::r.¥L-t~'t.nlfttGtJ:It'o

n1't~~Jill~A7

AI';):, ~$~'Eitr~AT

.A7'.l~. ~[adequate]1:31J'?, ~
l'fttGttlt

l§tm.:.ff!tftlSL "(I.- '-3[functioning

properlyJ':'.!::~~~iE[verifY]TQ

t:'~tE~ I¥J /'::'~~[inspected]~ntt~ttL'ft,tGftl.-

'0

.:.tLI::>O)ffli"!WJI;t, Jt~{t~n"(1t 'ftlttL

'0

eFR Part 820 Rev.05

Cd) AJl.[Personnel]. ~!MliHi~~ri,

(J) 8b1j[

A~il',

~ r\"'p, 3Z.!iUit~~;:t~U~[contactJTQ=-~7Ji, !M8b fij!~[healthl ti'i~liIcleanlinessJ, -to){t!2(J))\J~H.::ML.-C

!;:~£~.a:

&Jt-t bfr J!I!~~f::TmIJ2:;h,Q~*fi,

1lQl AOYrr!WJ [personal practices]' '& tNlll'!&[clothing]l.:0~ ~>lnJ:p:]{.a:{il'j[Il. tfgf,fJ..,tJfttt. L..,

fttJ~ttv

'0 ~~~1!rt,;L
\

-lli'fI¥J~':)~fJf-tJg~Wll:{'f~TQf~fd~:~~,

'bJi-Iff.JtJmll**.a:1'rJ..',3Z.limll~.a:~ ftt;:A~ I·tnf:ft~~ttv

(e)

f:'~? --C~fR.~;h,Q [supervised]=-c.t-,Jf;mE L.f,t

:J:"--:$'~*-'l3:..--1f;@[eontamination

control],

~!W!~~lfli,

-t:'(j)If/Jft!':R.lM11~¥~&!t

T ':cili-€iJ'!I!1¥J (':T~~n.:s%7~[sllbstances]I;:J:Qmi$,

X fim:!!fJ:l f.:%tT-3:::z:"--:$'~*-'l3
I':£:,~"C', i~[PJ[mix-upJ~Il15€,

:..--.t-[V5<·t;:~ O)~fllJ{:a:-ft{ft.lz:. L..t~ !tttGtoelt '0 L., t.llifif l·ttL

(I)

J!1jo/][Bllildings]. !!WJ!i, ~-I;U f::~fft~;h" J

~j:,~~7"[lt

f'f~.t-1T?t;:~

f9.:Ff:t;;Ql&4'Btv '[orderly handling]~1*WiE"C'~Q,. [-:B-ttA"'- A7'J~t~lt;h,!'it~Gt~1t '0 (g) .jjw.f[Equipment]. ,*!mii!r~1l3"

1:,1rf{(L., ~O)f~~[maintenancel

A(·.:f~mTQ~-C O)~~il)j5fiAE O)J!**lJi

wM~[adjustment), ::7!J -=-:..--1', lk.V{5!!fflil~?B:,&ft~?I.:,

~tml': T-lf 1~~n, (0(* ~

A

!W!f'F:(constrllctedJ~n, i112.Mi[placedJ~;h"lHtCinstalledJ~tGn "(J..'.0 ' t

=-t.a:fjj1:mEl.,f,t'tnf;ft~Gt~v -7 ~
;;I. -

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fj:, ~ i!Hlt #Hmanufacturing

specificationJ~.:m.:l*n~jjifT G=-t~ljHiET.Qt::.&)
'@;tr,

WI~:m, ::7!J -=:"--J/', -to){mO)~:@:

o)A7~;;I.-lv~1i'(j[Il.1.,,*,fE~l.,tJ:lttH~tJ:~tJ:v\ I=l {t, 1iHf1~i'd~:~11-::,f::.lf[individual ~

f~~m!WJli, ::;c:.Ht~tL

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\0

(2) ~~[InspectionJ. =-0)~~1j:,

(3)

*~~~*fj:,

~ff*mt$O)f*:i:.A-7~.::z.-Jvil~~Gn-cv\G=-'!:: x~{t~.t1

[adherenceJ:a:-f*fiET.QAEWllY-Jttt!t!1!i:~ , 11{IL\r~tLt::. =FJllrH:.t~?"'(~:Mi!J..,tt,·ttLftt,tl?ttv '0

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lOO [Adjustment]. ~

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\;

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[allowable tolerancelzn. ~w]lY-Jttlll'~~~£'~~TQti$:O)*f*, .:sm5F[visibly postedJI:5F~tL, fWdtiEl.,fJ:(tn.fttJ:t:Jt~v'0 (h) @'!~Hn(#[Manufactllring material]' !M~ffl"f;fn~, :l!X:v 'liro~J!~fT?$f:'$£

~&'bO)8b1t~.:~L-C~~fH:·1k.I£T 3Z.'if~ffl;Q~

c~Jli¥-J!::T?RIJ~ih..Q~-€rI·:'fi,

~3.~Ji~1!rfi, -ttt.;Q~J&'?~tp:tLt;:[removal];Q~,

J.!~
O)~~,

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(i)

mlltt*J f;:~f!?-C[limitedJ~~,6bGtt.t::.tp, flTt~~,[ensureJTG lJ;.. OI~::J;H.::I¥lTQ~IIi~a-pt.lrL.,*tE~J..,ft'ttL!~t~Gt~v '0 .:.O)J:?t~ittt

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0

13 !l!lJ1~!1W~a9:iJm[Automated process]. ~ATA~JJ:~, 701~::r-)v';::VE?-C,

3Z.tl:13 !l!tfr -j1-' 7ot~~:..--::7"·

~i!!r~*f"i, ~:lz:~nt;:
.m,

F:I ~f.:JI;:0v'-C::r::,...-t; .::z.-7'-' Y7r·?.::c7-0)/~)}7·~:bill~.tLG£.I..i~fH:'/~)}7·xiH~~n

''{It

:':/3:,,--a-rrvtl.!tttGttv'o :@:-Co)Y7r·'7.::c7-(j)~J!f±,

"~.n ,t,t't;h.,t:ftJ:~t~1t '0 /~!J7-'l3;_';iiSmlJ, "{v

14

lk.V-t:(J)~jIHi,

't,tl·t.t1f:f

CFR Part 820 Rev.OS

§ 820.72
(a) ~~,

~3!t,

atIJ1E, &Viliti1!:~-*if

[Inspection,

Measuring, and Test Equipment]

~Jtll:q:,B: V~!!j:~$:O)1ll'm![Conlrol of inspection, measuring, and test equipment]. 4Hl!:!Jj[~*ft, ~~itl¥J[mechanical], 0 !IlJJl¥J[automated], 3Z.1±~.:r~[electronic]#!€~:a::--atr, ~'"( 0)~1!t, mll:q:, .& V~~#1$iI~, -t (7)f!1! m ~ sf.](;:m1;a [suitable] "(:';bl?, 1f5c~}Jt~~ [valid results]~'b t:.i? -ttrEf.l iI~;bo[capable]::'C::~f*~iELt.tlt;h.,j"t~i?t,tv -, ~ !IY!~~.:&-It,
~1!t[inspected]~.n,

~$:;Ij~ 131i\"I¥J[routinely]'·.::~.1E[calibrated]~;h.,
,,("It

T.x.VP~tL,

i*~~.n

\Q::.),::a::-f*ffiETo-¥]1[il[1di'(IU'[ L..,~4j~#fl_,t,tfti1A-;ft~Gt~v

-. ::'O)=¥]I!fH':Ii,

:fm~O)f1f~

[accuracy

J. B: V{!1!ffl 0) ~

'Ii.(fitness] t.J~ ~ *It

~ n."5 J:?,

~$:O)

1&:f'& v',

f*ff:[preservation],

.& tJfJil:1T[storage]I.:OOT o~J.]([provisions]t.J~-a*;h.

"("It

,t,tlt;h.ltt,ti?f,tv

'0

:,n60)ffi"!WJI·t,

xli{t.~.n"("It 'f,tl·tnl:ff,tGt.t:v
(b) ecIE[Calibralion]. O)m~[specific directions],

\0

:t3{lEO)-¥WH':I:L

1Efi'ffi2:[accuracy],

&.. V~TIll[precision]f.:MT

Q*J.lIJ
3Z.li~

&. V~N~[limits]j'j~~*tL

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& V!2H~~-II~O)&'jf,·.::~~~:a::-'&';(TtJ~,

:SCfHI:';~;J1, -cit ,t,tlthril,t6f,tv

standards)'

'0
'0 00 Ji'J,

rn

f.:tiE~*[Calibration

~lE, inlJ)i:, &V~!!JJifl$:r.:.~mTQt1.1E£:$I±,

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lliI P>J~t[!i, xl;tmr[~itl~r':J:

:X'iOO[WUf.J£i1!itJl~m il'1±, ~~~~Ii~!ll -tQ':'~ilt-C~Qc

lJiB.fIi))'iI\liJilEt~[traceable]tO)~f~~-j"nl-;ffJ:6f,t""

l¥J~t,t""[not practical]mil', '

'~ifli,

§ 0) j1i=ffl.fg:O)£!i:,."5iffitl!iDndependent eproducible r

t L.., )im1:~Q£$iI~l.tv
records].

~~~11fI;t,

§ *~l$[in-house

standard]~1Ift1JLL..,t.llifl¥T9::,C;lj~-C~Qo (2) ~lE~c.iT<[Calibration lill:t3{lEO)

~.$(7)ili&~rJ, ~lEO) 13f;t, *~lEO)~nflf11f,

&. Vtk
3Z.li

a {·Ni,

)c:.{t.~;h.

'Lv \f,tftn':ff~GIJ:1t TQ.:&- ,

'0

::'nt;,O)~~li, Jiff:~t0.:&-t.J~$~ \

1H1:i$:I.:,

-to)iff<, Xlt~$&-1~m

'& V~~:1:(7)~lE(7)

,.:jtt;,;(LQ

[readily available]~fflr.:..m;T;[displayed]~nt>.r'ff~GI,t1t

§ 820.75

7't:l-e.A·.IW7~~3;"'7o-e-:Ar'±,

[Process Validation]

(a) 7"o-e:AO)/jxJF=t.Jl, tX[subsequentJ(7)~JE, :!j}iI'li,

B: V~!$'Ii:i!%~l':~iliE[fully
:'0)I't!JT'-~9;"'-ffl1WJ,

veri1ied]tJ~'{:'~t,tv'

1<~T'-~3/'~;:J:."5iWi!3rO)f~IDE[high

degree of assuranceJiI~1Tt,t;btt"

fi'(HJL~.nt.:=¥JI[fH.:.VE-?'L*~,~.nf~lttL'·il,tGt,tv'o
I·i, 13{t,

'&V-tO)~*

&. V.l'!JT'-~3;"'-*W.:&-0)~£,

!lG,~f,ttG}iI', \,

I<!J 7- r~tLt.:±IH~UMmajor
to be metJ,::.c:a::-1*iiET-3

equipment]&-~ 7-;., Jt1£l-:1t.2:tLt,tlttLf'fI,tGf,t1t (b) 4H!~~~*!;t,

mJEO)~::l<!lPJj:l.:~~~~a~f.:.iOO.g-'{:'e:Q[continue

t.:li:> I':, :;10-eA '.I'!J"T -V3;...-r.::l::llt."57p-eA·

/~7)-:>'-~~':::':7- L., &. V'i1rJ!l!To

15

CFH Part 820 Rev.05

¥lIIlH:~WtliL, *l~L..tt(j;h(:ftj:~tj:v
(1)

'0
• .f*~1fTQ*[qualilied individuam;:J:'?1'fb

~!M:Jl!r~;g"(";t, 7"0-eA·/<~T'~~3:,..;~~

;h.,f;:;:t::a-(*~iEL..tJ:ft;h!'itj:~ti:!t (2) 7"O-eA ·/-t!J7·-~9:,..;(;:(:;t, 7"o-e A, JZ l'i±: M#!l~O)/< (c) 7" 0 -e AO) ~]I!,

'0
&. "(}rrtmt:iY$, I~ft, ~1jili 13 ~,~tJ:~.g., ,

-r':::'::$1-1)/'~,

~ T - ~a :,..;~JM.?f:a-)(1IHI:; ~t;ft IttJ:t;,tj:1.Ltt '0

X (:;tliJIft.[deviationsMt~-?

t: ~iH±, !lW:lim

(';;1:,

:;:fo -t AO)~

'*

[review],&, V~N~fi:a-~Tv', ~,~tJ::FJ.g., O)fiS!WJfi,)(#{I:;~.n.;f:tr'ftt~tJ:v Subpart H

fIt;<1)T' -~a:,..;~~hIii:Ltj:'t;ft!:fti:~ti:v

'. ;:ttt;,

'0
[Acceptance Activities]

~~¥tJ:tE

§ 820.80 ~.i\, '{:"';·7U-eA, .& -a:l&t«-!.W.!1l'10).g-~~~ [Receiving, In-process, and Finished Device Acceptance] (a) -AA:I¥-J$~[GeneraJ]. ~!fiJJtl~E;*tLGo
(b) ~

*ft!.!!:~~*(i,

.g.:m!j:lj}t[acceplance activities]I::ImTG¥IIIJi:a:-$

ftL, ilf:~LfJ:fttL'tttGtt1.-

-. .g.tM~IjJEI':'li, M!~, ~l!ft, Xfi-tO)ft!!O)M!~iE[veriJicationJ

A -€i-:j§ *IJIE [Receiving acceptance activities]. ~!W! ~ ~

~~,

r±, A r.If JWl & [incoming

product]O)ftft.*UJE[acceptance]I':'I*J-tG=Fllwt~fI{j[3'[L,*,j~}!fLttrt.n.1j'tt~ttv'o Ii, PJT}tO)~~.rl\H.:..g.~TQ;:t::a:~1i, (c) .{:,..;.:;:fot

A -z;'0).g-~*1j

AfnjIDl!rfit

XI±tlJ'iM:~tttt'·t.n(:fttGttv

'0 .g.mn~,

:t:-@-;ft-z;'i!i)-?t:,zp(i, )(.fl:;~.hjd Ittt ~ti:v '0

lED n-process
\0

acceptance activities]. *

~3.§:~1f

f-;t, :e.~ttJj}-€r,

.{:,..;.:;:fot: AO)!,M,W:]n~,..g.~T ~~~*.J1H.:.illIT..g.T P&li:L, *,jg#fLft,·ttl,(j'tt6tj:1.-

.Q'::'~&f*1iiETQ.g.:j§!fIjIEO)~fitr!& ~.Jft,d~::l!i:, ~~,

.:.O)~JIIJiI."(J:,-1:,..;.:;:fO-eAO)!M~tl~,

.:Rliflf!0)t6!~iEilI1Tb.n.97'J~, .:R'J:~,~tt7J:~~,7.lq~c:,;hQ *-z;'I±, ffJm[controlled]2i-.n ':'c7'J~{¥:ffiE~tl"Jt~fl:;~.n;t.l.I-:ft~Gttv

.on '9
XIJ:

'0
*!.I!l!:iiI7/'[runL
Uy",

(d) 1flt?f.g.~*,JIE[Fjnal acceptance activities]' *jl~~1fli, ;:~:a:-~~iET.:o~fitr!:a:litnLL..,*fEfi!fLttlttLl"ittGttv\, (quarantineH¥:~~h,

ttl" \0 :.IIU~~Jtfi,

/<YTO)IN.~#'!.MHHik~Jll!I:&',[1inished deviceM~.g.~=&*IjJEmfl!l[acceptanceriteria](.;:-S-3.&TQ c 1!f~-W1~m:t?f!Jl,!~!J:, -U#f*~t~ X f:;t{tf!O)il1ff.It,tjJ~I."IJ\ ,'IT, "*.-z;'[unlilrelease]~m!~tl,ttltnf±Yt6 J;I. TO):jkl'ilU.:.tt.o *I."fiimiffi[for disLribution]O)t:.~ '::I±l8b~tL "(f±ttt;, ~7TQ*1:: l±h~7.I~7J::f"g(authorized]~nQ*I.";

ttl,.\:
(l) IN.t~Hj~-qA::$1-~i1'<[DMR]-zo~~~ht.:tiS!fi)Jn~, (2)

fUJi!I!i" .07-9 - [associated data], lk VJt.(7)

~,*[reviewed]7.l~~G * 1.":

(3) tlfj}.E:~tLt;:*(designated

individual O)!i-~I.:.J:~,

&T.J.
(4) 7J::MH.:. {itl~f1ft6;h.,G[dated]*"T~\ f-l (e) -€r~*IJJt~fi!<[Acceptance records]. *~~~*Ii, *:i'iLI·.:.~*~;h.,t:.*:m!flJIJ:Q)m!W:l~

CPR Parl 820 Rev.05

xiftft:L.ftlt;hI'itt~ttlt
(1)

'0 :.O)~iid:.,;t, -€r~*IjJEO)iiS!WJ7.J1~1Jill~nt:.:'~; .:to)~*:

: f!ffl L.t;:~$Q

J2J, TO)~J!ll7.J'II3*n.g:

(2) 1t:f*~~JJEO)T!!IiJJ;6!iCTL.t;: 13{1;

(3)

(4) -S-~*11JE:O)fifr!WJ7,r1'T ..:d.:.*0)!i-:t

(5) £:.~t~m~,

::;}1,~0)r,c~1·j:,

~wtmtlJW~tl<[DHRJO)-~!:L.t~'t;h,l"£f~

Gttlt'o § 820.86 -e-:mQ)!IJ\& [Acceptance Status] .g.~*IJJEm~[acceptance criteria]l;:ttf:-?-r-S-f:'&-e;ii;,.'57.p, /F-e-~-e;ii;,.'5tPa-

~W!~~*'';I:,

12D}lj-t G, ~ rf~(/).g.m (/)~;I(i£~J.rM WJt~=F~"(:'j'i'M~,L.t~(·t;J1.,I·'itct~tt],. *~(/):l*7R.(/)m5jIJ '0 [identification] (';I:, ~ ~ (/)

!iW iilr [manufacturing], § ~ [packaging], ~;if-; [labeling]. tm it (installation]. ,& VNj--I::· .A [servicingJO) JIR ~n7,riffiL.-("[throughput]$IEY!f~;h" ~>K~t1t;:~:t&
*,lJ:Effl!fllJ\:.1t~L.t:.~J1rlO)Jj,7.J", :a:-f*~i".:5'b(/)'t"ttltt1l±t.lGt~],. Subpart I ~2.~[distributedl -, {~m[usedlXf'imHWnstalled]~t1.g::c!:::

/F.g.:m~~[Nonconforming Product]
or nonconforming product]. ~!.W.!:l1~JfE;fI';l:, mJE(/)~*$lJi t.tE#jLftittL Nf1iIIi -Cit'ttltnli X:&:ft:(documentation].

§ 820.90 JF-S-:f§&! [Nonconforming Product]

(a) /F1t~J1~O)~m![Control [specified requirementsJI;:~1t fit.l~t~1t ft~ft. ~ffilli, (b) L.t~7.J~"?t.:~.fbO)1flY!I·':' --:>It '-c, ~jl~~r«gu.L.,

'c

::"0) 'f-jlliH:I';I:, /F..g.m ~ O)fri~,[identilication],

[evaluation]. 1lffl~l[segregationJ, B: Vt{:"O)M:&:[disposition] 1:.--:>],. '-C}E~~:h

v '0

/F.-a-m JIll O)R¥1i11i~.:. 1i1M j!t, lk V</F-a-:f.tc!:::t~-? t.:.Jtff ri, \ review and disposition].

(/)&>.:5;f [responsible
\0 ::..(/)

person]. RI';I:*nti&[organization]I:.ML. -riID~:l""to~,J!O).:jf~!!€iJ~, "2i*t1;fJ.rit~~f.tlt

s.V~itf';l:Jt:t:lI~~t1tJ.I'itt.Gtt.1t

/F-B-#f(/)"t'*,
(I) ~~~~~!i, I:. --:>It

&V~Ii:[Nonconrormity

/FilMJ1 (7)1I!t'* 0) Jtff:[responsibility]_

&. V~I':a-tk:l/).'5mmUauthorityJ

'-cmJ:EL.t:: EFIiIAa-i{i13t *,jt~ L.ft.{tt1'itt~t~1,.- \c EF[I~'t"f±, 1I!1!J:kc!:::mt!(/)7"o-e L.., .AI:. -']],. \-ctk:ab~.tt;t;llitt.Gt~lt \0 ~ii6ir(/)mfl:I';I:)(.1t:~tLtJ.ttt~Gf.llt \0 Jt1Lt{t:h:~';I:,

7F1lM (7)f~m Jlr

(2) ~!MJ1[~*I±,

(/)*~ t1.~iHhj"

.'5:fiHMjustification \

for use], B: V{~ffl.a:-fl;i8

L.t;:~

[individuaIJ(/)!fi-~ 7.J~I3*t1;Jd.litt.Gttlt

:tFii t:f1l.a:-¥iOCL.[reworkJL.t;:~, ~ ~*!WM~l7.J~~1i[current](/)*i8m.m l.k VM~ffiffi:a:-"2itr, ~lliL L.(7)

\. ~i1i:L., "& V'f!f~'ffiffi(/)m-[~J'':'I';I:. =f.i![U;:J:;.O!M
Jj.,

[approved specifications] ,..:...g.~i" .'5:.c!::::a:-(*~.iE-t.'5, fl}~~, ~J![fl.a:-iiiftL., *Jt~L.t~'t.nl;ff~~tt.lt ~"""(/)~~~(/)~~f;:~i" ft.v'o .'5tk::li:~E;

~wt Jijt~1fCS:[DHR]I:.Jti!ffr;L..tt.lt:h,-;ft.lG

17

CPR Part 820 Rev.05

Subpart § 820.100 ;ft'l(l) (a) *~~~if(i,

J ~lE, Nt V7~7

~Y3Y

[Corrective and Preventive Action]

{fJ'j£, NtV7~7~Y3Y {~IE,

[Corrective and Preventive Action] -:

& V;-"IVj7 ~:"--3:";(J)~hill~::OOTQEFJlm:frfl{nL *f~}'1Lft'fttLl .. L-, itt

'0 :'O)-¥)IWH::liJ2lrO)*lnil~"£""i.:h:tl!;fft';tt'J.,

)ttrr".1'ot A[analyzing processes], ~{'F~[work operations]. ?B:~~,[concessionslll~1t ~1tt¥f.H~r,-fj--I::"A~C~, 'i5ffl, Jl&1~1' '&V~O){It!O)~-An~;O), ~il~, XI:t-'tO){It!O) r~~MO)JJj(129 ctJ:o$~[existing], & t1~fiEt'.f[potentiaJ]:a:-litli~To r:I1~7 --9W~::
0 ~

OO;bor.m~.§[problem]O)fIt~[reoccurring]O)~.!it -t-otcl!h, ~r~[statistica[

(2) i\,!~,

~,~tt~.g.f:t,

il-;OfJ:tvtffHI~

methodology]:a:-f*fflLtt'lttLlftt6tt~';

7"O-eA, & VJ1Il~:/AT A I.:. rnJl!J!:-t-o:tl'lRiiJJRlZ§ r.:.rnJToltllH~[invesligatingJ: (3) :tI'il~~, &. rJllr:lnwrl=l~~O):;q:~a-I!fj("t.:tIJ !.:~,~ftfl.t:lE,s: O-=tI!IJ7 !1:/3 ~O)Mll:=m:; (4) J::1tcO){~lE, &.lP-f-I$7 !1:/3~il~1fwrt:'~"J, 12f{j)H~*:fJik~!Wl~V·, '::fjJ!!Ht-~.-a:-&(~~
ttl- '':'co)~~iL

&.V"'{!J7'-V3~;

(5) 7ij1[~:g2:tLt;:I~'~~rJ>~MH-a:-~~lE, lP-f-[jlj-t .Qt;:_~ 1.:.£,~ttjJrt~, XI±,¥JIIJi0)~!l!0)~1jIL

s.

lklJ1iEfl:
(6)

~fl, '.WiJt\3,

s: t±1'i@!1!l!,ft:.R.ml-t o'Nlf¥QilI,~li~!M~f..O)~m:f*WiE, )Z'±~'&frJ>'tuiO)TIW

'7"*~:;)~r
'0

1.:.i.tt:&O).ff:a-flTormr~h:~§;n[disseminaled]~tLo,::,cO)f*~:
(7) fIt~~nt:,,\1~rr>9Jill'H.:.lM-li!llTotf~t$ll~, ~~lE, &ryTI;jJ7!1:"--3~[RJr,n,

O)pltlJik[managementeview)O)t:.l!h 1.:.1!I±lTO':c; r
(b)

;.foif::mAE:~tLt:'~'"(O)$!WJ,
Subpart K ~~,

lk

v-t0) $i!S:51Hi, )(~f~2:tLtt'tt:h(:fttGtt1;

.&:rF§!MiOJifm! [Labeling, and Packaging Control]

§ 820.120

~t~H.~OJ~~ [Device Labeling]

~~tfl~IUlS!WJ:':'""")1; .:p11~a-Ii1ILrrL, vc *ftl~Ltt'lttL~Ittt:;,tt1;0 \ integrity]. ~~[JabelsJli, illif9iJO)~f*[customary condilions)-C-nDI fil!fflWjH~tp'i~fI~Degible]il~~fiEfJ:

,*~~m;g-I:t,

(a) 1VFO)%~'~HLabel [processing], f*~,

I&f&~-, i'Ji2.~, & rJt;,JYt'Wrg·li,

J:?FfJAilIJ[printedJ~tL,ttlJilitLftJ.,'J:'(.:.HltGtL""(J., \ft'tttLl"itt't:;,tt'l(b) ~jf-:O)~1!t[Labeling inspection]. ~~DabelingJ~imJE2:.nt;:_;,i:n:.t~, WI~~[expirationdatel1fl~IHft:%,

IEL-l; \.:.HaccuracYM~~:=m:~no

'D
&:,~ttm..g-, flWJ

*1lr jJr~O)mff.;[storage
*-Z:'(i, f*1f[storage],

instructions]' I&flH.:.MT.Q:j:~.ff.:, X l:ti5t!JE(J)t:.fJ) l.:.lliJMreleased

"?

lk V~O){!hO).trn I f.:.IMIT.Qm3F[anyadditional processing instructions]~'@;"tr-, ~Jft\t~Jj{n-;

for use]~n -tutt ;tt Ir \0

til rl'i. [release) Ii, rHi, &.lP~:=m:[examination]~ff

t::=ti"O)!i-~

a-"'2i"].;., 12Hj~$:ftl~m:l~[DI-IR](':'X~{~Ltt'ttt.(·IttGft1;
(c) ~;;FO)Of/~f[Labeling storage]. ,*~~~*I-i,

'0
-,

~lJJl;:pm}IJL[identification],

m~a-~}jlJ:

To.t?iB!:wt~tLt;:JJ~*-c"~ff-[Jabeling]a-~11f[store]Ltt"ttL(:;ftt'Gt.i:1;

CFR Part 820 Rev.05

(d) *~1f-~[Labeling

operations].

*!W!m:~~I-;t,

*~C1)r!f:iRJ:a:-I):1jl1: TQJ:.~j:~iF, & V§~ \ *lM~.::t;:::::.y l-.

0

{t-~[Iabeling and packaging operations]:a:-1flmLtttttLftttc:,ttlt I:;J:r>;VTI;:f!ffl Lt::*~[!abel ftttc:,tJ:~ \

(e) *rmifi:~[Conlrol

:;..r, X

and labeling]I-;t, ~:Jjtiffi*IHillftC~[DI-IR]{-;:Jt:j!?fI:;LttlttL § 820.65 1;:J::"J1~J!Rit%C1)~~iI'I~,~tt~~~;:f:;J:, Ni·tc:,;h

'"("It \tt~tn'tttc:,ft~

number].

1lrJm*%

liVlfiffiWl rR9 9=J[through the distribution]~~ffiH*I;:

§ 820.130

'0

~~:mtf,f(7)-E!~ [Device Packaging] !!\l!~~~ Ii, 12H~#,U~:~0)§ V Hfi\lt::z YT-T - f;: -:>It ,'"(" f";J:, ii.!H7iJ ~, lk [processing], f*=i'f, J&:t&, liH}~c~[distribution]tp';:~~~$iI\~fl[alteration],

0) ~

f4 1:(7) jJn I

xl:t?f)-

V:~~.Q'::~Q)ttltJ:.?I;:f&~+, ft-fJ.\l: (·jnrttt GtJ:t'0 ' Ltt I Subpart L J&~It', § 820.140

ili1:1f , i~j23l5:, :& rJWft [Handling, Storage. Distribution,

and Installation]

J&ID:lt' [Handling] *!IW~~*fi, [~.fo(7)I&tlk tp ~;:ilUpL?f;J.-V:, ;f;fl:;[deterioralionl

::Z/?'~*-~9Y,

_x.J-;t

-t(7)fihC1)iMJ1I;:PJM~~:a:- &Iti"" '::c:iI~ftltJ:.5{-;:,f*ffiEi-o-¥JIlfia-~li \ ftlt'o § 820.150

L, *ltlfffL-ftttnftttG

tlf;rg [Storage] (a) ~OOl!li:~~ri, ~J1llc7)f~T.::r:.v7[storage

~~

areal &V:tI.itI[stock

room]~m:IPJ, Y;I.-V:, use], XI-;t~cj2/r1-C:'(7)r,m:: ~.g-:m-J'J:l, xfJ:%'fl:;l...t;:: ~lJ.JttA]':;1;7' 0-7-

~fl:;, ::Z/?'~*--Y3/, XI-;t-'tO)iih, t!~c7)f!1!J1l£'"('[pending f::j1JHi{:~~:a:-.& 1£-t::.ctMtv \J:5 I;:, .&Vlr:l P::!!Jb[obsoleteL !W.!~ilq!1!JtJ, XIJ:lJji!*~n.o::.~tNJ:It

\J:.? 1;:~.fJm-t.o~[llfi:a:-fl'f..rrL, ~j~~Ltt('tn!:ft~Gt~

It': U\'fl'ltl(7)£Ij&!i(;:f=¥v'[overtime], !Wrfi'rQ)rl'ht(iI~*Jf~To:tJjhg'Ii,

V9Yi"?6£ I;: L, -'to)~m.[its btL. -Cit \t~'t:h~tfJ:l?tJ:v -,

(b) *~~~~':;J:,

conditions]:a::-iiNW (;:;fem1[assessed]i""Q~ft[mannerM~~fil:t:

'(*1:f.::r:.v7, ,&Vi"nttn~bO)~A[receipt

from], &VAJIIL[dispatch

to]{r'

jf(~,i"".Q)j'$a-~il&Lt;::-¥Jlma-VffiftL, § 820.160

*i~Lf.t't;h(·"fttGftv\,

~l* [Distribution] (a) *!1Wl!li:~~'t;.t, 1~8bil~m~,2:ntdapproved

for releaseJI2H~.jj_~(7)J,l.1.I~~i!*'':I±Hif2:no 1iYI1ll;f,i""o[reviewedo ensure]t::.Ob(7), t

\0

=c:a:-1*~iEL., &V~fl1'lI1.I~ft[ambiguiLies], X,-;trd1~-?t::!W!J'llil'j.llirnr~:h.Q,::ca-*r.-!'il;:~Y!

Tot:.bbt;:,

i!.)'C.:[purchase

ordersJ.a:-~I*,

'lr~,

&

Vi§c~c7)-¥IIlf..!~ii1EftL, ;it~Ltt~tn'"ftt~t~v ,j:JlJ:lf(il~Q~r.ij(!)giil!Jl::

~~¥,lM:C1)f!l.!JfJ~'I1:.[fitness

for use],

:R

W~ \5t;fI::Totl.i.g.f:t,

1f5i"}JWI [IN WJ;h.O) iM,fJ:l [expired devices], X fi

19

CPR Part 820 Rev.05

f.'1!mJiW.:!:.n~~~fl.l~JJt~Mf.:t "([beyond

acceptable

···]~fr;Lt:.~JI-,nl:,

mcJi!H.::i.:It~tLQ':'c

(j)ftv \J: ?tt~llm-r:1W;:IDE fttt f;fttl?~'::o l...-tt

(b)

*~ll[~~a,

T~(j)*rjH:''@;t!\ ffii!~~~[distribution
consignee]OJa.qs,

recordsHd*1t[maintainl \:

:R~i

.:e-OJFfrl£lj}pJf7.J~*Ij.Q[rererto the 10cation]J:?'.::I....tt~ttLl;:fft~ttlt (1) :lfifJ]O)5!ft%[initial

s.V{tffl:
&V~:I:;

(2) tljfniLt.::12H.ilHI!l~0J,f'J:I~ [identlflcation], (3) (4)

I±lfnt 13; &. V

b L.3i)fl, l"i, .:e-0}{t!!0)'fJm?j: % c

§ 820.170
(a)

WHt [Installation] tJiSN:a:£:,JH::T.oI2H;lH~~O)*!mllilt~1f'i,

~~¥]I[intest

~WJttfmft,

& tJtti~[inspectionl
1?~~TQJ:?tt~w.ltt ~ti#l&itl}c-~

£;,J!;tt

:t,Iftr'j:,

procedureJO)m:;f;Dnstructions]'.:.IMl-tG¥IIIN~ffi'n'z:L,

tftWLttlttL

~itt~ttlt
m:;f;,

'0 Hr:;f;,

& a¥II~I::I'j:, WHtft: l.:.~U;Hj!M*iI~~I&l-tQjffi

It '0

fm{;fa-f*~T

Q.jj Igj [directions]iI~'2i*n,tl.I;UtStt

!i\':'H~m:~ Ii,

1':::'0)

B: a¥JI[fl~*f,t[distribute],

)(li~~a-mHiQ1f[person

installing]~¥~2.LtttttL~"i

ttGft~\
(b) ~1,U®~MNftQ~fi, ~ff~tLt.::::,ca-{*ifiEL, ftfttLf:ffJ:GtJ:1t

WHt, fpt1f,

s.V~,~tt~!jJoj~fW!~~~O}~ti;;r-,

lk T}=FJllft'.::~Jt-?"(

mft't7.JiifiJiWJ-e3i:>-?t;::,~a-:;f;T:ijt1lt,

&. -a~~O)~*~)c:SHtL-

'0
ilDil<
[Records]

Subpart M

§ 820.180

-~~~~.Ij{

[General Requirements] !M~1riiI~[manufacturing establishment].

*.-e~;:Jt~tL 0).1f:~[responsible

"(It 'Q~-rO)'IlcAAfi, officialsllk.

::'cO}-r:~

.omm[Iocation]

I::

establishment]

I:. ft ~'re f~ ~13" J;J., :. tL ~ 0) ~ f.id;):, FDA

m.~[deteriorationJa-fti/HficL-,

*~~

a FDA O)~~'§7i~ftr:a~I;:.rri?A{)[reasonably
[maintain] Ltt
0) Jn1UHFDA

)('i~~~#
accessible]

j·ttL fi'tt ~ttlr 'c. 1lt~ ~~j? JIti1:IDt[inspected

employeesJ]ji ~ J1.,

[readily available] 1'::W-}IW[review], :l1::c~-r:~.QJ:.? ~.::~tL"(1t \f~'t;h.r:ftt~ttlt :

'0 ':'O)J:?tt~~

Ii, ~J~ti6i1iJ~[IegibleJ-r:,
f~ft.n11t.i:~t~1t ~:fIJmTQ:ijj-*fi,

~*=Doss]~~}jll::.T{)J:.?'.::1*~L

'0 ~ lWJ'7'~?'-

·7"O-E':;.rV:'--;1'·:...- 7-:r ..b,[automated data processing system] 'tt'tn'1ft~ftlt

r~;)I:77:;.r7"t-J&-?"(v

'0
FDA 7.J~*$: Part 20
(J)

(a) :m~H~W[ConfidentialityJ. mJE';:J:.Q~f}~~T~~drr¥lln\,

!Jl!!@~;(f(.:.c-?"(W*cjffi3f)GoctlMi, =8n\O)~:a::~!l):Jlt

.o[to aid]t:.3b, fE~n:,3i)Q \§"t-~-:7TQ

.:.c7i~-r:~GQ
(b) ~~O)*~JI1lI~'[Record retention period]. *Iit-r:~*~nQ~"(O)ffc~'fi, life](.:..:m~TGWlrll', {ftC,

~~.m!$0)

IDt~Hdesign], lk.ljWI1~itmWlrl'l'[expected

~~~*iI~rtnl&'.::

f:!tLt.::[release Ior commercial distribution] S 7i\G1-~tt<ct2if-.£.I...t[no

case less thanWi~:~L

20

CFR Part 820 Rev.05

tttt;f1.-!ftt6ttlt '0 (c) {9iJ;;'[Exceplions].

*:q~Jj:,§ 820.20(c) ~*-:/j/H.::.J:.:sa~,*,

;:::J/"7~?7-,

§ 820.22 JlpWIf';;:j!L &.

V § 820.50(a){.::.J:o-iJ"?"7-{.y-, fi'(iDL~ht;:=F)I~(,:(j:~m~noo {:f~~To~,*-:/)/"I'::'~TOftf:~.A[an

&V;:::J/~Jv7/1'O)il¥{11Ii(.::.rnJi-o~** 'iJ), .:.nc;,O)*lJ{(':J:~m.:eE2;.ht::.. employee in management with executive

Jl~~'@' Tot::..l/)0)-lj-77-{ .y-~~¥!li!rlijjJfl2;httv

m~~.ht::.. FDA O)lfflH~l.O)~\}!)jt;6'30-?t=m.g.~':Ij:, fM-rJi

respcnslbllltvjtf , *~!.:Jg*~~1,t="V

*-~
-(It

j/l,O)n~lJt,

&. t}&Nl(~1tt, & V&:,~ttU!r~,

F-l

~77-{""-0)~~;6~~nm~n,
~V9/[corrective tt 0tt It'c § 820.181 ~~fm~"V.A7-ileii.i< *m:!i~Ji~*I±, ~~~H~$~A?t-tc.~[DMR]tJ~

)(ifft~.h

'o':'c, ~hlliO)

H, & V~ME~nt=f@:1E7

action]I':0v'-Cli,

Jtl'il:L -CO)IDEJ!J1.a:-mtl:l[certifY in writing]LtJ:lt.h~f

[Device Master Record:DMR]

~n.t~~"VA?t-[C~[DMRJ~1jjl;~Lttl·ttLlfft6ftv

'0 :a.!W.!ill1:~*fi,

*
X

§ 820.40 1':1Jt-?-CftJJX;~;h."iJ;:~~~.ht::..tO)l:lIbo,:,c:a-{*lIiEL

t,tlttlAftt6tt;v'o *7-{:10)~~~$"VA?1-~c.~[DMRJ('::'I±, 1'j:-tO)m:(£mmtJ~ilC~iHrefer]~n -Cit'ttlthAtttGtt;It';

w. rO)~$iJt'@;*tLQiJ~,

(a) iim.Jff.JftlZJffii[drawings], fiYtfflGpX;~[compositionl :m1J[formulationJ, ~~[component]m*,

&V~7"·9':x.7-mm.~~tr,
m~:a:--atr, (c) iff $!flj 1E (d)
(e)

~~.tI~m.m;

(b) iRli'lff.Jft~~[equipment]O)~ji~~, !l\(!~JJrt~[production methods]' !.M~=Flllit B: V!W~!1t~

m. $ [acceptance

~~7"p-eAm.m;

criteria}, lk V{!J!

m To

1111 it fjjl; ir:m~ ~ [quality assurance

equipment]~-@;tr, ,~'Mt{~jUE¥JI~,&am~;

~1ii!i1.Jr*, 7"p~ A~-@;t.~, §~[packagingl fJ;iiN, f~~, &a-lj--l::~A[servicingJO)¥II~,

&. V:~VF[Jabeling]m.m; &. V

&.a1.Jlp.o

§ 820.184 ~~.fI~Cl)lM~l¥.Iti3ii.i< [Device History Record: DRHJ *~~~*I'j:,

I{,'YT,
P-y

~nJm~~c.~[DHRJ~f*~(maintajn]Lf~lthr;ftt;Gt~It'D

*!l\(!~~~I±,

l-. X (-'j:.::I.'::''Y l'O)I~JJlH~IM·}H:ff.£~trCt?f<[DJ-IRM~, 12l~~$:-VA?t-fiC~[DMRl

-Clt'o':'c:a-*fiETo¥M~~ftL-,
l]J. r O)·tff¥l1il~~*.hotp,

s.V

*.O)~*$~I.:1Jt-?-c!t!~~nt=t(/)"(,~Q':'C:iJ~~~n ff.j~~Ltt,·t.fL'fftGf~It iJ~ijI

(a) (b)

m [refer]~h
!lY!~ 13 : ~ii~lft;

\. ~1tHI!JM~c.f~[Dl-IR]'':li,

3Vim:f:E~FJr

-C~'fttttLf'iftt:.ftlt ';

(c) mJtOCI±I.fI'l[releascd distdbution]~:I:; for

(d) ~ ~tm$7)~12f1i.H~~"V A7-fjE~[DMR] [acceptance records];

1.:1Jt-?-Cll!!~2;;f1.,t::..':'C:~~lEI9~ TQ..g.*

re~

eFR Part 820 Rev,05

(e) *~@:;:1.":::':;.tH;:~;if.;~ht.:.-Vz~{_J~Blf~Vj;:[prima.ry identiflcation label]; &V

(t) 12H~.mtf.f(7)~1,IIJ[identificationsL'&lffil!.ffi ~ht.:.'i'Jill:i=%[control number], § 820.186 &b~VA7 .b.~G~ [Quality System Record: QSR]

*!.W.!~~~I±,

JbW'lAT A~~[QSR]~1*1fLf.t'thl'ft.t~fl~
"'(I;

-, tfl:.~'lA7 AKCfid;:lt, 'Q-¥fi~, &. If)(it{t~!IllitJ~,

\])l,

12:f1Jt:ff\t.$Cf)::$'-1'71;:fnJc;,i"[not specific type], *1¥l-r:~~~;h, &. If § 820.40 l;:mJE~tLt:.re~])~-2;"'itL,

~tt""C" 'tlltnt:ftl~tll;

\0

*~~~~'i,

=tLi:";:IIN)J:~tLtlv

;)("·i.:t<7)ml'£~mtJ~~iI!\t
§ 820.40 (7)mJEI;:t1E

iib'l!t'i.AT Ar.c.~[QSRJil~,

"?-Cf'fp_X" *1irg~t1t:.bO)"(:,~Q'::'.!::~f*IDELtllt.tL'ttt~ttJ,.'o § 820.198 ti-m77-1' Iv [Complaint Files]

(a) *!Mit~*fi,

~~77-1'

Iv~f*~LttlttIA'fttGftv

;:1.;:::'":/ Hformally de signate d uni l]~;:: IJ J .htlf1tJ:Gtllt'

(l)

*tr~ ml [receivi nsl, n~ ~[rev iewing], .& V:~ filli-t ~~

-, '::'(7)-¥IiWi"(-'["±, rO):$!jil\f~il=iiE~ .t;I. (7-1'b.!J-fJ:f±JJ[mannerJI.:J:IJ!I:11Jm~.tL.!J'::'c: . &. v:

'0 *!W.!~~*ri, 1EtCl':tI!JE~tLt.:.

.!J[evaluating]-¥Jffi~·Pm3'lL, *1~PIfLtt:t;!1,';ft.t~t.t" : ~"'(O)*fj!fli, ~-~.tLtdunilorm],

(2) I=l jjJH;:J:Q~'l1f'i, (3) =&tITil\,

o)il~,

~ipl': --::>It '"'(iR:;Q:i""Qt.:.~)O)~if-{ITIi~rr?'::'t:c

*_

~f'ntu~n:)cJ:1r:i"".!J'::'c;

§ 803 "Medical Device Reporting"I.:.m;Q:~ht.:.FDA""""(7)¥Il*il~~,JF.tb

(b)

~!!\!~~1~'j-fi,

i::"'(O)=&'If:t,rl1l,~it[investigationJ~~,~cTQbO)])~,

~1.l~I':'--::>~,I!lt~L,

lM~~~'i, w.J1!i &1'~c:L t.:.J!l!F-I3, V.::.O)t:k:~~ft .. d.:j{{f::1lf~~",@;U, ffc.~t-f*11f LtJ:ttnrttJ:t:,tl" &. : '0
~if-1itil.ftlt:(Llitt~t.t1t 12f~m.~,~;if.;, \:'t:~';t1t~tl}.g-li,
(c)

'0 iYMit~q=r;bft~

Xfi~~tM.ii~'.:ii.g-Lttlt'

RJfi!gti~P-I~To=&i1H.:--::>v '-C Ii, mffl.

(7)*·~j!fI.:--::>"'-cft!.:1WrI1til~fr:btL, f!Hl~~Cf)~,~ilVtv\m..g..a-~~, iVlH!t~n:btll·tttt:,t.tJ..

(d)

ntr'*, iiffrffi, &. a

mJE~.tL

'0
r<:

*Ji[ § 803 t·.:.m.~~tLt::FDA

(7)~lIFs--a:L.f.t'tt1ltftl?ftl; *tff77-1' -, § 820.198(e)\.:.~J}t~n

'*iW 1.:.--::> f-;1 , Itvr

t.:1lfI.:.J:IJJaI~1.l~'':lIltr*, ~if-1iffi, .&. VIlhHEt-rrfJ:v', XI:tgJ:j II&tt [K5.lIJ~ IthltfJ:~f.tJ,. Ltt

(l)

IvO)1JIJ0)77-1'lvCTo1.l~,
-C" 'otN¥fW::1.JU;;t, ;;$:Jti:0)

£.l T O)*J.l~J.:t*oWM1t(7)1iE~1.I~'@j*ntlJJ:tt~fJ:J,.' :

12:f~:mt~tJ\m.ml.:.:;r:-a-~ -r:~0t.:ip, ~tp;

(2) ~~?<m$:1.1\¥&~, Xt"±~WrI.:.{5t!:ffl~tt-Ct,,'t:.tp, ~il~; (3) ¥ai!r~nt:::JJ.{7iJ[incident], [relationship]tJ~ibQ1.I~o (e) ;;$::rj I.:J:Q mlit iI~1T:btLt.:.m-g-lt, W.iH~tCf) !fc.fi/di;;$:rJi (a)I;:J:.IJlE.;r.t ,.:. m JE~ .tLt::;:1.'='r V -C:-f*WLfJ:l·ttLl"itt;tt"
(I) ~~m*~O)~f¢;

x l:t.$:[adverse

event]t: ~~~4ml;:

{ilJGtpCifany](7)FMI-fif-

'0 ::'(7)IDM~tc.j~H;:fi, W, r(l)*lfiz.?-;"*h.I·:ffl;tJ:It':

22

CFR Part 820 J~ev.05

(2) (3)

*fjlt(])~N U :

{!1!m ~nt;:l2S.~tt:I!.r.~O)liIiUJIJ, (Pi' JI1l.ffl!%[identilicnLion and control number]; .& (4) *·rpfmd!~~(])~~, trJi, &tWeLl:~m:%; { (5) *tjlfO);.t;:IUnature], B: V~U~1 ;
(6)

WM1EO)

F-l

{-t. &

tJ~*;

(7)
(8)

~1illi~ntd*:iE7 7~3/; &. V :;S:ffl~{.~it..--..O)[ill~.·,

unit]iOi, !lW~1iillIDHestablishment]~

(0 m:!~~.:g-il~IE~I.:.t~lEL..t;: ,*ffl~J!J!.::r..:::.v Hcomplaint [reasonably accesslblejzf (g)

r'j:£IJO)!jJjfr-r:itt;,Q~~..g.li, WIH:!if2:.tLt;: ~,tff, &. VFJ,~?i!tlfc!,gl~d'j:, ~~1ltlI~l:b-B-$F.r..H':'.A-¥

liJfiEf~.t?'.:.L..tt~tn'ittGftlt \ !Mit~;f1.l~IE~f.:.t~:Q:L..t::~~9!1Jill.::r..:::.:/I"-7.l~, *1~:9H.:.iiiJQgj}iHi.*lJ-r:~*2:.nQ

f.:.A;PRftret,tJ:?f.:.L..ft{thrftt6ttlt':
RJi
keptJ~nQ*OOI7'J(])mf£it!!.;

~~I'j: • .I;A T(!)v '~.ntPO)*mlI*!O)~f]f"C'.g.J!~n{_J

(1) !Wt~~~O)re~1.I\jEA;~;:{*~[regularly (2) iifJJO)m£iffi~*(jnitial

distributor]O)p]f1"£±ilio
[Servicing]

Subpart N ~~I::"A

§ 820.200

~-l:".'A [Servicing]

(a) -IT-I::·.A7.I~FJrtEO)~*~JP~([speciJied requirementJf.:.~*.nQ!J)}~f':"'j:,

*!W@:~~'·i~

~ 1::".A7.lim:G:(])~;:jtJln:JH':'1T~L..'"(~jj(ff2:n, ~ffiE~nQt::.YJ ,.:.. fr.~, lk V.f.IIIfi-t-fI1o'LL.., *IU1fL.ft~tt1ltftc:,ttlt '0

(b) 4t~~~1\f/-'j:,
(c)

§ 820.100 O)m:Q:(.:.1ttJ..', iOO'WJft~~'H¥J-¥¥~[statislical

technology]~m

It \

-c..Jt-I::~.A¥fl*[service reporlJ'5:)ttJi'[analyzeJLftttn(-;ft~c:,ttv

'0

*1;f

§ 803 1;:m.}E~:nt.:.FDA"--"O)¥Il1!r7.l~£:,~tt.ffIJ[event]'.:.tMlTQ~-I::'·A$IH!r~~ft

t::*~~m~Ij:,
(d) ..Jt-I::"A¥fl~I±,
(1) (2)

~ [9JatJf::~{i'rT""~~ti~.fM~L.., § 820.198 '.:.m.:Q::TQ~**rJH.:.1Jl:0

"( ~lID.[process]L..ttlthlit.i:Gttlt

'0

Jt.f~~h, W. I:-O)*Jj[-t-~*tl.ftttGttv': ~-I::' A '5:n'"? td2Hlf~$0)~ fip; f~ffl ~nt.:.~~W~O)mtlt5jIJ, s.a~m!flHHidentification and
EI ;

control number];

(3) ~-e·.A(!)~~f[

(4) ~-I::"A~M!i1\fO)Jl:45;
(5) ~jjfii:L-t.:.-lf-I::~.A(1)I*!?t¥; (6) ~D~,

&a

».a~jf7~::1-;
Subpart 0

t!ta-H~~r¥~[Statistical

Techniques]

§ 820.250

~~tl¥J-¥U? [Statistical Techniques] (a) ~.~ttm.g., *!M~~1f("i, 7"ot.7.(])1il§.i:J

[capability].

B: V~81J¥.ft1:[characteristicsJO)

23

CPR Part 820 Rev.05

WF$(~[irm[acceptabilityJ.a:-fl~l statistical technology ]t.ti'k-~T

sn.,

ljfJmL,

*,~;jif:t)t:.~ 1;:&:::, { ~t,n'fi!Jt~~U(~"J~rMvalid

Q=Flllftt.tIitli.li:L., *,lli}.T-Lt.t(t;h.I'ftJ:~tJ:J.. \,

(b) -if /7"!J / Y • 7'7 /;b~)fJ v \ ~;hQ~.g. Ii, Jt ilf[writtenJ ~ L, ~WJtJ:~~tl¥J:IID ~n1I[rationale] l;:iik--:5v \t.:tO)'"(·tJ:tt;h.ftt~6tJ:J.. liilil, *ft¥Jf LtJ:lt;h.fttJ: t,tJ:v

'0 ~!.t~~~~li,

-!f/7'V/:;1'jJ71iiMljg]i-g

El8~1:%t

Lii-;T.Jl."ib'?, ~J!1.I~ib":>f.::.m1fli, -if :..--7'V/7' .7'7:"--1.I~1I~1*~;h.{):,~.a:-(Jf-ijiE-tQ~IIIIi.-a:\0

:'(7)rlfi!llbfi, Jt.{~~:h.""Cv \tJ: ft:h.lttt GfJ:v '0