ANSUTSO 17025-1999

AMERICAN NATIONAL STANDARD

General requirements for the competence
of testing and calibration laboratories
AMERICAN SOCIETY FOR QUALITY
P.O. BOX 3005
MILWAUKEE, WISCONSIN 53201
-3005
ANSt / t SO 17025-1999
AM ERICAN NATIONAL STAN DARD
General requirements for the competence
of testing and calibration laboratories
Approved as a Ameri can Nati onal Standard by:
Ameri can Soci ety for Qual i ty
Ameri can Soci ety for Testi ng and Materi al s
NCSL I nt ernat i onal
An Ameri can Nati onal Standard Approved i n November, 2000
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Caution Notice:This American National Standard may be revised or withdrawn at any time. The procedures of
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@2002 by ASa
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Addi ti onal resources avai l abl e from ASQ Qual i ty Press:
Managing the Metrology System, Second Edition
C. Robert Pennel l a
A Laboratory Quality Handbook of Best Practices and Relevant Regulations
Donal d C. Si nger, ed.
Guidelines for Laboratory Quality Auditing
Donal d C. Si nger and Ronal d P. Upton
ANSI/ASOC M1-1996
-
ANS for Calibration Syslerns
The Desk Reference of Statistical Qualitv Methods
Mark L. Crossl ey
Statistical Procedures for machine and Process Qualification Third Edition
Edgar Di etri ch and Al fred Schul ze
Glossary and Tables for Statistical Quality Control, Third Edition
ASQ Stati sti cs Di vi si on
The Quality Toolbox
Nancy R. Tague
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ANSt/rSO 17025-1999
Contents
Page
4 Management r equi r ement s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4. 4 Revi ew of r equest s, t ender s and cont r act s. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4. 5 Subcont r act i ng of t est s and cal i br at i ons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4. 6 Pur chasi ng ser vi ces and suppl i es . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.9 Control of nonconformi ng testi ng and/or cal i brati on work ........... .................7
5. 3 Accommodat i on and envi r onment al condi t i ons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.4 Test and cal i brati on methods and method val i dati on ..............12
5. 8 Handl i ng of t est and cal i br at i on i t ems. . . . . . . . . . . . . . . . . . . 18
5. 9 Assur i ng t he qual i t y of t est and cal i br at i on r esul t s. . . . . . . . . . . . . . . . . . 19
Annex A ( i nf or mat i ve) Nomi nal cr oss- r ef er ences t o I SO 9001 : 1994 and I SO 9002: 1994. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Annex B (i nformati ve) Gui del i nes for establ i shi ng appl i cati ons for speci fi c fi e| ds........... ...........24
ANSI/|SO 1702$1999
Foreword
ISO (the Internati onal Organi zati on for Standardi zati on) and IEC (the Internati onal El ectrotechni cal Commi ssi on)
form the speci al i zed system for worl dwi de standardi zati on. Nati onal bodi es that are members of ISO or IEC
parti ci pate i n the devel opment of Internati onal Standards through techni cal commi ttees establ i shed by the
respecti ve organi zati on to deal wi th parti cul ar fi el ds of techni cal acti vi ty. ISO and IEC techni cal commi ttees
col l aborate i n fi el ds of mutual i nterest. Other i nternati onal organi zati ons, governmental and non-governmental , i n
l i ai son wi th ISO and l EC, al so take part i n the work.
l nternati onal Standards are drafted i n accordance wi th the rul es gi ven i n the ISO/l EC Di recti ves, Part 3.
Draft Internati onal Standards adopted by the techni cal commi ttees are ci rcul ated to member bodi es for voti ng.
Publ i cati on as an Internati onal Standard requi res approval by at l east 75 % of the member bodi es casti ng a vote.
Attenti on i s drawn to the possi bi l i ty that some of the el ements of thi s Internati onal Standard may be the subj ect of
patent ri ghts. ISO and IEC shal l not be hel d responsi bl e for i denti fyi ng any or al l such patent ri ghts.
l nternati onal Standard ISO/| EC 17025 was prepared by ISO/CASCO, Commi ttee on Conformi ty Assessment.
Thi s f i r st edi t i on of I SO/ I EC 17025 cancel s and r epl aces I SO/ I EC Gui de 25: 1990.
Annexes A and B of thi s Internati onal Standard are for i nformati on onl v.
VI
ANSr/ t SO 17025-1999
l ntroducti on
Thi s Internati onal Standard has been
produced
as the resul l of extensi ve experi ence i n the i mpl ementati on of
ISO/IEC Gui de 25 and EN 45001, both of whi ch i t now repl aces. l t contai ns al l of the requi rements that testi ng and
cal i brati on l aboratori es have to meet i f they wi sh to demonstrate that they operate a qual i ty system, are techni cal l y
competent, and are abl e to generate techni cal l y val i d resul ts.
Accredi tati on bodi es that recogni ze the competence of testi ng and cal i brati on l aboratori es shoul d use thi s
Internati onal Standard as the basi s for thei r accredi tati on. Cl ause 4 speci fi es the requi rements for sound
management. Cl ause 5 speci fi es the requi rements for techni cal competence for the type of tests and/or cal i brati ons
the l aboratory undertakes.
The growth i n use of qual i ty systems general l y has i ncreased the need to ensure that l aboratori es whi ch form part
of l arger organi zati ons or offer other servi ces can operate to a qual i ty system that i s seen as compl i ant wi th
ISO 9001 or ISO 9002 as wel l as wi th thi s Internati onal Standard. Care has been taken, therefore, to i ncorporate al l
those requi rements of ISO 9001 and ISO 9002 that are rel evant to the scope of testi ng and cal i brati on servi ces that
are covered by the l aboratory' s qual i ty system.
Testi ng and cal i brati on l aboratori es that compl y wi th thi s Internati onal Standard wi l l therefore al so operate i n
accordance wi th ISO 9001 or ISO 9002.
Certi fi cati on agai nst ISO 9001 and ISO 9002 does not of i tsel f demonstrate the competence of the l aboratory to
produce techni cal l y val i d data and resul ts.
The acceptance of testi ng and cal i brati on resul ts between countri es shoul d be faci l i tated i f l aboratori es compl y wi th
thi s Internati onal Standard and i f they obtai n accredi tati on from bodi es whi ch have entered i nto mutual recogni ti on
agreements wi th equi val ent bodi es i n other countri es usi ng thi s Internati onal Standard.
The use of thi s Internati onal Standard wi l l faci l i tate cooperati on between l aboratori es and other bodi es, and assi st
i n the exchange of i nformati on and experi ence, and i n the harmoni zati on of standards and procedures.
vi i
NATI ONAL STANDARD ANSr/ rSO 17025-1999
General requi rements for the competence of testi ng and
cal i bration I aboratories
Scope
1.1 Thi s Internati onal Standard speci fi es the general requi rements forthe competence to carry out tests and/or
cal i brati ons, i ncl udi ng sampl i ng. l t covers testi ng and cal i brati on performed usi ng standard methods, non-standard
methods, and l aboratory-devel oped methods.
1.2 Thi s l nternati onal Standard i s appl i cabl e to al l organi zati ons performi ng tests and/or cal i brati ons. These
i ncl ude, for exampl e, fi rst-, second- and thi rd-party l aboratori es, and l aboratori es where testi ng and/or cal i brati on
forms part of i nspecti on and product certi fi cati on.
Thi s Internati onal Standard i s appl i cabl e to al l l aboratori es regardl ess of the number of personnel or the extent of
the scope of testi ng and/or cal i brati on acti vi ti es. When a l aboratory does not undertake one or more of the acti vi ti es
covered by thi s Internati onal Standard, such as sampl i ng and the desi gn/devel opment of new methods, the
requi rements of those cl auses do not appl y.
1.3 The notes gi ven provi de cl ari fi cati on of the text, exampl es and gui dance. They do not contai n requi rements
and do not form an i ntegral part of thi s Internati onal Standard.
1.4 Thi s Internati onal Standard i s for use by l aboratori es i n devel opi ng thei r qual i ty, admi ni strati ve and techni cal
systems that govern thei r operati ons. Laboratory cl i ents, regul atory authori ti es and accredi tati on bodi es may al so
use i t i n confi rmi ng or recogni zi ng the competence of l aboratori es.
1.5 Compl i ance wi th regul atory and safety requi rements on the operati on of l aboratori es i s not covered by thi s
l nternati onal Standard.
1.6 l f testi ng and cal i brati on l aboratori es compl y wi th the requi rements of thi s Internati onal Standard they wi l l
operate a qual i ty system for thei r testi ng and cal i brati on acti vi ti es that al so meets the requi rements of ISO 9001
when they engage i n the desi gn/devel opment of new methods, and/or devel op test programmes combi ni ng
standard and non-standard test and cal i brati on methods, and ISO 9002 when they onl y use standard methods.
Annex A
provi des
nomi nal cross-references between thi s Internati onal Standard and ISO900 1 and ISO9002.
ISO/l EC 17025 covers several techni cal competence requi rements that are not covered by ISO 9001 and
rso 9002.
NOTE 1 lt might be necessary to explain or inlerpret certain requirements in this International Standard to ensure that the
requi rement s are appl i ed i n a consi st ent manner. Gui dance f or est abl i shi ng appl i cat i ons f or speci f i c f i el ds, especi al l y f or
accredi t at i on bodi es (see I SO/ I EC Gui de 58: 1993. 4. 1. 3) i s gi ven i n annex B.
NOTE 2 lf a laboratory wishes accreditation for part or all of its testing and calibration aclivities, it should select an
accredi t at i on body t hat operal es i n accordance wi t h I SO/ l EC Gui de 58.
2 Normative references
The fol l owi ng normati ve documents contai n provi si ons whi ch, through reference i n thi s text, consti tute provi si ons of
thi s Internati onal Standard. For dated references, subsequent amendments to, or revi si ons of, any of these
publ i cati ons do not appl y. However, parti es to agreements based on thi s Internati onal Standard are encouraged to
i nvesti gate the possi bi l i ty of appl yi ng the most recent edi ti ons of the normati ve documents i ndi cated bel ow. For
ANSUTSO 1702s-1999
undated references, the l atest edi ti on of the normati ve document referred to appl i es. Members of ISO and IEC
mai ntai n regi sters of currentl y val i d Internati onal Standards.
ISO 9001 :1994, Quality systems
-
Model for quality assurance in design, development, production, installation
and servicing.
ISO 9002:1994, Quality systems
-
Model for quality assurance in production, installation and servicing.
ISO/lEC Guide 2, General terms and their definitions concerning standardization and related activities.
Vl M, Internati onal vocabul ary of basi c and general terms i n metrol ogy, i ssued by BIPM, l EC, IFCC, l SO, IUPAC,
I UPAP and OI ML.
NOTE 1 Further rel ated standards, gui des, etc. on subj ects i ncl uded i n thi s Internati onal Standard are grven i n the
bi bl i ography.
NOTE2 l t shoul d be noted that when thi s Internati onal Standard was bei ng devel oped, the revi si ons ol ISO900 1 and
ISO 9002 were anti ci pated to be publ i shed i n l al e 2000 as a merged ISO 9001 :2000. Thi s i s no l onger the case.
3 Terms and def i ni t i ons
For t he pur poses of t hi s I nt er nat i onal St andar d, t he r el evant t er ms and def i ni t i ons gi ven i n I SO/ l ECGui de2 and
VI M appl y.
NOTE General def i ni t i ons rel at ed t o qual i t y are gi ven i n I SO 8402, whereas l SOi l EC Gui de 2 gi ves def i ni t i ons speci f i cal l y
rel al ed t o st andardi zat i on, cert i f i cat t on and l aboral ory accredi t at i on. Where di f f erent def i ni t i ons are gi ven i n I SO 8402, t he
del i ni t i ons i n I SO/ I EC Gui de 2 and VI M are oref erred.
4 Management requi rement s
4. 1 Organi zat i on
4. 1. 1 The l abor at or y or t he or gani zat i on of whi ch i l i s par t shal l be an ent i t y t hat can be hel d l egal l y r esponsi bl e.
4.1.2 l t i s the responsi bi l i ty of the l aboratory to carry out i ts testi ng and cal i brati on acti vi ti es i n such a way as to
meet the requi rements of thi s Internati onal Standard and to sati sfy the needs of the cl i ent, the regul atory authori ti es
or organi zati ons provi di ng recogni ti on.
4.1.3 The l aboratory management system shal l cover work carri ed out i n the l aboratory' s permanent faci l i ti es, at
si tes away from i ts permanenl faci l i ti es, or i n associ ated temporary or mobi l e faci l i ti es.
4.1.4 l f the l aboratory i s part of an organi zati on performi ng acti vi ti es other than testi ng and/or cal i brati on, the
responsi bi l i ti es of key personnel i n the organi zati on that have an i nvol vement or i nfl uence on the testi ng and/or
cal i brati on acti vi ti es of the l aboratory shal l be defi ned i n order to i denti fy potenti al confl i cts of i nterest.
NOTE 1 Where a l aboratory i s part of a l arger organi zati on, the organi zati onal arrangements shoul d be such that
departments havi ng confl i cti ng i nterests, such as producti on, commerci al marketi ng or fi nanci ng do not adversel y i nfl uence the
l aboratory' s compl i ance wi th the requi rements of thi s Internati onal Standard.
NOTE 2 l f the l aboratory wi shes to be recogni zed as a thi rd-party l aboratory, i t shoul d be abl e to demonstrate that i t i s
i mparti al and that i t and i ts personnel are free l rom any undue commerci al , fi nanci al and other pressures whi ch mi ght i nfl uence
thei r techni cal j udgement. The thi rd-party testi ng or cal i brati on l aboratory shoul d not engage i n any acti vi ti es that may endanger
the trust i n i ts i ndependence oJ j udgement and i ntegri ty i n rel ati on to i ts testi ng or cal i brati on acti vi ti es.
ANSt / t SO 17025-1999
4. 1. 5 The l abor at or y shal l
a) have manageri al and techni cal personnel wi th the authori ty and resources needed to carry out thei r duti es and
to i denti fy the occurrence of departures from the qual i ty system or from the procedures for performi ng tests
and/or cal i brati ons, and to i ni ti ate acti ons to prevent or mi ni mi ze such departures (see al so 5.2);
b) have arrangements to ensure that i ts management and personnel are free from any undue i nternal and
external commerci al , fi nanci al and other pressures and i nfl uences that may adversel y affect the qual i ty of thei r
WOTK;
c) have pol i ci es and procedures to ensure the protecti on of i ts cl i ents' confi denti al i nformati on and propri etary
ri ghts, i ncl udi ng procedures for protecti ng the el ectroni c storage and transmi ssi on of resul ts;
d) have pol i ci es and procedures to avoi d i nvol vement i n any acti vi ti es that woul d di mi ni sh confi dence i n i ts
competence, i mparti al i ty, j udgement
or operati onal i ntegri ty;
e) defi ne the organi zati on and management sl ructure of the l aboratory, i ts pl ace i n any parent organi zati on, and
the rel ati onshi ps between qual i ty management, techni cal operati ons and support servi ces;
f) speci fy the responsi bi l i ty, authori ty and i nterrel ati onshi ps of al l personnel who manage, perform or veri fy work
affecti ng the qual i ty of the tests and/or cal i brati ons;
S)
provi de adequate supervi si on of testi ng and cal i brati on staff, i ncl udi ng trai nees, by persons fami l i ar wi th
methods and procedures, purpose of each test and/or cal i brati on, and wi th the assessment of the test or
cal i brati on resul ts;
h) have t echni cal management whi ch has over al l r esponsi bi l i t y f or t he t echni cal oper at i ons and t he pr ovi si on of
the resources needed to ensure the requi red qual i ty of l aboratory operati ons;
i ) appoi nt a member of staff as qual i ty manager (however named) who, i rrespecti ve of other duti es and
responsi bi l i ti es, shal l have defi ned responsi bi l i ty and authori ty for ensuri ng that the qual i ty system i s
i mpl emented and fol l owed at al l ti mes; the qual i ty manager shal l have di rect access to the hi ghest l evel of
management at whi ch deci si ons are made on l aboratory pol i cy or resources,
j ) appoi nt deput i es f or key manager i al per sonnel ( see not e) .
NOTE Indi vi dual s may have more than one l uncti on and i t may be i mpracti cal to appoi nt deputi es for every functi on.
4.2 Quality system
4.2.1 The l aboratory shal l establ i sh, i mpl ement and mai ntai n a qual i ty system appropri ate to the scope of i ts
acti vi ti es. The l aboratory shal l document i ts pol i ci es, systems, programmes, procedures and i nstructi ons to the
extent necessary to assure the qual i ty of the test and/or cal i brati on resul ts. The system' s documentati on shal l be
communi cat ed t o, under st ood by, avai l abl e t o, and i mpl ement ed by t he appr opr i at e per sonnel .
4.2.2 The l aboratory' s qual i ty system pol i ci es and obj ecti ves shal l be defi ned i n a qual i ty manual (however
named). The overal l obj ecti ves shal l be documented i n a qual i ty pol i cy statement. The qual i ty pol i cy statement shal l
be i ssued under the authori ty of the chi ef executi ve. l t shal l i ncl ude at l east the fol l owi ng:
a) the l aboratory management' s commi tment to good professi onal practi ce and to the qual i ty of i ts testi ng and
cal i brati on i n servi ci ng i ts cl i ents;
b) the management' s statement of the l aboratory' s standard of servi ce;
c) the obj ecti ves of the qual i ty system;
d) a requi rement that al l personnel concerned wi th testi ng and cal i brati on acti vi ti es wi thi n the l aboratory
f ami l i ar i ze t hemsel ves wi t h t he qual i t y document at i on and i mpl ement t he pol i ci es and pr ocedur es i n t hei r wor k;
ano
ANSUTSO 17025-1999
e) the l aboratory management' s commi tment to compl i ance wi th thi s Internati onal Standard.
NOTE The qual i ty pol i cy statement shoul d be conci se and may i ncl ude the requi rement that tests and/or cal i brati ons shal l
al ways be carrred out i n accordance wi th stated methods and cl i ents' requi rements. When the test and/or cal i brati on l aboratory
i s part of a l arger organi zati on, some qual i ty pol i cy el ements may be i n other documents.
4.2.3 The qual i ty manual shal l i ncl ude or make reference to the supporl i ng procedures i ncl udi ng techni cal
procedures. l t shal l outl i ne the structure of the documentati on used i n the qual i ty system.
4.2.4 The rol es and responsi bi l i ti es of techni cal management and the qual i ty manager, i ncl udi ng thei r
r esponsi bi l i t y f or ensur i ng compl i ance wi t h t hi s I nt er nat i onal St andar d, shal l be def i ned i n t he qual i t y manual .
4.3 Document control
4.3.1 General
The l aboratory shal l establ i sh and mai ntai n procedures to control al l documents that form part of i ts qual i ty system
(i nternal l y generated or from external sources), such as regul ati ons, standards, other normati ve documents, test
andl or cal i brati on methods, as wel l as drawi ngs, software, speci fi cati ons, i nstructi ons and manual s.
NOTE 1 In thi s context
"document"
coul d be pol i cy statements, procedures, speci fi cati ons, cal i brati on tabl es, charts, text
books, posters, noti ces, memoranda, software, drawi ngs, pl ans, etc. These may be on vari ous medi a, whether hard copy or
el ectroni c, and they may be di gi tal , anal og, photographi c or wri tten.
NOTE 2 The control of data rel ated to testi no and cal i brati on i s covered i n5.4.7. The control of records i s covered i n4.12.
4.3.2 Document approval and i ssue
4.3.2.' l Al l documents i ssued to personnel i n the l aboratory as part of the qual i ty system shal l be revi ewed and
approved for use by aul hori zed personnel pri or to i ssue. A master l i st or an equi val ent document control procedure
i denti fyi ng the current revi si on status and di stri buti on of documents i n the qual i ty system shal l be establ i shed and
be readi l y avai l abl e to precl ude the use of i nval i d and/or obsol ete documenl s.
4. 3. 2. 2 The pr ocedur e( s) adopt ed shal l ensur e t hat :
a) authori zed edi ti ons of appropri ate documents are avai l abl e at al l l ocati ons where operati ons essenti al to the
effecti ve functi oni ng of the l aboratory are performed;
b) documents are peri odi cal l y revi ewed and, where necessary, revi sed to ensure conti nui ng sui tabi l i ty and
compl i ance wi t h appl i cabl e r equi r ement s;
c) i nval i d or obsol ete documents are promptl y removed from al l poi nts of i ssue or use, or otherwi se assured
agai nst uni ntended use;
d) obsol ete documents retai ned for ei ther l egal or knowl edge preservati on purposes are sui tabl y marked.
4.3.2.3 Qual i ty system documents generated by the l aboratory shal l be uni quel y i denti fi ed. Such i denti fi cati on
shal l i ncl ude the date of i ssue and/or revi si on i denti fi cati on, page numberi ng, the total number of pages or a mark
t o si gni f y t he end of t he document , and t he i ssui ng aut hor i t y( i es) .
4.3.3 Document changes
4.3.3.1 Changes to documents shal l be revi ewed and approved by the same functi on that performed the
ori gi nal revi ew unl ess speci fi cal l y desi gnated otherwi se. The desi gnated personnel shal l have access to perti nent
background i nformati on upon whi ch to base thei r revi ew and approval .
4.3.3.2 Where practi cabl e, the al tered or new text shal l be i denti fi ed i n the document or the appropri ate
attachments.
ANSt / l SO 17025-1999
4.3.3.3 l f the l aboratory' s documentati on control system al l ows for the amendment of documents by hand
pendi ng t he r e- i ssue of t he document s, t he pr ocedur es and aut hor i t i es f or such amendment s shal l be def i ned.
Amendments shal l be cl earl v marked, i ni ti al l ed and dated. A revi sed document shal l be formal l y re-i ssued as soon
as practi cabl e.
4.3.3.4 Procedures shal l be establ i shed to descri be how changes i n documents mai ntai ned i n computeri zed
systems are made and control l ed.
4.4 Review of requests, tenders and contracts
4.4.1 The l aboratory shal l establ i sh and mai ntai n procedures for the revi ew of requests, tenders and contracts.
The pol i ci es and procedures for these revi ews l eadi ng to a contract for testi ng and/or cal i brati on shal l ensure that:
a) the requi rements, i ncl udi ng the methods to be used, are adequatel y defi ned, documented and understood (see
5. 4. 2) ;
b) the l aboratory has the capabi l i ty and resources to meet the requi rements,
c) the appropri ate test and/or cal i brati on method i s sel ected and capabl e of meeti ng the cl i ents' requi rements
( see
5. 4. 2) .
Any di fferences between the request or tender and the contract shal l be resol ved before any work commences.
Each contract shal l be acceptabl e both to the l aboratory and the cl i ent.
NOTE 1 The request, tender and contract revi ew shoul d be conducted i n a practi cal and effi ci ent manner, and the effect ol
fi nanci al , l egal and ti me schedul e aspects shoul d be taken i nto account. For i nternal cl i ents, revi ews of requests, tenders and
contracts can be
performed i n a si mpl i fi ed wav.
NOTE 2 The revi ew of capabi l i ty shoul d establ i sh that the l aboratory possesses the necessary physi cal , personnel and
i nformati on resources, and that the l aboratory' s personnel have the ski l l s and experti se necessary for the performance of the
tests and/or cal i brati ons i n questi on. The revi ew may al so encompass resul ts of earl i er parti ci pati on i n i nterl aboratory
compari sons or profi ci ency testi ng and/or the runni ng ol tri al test or cal i brati on programmes usi ng sampl es or i tems of known
val ue i n order to determi ne uncertai nti es of measurement, l i mi ts oJ detecti on, conJi dence l i mi ts, etc.
NOTE 3 A contract may be any wri tten or oral agreement to provi de a cl i ent wi th testi ng and/or cal i brati on servi ces.
4.4.2 Records of revi ews, i ncl udi ng any si gni fi cant changes, shal l be mai ntai ned. Records shal l al so be
mai ntai ned of
perti nent di scussi ons wi th a cl i ent rel ati ng to the cl i ent' s requi rements or the resul ts of the work
duri ng the peri od of executi on of the contract.
NOTE For revi ew oJ routi ne and other si mpl e tasks, the date and the i denti fi cati on (e.9. the i ni ti al s) of the person i n the
l aboratory responsi bl e for carryi ng out the contracted work are consi dered adequate. For repeti ti ve routi ne tasks, the revl ew
need be made onl y at the i ni ti al enqui ry stage or on granti ng of the contract for on-goi ng routi ne work performed under a general
agreement wi th the ci l ent, provi ded that the cl i ent' s requi rements remai n unchanged. For new, compl ex or advanced testi ng
and/or cal i brati on tasks, a more comprehensi ve record shoul d be mai ntai ned.
4.4.3 The revi ew shal l al so cover any work that i s subcontracted by the l aboratory.
4.4.4 The cl i ent shal l be i nformed of anv devi ati on from the contract.
4.4.5 l f a contract needs to be amended after work has commenced, the same contract revi ew process shal l be
repeated and any amendments shal l be communi cated to al l affected personnel .
4.5 Subcontracting of tests and calibrations
4.5.1 When a l aboratory subcontracts work whether because of unforeseen reasons (e.9. workl oad, need for
further expeni se or temporary i ncapaci ty) or on a conti nui ng basi s (e.9. through permanent subcontracti ng, agency
or franchi si ng arrangements), thi s work shal l be pl aced wi th a competent subcontractor. A compel ent subcontractor
i s one that, for exampl e, compl i es wi th thi s Internati onal Standard for the work i n questi on.
ANSUISO 1702s-1999
4.5.2 The l aboratory shal l advi se the cl i ent of the arrangement i n wri ti ng and, when appropri ate, gai n the
approval of the cl i ent, preferabl y i n wri ti ng.
4.5.3 The l aboratory i s responsi bl e to the cl i ent for the subcontractor' s work, except i n the case where the cl i ent
or a regul atory authori ty speci fi es whi ch subcontractor i s to be used.
4.5.4 The l aboratory shal l mai ntai n a regi ster of al l subcontractors that i t uses for tests and/or cal i brati ons and a
record of the evi dence of compl i ance wi th thi s Inl ernati onal Standard for the work i n questi on.
4.6 Purchasing services and supplies
4.6.1 The l aboratory shal l have a pol i cy and procedure(s) for the sel ecti on and purchasi ng of servi ces and
suppl i es i t uses that affect the qual i ty of the tests and/or cal i brati ons. Procedures shal l exi st for the purchase,
recepti on and storage of reagents and l aboratory consumabl e materi al s rel evant for the tests and cal i brati ons.
4.6.2 The l aboratory shal l ensure that purchased suppl i es and reagenl s and consumabl e materi al s that affect the
qual i ty of tests and/or cal i brati ons are not used unti l they have been i nspected or otherwi se veri fi ed as compl yi ng
wi th standard speci fi cati ons or requi rements defi ned i n the methods for the tests and/or cal i brati ons concerned.
These servi ces and suppl i es used shal l compl y wi th speci fi ed requi rements. Records of acti ons taken to check
compl i ance shal l be mai nt ai ned.
4.6.3 Purchasi ng documents for i tems affecti ng the qual i ty of l aboratory output shal l contai n data descri bi ng the
servi ces and suppl i es ordered. These purchasi ng documents shal l be revi ewed and approved for techni cal content
pri or to rel ease.
NOTE The descri pti on may i ncl ude type, cl ass, grade, preci se i denti {i cati on, speci fi cati ons, drawi ngs, i nspecti on
i nstructi ons, other techni cal data i ncl udi ng approval of test resul ts, the qual i ty requi red and the qual i ty system standard under
whi ch t hey wer e made.
4.6.4 The l aboratory shal l eval uate suppl i ers of cri ti cal consumabl es, suppl i es and servi ces whi ch affect the
qual i ty of testi ng and cal i brati on, and shal l mai ntai n records of these eval uati ons and l i st those approved.
4.7 Servi ce to the cl i ent
The l aboratory shal l afford cl i ents or thei r represental i ves cooperati on to cl ari fy the cl i ent' s request and to moni tor
the l aboratory' s performance i n rel ati on to the work performed, provi ded that the l aboratory ensures confi denti al i ty
t o ot her cl i ent s.
NOTE 1 Such cooperati on may i ncl ude:
a) provi di ng the cl i ent or the cl i ent' s representati ve reasonabl e access to rel evant areas of the l aboratory for the wi tnessi ng of
tests and/or cal i brati ons performed for the cl i ent;
b) preparati on, packagi ng, and di spatch of test and/or cal i brati on i tems needed by the cl i ent for veri fi cati on purposes.
NOTE 2 Cl i ents val ue the mai ntenance of good communi cati on, advi ce and gui dance i n techni cal matters, and opi ni ons and
i nterpretati ons based on resul ts. Communi cati on wi th the cl i ent, especi al l y i n l arge assi gnments, shoul d be mai ntai ned
throughout the work. The l aboratory shoul d i nl orm the cl i ent of any del ays or maj or devi ati ons i n the performance of the tests
and/or cal i brati ons.
NOTE 3 Laboratori es are encouraged to obtai n other feedback, both posi ti ve and negati ve, l rom thei r cl i ents (e.9. cl i ent
surveys). The feedback shoul d be used to i mprove the qual i ty system, testi ng and cal i brati on acti vi ti es and cl i ent servi ce.
4. 8 Compl ai nt s
The l aboratory shal l have a pol i cy and procedure for the resol uti on of compl ai nts recei ved from cl i ents or other
parti es. Records shal l be mai ntai ned of al l compl ai nts and of the i nvesti gati ons and correcti ve acti ons taken by the
l aboratory (see al so 4.10).
ANSt / t SO 17025-1999
4.9 Control of nonconformi ng testi ng and/or cal i brati on work
4.9.1 The l aboratory shal l have a pol i cy and procedures that shal l be i mpl emented when any aspect of i ts testi ng
and/or cal i brati on work, or the resul ts of thi s work, do not conform to i ts own procedures or the agreed
requi rements of the cl i ent. The pol i cy and procedures shal l ensure that:
a) the responsi bi l i ti es and authori ti es for the management of nonconformi ng work are desi gnated and acti ons
(i ncl udi ng hal ti ng of work and wi thhol di ng of test reports and cal i brati on certi fi cates, as necessary) are defi ned
and taken when nonconformi ng work i s i denti fi ed;
b) an eval uati on of the si gni fi cance of the nonconformi ng work i s made;
c) correcti ve acti ons are taken i mmedi atel y, together wi th any deci si on about the acceptabi l i ty of the
nonconf or mi ng wor k;
d) where necessary, the cl i ent i s noti fi ed and work i s recal l ed;
e) the responsi bi l i ty for authori zi ng the resumpti on of work i s defi ned.
NOTE l denti fi cati on of nonconformi ng work or probl ems wi th the qual i ty system or wi th testi ng and/or cal i brati on acti vi ti es
can occur at vari ous pl aces wi thi n the qual i ty system and techni cal operati ons. Exampl es are customer compl ai nts, qual i ty
control , i nstrument cal i brati on, checki ng of consumabl e materi al s, staff observati ons or supervi si on, test report and cal i brati on
certi fi cate checki ng, management revi ews and i nternal or external audi ts.
4.9.2 Where the eval uati on i ndi cates that the nonconformi ng work coul d recur or that there i s doubt about the
compl i ance of the l aboratory' s operati ons wi th i ts own pol i ci es and procedures, the correcti ve acti on procedures
gi ven i n 4. 10 shal l be pr ompt l y f ol l owed.
4.10 Corrective action
4. 10. 1 Gener al
The l aboratory shal l establ i sh a pol i cy and procedure and shal l desi gnate appropri ate authori ti es for i mpl ementi ng
correcti ve acti on when nonconformi ng work or departures from the pol i ci es and procedures i n the qual i ty system or
techni cal operati ons have been i denti fi ed.
NOTE A probl em wi th the qual i ty system or wi th the techni cal operati ons of the l aboratory may be i denti fi ed through a
vari ety of acti vi ti es, such as control of nonconformi ng work, rnternal or external audi ts, management revi ews, feedback from
clients or stafJ observations.
4.10.2 Cause anal ysi s
The procedure for correcti ve acti on shal l start wi th an i nvesti gati on to determi ne the root cause(s) of the probl em.
NOTE Cause anal ysi s i s the key and someti mes the most di ffi cul t part i n the correcti ve acti on procedure. Often the root
cause i s not obvi ous and thus a careful anal ysi s of al l potenti al causes o1 the probl em i s requi red. Potenti al causes coul d
i ncl ude cl i ent requi rements, the sampl es, sampl e speci fi cati ons, methods and procedures, staff ski l l s and trai ni ng, consumabl es,
or equi pment and i ts cal i brati on.
4.10.3 Sel ecti on and i mpl ementati on of correcti ve acti ons
Where correcti ve acti on i s needed, the l aboratory shal l i denti fy potenti al correcti ve acti ons. l t shal l sel ect and
i mpl ement the acti on(s) most l i kel y to el i mi nate the probl em and to prevent recurrence.
Correcti ve acti ons shal l be to a degree appropri ate to the magni tude and the ri sk of the probl em.
The l aboratory shal l document and i mpl ement any requi red changes resul ti ng from correcti ve acti on i nvesti gati ons.
ANSyI SO 17025-1999
4.10.4 Moni tori ng of correcti ve acti ons
The l aboratory shal l moni tor the resul ts to ensure that the correcti ve acti ons taken have been effecti ve.
4.10.5 Addi ti onal audi ts
Where the i denti fi cati on of nonconformances or departures casts doubts on the l aboratory' s compl i ance wi th i ts
own pol i ci es and procedures, or on i ts compl i ance wi th thi s Internati onal Standard, the l aboratory shal l ensure that
the appropri ate areas of acti vi ty are audi ted i n accordance wi th 4.1 3 as soon as possi bl e.
NOTE Such addi ti onal audi ts often fol l ow the i mpl ementati on of the correcti ve acti ons to conJi rm thel r effecti veness. An
addi ti onal audi t shoul d be necessary onl y when a seri ous i ssue or ri sk to the busi ness i s i denti fi ed.
4.11 Preventive action
4.11.1 Needed i mprovements and potenti al sources of nonconformances, ei ther techni cal or concerni ng the
qual i ty system, shal l be i denti fi ed. l f preventi ve acti on i s requi red, acti on pl ans shal l be devel oped, i mpl emented
and moni tored to reduce the l i kel i hood of the occurrence of such nonconformances and to take advantage of the
opportuni ti es for i mprovement.
4.11.2 Procedures for preventi ve
acti ons shal l i ncl ude the i ni ti ati on of such acti ons and appl i cati on of control s to
ensure that they are effecti ve.
NOTE 1 Preventi ve acti on i s a pro-acti ve process to i denti fy opportuni ti es for i mprovement rather than a reacti on to the
i denti fi cati on of probl ems or compl ai nts.
NOTE 2 Apart from the revi ew of the operati onal procedures, l he preventi ve acti on mi ght i nvol ve anal ysi s of data, i ncl udi ng
trend and ri sk anal yses and proti ci ency{esti ng resul ts.
4.12 Control of records
4. 12. 1 Gener al
4.12.' 1.' l The l aboratory shal l establ i sh and mai ntai n procedures for i denti fi cati on, col l ecti on, i ndexi ng, access,
fi l i ng, storage, mai ntenance and di sposal of qual i ty and techni cal records. Qual i ty records shal l i ncl ude reports from
i nternal audi ts and management revi ews as wel l as records of correcti ve and preventi ve acti ons.
4.12.1.2 Al l records shal l be l egi bl e and shal l be sl ored and retai ned i n such a way that they are readi l y
retri evabl e i n faci l i ti es that provi de a sui tabl e envi ronment to prevent damage or deteri orati on and to prevent l oss.
Retenti on ti mes of records shal l be establ i shed.
NOTE Records may be i n any medi a, such as hard copy or el ectroni c medi a.
4. 12. 1. 3 Al l r ecor ds shal l be hel d secur e and i n conf i dence.
4.12.1.4 The l aboratory shal l have procedures to protect and back-up records stored el ectroni cal l y and to
prevent unauthori zed access to or amendment of these records.
4.12.2 T echnical records
4.12.2.1 The l aboratory shal l retai n records of ori gi nal observati ons, deri ved data and suffi ci ent i nformati on to
establ i sh an audi t trai l , cal i brati on records, staff records and a copy of each test repoft or cal i brati on certi fi cate
i ssued. for a defi ned
peri od.
The records for each test or cal i brati on shal l contai n suffi ci ent i nformati on to faci l i tate,
i f possi bl e, i denti fi cati on of factors affecti ng the uncertai nty and to enabl e the test or cal i brati on to be repeated
under condi ti ons as cl ose as possi bl e to the ori gi nal . The records shal l i ncl ude the i denti ty of personnel responsi bl e
for the sampl i ng, performance of each test and/or cal i brati on and checki ng of resul ts.
NOTE 1 In certai n fi el ds i t may be i mpossi bl e or i mpracti cal to retai n records of al l ori gi nal observati ons.
ANSt / t SO 17025-1999
NOTE 2 Techni cal records are accumul ati ons of data (see 5.4.7) and i nformati on whi ch resul t l rom carryi ng out l ests and/or
cal i brati ons and whi ch i ndi cate whether speci l i ed qual i ty or process parameters are achi eved. They may i ncl ude forms,
contracts, work sheets, work books, check sheets, work notes, control graphs, external and i nternal test reports and cal i brati on
certi fi cates. cl i ents' notes. oapers and feedback.
4.12.2.2 Observati ons, data and cal cul ati ons shal l be recorded at the ti me they are made and shal l be
i denti fi abl e to the speci fi c task.
4.12.2.3 When mi stakes occur i n records, each mi stake shal l be crossed out, not erased, made i l l egi bl e or
del eted, and the correct val ue entered al ongsi de. Al l such al terati ons to records shal l be si gned or i ni ti al l ed by the
person maki ng the correcti on. In the case of records stored el ectroni cal l y, equi val ent measures shal l be taken to
avoi d l oss or change of ori gi nal data.
4. 13 l nt ernal audi t s
4.13.1 The l aboratory shal l peri odi cal l y, and i n accordance wi th a predetermi ned schedul e and procedure,
conduct i nternal audi ts of i ts acti vi ti es to veri fy that i ts operati ons conti nue to compl y wi th the requi rements of the
qual i ty system and thi s Internati onal Standard. The i nternal audi t programme shal l address al l el ements of the
quafi ty system, i ncl udi ng the testi ng andl or cal i brati on acti vi ti es. l t i s the responsi bi l i ty of the qual i ty manager to
pl an and organi ze audi ts as requi red by the schedul e and requested by management. Such audi ts shal l be carri ed
out by trai ned and qual i fi ed personnel who are, wherever resources permi t, i ndependent of the acti vi ty to be
audi t ed.
NOTE The cycl e for i nternal audi ti ng shoul d normal l y be compl eted i n one year.
4.13.2 When audi t fi ndi ngs cast doubt on the effecti veness of the operati ons or on the correcl ness or val i di ty of
the l aboratory' s test or cal i brati on resul ts. the l aboratory shal l take ti mel y correcti ve acti on, and shal l noti fy cl i ents i n
wri ti ng i f i nvesti gati ons show that the l aboratory resul ts may have been affected.
4.13.3 The area of acti vi tv audi ted. the audi t fi ndi nqs and correcti ve acti ons that ari se from them shal l be
recorded.
4.13.4 Fol l ow-up audi t acti vi ti es shal l veri fy and record l he i mpl ementati on and efl ecti veness of the correcti ve
acti on taken.
4.14 Management revi ews
4.14.1 In accordance wi th a predetermi ned schedul e and procedure, the l aboratory' s executi ve management shal l
peri odi cal l y conduct a revi ew of the l aboratory' s qual i ty system and testi ng andl or cal i brati on acti vi ti es to ensure
thei r conti nui ng sui tabi l i ty and effecti veness, and to i ntroduce necessary changes or i mprovements. The revi ew
shal l take account of:
the sui tabi l i ty of pol i ci es and procedures;
reports from manageri al and supervi sory personnel ;
the outcome of recent i nternal audi ts;
correcti ve and
preventi ve acti ons;
assessments by external bodi es;
the resul ts of i nterl aboratory compari sons or profi ci ency tests;
changes i n the vol ume and type of the work;
cl i ent feedback:
9
ANSmSO 17025-1999
comol ai nts:
other rel evant factors, such as qual i ty control acti vi ti es, resources and staff trai ni ng'
NOTE 1 A typi cal peri od for conducti ng a management revl ew i s once every I2 months.
NOTE 2 Resul ts shoul d feed i nto the l aboratory pl anni ng system and shoul d i ncl ude the goal s, obj ecti ves and acti on pl ans
f or the comi ng year.
NOTE 3 A management revi ew rncl udes consi derati on of rel ated subj ects at regul ar management meeti ngs
4.14.2 Fi ndi ngs from management revi ews and the acti ons that ari se from them shal l be recorded' The
management shal l ensure that those acti ons are carri ed out wi thi n an appropri ate and agreed ti mescal e.
5 Techni cal r equi r ement s
5. 1 General
5.1.1 Many factors determi ne the correctness and rel i abi l i ty of the tests and/or cal i brati ons
performed by a
l aboratory. These factors i ncl ude contri buti ons f rom:
-
human f act or s ( 5. 2) ;
accommodal i on and envi r onment al condi t i ons ( 5. 3) ;
t est and cal i br at i on met hods and met hod val i dat i on ( 5. 4) ;
equi pment ( 5. 5) ;
measur ement t r aceabi l i t Y ( 5. 6)
;
sampl i ng ( 5. 7) ;
t he handl i ng of t est and cal i br at i on i t ems ( 5. 8) .
5.,1.2 The extent fo whi ch the factors contri bute to the total uncertai nty of measurement di ffers consi derabl y
between (types of) tests and between (types of) cal i brati ons. The l aboratory shal l take account of these factors i n
devel opi ng t est anct cal i br at i on met hods' and
pr ocedur es, i n t he t r ai ni ng and qual i f i cat i on of per sonnel , and i n t he
sel ecti on and cal i brati on of the equi pment i t uses.
5.2 Personnel
5.2.1 The l aboratory management shal l ensure the competence of al l who operate speci fi c equi pment, perform
tests and/or cal i brati ons, eval uate resul ts, and si gn test reports and cal i brati on certi fi cates. When usi ng staff who
are undergoi ng trai ni ng, appropri ate supervi si onl hal l be provi ded. Personnel
performi ng speci fi c tasks shal l be
qual i fi ed on tne Oasi s oi appropri ate educati on, trai ni ng, experi ence and/or demonstrated ski l l s' as requi red'
NOTE 1 In some techni cal areas (e.g. non-destructi ve testi ng) i t may be requi red that the personnel performi ng certai n tasks
hol d personnel certi fi cati on. The l aboratory i s responsrbte foi futfi tti ng speci fi ed personnel certi fi cati on requi rements. The
reoui rements Jor
personnel certi fi cati on mi ght be regul atory, i ncl uded i n the standards for the speci fi c techni cal l i el d, or requi red
by the cl i ent.
NOTE 2 The personnel responsi bl e for the opi ni ons and i nterpretati on i ncl uded i n test reports shoul d, i n addi ti on to the
appropri ate qual i fi cati ons, trai ni ng, experi ence and sati sfactory knowl edge of the testi ng carri ed out' al so have:
rel evant knowl edge of the technol ogy used for the manufacturi ng of the i tems, materi al s, products, etc. tested, or the way
they are used or i ntended to be used, and of the del ects or degradati ons whi ch may occur duri ng or i n servrce;
1 0
I
ANSt/tSO 17025-1999
knowl edge of the general requi rements expressed i n the l egi sl ati on and standards, and
an understandi ng of the si gni l i cance of devi ati ons found wi th regard to the normal use of the i tems, materi al s, products'
etc. concerned.
5.2.2 The management of the l aboratory shal l formul ate the goal s wi th respect to the educati on, trai ni ng and
ski l l s of the l aboratory personnel . The l aboratory shal l have a pol i cy and procedures for i denti fyi ng trai ni ng needs
and provi di ng trai ni ng of personnel . The trai ni ng programme shal l be rel evant to the present and anti ci pated tasks
of the l aboratory.
5.2.3 The l aboratory shal l use personnel who are empl oyed by, or under contract to, the l aboratory. Where
contracted and addi ti onal techni cal and key supporl personnel are used, the l aboratory shal l ensure that such
personnel are supervi sed and competent and that they work i n accordance wi th the l aboratory' s qual i ty system.
5.2.4 The l aboratory shal l mai ntai n current
j ob descri pti ons for manageri al , techni cal and key support personnel
i nvol ved i n tests and/or cal i brati ons.
NOTE Job descri pti ons can be deJi ned i n many ways. As a mi ni mum, the l ol l owi ng shoul d be defi ned:
the responsi bi l i ti es wi th respect to performi ng tests and/or cal i brati ons;
the responsi bi l i ti es wi th respect to the pl anni ng of tests and/or cal i brati ons and eval uati on ol resul ts;
-
the responsi bi l i ti es for reporti ng opi ni ons and i nterpretati ons;
the responsi bi l i ti es wi th respect to method modi fi cati on and devel opment and val i dati on of new methods;
experti se and experi ence requi red,
qual i fi cati ons and trai ni ng programmes;
manageri al duti es.
5.2.S The management shal l authori ze speci fi c personnel to perform padi cul ar types of sampl i ng, test and/or
cal i brati on, to i ssue test reports and cal i brati on cerl i fi cates, to gi ve opi ni ons and i nterpretati ons and to operate
parl i cul ar types of equi pment. The l aboratory shal l mai ntai n records of the rel evant authori zati on(s), competence,
educat i onai and pr of essi onal qual i f i cat i ons, t r ai ni ng, ski l l s and exper i ence of al l t echni cal per sonnel , i ncl udi ng
contracted personnel . Thi s i nformati on shal l be readi l y avai l abl e and shal l i ncl ude the date on whi ch authori zati on
and/or comoetence i s confi rmed.
5. 3 Accommodat i on and envi r onment al condi t i ons
5.3.1 Laboratory faci l i ti es for testi ng and/or cal i brati on, i ncl udi ng but not l i mi ted to energy sources, l i ghti ng and
envi ronmental condi ti ons, shal l be such as to faci l i tate correct performance of the tests and/or cal i brati ons.
The l aboratory shal l ensure that the envi ronmental condi ti ons do not i nval i date the resul ts or adversel y affect the
requi red qual i ty of any measurement. Parti cul ar care shal l be taken when sampl i ng and tests and/or cal i brati ons
are undertaken at si tes other than a permanent l aboratory faci l i ty. The techni cal requi rements for accommodati on
and envi ronmental condi ti ons that can affect the resul ts of tests and cal i brati ons shal l be documented.
5.3.2 The l aboratory shal l moni tor, control and record envi ronmental condi ti ons as requi red by the rel evant
speci fi cati ons, methods and procedures or where they i nfl uence the qual i ty of the resul ts. Due attenti on shal l be
pai d, for exampl e, to bi ol ogi cal steri l i ty, dust, el ectromagneti c di sturbances, radi ati on, humi di ty, el ectri cal suppl y,
temperature, and sound and vi brati on l evel s, as appropri ate to the techni cal acti vi ti es concerned. Tests and
cal i brati ons shal l be stopped when the envi ronmental condi ti ons
j eopardi ze the resul ts of the tests and/or
cal i br at i ons.
5.3.3 There shal l be effecti ve separati on between nei ghbouri ng areas i n whi ch there are i ncompati bl e acti vi ti es.
Measures shal l be taken to prevent cross-contami nati on.
S.3.4 Access to and use of areas affecti ng the qual i ty of the tests and/or cal i brati ons shal l be control l ed. The
l aboratorv shal l determi ne the extent of control based on i ts parti cul ar ci rcumstances.
1 1
ANSUTSO 1702s-1999
5.3.5 Measures shal l be taken to ensure good housekeepi ng i n the l aboratory. Speci al procedures
shal l be
prepared where necessary.
5.4 Test and cal i brati on methods and method val i dati on
5.4.1 General
The l aboratory shal l use appropri ate methods and procedures for al l tests and/or cal i brati ons wi thi n i ts scooe.
These i ncl ude sampl i ng, handl i ng, transport, storage and preparati on of i tems to be tested and/or cal i brated, and.
where appropri ate, an esti mati on of the measurement uncertai nty as wel l as stati sti cal techni ques for anal ysi s of
test and/or cal i brati on data.
The l aboratory shal l have i nstructi ons on the use and operati on of al l rel evant equi pment, and on the handl i ng and
preparati on of i tems for testi ng and/or cal i brati on, or both, where the absence of such i nstructi ons coul d j eopardi ze
the resul ts of tests andl or cal i brati ons. Al l i nstructi ons, standards, manual s and reference data rel evant to the work
of the l aboratory shal l be kept up to date and shal l be made readi l y avai l abl e to personnel (see 4.3). Devi ati on f rom
test and cal i brati on methods shal l occur onl y i f the devi ati on has been documented, techni cal l y j usti fi ed,
authori zed,
and accepted by the cl i ent.
NOTE Internati onal , regi onal or nati onal standards or other recogni zed speci fi cati ons that contai n suffi ci ent and conci se
l nformati on on how to perform the tests and/or cal i brati ons do not need to be suppl emented or rewri tten as i nternal procedures i f
these standards are wri tten i n a way that they can be used as publ i shed by the operati ng staff i n a l aboratory. l t may be
necessary to provi de addi ti onal documentati on for optronal steps i n the method or addi ti onal detai l s.
5.4.2 Sel ecti on of methods
The l aboratory shal l use test andl or cal i brati on methods, i ncl udi ng methods for sampl i ng, whi ch meet the needs of
the cl i ent and whi ch are appropri ate for the tests and/or cal i brati ons i t undertakes. Methods oubl i shed i n
i nternati onal , regi onal or nati onal standards shal l preferabl y
be used. The l aboratory shal l ensure that i t uses the
l atest val i d edi ti on of a standard unl ess i t i s not appropri ate or possi bl e
to do so. When necessarv, the standard
shal l be suppl emented wi th addi ti onal detai l s to ensure consi stent appl i cati on.
When the cl i ent does not speci fy the method to be used, the l aboratory shal l sel ect appropri ate methods that have
been publ i shed ei ther i n i nternati onal , regi onal or nati onal standards, or by reputabl e techni cal organi zati ons, or i n
rel evant sci enti fi c texts or j ournal s,
or as speci fi ed by the manufacturer of the equi pment. Laboratory-devel oped
methods or methods adopted by the l aboratory may al so be used i f they are appropri ate for the i ntended use and i f
they are val i dated. The cl i ent shal l be i nformed as to the method chosen. The l aboratory shal l confi rm that i t can
properl y operate standard methods before i ntroduci ng the tests or cal i brati ons. l f the standard method changes, the
confi rmati on shal l be repeated.
The l aboratory shal l i nform the cl i ent when the method proposed by the cl i ent i s consi dered to be i nappropri ate or
out of date.
5.4.3 Laboratory-devel oped methods
The i ntroductl on of test and cal i brati on methods devel oped by the l aboratory for i ts own use shal l be a pl anned
acti vi ty and shal l be assi gned to qual i fi ed personnel equi pped wi th adequate resources.
Pl ans shal l be updated as devel opment proceeds and effecti ve communi cati on amongst al l personnel i nvol ved
shal l be ensur ed.
5.4.4 Non-standardmethods
When i t i s necessary to use methods not covered by standard methods, these shal l be subj ect to agreement wi th
the cl i ent and shal l i ncl ude a cl ear speci fi cati on of the cl i ent' s requi rements and the purpose of the test and/or
cal i brati on. The method devel oped shal l have been val i dated appropri atel y before use.
1 2
ANSt/tSO 17025-1999
NOTE For new t est and/ or cal i brat i on met hods, procedures shoul d be devel oped pri or t o t he t est s and/ or cal i brat i ons bei ng
pert ormed
and shoul d cont ai n at l east t he f ol l owi ng i nf ormat t on:
a) appropri at ei dent i f i cat i on;
b) scope;
c) descri pt i on of t he t ype ol i t em t o be t est ed or cal i brat ed;
d) paramet ers or quant i t i es and ranges t o be det ermi ned;
e) apparat us and equi pment , i ncl udi ng t echni cal perf ormance requi rement s;
f ) ref erence st andards and ref erence mat eri al s requi red;
S)
envi ronment al condi t i ons requi red and any st abi l i zat i on peri od needed;
h) descri pt i on of t he procedure, i ncl udi ng
af f i xi ng of i dent i f i cat i on marks, handl i ng, t ransport i ng, st ori ng and preparat i on of i t ems,
checks t o be made bef ore t he work i s st art ed,
checks t hat t he equi pment i s worki ng properl y and, where requi red, cal i brat i on and adj ust ment oJ t he equi pment
beJore each use,
t he met hod of recordi ng t he observat i ons and resul t s,
any saf et y measures t o be observed;
r) cri t eri a and/ or requrrement s f or approval / rej ect i on;
j )
dat a t o be recorded and met hod of anal ysi s and present at i on;
k) t he uncert ai nt y or t he procedure Jor est i mat i ng uncert ai nt y
5. 4. 5 Val i dat i on of met hods
5. 4. 5. 1 Val i dat i on i s t he conf i rmat i on by exami nat i on and t he provi si on of obj ect i ve evi dence t hat t he part i cul ar
requi rement s f or a speci f i c i nt ended use are f ul f i l l ed.
5. 4. 5. 2 The l aborat ory shal l val i dat e non-st andard met hods, l aborat ory-desi gned/ devel oped
met hods,
st andard met hods used out si de t hei r i nt ended scope, and ampl i f i cat i ons and modi f i cat i ons of st andard met hods t o
conf i rm t hat t he met hods are f i t f or t he i nt ended use. The val i dat i on shal l be as ext ensi ve as i s necessary t o meet
t he needs of t he gi ven appl i cat i on or f i el d of appl i cat i on. The l aborat ory shal l record t he resul t s obt ai ned, t he
orocedure used f or t he val i dat i on, and a st at ement as t o whet her t he met hod i s f i t f or t he i nt ended use'
NOTE 1 Val i dat i on may i ncl ude procedures f or sampl i ng, handl i ng and t ransport at i on.
NOTE 2 The t echni ques used f or t he det ermi nat i on o1 t he perf ormance of a met hod shoul d be one of , or a combi nat i on of .
t he f ol l owi ng:
cal i brat i on usi ng ref erence st andards or rel erence mat eri al s;
compari son of resul t s achi eved wi t h ot her met hods;
i nt erl aborat ory compart sons;
syst emat i c assessment of t he f act ors i nf l uenci ng t he resul t ;
assessment of t he uncert ai nt y of t he resul t s based on sci ent i f i c underst andi ng of t he t heoret i cal pri nci pl es ol t he met hod
and pract i cal experi ence.
NOTE 3 When some changes are made i n t he val i dat ed non-st andard met hods, t he i nf l uence of such changes shoul d be
document ed and, i f appropri at e, a new val i dat i on shoul d be carri ed out .
5. 4. 5. 3 The range and accuracy of t he val ues obt ai nabl e f rom val i dat ed met hods (e. 9. t he uncert ai nt y of t he
resul t s, det ect i on l i mi t , sel ect i vi t y of t he met hod, l i neari t y, l i mi t of repeat abi l i t y and/ or reproduci bi l i t y, robust ness
agai nst ext ernal i nf l uences and/ or cross-sensi t i vi t y agai nst i nt erf erence f rom t he mat ri x of t he sampl e/ t est obj ect )'
as assessed f or t he i nt ended use, shal l be rel evant t o t he cl i ent s' needs'
1 3
ANSI/l SO 17025-1999
NOTE 1 Val i dat i on i ncl udes speci t i cat i on of t he requi rement s, det ermi nat i on of t he charact eri st i cs of t he met hods, a check
t hat t he requi rement s can be t ul t i l l ed by usi ng t he met hod, and a st at ement on t he val i di t y.
NOTE 2 As met hod-devel opment proceeds, regul ar revi ew shoul d be carri ed out t o veri f y t hat t he needs of t he cl i ent are st i l l
bei ng t ul f i l l ed. Any change i n requi rement s requi ri ng modi f rcat i ons t o t he devel opment pl an shoul d be approved and aut hori zed.
NOTE 3 Val i dat i on i s al ways a bal ance bet ween cost s, ri sks and t echni cal possi bi l i t i es. There are many cases i n whi ch t he
range and uncert ai nt y of t he val ues (e. 9. accuracy, det ect i on l i mi t , sel ect i vi t y, l i neari t y, repeat abi l i t y, reproduci bi l i t y, robust ness
and cross-sensi t i vi t y) can onl y be gi ven i n a si mpl i f i ed way due t o l ack of i nl ormat i on.
5.4.6 Esti mati on of uncertai nty of measurement
5.4.6.1 A cal i brati on l aboratory, or a testi ng l aboratory performi ng i ts own cal i brati ons, shal l have and shal l
appl y a procedure to esti mate the uncertai nty of measurement for al l cal i brati ons and types of cal i brati ons.
5.4.6.2 Testi ng l aboratori es shal l have and shal l appl y procedures for esti mati ng uncertai nty of measurement.
In certai n cases the nature of the test method may precl ude ri gorous, metrol ogi cal l y and stati sti cal l y val i d,
cal cul ati on of uncertai nty of measurement. In these cases the l aboratory shal l at l east attempt to i denti fy al l the
components of uncertai nty and make a reasonabl e esti mati on, and shal l ensure that the form of reporti ng of the
resul t does not gi ve a wrong i mpressi on of the uncertai nty. Reasonabl e esti mati on shal l be based on knowl edge of
the performance of the method and on the measurement scope and shal l make use of, for exampl e, previ ous
experi ence and val i dati on data.
NOTE 1 The degree of ri gor needed i n an esti mati on of uncertai nty of measurement depends on factors such as:
the requi rements of the test method;
the requi rements of the cl i ent;
the exi stence of narrow l i mi ts on whi ch deci si ons on conl ormance to a speci fi cati on are based.
NOTE 2 In those cases where a wel l -recogni zed test method speci fi es l i mi ts to the val ues of the maj or sources of uncertai nty
of measurement and speci fi es the form of presentati on of cal cul al ed resul ts, the l aboratory i s consi dered to have sati sfi ed thi s
cl ause by fol l owi ng the test method and reporti ng i nstructi ons (see 5.10).
5.4.6.3 When esti mati ng the uncertai nty of measurement, al l uncertai nty components whi ch are of i mportance
i n the gi ven si tuati on shal l be taken i nto accounl usi ng appropri ate methods of anal ysi s.
NOTE 1 Sources contri buti ng to the uncertai nty i ncl ude, but are not necessari l y l i mi ted to, the reference standards and
reterence materi al s used, methods and equi pment used, envi ronmental condi ti ons, properti es and condi ti on of the i tem bei ng
tesl ed or cal i brated, and the operator.
NOTE 2 The predi cted l ong-term behavi our of the tested and/or cal i brated i tem i s not normal l y taken i nto account when
esti mati ng the measurement uncertai nty.
NOTE 3 For further i nformati on, see ISO 5725 and the Gui de to the Expressi on of Uncertai ntv i n Measurement
(see
bi bl i ography).
5.4.7 Control of data
5.4.7.1 Cal cul ati ons and data transfers shal l be subj ect to appropri ate checks i n a systemati c manner.
5.4.7.2 When computers or automated equi pment are used for the acqui si ti on, processi ng, recordi ng,
repodi ng, storage or retri eval of test or cal i brati on data, the l aboratory shal l ensure that:
a) computer software devel oped by the user i s documented i n suffi ci ent detai l and i s sui tabl y val i dated as bei ng
adequate for use;
b) procedures are establ i shed and i mpl emented for protecti ng the data; such procedures shal l i ncl ude, but not be
l i mi ted to, i ntegri ty and confi denti al i ty of data entry or col l ecti on, data storage, data transmi ssi on and data
processrng;
1 4
ANSt / t SO 17025-1999
c) comput ers and aut omat ed equi pment are mai nt ai ned t o ensure proper f unct i oni ng and are provi ded wi t h t he
envi ronment al and operat i ng condi t i ons necessary t o mai nt ai n t he i nt egri t y of t est and cal i brat i on dat a.
NOTE Commerci al of f -t he-shel f sof t ware (e. 9. wordprocessi ng, dat abase and st at i st i cal programmes) i n general use
wi t hi n t hei r desi gned appl i cat i on range may be consi dered t o be sut f i ci ent l y val i dat ed. However, l aborat ory sof t ware
conl i gurat i on/ modi l i cat i ons shoul d be val i dat ed as i n 5. 4. 7. 2a).
5. 5 Equi pment
5. 5. 1 The l abor at or y shal l be f ur ni shed wi t h al l i t ems of sampl i ng, measur ement and t est equi pment r equi r ed f or
the correct performance of the tests and/or cal i brati ons (i ncl udi ng sampl i ng, preparati on of test and/or cal i brati on
i tems, processi ng and anal ysi s of test and/or cal i brati on data). In those cases where the l aboratory needs to use
equi pment outsi de i ts permanent control , i t shal l ensure that the requi rements of thi s Internati onal Standard are
met .
5.5.2 Equi pment and i ts software used for testi ng, cal i brati on and sampl i ng shal l be capabl e of achi evi ng the
accuracy requi red and shal l compl y wi th speci fi cati ons rel evant to the tests and/or cal i brati ons concerned.
Cal i brati on programmes shal l be establ i shed for key quanti ti es or val ues of the i nstruments where these properti es
have a si gni fi cant effect on the resul ts. Before bei ng pl aced i nto servi ce, equi pment (i ncl udi ng that used for
sampl i ng) shal l be cal i brated or checked to establ i sh that i t meets the l aboratory' s speci fi cati on requi rements and
compl i es wi th the rel evant standard speci fi cati ons. l t shal l be checked and/or cal i brated before use (see 5.6).
5.5.3 Equi pment shal l be operated by authori zed personnel . Up{o-date i nstructi ons on the use and mai nl enance
of equi pment (i ncl udi ng any rel evant manual s provi ded by the manufacturer of the equi pment) shal l be readi l y
avai l abl e for use by the appropri ate l aboratory personnel .
5.5.4 Each i tem of equi pment and i ts software used for testi ng and cal i brati on and si gni fi cant to the resul t shal l ,
when practi cabl e, be uni quel y i denti fi ed.
5.5.5 Records shal l be mai ntai ned of each i tem of equi pment and i ts software si gni fi cant to the tests and/or
cal i brati ons performed. The records shal l i ncl ude at l east the fol l owi ng:
a) the i denti ty of the i tem of equi pment and i ts software;
b) the manufacturer' s name, type i denti fi cati on, and seri al number or other uni que i denti fi cati on;
c) checks that equi pment compl i es wi th the speci fi cati on (see 5.5.2);
d) the current l ocati on, where appropri ate;
e) the manufacturer' s i nstructi ons, i f avai l abl e, or reference to thei r l ocati on;
dates, resul ts and copi es of reports and certi fi cates of al l cal i brati ons, adj ustments, acceptance cri teri a, and
the due date of next cal i brati on;
S)
the mai ntenance pl an, where appropri ate, and mai ntenance carri ed out to date;
h) any damage, mal functi on, modi fi cati on or repai r to the equi pment.
5.5.6 The l aboratory shal l have procedures for safe handl i ng, transport, storage, use and pl anned mai ntenance
of measuri ng equi pment to ensure proper functi oni ng and i n order to prevent contami nati on or deteri orati on.
NOTE Addi ti onal procedures may be necessary when measuri ng equi pment i s used outsi de the permanent l aboratory for
tests, cal i brati ons or sampl i ng.
5.5.7 Equi pment that has been subj ected to overl oadi ng or mi shandl i ng, gi ves suspect resul ts, or has been
shown to be defecti ve or outsi de speci fi ed l i mi ts, shal l be taken out of servi ce. l t shal l be i sol ated to prevent i ts use
or cl earl y l abel l ed or marked as bei ng out of servi ce unti l i t has been repai red and shown by cal i brati on or test to
1 5
ANSt/tSO 1702s-1999
perform correctl y. The l aboratory shal l exami ne the effect of the defect or departure from speci fi ed l i mi ts on
previ ous tests and/or cal i brati ons and shal l i nsti tute the
"Control
of nonconformi ng work" procedure (see 4.9).
5.5.8 Whenever practi cabl e, al l equi pment under the control of the l aboratory and requi ri ng cal i brati on shal l be
l abel l ed, coded or otherwi se i denti fi ed to i ndi cate the status of cal i brati on, i ncl udi ng the date when l ast cal i brated
and the date or expi rati on cri teri a when recal i brati on i s due.
5.5.9 When, for whatever reason, equi pment goes outsi de the di rect control of the l aboratory, the l aboratory shal l
ensure that the functi on and cal i brati on status of the equi pment are checked and shown to be sati sfactory before
the equi pment i s returned to servi ce.
5.5.10 When i ntermedi ate checks are needed to mai ntai n confi dence i n the cal i brati on status of the equi pment,
these checks shal l be carri ed out accordi no to a defi ned orocedure.
5.5.11 Where cal i brati ons gi ve ri se,o " ]", of correcti on factors, the l aboratory shal l have procedures to ensure
that copi es (e.9. i n computer software) are correctl y updated.
5.5.' 12 Test and cal i brati on equi pment, i ncl udi ng both hardware and software, shal l be safeguarded from
adj ustments whi ch woul d i nval i date the test and/or cal i brati on resul ts.
5. 6 Measurement t raceabi l i t y
5.6.1 General
Al l equi pment used f or t est s and/ or cal i br at i ons, i ncl udi ng equi pment f or subsi di ar y measur ement s ( e. 9. f or
envi ronmental condi ti ons) havi ng a si gni fi cant effect on the accuracy or val i di ty of the resul t of the test, cal i brati on
or sampl i ng shal l be cal i brated before bei ng put i nto servi ce. The l aboratory shal l have an establ i shed programme
and procedure for the cal i brati on of i ts equi pment.
NOTE Such a programme shoul d i ncl ude a system for sel ecti ng, usi ng, cal i brati ng, checki ng, control l i ng and mai ntai ni ng
measurement standards, rel erence materi al s used as measurement standards, and measuri ng and test equi pment used to
oerform tests and cal i brati ons.
5.6.2 Speci fi c requi rements
5.6.2.1 Cal i brati on
5.6.2.1.1 For cal i brati on l aboratori es, the programme for cal i brati on of equi pment shal l be desi gned and
operated so as to ensure that cal i brati ons and measurements made by the l aboratory are traceabl e to the
lnternational System of Units (Sl) (Sysfeme international d'unit6s).
A cal i brati on l aboratory establ i shes traceabi l i ty of i ts own measurement standards and measuri ng i nstruments to
the Sl by means of an unbroken chai n of cal i brati ons or compari sons l i nki ng them to rel evant pri mary standards of
the Sl uni ts of measurement. The l i nk to Sl uni ts may be achi eved by reference to nati onal measuremenl
standards. Nati onal measurement standards may be pri mary standards, whi ch are pri mary real i zati ons of the Sl
uni ts or agreed representati ons of Sl uni ts based on fundamental physi cal constants, or they may be secondary
standards whi ch are standards cal i brated by another nati onal metrol ogy i nsti tute. When usi ng external cal i brati on
servi ces, traceabi l i ty of measurement shal l be assured by the use of cal i brati on servi ces from l aboratori es that can
demonstrate competence, measurement capabi l i ty and traceabi l i ty. The cal i brati on cedi fi cates i ssued by these
l aboratori es shal l contai n the measurement resul ts, i ncl udi ng the measurement uncertai nty and/or a statement of
compl i ance wi t h an i dent i f i ed met r ol ogi cal speci f i cat i on ( see al so 5. 10. 4. 2) .
NOTE 1 Cal i brati on l aboratori es tul ti l l i ng the requi rements of thi s Internati onal Standard are consi dered to be competent. A
cal i brati on cerl i fi cate beari ng an accredi tati on body l ogo from a cal i brati on l aboratory accredi ted to thi s l nternati onal Standard,
for the cal i brati on concerned, i s suffi ci ent evi dence of traceabi l i tv of the cal i brati on data reported.
NOTE 2 Traceability to Sl units of measurement may be achieved by reference to an appropriate primary standard (see
VIM:1993,6.4) or by reference to a natural constant, the val ue of whi ch i n terms of the rel evant Sl uni t i s known and
1 6
ANS!/|SO 17025-1999
recommended by the General Conference of Wei ghts and Measures (CGPM) and the Internati onal Commi ttee for Wei ghts and
Measur es
( CI PM) .
NOTE 3 Cal i brati on l aboratori es that mai ntatn thei r own pri mary standard or representati on of Sl uni ts based on fundamental
physi cal constants can cl ai m traceabi l i ty to the Sl system onl y after these standards have been compared, di rectl y or i ndi rectl y,
wi th other si mi l ar standards o1 a nal i onal metrol ogy i nsti tute.
NOTE 4 The term
,' i denti fi ed
metrol ogi cal speci fi cati on" means that i t must be cl ear from the cal i brati on certi fi cate whi ch
speci Ji cati on the measurements have been compared wi th, by i ncl udi ng the speci fi cati on or by gi vi ng an unambi guous reference
to the sDeci frcati on.
NOTE S When the terms
"i nternatronal
standard" or
"nati onal
standard" are used i n connecti on wi th traceabi l i ty, i t i s assumed
that these standards ful fi l the properti es of pri mary standards for the real i zati on of Sl uni ts.
NOTE 6 Traceabi l i ty to nati onal measurement standards does not necessari l y requi re the use of the nati onal metrol ogy
i nsti tute of the country i n whi ch the l aboratory i s l ocated
NOTE 7 l f a cal i brati on l aboratory wi shes or needs to obtai n traceabi l i ty from a nati onal metrol ogy i nsti l ute other than i n i ts
own country, thi s l aboratory shoul d i el ect a nati onal metrol ogy i nsti tute that acti vel y parti ci pates i n the acti vi ti es of BIPM ei ther
di rectl y or through regi onal groups.
NOTE B The unbroken chai n o1 cal i brati ons or compari sons may be achi eved i n several steps carri ed out by di fferent
l aboratori es that can demonstrate traceabi l i ty.
5.6.2.1.2 There are certai n cal i brati ons that currentl y cannot be stri ctl y made i n Sl uni ts. In these cases
cal i brati on shal l provi de confi dence i n measurements by establ i shi ng traceabi l i ty to appropri ate measurement
standards such as:
the use of certi fi ed reference materi al s provi ded by a competent suppl i er to gi ve a rel i abl e physi cal or chemi cal
characteri zati on of a materi al ;
-
the use of speci fi ed methods and/or consensus standards that are cl earl y descri bed and agreed by al l parti es
concer ned.
Parti ci pati on i n a sui tabl e programme of i nterl aboratory compari sons i s requi red where possi bl e.
5.6.2.2 Testi ng
5. 6. 2. 2. 1 For t est i ng l abor at or i es, t he r equi r ement s gi ven i n 5. 6. 2. 1 appl y f or measur i ng and t est equi pment wi t h
measuri ng functi ons used, unl ess i t has been establ i shed that the associ ated contri buti on from the cal i brati on
contri butes l i tfl e to the total uncertai nty of the test resul t. When thi s si tuati on ari ses, the l aboratory shal l ensure that
the equi pment used can provi de the uncertai nty of measurement needed.
NOTE The enent to whi ch the requi rements i n 5.6.2.1 shoul d be tol l owed depends on the rel al i ve contri buti on of the
cal i brati on uncertai nty to the total uncertai nty. l l cal i brati on i s the domi nant factor, the requi rements shoul d be stri ctl y fol l owed
5.6.2.2.2 Where traceabi l i ty of measurements to Sl uni ts i s not possi bl e and/or not rel evant, the same
requi rements for traceabi l i ty to, for exampl e, certi fi ed reference materi al s, agreed methods and/or consensus
standards, are requi red as for cal i brati on l aboratori es (see 5.6.2.1 ' 2).
5.6.3 Reference standards and reference materi al s
5.6.3.1 Referencestandards
The l aboratory shal l have a programme and procedure for the cal i brati on of i ts reference standards. Reference
standards shal l be cal i brated by a body that can provi de traceabi l i ty as descri bed i n 5.6.2.1. Such reference
standards of measurement hel d by the l aboratory shal l be used for cal i brati on onl y and for no other purpose'
unl ess i t can be shown that thei r
performance as reference standards woul d not be i nval i dated. Reference
standards shal l be cal i brated before and after any adj ustment'
1 7
ANSyISO 17025-1999
5.6.3.2 Referencemateri al s
Reference materi al s shal l , where
possi bl e, be traceabl e to Sl uni ts of measurement, or to certi fi ed reference
materi al s. Internal reference materi al s shal l be checked as far as i s techni cal l y and economi cal l y practi cabl e'
5. 6. 3. 3 I nt er medi at echecks
Checks needed to mai ntai n confi dence i n the cal i brati on status of reference, pri mary, transfer or worki ng standards
and reference materi al s shal l be carri ed out accordi ng to defi ned procedures and schedul es
5.6.3.4 TransPort and storage
The l aboratory shal l have procedures for safe handl i ng, transport, storage and use of reference standards and
reference materi al s i n order to prevent contami nati on or deteri orati on and i n order to protect thei r i ntegri ty.
NOTE Addi ti onal procedures may be necessary when reference standards and reference materi al s are used outsi de the
permanent l aboratory for tests, cal i brati ons or sampl i ng.
5. 7 Sampl i ng
5. 7. 1 The l abor at or y shal l have a sampl i ng pl an and pr ocedur es f or sampl i ng when i t car r i es out sampl i ng of
subst ances, mat er i al s or pr oduct s f or subsequent t est i ng or cal i br at i on. The sampl i ng pl an as wel l as t he sampl i ng
procedure shal l be avai l abl e at the l ocati on where sampl i ng i s underl aken. Sampl i ng pl ans shal l , whenever
reasonabl e, be based on appropri ate stati sti cal methods. The sampl i ng process shal l address the factors to be
control l ed to ensure the val i di ty of the test and cal i brati on resul ts.
NOTE 1 Sampl i ng i s a del i ned procedure whereby a part of a substance, materi al or product i s taken to provi de for testi ng or
cal i brati on of a representati ve sampl e of the whol e. dampl i ng may al so be requi red by the appropri ate speci fi cati on for whi ch the
subsl ance, matenat or product i s to be tested or cal i brated. In certai n cases (e.g. l orensi c anal ysi s), the sampl e may not be
representati ve but i s determi ned by avai l abi l i ty.
NOTE 2 Sampl i ng procedures shoul d descri be the sel ecti on, sampl i ng pl an, wi thdrawal and preparati on oJ a sampl e or
sampl es from a substance, materi al or product to yi el d the requi red i nformati on.
5. 7. 2 Wher e t he cl i ent r equi r es devi at i ons, addi t i ons or excl usi ons f r om t he document ed sampl i ng pr ocedur e,
these shal l be recorded i n detai l wi th l he appropri ate sampl i ng data and shal l be i ncl uded i n al l documents
contai ni ng test and/or cal i brati on resul ts, and shal l be communi cated to the appropri ate personnel .
5.2.3 The l aboratory shal l have procedures for recordi ng rel evant data and operati ons rel ati ng to sampl i ng that
forms part of the testi ng or cal i brati on that i s undertaken. These records shal l i ncl ude the sampl i ng
procedure used,
the i denti fi cati on of the sampl er, envi ronmental condi ti ons (i f rel evant) and di agrams or other equi val ent means to
i denti fy the sampl i ng l ocati on as necessary and, i f appropri ate, the stati sti cs the sampl i ng procedures are based
uDon.
5.8 Handl i ng of test and cal i brati on i tems
5.8.1 The l aboratory shal l have procedures for the transportati on, recei pt, handl i ng, protecti on, storage, retenti on
and/or di sposal of test and/or cal i brati on i tems, i ncl udi ng al l provi si ons necessary to protect the i ntegri ty of the test
or cal i brati on i tem, and to protect the i nterests of the l aboratory and the cl i ent.
5.g.2 The l aboratory shal l have a system for i denti fyi ng test and/or cal i brati on i tems. The i denti fi cati on shal l be
retai ned throughout the l i fe of the i tem i n the l aboratory. The system shal l be desi gned and operated so as to
ensure that i tems cannot be confused physi cal l y or when referred to i n records or other documents' The system
shal l , i f appropri ate, accommodate a sub-di vi si on of groups of i tems and the transfer of i tems wi thi n and from the
l aboratory.
5.g.3 Upon recei pt of the test or cal i brati on i tem, abnormal i ti es or departures f rom normal or speci fi ed condi ti ons,
as descri bed i n the test or cal i brati on method, shal l be recorded. When there i s doubt as to the sui tabi l i ty of an i tem
for test or cal i brati on, or when an i tem does not conform to the descri pti on provi ded, or the test or cal i brati on
1 8
ANSI / I SO 17025-1999
requi red i s not speci fi ed i n suffi ci ent detai l , the l aboratory shal l consul t the cl i ent for further i nstrucl i ons before
pr oceedi ng and shal l r ecor d l he di scussi on.
5.8.4 The l aboratory shal l have procedures and appropri ate faci l i ti es for avoi di ng deteri orati on, l oss or damage to
t he t est or cal i br at i on i t em dur i ng st or age, handl i ng and pr epar at i on. Handl i ng i nst r uct i ons pr ovi ded wi t h t he i t em
shal l be fol l owed. When i tems have to be stored or condi ti oned under speci fi ed envi ronmental condi ti ons, these
condi ti ons shal l be mai ntai ned, moni tored and recorded. Where a test or cal i brati on i tem or a porti on of an i tem i s
to be hel d secure, the l aboratory shal l have arrangements for storage and securi ty that protect the condi ti on and
i ntegri ty of the secured i tems or porti ons concerned.
NOTE 1 Where test i tems are to be returned i nto servi ce after testi ng, speci al care i s requi red to ensure that they are not
damaged or i nj ured duri ng the handl i ng, testi ng or stori ng/wai ti ng processes.
NOTE 2 A sampl i ng procedure and i n{ormati on on storage and transport of sampl es, i ncl udi ng i nformati on on sampl i ng
factors i nfl uenci ng the test or cal i brati on resul t, shoul d be provi ded to those responsi bl e for taki ng and transporti ng the sampl es.
NOTE 3 Reasons for keepi ng a test or cal i brati on i tem secure can be l or reasons of record, safety or val ue, or to enabl e
compl ementary tests and/or cal i brati ons to be pertormed l ater.
5.9 Assuring the quality of test and calibration results
The l aboratory shal l have qual i ty control procedures for moni tori ng the val i di ty of tests and cal i brati ons undertaken.
The resul ti ng data shal l be recorded i n such a way that trends are detectabl e and, where practi cabl e, stati sti cal
techni ques shal l be appl i ed to the revi ewi ng of the resul ts. Thi s moni tori ng shal l be pl anned and revi ewed and may
i ncl ude, but not be l i mi t ed t o, t he f ol l owi ng:
a) regul ar use of certi fi ed reference materi al s and/or i nternal qual i ty control usi ng secondary reference materi al s:
b) parti ci pati on i n i nterl aboratorycompari son orprofi ci ency-testi ng
programmes;
c) repl i cate tests or cal i brati ons usi ng the same or di fferent methods;
d) retesti ng or recal i brati on of retai ned i tems;
e) correl ati on of resul ts for di fferent characteri sti cs of an i tem.
NOTE The sel ected methods shoul d be appropri ate for the type and vol ume of the work undertaken
5. 10 Report i ng t he resul t s
5. 10. 1 Gener al
The resul ts of each test, cal i brati on, or seri es of tests or cal i brati ons carri ed out by the l aboratory shal l be reponed
accuratel y, cl earl y, unambi guousl y and obj ecti vel y, and i n accordance wi th any speci fi c i nstructi ons i n the test or
cal i brati on methods.
The r esul t s shal l be r epor t ed, usual l y i n at est r epor t or a cal i br at i on cer t i f i cat e ( see not e 1) , and shal l i ncl ude al l t he
i nformati on requested by the cl i ent and necessary for the i nterpretati on of the test or cal i brati on resul ts and al l
i nf or mat i on r equi r ed by t he met hod used. Thi s i nf or mat i on i s nor mal l y t hat r equi r ed by 5. 10. 2, and 5. . 1 0. 3 or 5. 10. 4.
l n the case of tests or cal i brati ons
performed for i nternal cl i ents, or i n the case of a wri tten agreement wi th the
cl i ent , t he r esul t s may be r epor t ed i n a si mpl i f i ed way. Any i nf or mat i on l i st ed i n 5. 10. 2 t o 5. 10. 4 whi ch i s not
reported to the cl i ent shal l be readi l y avai l abl e i n the l aboratory whi ch carri ed out the tests and/or cal i brati ons.
NOTE 1 Test reports and cal i brati on certi ti cates are someti mes cal l ed test certi fi cates and cal i brati on reports, respecti vel y.
NOTE 2 The test reports or cal i brati on certi {i cates may be i ssued as hard copy or by el ectroni c data transfer provi ded that
the reoui rements of thi s Internati onal Standard are met.
1 9
ANSUI SO 17025-1999
5.10.2 Test reports and cal i brati on certi fi cates
Each test reoort or cal i brati on certi fi cate shal l i ncl ude at l east the fol l owi ng i nformati on, unl ess the l aboratory has
val i d reasons for not doi ng so:
a) a ti tl e (e.9.
"Test
Report" or
"Cal i brati on
Certi fi cate");
b) the name and address of the l aboratory, and the l ocati on where the tests and/or cal i brati ons were carri ed out,
i f di fferent from the address of the l aboratory;
c) uni que i denti fi cati on of the test report or cal i brati on cefi i fi cate (such as the seri al number), and on each page
an i denti fi cati on i n order to ensure that the page i s recogni zed as a part of the test report or cal i brati on
cefi i fi cate, and a cl ear i denti fi cati on of the end of the test report or cal i brati on certi fi cate,
d) the name and address of the cl i ent;
e) i denti fi cati on of the method used;
f) a descri pti on of , the condi ti on of
,
and unambi guous i denti fi cati on of the i tem(s) tested or cal i brated;
S)
the date of recei pt of the test or cal i brati on i tem(s) where thi s i s cri ti cal to the val i di ty and appl i cati on of the
resul l s, and the date(s) of performance of the test or cal i brati on;
h) reference to the sampl i ng pl an and procedures used by the l aboratory or other bodi es where these are
rel evant to the val i di ty or appl i cati on of the resul ts;
i ) the test or cal i brati on resul ts wi th, where appropri ate, the uni ts of measurement;
t)
the name(s), functi on(s) and si gnature(s) or equi val ent i denti fi cati on of person(s) authori zi ng the test report or
cal i brati on certi f i cate;
k) where rel evant, a statement to the effect that the resul ts rel ate onl y to the i tems tested or cal i brated'
NOTE 1 Hard copi es of test reports and cal i brati on certi fi cates shoul d al so i ncl ude the page number and total number of
pages.
NOTE 2 l t i s recommended that l aboratori es i ncl ude a sl atement speci fyi ng that the test report or cal i brati on certi fi cate shal l
nol be reproduced except i n ful l , wi thout wri tten approval of the l aboratory
5.10.3 Test reports
5.10.3.1 In addi ti on to the requi rements l i sted i n 5.10.2, test reports shal l , where necessary for the i nterpretati on
of the test resul ts, i ncl ude the fol l owi ng:
a) devi ati ons from, addi ti ons to, or excl usi ons from the test method, and i nformati on on speci fi c test condi ti ons,
such as envi ronmental condi ti ons;
where rel evant, a statement of compl i ance/non-compl i ance wi th requi rements and/or speci fi cati ons;
where appl i cabl e, a Statement on the esti mated uncertai nty of measurement; i nformati on on uncertai nty i s
needed i n test reports when i t i s rel evant to the val i di ty or appl i cati on of the test resul ts, when a cl i ent' s
i nstructi on so requi res, or when the uncertai nty affects compl i ance to a speci fi cati on l i mi t;
where appropri ate and needed, opi ni ons and i nterpretati ons (see 5' 10.5);
addi ti onal i nformati on whi ch may be requi red by speci fi c methods, cl i ents or groups of cl i ents.
b)
c)
d)
e)
20
ANSt/tSO 17025-1999
5. 10. 3. 2 I n addi t i on t o t he r equi r ement s l i st ed i n 5. 10. 2 and 5. 10. 3. 1, t est r epons cont ai ni ng t he r esul t s of
sampl i ng shal l i ncl ude the fol l owi ng. where necessary for the i nterpretati on of test resul ts:
a) t he dat e of sampl i ng;
b) unambi guous i denti fi cati on of the substance, materi al or product sampl ed (i ncl udi ng the name of the
manufacturer, the model or type of desi gnati on and seri al numbers as appropri ate);
c) the l ocati on of sampl i ng, i ncl udi ng any di agrams, sketches or photographs;
d) a reference to the sampl i ng pl an and procedures used;
e) detai l s of any envi ronmental condi ti ons duri ng sampl i ng that may affect the i nterpretati on of the test resul ts;
f) any standard or other speci fi cati on for the sampl i ng method or procedure, and devi ati ons, addi ti ons to or
excl usi ons from the soeci fi cati on concerned.
5.10.4 Cal i brati on certi fi cates
5. 10. 4. 1 I n addi t i on t o t he r equi r ement s l i st ed i n 5. 10. 2, cal i br at i on cer t i f i cat es shal l i ncl ude t he f ol l owi ng, wher e
necessary for the i nterpretati on of cal i brati on resul ts:
a) the condi ti ons (e.g. envi ronmental ) under whi ch the cal i brati ons were made that have an i nfl uence on the
measurement resul ts;
b) the uncertai nty of measurement and/or a statement of compl i ance wi th an i derrti fi ed metrol ogi cal speci fi cati on
or cl auses thereof ;
c) evi dence t hat t he measur ement s ar e t r aceabl e ( see not e 2 i n 5. 6. 2. 1. 1) .
5.10.4.2 The cal i brati on certi fi cate shal l rel ate onl y to quanti ti es and the resul ts of functi onal tests. l f a statement
of compl i ance wi th a speci fi cati on i s made, thi s shal l i denti fy whi ch cl auses of the speci fi cati on are met or not met.
When a statement of compl i ance wi th a speci fi cati on i s made omi tti ng the measurement resul ts and associ ated
uncertai nti es, the l aboratory shal l record those resul ts and mai ntai n them for possi bl e future reference.
When statements of compl i ance are made, the uncertai ntv of measurement shal l be taken i nto account.
5.10.4.3 When an i nstrument for cal i brati on has been adj usted or repai red, the cal i brati on resul ts before and
after adj ustment or repai r, i f avai l abl e, shal l be reported.
5.10.4.4 A cal i brati on certi fi cate (or cal i brati on l abel ) shal l not contai n any recommendati on on the cal i brati on
i nterval except where thi s has been agreed wi th the cl i ent. Thi s requi rement may be superseded by l egal
regul ati ons.
5.10.5 Opi ni ons and i nterpretati ons
When opi ni ons and i nterpretati ons are i ncl uded, the l aboratory shal l document the basi s upon whi ch the opi ni ons
and i nterpretati ons have been made. Opi ni ons and i nterpretati ons shal l be cl earl y marked as such i n a test report.
NOTE 1 Opi ni ons and i nterprel ati ons shoul d not be confused wi th i nspecti ons and product certi fi cati ons as i ntended i n
ISO/IEC 17020 and ISO/IEC Gui de 65.
NOTE 2 Opi ni ons and i nterpretati ons i ncl uded i n a test report may compri se, but not be l i mi ted to, the fol l owi ng:
an opi ni on on the statement of compl i ance/noncompl i ance of the resul ts wi th requi rements;
f ul f i l ment of contractual requi rements:
recommendati ons on how to use the resul ts:
gui dance to be used for i mprovements.
21
ANSUI SO 17025-1999
NOTE 3 l n many cases i t mi ght be appropri at e t o communi cat e t he opi ni ons and i nt erpret at i ons by di rect di al ogue wi t h t he
cl i ent . Such di al ogue shoul d be wri t t en down.
5.10.6 Testi ng and cal i brati on resul ts obtai ned from subcontractors
When the test report contai ns resul ts of tests performed by subcontractors, these resul ts shal l be cl earl y i denti fi ed.
The subcontractor shal l report the resul ts i n wri ti ng or el ectroni cal l y.
When a cal i brati on has been subcontracted, the l aboratory performi ng the work shal l i ssue the cal i brati on certi fi cate
to the contracti ng l aboratory.
5.10.7 El ectroni c transmi ssi on of resul ts
l n the case of transmi ssi on of test or cal i brati on resul ts by tel ephone, tel ex, facsi mi l e or other el ectroni c or
el ectromagneti c means, the requi rements of thi s Internati onal Standard shal l be met (see al so 5.4.7).
5.10.8 Format of reports and certi fi cates
The format shal l be desi gned to accommodate each type of test or cal i brati on carri ed out and to mi ni mi ze the
possi bi l i t y of mi sunder st andi ng or mi suse.
NOTE 1 Attenti on shoul d be gi ven to the l ay-out of the test report or cal i brati on certi fi cate, especi al l y wi th regard to the
presentati on of the test or cal i brati on data and ease of assi mi l ati on by the reader.
NOTE 2 The headi ngs shoul d be standardi zed as far as possi bl e.
5.10.9 Amendments to test reports and cal i brati on certi fi cates
Materi al amendments to a test report or cal i brati on certi fi cate after i ssue shal l be made onl y i n the form of a further
document, or dal a transfer, whi ch i ncl udes the statement:
"suppl ement
to Test Report
[or
Cal i brati on Certi fi cate], seri al number ...
[or
as otherwi se i denti fi ed]",
or an equi val ent form of wordi ng.
Such amendments shal l meet al l the requi rements of thi s Internati onal Standard.
When i t i s necessary to i ssue a compl ete new test report or cal i brati on certi fi cate, thi s shal l be uni quel y i denti fi ed
and shal l contai n a reference to the ori gi nal that i t repl aces.
22
ANSt/tSO 17025-1999
Annex A
(i nformati ve)
Nomi nal cross-ref erences t o I SO 9001: 1994 and I SO 9002: 1994
Tabl e A.1
-
Nomi nal cross-references to ISO 9001:1994 and ISO 9002:1994
I SO 9001: 1994 ISO 9002:1994 tso/rEc 17025
Cl ause 1 Cl ause 1 Cl ause 1
Cl ause 2 Cl ause 2 Cl ause 2
Cl ause 3 Cl ause 3 Cl ause 3
A
1
4 . 1 . 1 4. 1. 3, 4. 2. 2
A
. 2. 1 4. 1. 2. 1 4. 1. 5 a) , t ) , h\ ; 4. 2. 4; 4. 9. 1 a) ; 4. 10. 1 and 5. 2. 5
4 . z . z 4. 1. 2. 2 4. 1. 5 a) , q) , h) and 5. 5. 1
. 2. 3 4 . 1 . 2 . 3 4. 1. 5 i )
A
+ . t . J 4. 14
4. 2. 1 and 4. 2. 2 4. 2. 1 and 4. 2. 2 4. 2. 1
,
4. 2. 2, 4. 2. 3
4. 2. 3 4. 2. 3 4. 2. 1, 4. 2. 2 and 4. 14
4. 3 4. 3 4. 4
4. 4 4. 4 ( n. a. \ 1 . 5, 5. 4. 2, 5. 4. 3, 5. 4. 4, 5. 4. 5
4. 5 4. 5 4. 3, 5. 4. 7, 5. 5. ' t 1
4. 6. ' l 4. 6. 1 4. 6, 5. 5, 5. 6. 1, 5. 6. 2. 1 , 5. 6. 2. 2
4. 6. 2 4. 6. 2 4. 5, 4. 6
+ . o . J 4. 6. 3 4. 6
4. 6. 4 4. 6. 4 4. 5, 4. 6. 4, 4. 7, 5. 5. 2
4. 7 5. 8, 5. 10. 6
4. 8 4. 8 5. 5. 4, 5. 8
4. 9 4. 9 4. 12, 5. 3, 5. 4, 5. 5, 5. 8, 5. 9
4. 1 0. 1 4. 1 0. I 5. 4
4. 10. 2 4. 10. 2 4. 5, 4. 6, 5. 5. 2, 5. 8
4. 10. 3 4. 10. 3 4. 9, 5. 5. 9, 5. 8. 3, 5. 8. 4, 5. 9
4. 10. 4 4. 10. 4 5. 4. 7, 5. 9, 5. 10. 1
4. 10. 5 4. 10. 5 + - | z . z
4. 11. 1 4. 11. 1 5. 4, 5. 5, 5. 6
4. 11. 2 4. 11. 2 5. 3, 5. 4. 1, 5. 4. 5, 5. 5, 5. 6
4. 12 4 . 1 2 5. 5. 12, 5. 8, 5. 9. 2
4 . 1 3 4 . 1 3 4. 9
4. 14 4. 14. 1 4. 10 and 4. 1 1
4. 15 4 . 1 5 5. 9
4 . 1 6 4 . 1 6 4. 12
4. 17 4 . 1 7 4. 10. 5, 4. 13 ( 4. 12)
4 . t 8 4 . 1 8 5. 2, 5. 5. 3
4 . 1 9 4 . 1 9 4. 7
,
5. 2. 1, 5. 10. 5
4. 20 4. 20 c. : ,
f l . ?. = f l ot appl i cabl e
ISO/l EC 17025 covers several techni cal competence requi rements that are not covered by ISO 9001:1994 and
I SO 9002: 1994.
23
ANSUI SO 17025-1999
Annex B
(i nformati ve)
Gui del i nes f or est abl i shi ng appl i cat i ons f or speci f i c f i el ds
8.1 The requi rements speci fi ed i n thi s Internati onal Standard are stated i n general terms and, whi l e they are
appl i cabl e to al l test and cal i brati on l aboratori es, expl anati ons mi ght be needed. Such expl anati ons on appl i cati ons
are herei n rel erred to as appl i cati ons. Appl i cati ons shoul d not i ncl ude addi ti onal general requi rements not i ncl uded
i n thi s Internati onal Standard.
8.2 Appl i cati ons can be thought of as an el aborati on of the general l y stated cri teri a (requi rements) of thi s
Internati onal Standard for speci fLd fi el ds of test and cal i brati on, test technol ogi es,
products, materi al s or speci fi c
tests or cal i brati ons. nccol Oi ngl y, appl i cati ons shoul d be establ i shed by persons havi ng appropri ate techni cal
knowl edge and expe1en"", "nd' snorl d address i tems that are essenti al or most i mportant for the proper conduct of
a test or cal i brati on.
8.3 Dependi ng on the appl i cati on at hand, i t may be necessary to establ i sh appl i cati ons for the techni cal
requi rements of thi s Internati onal Standard. Establ i shi ng appl i cati ons may be accompl i shed by si mpl y provi di ng
detai l or addi ng exl ra rnformati on to the al ready general l ! si ai ed requi rements i n each of the cl auses (e.g' speci fi c
l i mi tati ons to the temperature and humi di ty i n the l aboratory)'
In some cases the appl i cati ons wi l l be qui te l i mi ted, appl yi ng onl y to a gi ven test or cal i brati on method or to a group
of cal i brati on or test methods. In other cases the appl i cati ons may be qui te broad, appl yi ng to the testi ng or
cal i brati on of vari ous
products or i tems or to enti re fi el ds of testi ng or cal i brati on.
8.4 l f the appl i cati ons appl y to a group of test or cal i brati on methods i n an enti re techni cal fi el d' common wordi ng
shoul d be used for al l of the methods.
Al ternati vel y, i t may be necessary to devel op a separate document of appl i cati ons to suppl ement thi s Internati onal
Standard for speci fi c types or gi oups of tests or cal i brati ons,
products, materi al s or techni cal fi el ds of tests or
cal i brati ons. Such a oocument s6oul d provi de onl y the necessary suppl ementary i nformati on, whi l e mai ntai ni ng thi s
Internati onal Standard as the governi ng documeni through reference. Appl i cati ons whi ch are too speci fi c shoul d be
avoi ded i n order to l i mi t the prol i ferati on of detai l ed documents'
8.5 The gui dance rn thi s annex shoul d be used by accredi tati on bodi es and other types of eval uati on bodi es
when they devel op appl i cati ons for thei r own purposes (e.9. accredi tati on i n speci fi c areas).
24
ANSt / t SO 17025-1999
Bi bl i ography
11l
ISO 5725-1 ,
Accuracy (trueness and precision) of measurement methods and results
-
Part 1: General
principles and definitions.
12)
ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results
-
Parl 2: Basic
method for the determination of repeatability and reproducibility of a standard measurement method.
t3l
ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results
-
Part 3:
lntermediate measures of the precision of a standard measurement method.
t4l
ISO 5725-4, Accuracy (trueness and precision) of measurement methods and results
-
Paft 4: Basic
methods for the determination of the trueness of a standard measurement method.
t5l
ISO 5725-6, Accuracy (trueness and precision) of measurement methods and results
-
Part 6: Use in
practice of accuracy values.
t6l
ISO 8402, Quality management and quality assurance
-
Vocabulary.
t7)
ISO 9000-1 :1994, Quality management and quality assurance standards
-
ParI 1: Guidelines for selection
and use.
t8l
ISO 9000-3: 1997, Quality management and quality assurance standards
-
Part 3: Guidelines for the
application of ISO 9001 :1994 to the development, supply, installation and maintenance of computer
software.
tgl
ISO 9004-1 :1994, Quality management and quality system elements
-
Part 1: Guidelines.
[10]
ISO 9004-4:1993, Quality management and quality system elements
-
Pari 4: Guidelines for quality
improvement.
[1
1] ISO 1001 1-1
, Guidelines for auditing quality systems
-
Parl 1: Auditing.
112)
ISO 1001 1-2, Guidelines for auditing quality systems
-
Paft 2: Qualification criteria for quality system
auditors.
[13]
ISO 1001 1-3, Guidelines for auditing quality systems
-
Part 3: Management of audit programmes.
[14]
ISO 10012-1
, Quality assurance requirements for measuring equipment
-
Part 1 : Metrological conf irmation
for measuring equipment.
t15l
ISO 10012-2, Quality assurance requirements for measuring equipment
-
Paft 2: Guidelines for control of
meas u re m ent p rocesses.
[16]
ISO/IEC 17020, General criteria for the operation of various types of bodies pertorming inspection.
[17]
ISO Guide 30, Terms and definitions used in connection with reference materials.
[18]
ISO Guide 31
,
Contents of ceriificates of reference materials.
[19]
ISO Guide 32, Calibration in analytical chemistry and use of certified reference materials.
[20]
ISO Guide 33, Uses of certified reference materials.
121)
ISO Guide 34, General requirements for the competence of reference material producers.
25
ANSUISO 17025-1999
ISO Guide 35, Certification of reference materials
-
General and statistical principles.
lso/lEc Guide 43-1 ,
Proficiency testing by intertaboratory comparisons
-
Parl 1: Development and
operation of proficiency testing schemes.
ISO/IEC Guide 43-2, Proficiency testing by interlaboratory comparisons
-
Part 2: Selection and use of
proficiency testing schemes by laboratory accreditation bodies.
lso/lEC Guide 58:1gg3, Calibration and testing laboratory accreditation systems
-
General requirements
for operation and recognition.
ISO/lEC Guide 65, General requirements for bodies operating product certification systems'
Gui de to the Expressi on of l Jncerl ai nty i n Measurement, i ssued by BIPM, l EC, IFCC, l SO, IUPAC' IUPAP
and OI ML.
Informati on and documents on l aboratory accredi tati on can be found on the ILAC (l nternati onal Laboratory
Accredi tati on Cooperati on): www.i l ac.org.
[22]
[23]
124l
[25]
[26]
127)
[28]
26
Amerlcln Socl.ty tol Ourllty
'lrNl n -n
i EE A\T I
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.
Quality Press
600 N. Plankinton Avenue
Milwaukee, Wisconsin 53203
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Fd 414-272-1734
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E-mai l : autho6@asq.org
T17025
Pri nted i n the Uni ted States of Ameri ca