MALAYSIAN _ mstsonec 17025:2017
STANDARD
General requirements for the\competence of
testing and calibration laboratories
(Second revision)
(ISONEC 17025:2017,4DT)
(Published by Standards Malaysia in 2018)
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Uy
es: 03.120.20
© Copyright 2018
DEPARTMENT OF STANDARDS MALAYSIA DEVELOPMENT OF MALAYSIAN STANDARDS.
‘The Department of Standards Malaysia (STANDARDS MALAYSIA) is the national
standards and aceedkaton boty of Malaya,
‘The main funcion of STANDARDS MALAYSIA is fo foster and promo standards,
standardisation and acredation 26 a moans of advance the naional econar promoting
‘uaa etn a ovement beneang he heat ard sly fe pth peeing
‘he consumers, foasing. domestic. and iforatonal tase and furtnenng soar
‘cooperation in alaion wo standards and eandaraton, ~
@
alason Standart (5) ae developed tough conse by cormaoes which eae
‘ncodroreseraion ol producers cfmuers an ther in lar Paget 28
‘nay be appropriate lo tho subject at hand. To be grantee extent po =
‘Standards re slgned oo ar asopton of eration Sanda Aprval oP anda
2 Mayan Sanars covered by tne Slancards of Malaysia et 100 [Ae Maayan i
‘Stand ate revewed panos The use of Malaysian Stand Yay excap 89
fara ey ar mage mana y repay aad by moana ova, ea
|Shaor sy oer mia way
Forte paves Natya Stats, ne oig dete or
Revision: A process where existing Malaysian Standat@% reviewed and ipdated which
‘esulled inthe pubicaton of new eon of to Mal ar
ef Me ani! ee ib er comton
‘Sdconfrmed bats contes ae carers
‘Amendment: A process whe a pov i at Matson Standard i tered, The
Seaperep min aremassee ie shane ese tease aaa
Stancaré Amendments as andlor actors nate.
Tectnal congas sled et of cur aon hh ed crac
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Cal eae oxy Ena meoneBiim my i Ms ISONEC 17025:2017
Contents
Committee representation,
National foreword,
Foreword
Introduction
1 Scope,
Normative references
2
3 Termsand definitions
4 General requirements.
aT mpareaty
42° Connon
5 Structural requirements
6 Resource requlrements
61 Gener
€2 Personnel
63 Facltes and enconmental conditions
64 Eaupment
65 Metrologaltacabiy
66 Exeraly provided prodcts and services
7 Process requirements &
72 Rev frets tender and contracts
72. Seletionvereaton and validation of whods
721” Setecion and verieation of eebode
722 Validation ome.
za Semping ss
74 Mandingtiest or brain ts
75 Tecnlal records
76 Brauation ofmessuremg dncertainty
77 Ensuring he vay obs
78 Reporting result
Tat Gone
782 Comp) Yequirements reports (et calraion or sniing)
783. Speae requirements fortest reports
784 _ syicrequlrement fr ellratoncericates
785 ¢ feporting sampling = specie requirements
72g Oeporting statements ofconormiy
7.9 Reporting opinions and interpretations
ABB Amenamentato reports
7.9. @Xomplaints
4 homeo wrk
(STANDARDS MALAYSU 200. A phe esened Ms Isonec 17025:2017
Foreword
150 (the International Organization for Standardization) \s @ worldwide feleration of national
standards bodies (ISO member bodies. The work of preparing International Standards ls normally
Carried out through 150 technical committees. Each member body interested ia a subject for which
4 technical committee has been established has the right to be represented on that committee
International organization, governmental and non-governmental in ais witht SO, also take pa in
the work Inthe ld of conformity assessment, 150 and the International Electrotechnical Commission
{iC} devel jin 0/1 documents under the management ofthe 10 Commitee oa Cong
assessment (1S0/CASCO), &)
‘The procedures used to develop this document and those intended for its further mgghiane are
‘described in the 1S0/1EC Directives, Part. In particular the different approval citrka wie for the
fiferen types of 80 documents shouldbe noted This document was drafted in aeegtlance with the
atari ules ofthe ISO/IEC Directives, Part 2 (Gee wvauisaaraacecives).
‘Attention is drawn to the possibility that some ofthe elements of ths documert may be the subject of
patent rights 190 shall not be held responsible for identifying any or alt tkthpatent rights Details of
ny patent rights identified during the development ofthe document wife in the Introduction and/or
‘onthe s0 is of patent declaration rested se ssa.
Ayre name sein this documents information ven for bRZonvenience ses and oes nat
osate an endasemene e
ttn (0) pnp gal ears (cee lone
ies x
‘as camer ws prepare 50 oi on ofr Assen (Aan raed
Erving nano sto GORGE EE ns spinels
This third edition cancels and replace he second etion (ISO/IEC 170252085), which hasbeen
technically revised. s
— the riscbasedthinkig(@pplied in this edition has enabled some reduion in prescriptive
reurements andthe spacement ty pvormance bse elements
— thereisgreater@sbilty chan inthe previous editonin therequirementsfor processes, procedures,
documented ifprination and organizational responsibiliies,
gd taoratary” has een added 83.8
K
& ‘Ms ISOMEC 17025:2017
Introduction
‘This document has been developed withthe objective of promoting confidence inthe operation of
laboratories. This document contains Fequlrements fr laboratories to enable them to demonstrate they
‘operate competently, nd are able to generate valid results. Laboratories that conform to this document
‘mllalso operate generally in acordance with the principles of 80 900,
‘This document requires the laboratory to plan and implement actonsto addres rsksand opportunities,
Addressing both risks and opportunites establishes a bass for increasing the effectiveneys of the
‘management system, achleving improved results and preventing negative effect. The Jalpeatory is
‘responsible for deciding which isks and opportunites need tobe addressed, YS
“The use ofthis document wil faclitte cooperation between laboratories and oth
Inthe exchange of information and experience, and inthe harmonization of standayls and procedures
The acceptanc ests eee counties facta fboratre conned ts document
Inthis document the foowing verbal forms are used: ,
= “shal ndeates a requirement;
‘should indicates a recommendation
= “may” indicates a permission:
= “can indicates a possibilty ora capability. ek
Pret can edie ein
S
for the purposes of esearch, users are encoded to share ther views on thls document and their
priorities for changes to future editions. liga the link below to take par inthe online Survey
ae
w Le aNonoe MAAYSIA2016-/
son esas Ms ISOMEC 17025:2017
General requirements for the competence of testing and
calibration laboratories
1 Scope
hls document species te gene requiemens fo the competence, mpacaty an open
Dperan taboo
‘his document is applicable to all organizations performing laboratory atvises, rales of the
numberof personnel,
Co
Laboratory customers, regulatory authorities, organizations and schemes DAME peer-assessment,
Sea os ah ers docket i ofrming or rege comps of
laboratories.
Se
2. Normative references
‘The following documents are refered to inthe text n such aay that some oral of their content
nets requirements of hs document Fr dated ree ony the ein ced aps For
Undated references, the latest edition of the referenced acgment (including any amendments) apples.
ISO/IBC Guide 99, ternational vocabulary of met ‘Base ond general exncepes and associated
terms (VIM) <
1S0/1EC 17000, Conformity assessment — Vocal and general principles
3. Terms and definitions
For the purposes of this docus
10/1EC 17000 and the =
a Spars Sire ees
intpart F
gait nz geen erga
the terms and definitions given in ISO/IEC Guide 99 and
‘Note 2 to entry: Otter terms that are useful in conveying the element of partiality tnclude “treedom tram
anil a interests" freedom from bata of projet neutrality aenesopen-nindednes ven
andednes” “detachment “blonce
[SOURCE: 1S0/18¢ 17021-1:2015, 3.2, modified —‘The words “the certification body" have been replaced
by “the laboratory" in Note 1 to entry, and the word “independence” has been deleted from the ist
Note 2to entry]
1) Also known a)C0M 200.
STANDARDS MALAYSIA 2018-Alrgh ean 1 MS ISONEC 17025:2017
32
complaint
Expression of lssatisfacton by any person or organization toa laboratory (3.6), atingtothe activities
rresuts ofthat laboratory, where a responses expected
[SOURCE:10/18C 17000:2004, 6.5, modified — The words “ther than appeaY” have been deleted, and
{he words “a conformity assessment body or acteditation body, relating to the activities of that body"
have been replace by "laboratory, eating to the activities or results ofthat hboratory"]
aa
{interlaboratory comparison
trganization, performance and evaluation of measurements or tests o
fe or more laboratories in accordance with predetermined conditio
SOURCE: Is0/18C 17043:2010, 24]
34
intralaboratory comparison
ryanlaation performance and evaluation of measurements or tests baMphe same oF similar items
‘ithin the same laboratory (15) n accordance with predetermined gotions
38 oO
proficiency testing ie
are ay rE pane performance against prevestabjgied eriterla by means of inelboratory
omparisons (23), <
ISOURCE:1S0/1EC 17043:2010, 7, modified —NoteS€o entry have been delete)
36 2
laboratory S
Ber annem egg Sete
s
— retae mont generar atin
= calibration;
Note 1 to entry: In the ae of this document, “laboratory activities” refer to the three above-mentioned
oe
ar &
aN
ang
eden bec evidence eat given em als specified requirements
AMPLE — Confirmation that a given relerence material as claimed is homogenso8s fr the quantity value
[Snimeasurement procedure concerned, down tye measurement portion having massof 10mg
EXAMPLE2 Confirmation that performance properties or legal requirements of 3 measuring system are
achieved
[EXAMPLES Conflmation hat target measurement uncertainty canbe met.
‘Note 1 tenry: When applicable, measurement uncertainty shouldbe taken nto corsideration
Note 2 to entry: The tem may be, for example,» process, measurement procedure, matrlal compound, oF
reasuengsytem, ‘Ms ISOnEC 17025:2017
Note 3to entry: The spcitied requirements may be, for example, that manufacturers petitions ate met
Note 4 o entry: Veriflatlon in egal metrology defined in VIML, and in conformity assessment in general
pertains tothe examination and marking and/or suing oa verfeation certs fr ameasuring stem
Note 5 to entry: Verifleaton shoud not be confuted ith allration. Not every vrilicaton avidin (23),
Note 6 to entry: n chemistry, verifeation ofthe identity ofthe entity involved or ofactiiy requires descriplon
ofthe structure or properties ofthat entity racy,
[SOURCE:1S0/IBC Guide 99:2007, 2.44}
a9
‘aldation ®
verifeation (25) where he pected requirements re adeqste fran intendeduse OY
EXAMPLE A measurement procedure, ordinally used for the measurement concentration of
inhuman serum
"nitrogen in water maybe valiate le for measurement of mass concntaton of
[SOURCE: IS0/18C Guide 99:2007, 245]
4 General requirements
44 Impartiality
allow commercial financial or other prageres to compromise Impartiality.
414 The laboratory shallidenirsks to ts impartiality onan on-going basis. This shal include those
"sks that arse from ts activi) or from its relatonships or from the Felatonships of es personnel,
However, such laonshipg grat necessary present laboratory witha ska partial
44.3. The laboratory sal be cers ‘he impartiality of ts laboratory sce and shall not
NOTE A relationship threatens the impartiality of the Iaboratry can be based on ownership,
sovernance, managepenpersonnel, shared resources, lances, contracts marketing nding branding) td
yment of ln gman other induces forth tral aw castemes te
44.5 _Ifarighoimpartiaity is identified the laboratory shall be able to demonstrate how iteliminates
Or minimigasuc rise
<
ss
42 €onfidentiai
Ss a
42.1 The laboratory shall be responsible, through legally enforceable commitments, for the
‘management of all information obtained or created during the performance of laboratory activites:
‘The laboratory shall inform the customer in advance of the information Ieintendsto place in the public
domain. Except for information thatthe customer makes publi availabe, or when agreed between the
laboratory and the customer (eg forthe purpose af responding to complaints), al other information i
considered proprietary information nd shall be reganded as confident.
42.2 When the laboratory is required by law or authorized by contractal arangements to release
‘confidential Information, the customer oF individual concerned shall unless Frohbited by lav, be
‘notified ofthe information provided,
‘©TANOARDS MALAYSIA 208-Ate sened 3 Ms ISONEC 17025:2017
42.3 Information about the customer obtained from sources other than the customer (eg complainant,
‘ogulators) shall be confidential between the customer and the laboratory. The provider (source ofthis
{information shall be confidential to the laboratory and shall not be shared wth the customer unless
agreed by the source.
424. Personnel, including any committee members, contractors, personnel of external bodies,
Individuals acting onthe laboratory's behalt, shall keep confdental al informsion obtained or created
©} ditional information that may be required by spectic methods, authorities, customer gr0ups
ot eustomers. os
©
Y
783.2 Where the laboratory is responsible for the sampling activity, test septs shall meet the
equtement sted 75 where necessary for the interpretation fest esl
7A Specificrequirements fr calibration certificates
ion
7.8441 In addon to the requirements sted In 222, calbrafon cetirates shall include the
folowing
2). the measurement uncertainty of the measurement reslg sented in thesame unit as tat ofthe
Imeaurandorin aterm elatvetothemeasurand (eg en
NOTE Acorn to 50/1 uid 95, ameasureKQT ests eral expressed asa singe measured
{uotry ve ncludinguni of mensremest and @gSsuremen sna
1b) the conditions (¢, environmental) under yibich the calibrations were made that have an influence
6. statement identifying how the meaSbrements are metrloialy traceable (se nes.
6) theres before and ater anystmet or reat fave
© where relevant a statement
where appropriate pions and interpretations (se 262)
nfrmty wth requementsrsetxtons (ee 2.6
7842. whereseafinay responsi forthe sampling acinar cetintesshl meet
‘Bevequremesht nL her nee te erp aes esa
7.843 A difration certificate or calibration label shall not contain any recommendation on the
calibratjag}nterval except where thishas been agreed with the customer
“
2agSteprng spectre
Gere the laboratory is responsible forthe sampling ativity in ation oth requlrements sted in
128.2, reports sal include the fllowing, where necessary forthe interpretato of results
4) the date of sampling
unique identification ofthe item or material sampled (including the name othe manufacturer, the
model or type of designation and serial numbers as appropriate)
6) thelocation of sampling, including any diagrams, sketches or photographs;
48) areference tothe sampling plan and sampling method
6) detals of any environmental conditions during sampling that affect the interpretation of the
results;
16 LO STAIOARDS MALAYSIA2018- Argh send ‘Ms ISOIEC 17025:2017
1) Information required to evaluate measurement uncertainty for subsequent testing or cabration
86 Reporting statements of conformity
7.8.1 When a statement of conformity to a specification oF standards provided, the laboratory shall
document the decision rule employed taking into account the level of risk (ach as fle accept and false
‘reject and statistical assumptions) assocated with the decision rule employed, and appl the decsion rule,
Nore are econ rues prserbdby the eustomerregltions rormati uments a
7.862 The laboratory shall report on the statement of conformity, such thatthe on leary
identi: ce
8). towhich results the statement of conformity apples, e
1) which specifications, standards or parts thereof are met or not met:
6 the decison rule ple (alesis ineentn the requested speiiao standard)
NOTE fertrtheriefrmates,seISOMEE Gale 98-4
7.87 Reporting opinions and interpretations SS
&
7.8.7. When opinions and interpretations are spent laboratory shall ensure that only
personnel authorized forthe expression of opinions and itr pretatons release the respective statement
{he laboratory shall document the basis upon which thgepions and interpretations ave been made.
NOTE tis ingot to dtingsh opens gfSnerpeatns om semen nspectns 28
roduc certains as tnd in S0/EE 17QAQQAA IEC 1706, and from tater of contre a8
Fefered in
2.
7.8.2.2_The opinions and interpretatigS expressed in reports shall be based on the results obtained
from theese raat te pb arty Mente such
7.82.3. When opinions and enn are directly communicated by dialogue with the customer,
sees rained
788 Amendments @Feports
7.88.1 When afliSued report needs tobe changed, amended or reissved, any change of information
shall be clear @enuited and where appropriate, the reason fr the change included nthe repo.
Ss
7.88.2 gnendments toa report afer issue shall be made only inthe form ofa further document, oF
data diner, which includes the statement ‘Amendment to Repor, serial number. or as otherwise
‘dentnedy,or an equivalent form of wording,
Such amendments shall meet all the requirements of this document.
7.98.3 When itis necessary ta issue a complete new report, ths shall be uniquely denied and shall
contain a reference tothe original that it replaces
7.9 Complaints
7.9 The laboratory shall have a documented process to receive evaluate and nake decislons on
complains.
‘sranoARDS MALAYSA 018A gleaned ” MS ISONEC 17025:2017
7.92 A description of the handling process for complains shall be avalable to any interested party
‘on request Upon feceipt ofa complaint, the laboratory shall confirm whether the complnint relates
te laboratory scivities that itis responsible for and I's, shall deal with I. The laboratory shall be
responsible forall decisions tall level ofthe handling process for complaints.
7.9.3 The proces for handling complaints shall include atleast the following elements and methods
1) description ofthe process for receiving validating, investigating the compint, ad ta what
Setions are tobe taken in respons to
1b) tracking and recording complaints, including actions undertaken to resolve them: s
6) ensuring that any appropriate action is taken. ©
7.94 ‘The laboratory ceciing the compli shall be cesponsble for gathGigd and veiping al
hecessary information to validate the complaint.
79 Whenever posible the laboratory shall acknowledge receipt of RS omplaint and provide the
complainant with progress reports andthe outcome. oO
7.96 The outcomes to be communicated to the complainan@sfall be made by, or reviewed and
Aoproved yds) ot valved i he gal abraepactties inquest.
NOTE Thiscanbe performed by external personnel ws
79.7 Whenever possible the laboratory shall xem notice o the end ofthe complaint handling
tothe complainant. Rd
s
7.40 Nonconformingwork <<
‘7404. The laboratory shall havea probeQure that shall be implemented when any aspect ofitslaboratory
‘ctities or results of his work do ox conform to its own procedures or the agred requirements of the
customer (eg equipment or engonmental conditions are out af specified lms, results of monitoring
iBttomeat shedted cere procelure shall ensure at
a ‘terrane Panter forthe manage of ncotorming trae dei
1) actions (inca atting or repeating of work and withholding of reports as necessary) are based
Sooner catia by eatery
om ears ofthe significance ofthe nonconforming wor inching an impact analysis
4 eta on the actly the nonconforming works
82 Management system documentation (Optio A) we 821 Laboratory management shall etabish(Vocument, and maintain polides and objectives for the fulfilment ofthe purposes af this ‘and shall ensute thatthe polices and objectives are acknowledged and implemented at al levefSgt the laboratory organization. 82.2 The policies and objectives sui Sdress the competence, impartiality and consistent operation ofthe laboratory. S So 22 Laboratory manage shall provide evidence of comment to the development and Implementation ofthe mangyement system ando continually improving is eetveness 824 Alldocumetigtion, processes, ystems, record rested to theflment the requirements of this document gle incuded in eerened fom, o inked the management stem < 825 All gérSonnel involved in laboratory activites shall have acess to the pars ofthe management System odementtion and elated information tat are appleable to ther responsible. 2g Konto of management tom dco (pon 83:1 The laboratory shall contol the documents (internal and external) tha relate to the fulsment of this document [NOTE In this content, “documents” can be poy statements, procedures, speciation, manufacturer's Instructions calibration tables, chart, textbook, posters noices, memoranda, drawings plans et. These can beonvorivemediasuchashard copy o digital, {83.2 Thelaboratory shall ensure that 4) documents are approved fr adequacy prior to isue by authorized personne 20 ‘© STANDARDS MALAYSA2018- ieee Ms ISOEC 17025:2017 1) documents are periodieally reviewed, and updated as necessary ©) changes and the current revision status of dacuments are identified; 1) relevant versions of applicable documents are available at points of use and, where necessary, thei Aisteibution is controle; ©) documents are uniquely identified 0) aed se of st ncaments preven ute ection ceeds them they are retained for any purpose. ~ » 8.4 Control of records (Option A) 241M arti shal esalsh andes lepble reads demonstrate, 5f _ requirements in this document, Ri 842 The laboratory shall implement the controls needed for the identically, sorage, protection, ‘acieup, archive, retrieval retention time, and disposal fits records. The shall retin records for a period consistent with its contractual obligations. Access to these recurs shall 3e consistent with ‘Secondo commitnents and rears Sal be rend aatale,> NOTE Addons requirements raring technical records are gag o 85 Actions tauddress risks and opportunities (Opyah A) 854, tehbonoy short is andopee essed ebb ota K ss 4) lve assurance thatthe management systaPiewes ts intended results; 1b) enhance opportunities to achieve the pihose and objectives ofthe laboratory; 0. vnc dine pt resin the laboratory activities: achieve improvement Ss 852 The lbortory shal 2), actlnsto adress GSE risks and opportune > rows: tg iptemen hs ans manage sytem: - _guterneetectvensot these actions woreOintoush this acumen species ta the bua plans actions to ares sks, tere 0 equrtment for formal methods fr risk management o documented risk management process Laboratree an decide whether or not to dvelop a mae extensive rk management methndsiogy tam srequted by thie locament ex through the appieation of ober guidance or standards. 85:3 Actions taken to address risk and opportunites shall be proportional to the patential impact on the validity ofaboratory results NOTE options to address risks can neue identifying and avoiding threats taking skin order to pursue an ‘opportunity eliminating the esksouree changing the ksthod or consequence, sharing ters, o eaiing Fok by informed detsion. STANDARDS UALAYSIA2018- Aah eee 2 Ms ISONEC 17025:2017 NOTE2 Opportunites canleadto expanding the scope ofthe laboratory sci, dressing new customers, Using ew technology ad ates posibiis ta address customer needs 86 Improvement (Option A) {861 The laboratory shall identify and select opportunities for Improvement and implement any necessary ations. NOTE Opportunities for improvement can be ientifed through the review ofthe operational prgedres, These ofthe pecs overactive auditresuts corrective acon, managemen; review, SURES FOR personel rekasessment, anaes of data and profiency testing esis {862 The laboratory shall seek feedback, both postive and negative, from its custagep/The feedback Shall be analysed and used to improve the management sytem, laboratory agiis and customer NOTE Bxamplrofthetpeseffeedbac ince cstmer sattctonsuryys/emmuicaton errs ad Tove ofrepors wth costumers ww Se 8.7 Corrective actions (Option A) eS Ah er 2 concernant asap OSS Mateetewcomiioma + 2 eee eK x 0) eat thened or action emg cose ofthe onconormty nord that oes not ‘recur or occur elsewhere, by: _ — reviewing and analysing pi Ronconformty, determining the caugefbf the nonconfortity; Teenie GS ncn of ay omen ay dS a «review theghiettiveness of any corrective action taken: 9. updatg¢d8s and opportunities determined during planning ifnecessary bgt enmacmsyen rc gb? coe sss els entra 13 The laboratory shal retain records as evidence of 4) thenature of the nonconformitescause(3) and any subsequent actions taken: 1) theresuts of any corrective ation. 2 STANDARDS MALAYSIA 2086 -Alighsstied MS ISONEC 17025:2017 ‘8.8 Internal audits (Option A) 881 The laboratory shall conduct internal audits at planned intervals to provice information on ‘whether the management system: 3) conforms to — the laboratory's own requirements for its management system, Including the laboratory activities » . a 2) plan, establish implement and maintain an audit prograrame including the §Ymaency, methods, "sponse anning requirements an reporting, whch hal ak action he imporeance ofthe aborator actives concerned changes affecting the ator and the rests of previous audits oe 'b) define the audit criteria and scope for each audit; oO € envurtha the res ofthe ads arreprtedto eleven xSdpment a implemen propa corectn andcorecive segue de 6) retainrecrdsas evidence ofthe implementation of ag Sct programme and the audit results NOTE 15019011 provides guidance or internat aud provides aes 8.9. Management reviews (Option a), AS Q aoa ese cot a es ‘ensure ts continuing suitability, adlequacyand effectiveness including the sated polices and objectives Felted tothe fltiment ofthis doce sS “ 8.92 The inputs to manager review shall be recorded and shall include information related to the aan oS a changes in internafudd external issues that are relevant tothe laboratory; anager “ cies and procedures; 9) Scome ofrecentinternal audits 1) corrective ations 8) assessments by external bodies; 1h) changes in the volume and type ofthe work or inthe range of laboratory activities 1) customer and personnel feedback, i) complaints; 1) effectiveness of any Implemented improvements .eTANOHROS MALAYSIA2018- Aste mend 23 (Ms ISONEC 17025:2017 1) adequacy of resources; rn) results of isk identification; 1) outcomes ofthe assurance ofthe validity of results: and 1) other relevant factors, such as monitoring activities and training {893 The outputs from the management review shall record all decisions and ction relate to a eas 4) thecffectiveness ofthe management system and ts processes » som e provision ofrequired resources oO any need for change. u Ce sTAoaRDS MALAYIA218-A peer Ms ISONEC 17025:2017 Annex A (informative) Metrological traceability AA General eral RS ‘This annex provides additional information on metrological traceability, which is an import yncept eases daar eaten ee nee A2 Establishing metrological traceability as A2A_ Netrological traceability is established by considering, and then engefn) the llowing a} the specification ofthe measurand (quantity to be measured); the spe (quantity % go ©) documented unroken cnn of calrationsgung back afd an spree references iaoropriteelrences ce nna otra sets din a €) it meatrenn encray foredh tpn the Sy han eed acd agreed methods, 2 4) that each step of the chain is performed in geQordance with appropriate methouls, with the measurement results and with associated, wasurement uncertainties, =<, “s {ken ito actount to disseminate pologal uaceality to measurement resue tthe ubortors oa associated uncertaintbs) are sometimes Used to disseminate metrological traceability Ths approach, in which the specigtin limits are imported as the source of uncertainty, is dependent upon: = the ghecicaton limits subsequently belng treated in a technically appropriate way in the ungertinty budget ‘Thetechnica bass or tis approach that the declared conformance to aspecifiatien defines rane ofmeasurementvaies within which the tre vue is expected tle at a pecfed eel of confident ‘which considers bothany bas rom thetrucvahie aswel asthe mesoutemen cern EXAMPLE The useofO1ML R111 cass welghts to calibrate balance A3- Demonstrating metrological traceability A341 Laboratories are responsible for establishing metrological traceability in accerdance with this document. Calibration results from laboratories conforming to this document provide metroogleal Staion LAYSIAZ08- Age send as ‘Ms ISONEC 17025:2017 teaceabily. Certified values of certified reference materials from reference material producers Conforming to ISO 17034 provide metrological waceabity. There are various ways to demonstrate onformity with this document: third party recognition (such as an accreditation Body), external ‘SSeessment by customers or sel-assessmentlnternationally accepted pats include, Dut are not imited tothe following. ') Calibration and measurement capabilities that have been acredited by an a Subject to the ILAC (International Laboratory Accreditation Cooperation) Regional Arrangements recognized by LAC have demonstrated metrologic ‘credited laboratories are publicly availble from their respective accredva ‘83.2 The Jone BIPM, OM (ternational Ogniation of gat Metin), LAC and 180 Decarton sa netrologleal Traceability provides specific quldance when there Isa.eedto demonstrate international cceptablity othe metrological traceability chai, ‘2 26 Le STAIOAROS MALAYSAZO8-Aegeseed Ms ISONEC 17025:2017 Annex B informative) Management system options B.A. Growth Inthe use of management systems generally bas Increased the nd to ensure Uaortos can operate a managenent scm ta sete conorming to 160 001, a ag to ths document A's rut, tis Wocumen proves two opto for the ruremens raps Ue implemenntonfaanagenen ten: ee B2_ Option A (see 8.3.2) lists the minimum requirements for implementation of amiagement system tha uborory. Care his been ent incorporate al use erent of 190900 a are relat se ea iin cs coved the meet gm Lehre t coy ith ls Zand plement pion hf Cas wil rep operate erly ‘Stordance wth the pines BD S00 eS J 13 option Be 13) allows labrtores to esbish and malan 4 manaement sytem in Sree ie egenens of 0 SEO ne Oe Reports a one ent nn of cs ti & Lavras hat mpeg nice Battaue ea eee Slko operate in accordance with 180 9001, Conformity ean System within which the i laboratory operates tothe requlrements of $0 9001 does Nat, nitsell, demonstrate he competence of the laboratory to produce techalcaly valid data an “This is accomplished through compliance ‘with Causes to 2. s 24 both options are Intended to achieve {Bane result nthe pefrmance of the management Smtemandconplance witlaseaa 9 $ NOTE Documents, dats and seats of documented information as wie in 150.9001 and ‘other management system standards capt dncusent covered inf. the contol of eordsis covered a Ishoratory ative iscovered in Z1L LE STANOHROS MALAYSIA 2018- Alri etre n MS ISOMEC 17025:2017 BS Figuce BL illustrates an example of a possble Schematic representation of the operational rocesses of laboratory, as described i Clause 2 28 STANDARD WALAYAAZ01-A ahead Ms ISONEC 17025:2017 Bibliography [1] 1S0 57254, Accuracy (trueness and precision) of measurement methods and results — Part I: General principles and definitions (a) 18057252 Acay ree and precio) ofmensrement methods apd ress — Part 2 Bai eto deermnetin of eet and ero andar mearrent tod [B] 180 5725-3, Accuracy (trueness and precision) of measurement methods and results — Ss cae oe a ae te e [4] 180.5725-4, Accuracy (trueness and precision) of measurement methods and restits rtf dann sn estan mee 15} 18057256 Accuray(reness and precio) of measureent method and FN in practice ofacuracy values {61 150.9000, uoliy management systems — Fundamentals ond voeabujag Pore 6: Use 17] 1809001, Quality managementsystems— Requirements (8.10012, Meer: management tons — Rouen or mensrne: process and measuring equipment 19] So/tC12207, tems and software enincering—gpPiere fe de process {10} 1S0 15189, Medica! laboratories — Requirement [11] 180 15194, tn vitro diagnostic medical iS Boll erin Requirement for ee ree enforiyessnentbotes 113} IOytEC 1702, conormiyeSSimen — Requirements forthe operation of aroustype of bos rn pce (8) sojtz 7014, gmty asesment — Reqrenen for buds prong ee ond Caan eens Par Rass jualty and competence Measurement of quantities in samples of rence materials ond the content of supporting [as] 18017034, hp requirements forthe competence of reference ‘material producers 16 wore onformiy esesment— Genera requirments or pofieny xing by g817065, Conformity assesment — Requirement for bodies certifying products, processes 8) Sonn Inver dagnostiemediel deviees — Measurement of uantiiesin bei samples — ‘Merological traceability of values assigned to calibrators nd contrl materials 119} 15019011, Guidelines for audting menagement systems [20] 180 21748, Guidonce for the use of repeatbiliy,reproducbiey and trumess estimates in measurement uncertainty evaluation [21] 150 31000, Risk management — Guidelines [22] 180 Guide 30, Reference materials — Selected terms and definitions STANDARDS MALAYSIA 218-Aliemaened 2 (Ms ISOnEC 17025:2017 ps} eq ps} 26) en (28) ea) (20) ia) (32) a) Ba (5) SO Guide 31, Reference materials — Contents of eertfleates, labels and accompanying documentation 150 Guide 33, Reference materials — Good practice in using reference maerals 150 Guide 35, Reference materials — Guidance or characterization and asessment of omagenelty ‘nd stably 10 Guide 80, Guidance or the inhouse preparation of quality contro! me:erials (QCMs) 'S0/1BC Gude 98-3, Uncertain of measurement — Port 3 Guide to the spresonofiertanty ‘nmeasurement (GUM:1995) Ss IE ae 84, Ur of meme — Pr ao eng) ery in tte IB Gd 15, pplication of uncertsintyof easement to conforma Sedesent aces the electrotechncal sector ah! Join BIPM, OL, LAC and 10 dedaraion on metrological rae, 2011 Internationa Laboratory Acredtaton Cooperation (LAC) ‘mcernaional ocobuloryof terms in egal metrology (VIYGHOINL Vi: 20'S Ie 01a, eatin of meanenee eacS The role of measurement uncertaney in conformity assessment 2) apoio tls /comnan/pdl/BIPM-DIML-ILAC:IS0 int dlration 2011. 3) tuna 4) ns musurache org /images/stes/Caldes/pd/EEE RM. DG ple 5) n/wushigmors/en/oublicaons/tbochutel 30 ‘2 ermennoe INLAYS 2016- Ata eenes ‘Acknowledgements Members of Technical Commitee on Conformity Assessment Dat FadohBaharin Chan) Deparment of Standards Malaya Ns ogee emp Secretar) Sir Berhad Me Cag Kuang Hog! Constucon nds Deeper Sours SS Mc Rotana Abd Manan Malla ~ We Syed azn Ab Gan Conston Research nse ot a Ne Atmad azn Abas Rabin “Oo NeVienSdorg Wan One! Department of Chemisty, Upap Me Roses Saad! ic eee S Me Row Egg Ry cerns US Ne Tan Wa Keong” Insect Quel Malaya Me Joison Bo Tan in 2 Ne Sara Janes laysaeSectaton of Sandards Vers Me Parama lower SIRIMGRS Intemational San Bha Ne Nur Fadhlan Mena ‘ Me Data Katara! @ We Basen H Searal! 3 Newend Harm imam Musin—_S ‘ove riaanat San ng g@SY net Para ala toneareatn ter cD Ms Roe Tain ° Members of Working Graon Revision of SOMEG 17025 vn aoa ena Caan) Supa. Stes Naays Meonerirs tad raSsteeccay) Snr Bed tihorhanater Chee pref has, ays We ieee Deprnertt Standards ayia Me Sais Sana Pores Researches Naya Drie Nec a aah’ Inept Sora Sian Se Mtr Ko Phong!You might also like
