XYZ Company

ISO/IEC 17025 QUALITY MANUAL

Revision 1
Date: //01


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CONTROLLED CO!Y
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SAM!LE
Note: T(is sa)*#e )an&a# on#+ ,ontains *a"tia# te-t. t(e"e/o"e. t(e n&)0e"in1 is not
,onse,&tive2
XYZ COMPANY
ISO/IEC 17025 QUALITY MANUAL
REV. 1 ATE! XX/XX/XX "A#E 2 O$ 12
TA3LE O4 CONTENTS
Introduction.4
Quality Policy Statement. 5
1.0 Scope....................................................................................................................................6
2.0 References............................................................................................................................7
.0............................................................................................!erms and "efinitions
..................................................................................................................................7
4.0 #ana$ement Re%uirements...................................................................................................&
4.1 'r$ani(ation................................................................................................................&
4.2 Quality System..........................................................................................................11
4. "ocument )ontrol.....................................................................................................1
4.4 Re*ie+ of Re%uests, !enders, and )ontracts..........................................................1

4.5 Su-contractin$ of !ests and )ali-rations................................................................14
4.6 Purc.asin$ Ser*ices and Supplies...........................................................................15
4.7 Ser*ice to t.e )lient..................................................................................................16
4.& )omplaints................................................................................................................17
4./ )ontrol of 0onconformin$ !estin$ and1or )ali-ration 2or3....................................17
4.10 )orrecti*e 4ction.......................................................................................................1&
4.11 Pre*enti*e 4ction......................................................................................................1/
4.12 )ontrol of Records....................................................................................................1/
4.1 Internal 4udits...........................................................................................................1/
4.14 #ana$ement Re*ie+s...............................................................................................1/
XYZ COMPANY
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5.0 !ec.nical Re%uirements......................................................................................................20
5.1 !ec.nical Re%uirements 5 6eneral..........................................................................20
5.2 Personnel..................................................................................................................20
5. 4ccommodations and 7n*ironmental )onditions.....................................................21
5.4 !est and )ali-ration #et.ods and #et.od 8alidation.............................................2
5.5 7%uipment.................................................................................................................26
5.6 #easurement !racea-ility.........................................................................................2/
5.7 Samplin$....................................................................................................................41
5.& 9andlin$ and !ransportation of !est and1or )ali-ration Items................................51
5./ 4ssurin$ t.e Quality of !est and )ali-ration Results...............................................6
5.10 Reportin$ t.e Results...............................................................................................67
XYZ COMPANY
ISO/IEC 17025 QUALITY MANUAL
REV. 1 ATE! XX/XX/XX "A#E & O$ 12
INTRODUCTION
:;< )ompany reco$ni(es its responsi-ility as pro*ider of %uality ser*ices. !o t.is end,
:;< )ompany .as de*eloped and documented a %uality mana$ement system to -etter
satisfy t.e needs of its customers and to impro*e mana$ement of t.e company. !.e %uality
system complies +it. t.e international standard IS'1I7) 17025, 1/// and IS' /001=2000.
!.is manual .as -een prepared to define t.e %uality system, esta-lis. responsi-ilities of
t.e personnel affected -y t.e system, and to pro*ide $eneral procedures for all acti*ities
comprisin$ t.e %uality system. In addition, t.is manual is utili(ed for t.e purpose of
informin$ our customers of t.e %uality system, and +.at specific controls are implemented
to assure ser*ice %uality.
!.is manual +ill -e re*ised as necessary to reflect t.e %uality system currently in use. It is
issued on a controlled copy -asis to all internal functions affected -y t.e %uality system and
on an uncontrolled copy -asis to customers and suppliers> alt.ou$., it can -e issued to
customers on a controlled copy -asis upon customer re%uest.
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@0ameA, President
520 Mana1e)ent Re6&i"e)ents
521 O"1ani7ation an' Mana1e)ent
XYZ COMPANY
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4.1.1 :;< )ompany .olds le$al responsi-ility for its operation and is or$ani(ed to
operate in accordance +it. t.e re%uirements of IS'1I7) 17025, +.et.er
carryin$ out +or3 in its permanent facilities or on location, at customer sites.
4.1.2 :;< )ompany is not part of an or$ani(ation performin$ acti*ities ot.er t.an
testin$ and1or cali-ration> t.erefore, t.ere is no potential conflict of interest
amon$st its personnel.
!.e or$ani(ation of :;< )ompany is illustrated -elo+ in Bi$ure 1.
522 Q&a#it+ S+ste)
52221 Do,&)entation o/ t(e S+ste)
4.2.1.1 !.e Quality #anual is t.e principal document t.at defines t.e
%uality system at :;< )ompany.
4.2.1.2 Quality System Procedures are documented to esta-lis. and
maintain continuity of eac. acti*ity or function affectin$ %uality.
Quality procedures +ill -e readily a*aila-le to personnel for
reference and implementation. !.e %uality document structure
contains t.is Quality #anual, Quality Procedures, 2or3
Instructions, and Quality Records.
528 Q&a#it+ !o#i,+
4..1 :;< )ompany Quality Policy=
:;< )ompany +ill pro*ide our employees +it. ade%uate procedures to satisfy
standards accepta-le to most industrial entities. 2e +ill stri*e to impro*e t.e
%uality of our ser*ices at reduced cost and to constantly satisfy t.e
eCpectations of our customers and rele*ant a$encies.
!.e Senior #ana$ement and Staff of :;< )ompany also underta3e to ensure
t.at all acti*ities are conducted in strict accordance +it. company
documented procedures and comply +it. t.e re%uirements of t.e IS'1I7)
17025 Standard.
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525 Revie: o/ Re6&ests. Ten'e"s. an' Cont"a,ts
4.4.1 )ontract1order re*ie+ is an inte$ral part of t.e %uality system at :;<
)ompany. 4ll contracts1orders are re*ie+ed and accepted only if t.e
re%uirements are clear and understood, and t.e company .as t.e capa-ility
and capacity to assure full customer eCpectations.
4.4.2 Records of re*ie+s, includin$ any si$nificant c.an$es, are maintained.
4.4. )ommunications are maintained +it. t.e client from re%uest1%uote t.rou$.
commencement of +or3. !.is includes informin$ t.e client of any de*iation
from t.e contract.
4.4.4 !.e process for contract re*ie+ is furt.er defined in t.e )ontract Re*ie+
Procedure.
52; Cont"o# o/ Non,on/o")in1 Testin1 an'/o" Ca#i0"ation <o"=
4./.1 :;< )ompany .as esta-lis.ed and maintains a policy and procedures t.at
are implemented +.en any aspect of its testin$ and1or cali-ration +or3, or t.e
results of t.is +or3, do not conform to its o+n procedures or t.e a$reed
re%uirements of t.e client.
4./.2 !.e policy and procedures s.all ensure t.at nonconformin$ +or3 or pro-lems
t.at do not conform to re%uirements are identified and mana$ed, to pre*ent
unintended use or deli*ery. !.is procedure ensures t.at nonDconformin$
+or3 or pro-lems are corrected, +.ere applica-le, and su-Eect to *erification
after correction to demonstrate conformity. 2.ere re%uired -y t.e contract,
t.e proposed rectification of nonDconformin$ +or3 or pro-lems is reported for
concession to t.e customer, t.e end user, re$ulatory -ody, or ot.er
applica-le aut.ority.
4./. Identification of nonconformin$ +or3 or pro-lems +it. t.e %uality system or
+it. testin$ and1or cali-ration acti*ities can occur at *arious points +it.in t.e
%uality system, and tec.nical operations suc. as customer complaints, %uality
control, instrument cali-ration, c.ec3in$ of consuma-le materials, staff
o-ser*ations or super*ision, test report and cali-ration certificate c.ec3in$,
mana$ement re*ie+s, and internal or eCternal audits.
4./.4 2.ere t.e e*aluation indicates t.at t.e nonconformin$ +or3 could recur or
t.at t.ere is dou-t a-out t.e compliance of :;< )ompany operations +it. its
o+n policies and procedures, t.e correcti*e actions procedure s.all -e
follo+ed to identify t.e root cause@sA of t.e pro-lem and to eliminate t.is
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@t.eseA cause@sA.
4./.5 !.e process for nonconformin$ testin$ and1or cali-ration +or3 is furt.er
defined in t.e )ontrol of 0onconformin$ !estin$ or )ali-ration 2or3
Procedure.
520 Te,(ni,a# Re6&i"e)ents
521 Te,(ni,a# Re6&i"e)ents > ?ene"a#
5.1.1 :;< )ompany reco$ni(es t.at many factors determine t.e correctness and
relia-ility of t.e tests and1or cali-ration performed -y a la-oratory. !.ese
factors include contri-utions from= .uman factors @5.2A, accommodation and
en*ironmental conditions @5.A, test and cali-ration met.ods and met.od
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*alidation @5.4A, e%uipment @5.5A, measurement tracea-ility @5.6A, and .andlin$
of test and cali-ration items @5.&A.
5.1.2 !.e eCtent to +.ic. t.e factors contri-ute to t.e total uncertainty of
measurement differs considera-ly -et+een @types ofA tests and -et+een
@types ofA cali-rations. :;< )ompany ta3es into account t.ese factors in
de*elopin$ test and cali-ration met.ods and procedures, in t.e trainin$ and
%ualification of personnel, and in t.e selection and cali-ration of t.e
e%uipment it uses.
522 !e"sonne#
5.2.1 :;< )ompanyFs mana$ement ensures t.e competency of all +.o operate
specific e%uipment, +.o perform tests and1or cali-rations, e*aluate results
and si$n test reports and cali-ration certificates. 2.en usin$ staff t.at is
under$oin$ trainin$, ade%uate and appropriate super*ision is pro*ided.
Personnel performin$ specific tas3s are %ualified on t.e -asis of appropriate
education, trainin$, eCperience, and1or demonstrated s3ills, as re%uired.
52525 @a#i'ation o/ )et(o's
5.4.5.1 4ll standard and nonDstandard test met.ods and procedures are
*alidated to ensure t.at suc. met.ods and procedures are fit for t.eir
intended use and are rele*ant to t.e re%uirements of IS'1I7) 17025
)lause 5.4.5 as +ell as t.e client.
5.4.5.2 !.e results of suc. *alidation are recorded to$et.er +it. t.e procedure
utili(ed and any ot.er rele*ant information. !.e record states +.et.er
t.e met.od or procedure is fit for t.e intended use.
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5252A Un,e"taint+ o/ Res&#ts
5.4.6.1 !.e uncertainty of cali-ration results are calculated and documented in
accordance +it. t.e re%uirements of IS'1I7) 17025 )lause 5.4.6.
5.4.6.2 "ocumented procedures detail t.e met.ods used for estimatin$
uncertainty of measurement and include all uncertainty components,
+.ic. are of importance in t.e $i*en situation.
5.4.6. !.e data rele*ant to a particular test is presented on t.e test certificate
or test report.
5210 Re*o"tin1 t(e Res&#ts
)rossDreferences=
IS' 17025=1/// Section 5.10
IS' /001=2000 Section 7.1, 7.4., 7.5.1, 7.5.4, &.2.4
5.10.1 !.e results of eac. test, cali-ration, or series of tests or cali-rations carried
out -y t.e la-oratory are reported accurately, clearly, unam-i$uously, and
o-Eecti*ely, and in accordance +it. any specific instructions in t.e test or
cali-ration met.ods. !.e results are normally reported in a test report or a
cali-ration certificate and include all t.e information re%uested -y t.e client
and necessary for t.e interpretation of t.e test or cali-ration results, and all
information re%uired -y t.e met.od used. In t.e case of test or cali-rations
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performed for internal clients, or in t.e case of a +ritten a$reement +it. t.e
client, t.e results may -e reported in a simplified +ay and may not re%uire t.e
formali(ed cali-ration certificate, -ut all data @data t.at +ould -e on an actual
cali-ration certificate if one +ere to -e $eneratedA is readily a*aila-le and
3ept permanently on file
5.10.2 !est reports and cali-ration certificates
Gnless eCceptional reasons for not doin$ so eCist, eac. test report or
cali-ration certificate includes all t.e follo+in$ information as a minimum=
aA a title @e.$. H!est ReportH or H)ali-ration )ertificateHA>
-A name and address of la-oratory and location +.ere t.e tests and1or
cali-rations +ere carried out if different from t.e address of t.e
la-oratory>
cA uni%ue identification of t.e test report or cali-ration certificate @suc. as
serial num-erA and on eac. pa$e an identification in order to ensure
t.at t.e pa$e is reco$ni(ed as a part of t.e test report or cali-ration
certificate and a clear identification of t.e end of t.e test report or
cali-ration certificate>
dA name and address of t.e client placin$ t.e order>
eA identification of t.e met.od used>
fA description of, t.e condition of, and unam-i$uous identification of t.e
item@sA tested or cali-rated>
$A date of receipt of test or cali-ration item@sA and date@sA of performance
of t.e test or cali-ration +.ere rele*ant to t.e *alidity and application
of t.e results>
.A reference to samplin$ procedures used -y t.e la-oratory or ot.er
-odies +.ere t.ese are rele*ant to t.e *alidity or application of t.e
results
iA test or cali-ration results +it. units of measurement>
EA t.e name@sA, function@sA and si$nature@sA or e%ui*alent identification of
person@sA aut.ori(in$ t.e test report or cali-ration certificate>
3A +.ere rele*ant, a statement to t.e effect t.at t.e results relate only to
t.e items tested or cali-rated>
lA a statement specifyin$ t.at t.e test report or cali-ration certificate s.all
not -e reproduced, eCcept in full, +it.out +ritten appro*al of t.e
la-oratory>
mA pa$e num-er and total num-er of pa$es.
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