General requirements for the

competence of Testing and

Calibration Laboratories
Presentation by
B. Sudarsan
Lead Assessor - NABL

Contents of IS ! I"C #$%&' ( #)))
&. Scope
*. Normati+e ,eferences
-. Terms and .efinitions
'. /anagement ,equirements
0. Technical ,equirements
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#. SC1"

Specifies requirements applicable to Testing !

Calibration laboratories

Notes gi+en in the standard are for guidance and

do not contain requirements

Standard is meant for use b2 laboratories3

clients3 accreditation bodies etc.

Compliance 4ith the regulator2 and safet2

requirements are not co+ered b2 the standard5

Compliance 4ith this standard ensures

compliance 4ith IS )%%# ! )%%& (#))-
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5 &. N,/ATI6" ,"7","NC"S
IS )%%# (#))- 8ualit2 S2stems 9 /odel for
8ualit2 Assurance in .esign3 .e+elopment3
1roduction3 Installation and Ser+icing
IS )%%& (#))- 8ualit2 S2stems 9 /odel for
8ualit2 Assurance in 1roduction3 Installation
and Ser+icing
IS ! I"C Guide & ( General terms and their
definitions concerning standardi:ation
6I/( International 6ocabular2 of basic and
general terms in metrolog2
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*. T",/S AN. ."7INITINS

Terms gi+en in IS! I"C guide & and 6I/

are applicable

Also terms gi+en IS ;-%& ( #))- are

applicable for general definitions
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-. /ANAG"/"NT ,"8<I,"/"NTS
-.# rgani:ation
-.& 8ualit2 s2stem
-.* .ocument control
-.- ,e+ie4 of requests3 tenders and contracts
-.' Subcontracting of tests and calibrations
-.0 1urchasing ser+ices and supplies
-.$ Ser+ice to client
-.; Complaints
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-. /ANAG"/"NT ,"8<I,"/"NTS 9contd.
-.) Control of non-conforming testing! calibration
-.#% Correcti+e actions
-.## 1re+enti+e actions
-.#& Control of records
-.#* Internal audits
-.#- /anagement re+ie4s
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-.# ,GANI=ATIN
-.#.# Laborator2 ! organi:ation shall be an
entit2 that can be held legall2 responsible
-.#.& Laborator2 to carr2 out acti+ities to meet the
requirements of this standard3 clients3
regulator2 authorities and organi:ations
pro+iding recognition
-.#.* /anagement s2stem to co+er permanent3
temporar2 and mobile facilities
-.#.- If laborator2 is part of an organi:ation
ha+ing different acti+ities3 responsibilit2 of
>e2 personnel shall be defined
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-.#.' The laborator2 shall ha+e
b? /anagerial and technical personnel
c? 1olicies and procedures to ensure personnel are
free from undue pressures
d? 1olicies and procedures to ensure protection of
client@s confidential information
e? 1olicies and procedures to a+oid in+ol+ement in
an2 acti+ities that 4ould diminish confidence
f? .efined management structure
g? .efined authorit2 and responsibilit2 and inter-
relationship of personnel

Adequate super+ision of testing ! calibration staff

Technical management

Appointment of 8ualit2 /anger

.eputies for >e2 /anagement personnel

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-.& 8<ALITA SAST"/
-.&.# "stablish3 maintain and implement 8ualit2
S2stem appropriate to the scope of acti+ities
4.2.2 8ualit2 S2stem 1olicies and bBecti+es
shall be defined in 8ualit2 /anual. 8ualit2
1olic2 shall be issued under the authorit2 of
chief eCecuti+e and shall Contain
h? Commitment to good professional practices
i? Statement of laborator2@s ser+ice
B? bBecti+es of 8ualit2 S2stem
>? ,equirement that personnel concerned get
familiari:ed 4ith 8ualit2 S2stem
l? Commitment to compl2 4ith IS!I"C #$%&'(#)))
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-.&.* 8ualit2 /anual shall include ! refer to
supporting procedures and outline structure
of 8ualit2 S2stem
-.&.- .efined responsibilit2 and authorit2 of
technical management and 8ualit2 /anager
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-.* .C</"NT CNT,L
-.*.# G"N",AL
1rocedure for .ocument Control3 co+ering
documents of internal and eCternal origin5
-.*.& .C</"NT A11,6AL AN. ISS<"
-.*.&.# Appro+al of .ocuments b2 authori:ed
personnel. /aintenance of /aster List5
-.*.&.& The procedure shall ensure that
i? A+ailabilit2 of authori:ed appropriate documents
B? 1eriodic re+ie4 and re+ision as needed
>? ,emo+al of obsolete! in+alid documents
l? Suitable identification of obsolete document
retained for >no4ledge! legal purposes
-.*.&.* <nique identification( date. ,e+ision status3
page number and number pages
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-.*.* .C</"NT CDANG"S
-.*.*.# Appro+al of changes b2 the same agenc2 as
original issue or authori:ed other4ise
-.*.*.& Identification of changes either on the
document or on attachments
-.*.*.* If manual corrections are permitted define the
same in the procedure
-.*.*.- If documents are maintained on computer
memor2 define the controls
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-.- ,"6I"E 7 ,"8<"STS3 T"N.",S AN.
CNT,ACTS
-.-.# "stablish and maintain documented procedure
for re+ie4 of requests3 tenders and contracts for
testing ! calibration. The procedure shall co+er
f? "nsure that the requirements are adequatel2
defined3 documented and understood
b? Laborator2 has the capabilit2 and resources to
meet the requirements
c? Selection of appropriate test! calibration method.
,esolution of differences bet4een contract and
tender3 if an2
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-.-.& /aintenance of records of re+ie4
-.-.* ,e+ie4 also to co+er sub-contracted 4or>
-.-.- Client to be informed an2 de+iation
-.-.' Amendments to a contract shall also to be
re+ie4ed and communicated
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-.' S<BCNT,ACTING 7 T"STS AN.
CALIB,ATINS
-.'.# If laborator2 sub-contracts the 4or>3 this
shall be done on suitable subcontractors(
satisf2ing the requirements of this standard
-.'.& Information to client on such arrangement
-.'.* Laborator2 shall be responsible for
subcontractor@s 4or>
-.'.- /aintenance of register of subcontractors
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-.0 1<,CDASING S",6IC"S AN. S<11LI"S
-.0.# 1rocedure for selection and purchasing of
ser+ices and supplies that affect qualit2 of
tests! calibration
-.0.& <se of purchased materials onl2 after
inspection ! +erification
-.0.* ,e+ie4 and appro+al of purchase documents
before release
-.0.- "+aluation of suppliers and maintenance of
records F for critical materials?
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-.$ S",6IC" T CLI"NT
Laborator2 shall afford client cooperation to
clarif2 client@s request and monitor performance
of laborator2 in relation to 4or> performed and
protect confidentialit2 of other clients
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-.; C/1LAINTS

1rocedure for resolution of complaints from

clients and other parties

/aintenance of ,ecords of Complaints

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-.) CNT,L 7 NNCN7,/ING
T"STING! CALIB,ATIN
-.).# 1rocedure for dealing 4ith nonconforming
testing! calibration. The procedure shall ensure
e? Authorit2 for management of nonconforming
4or> to be defined
b? "+aluation of nonconforming 4or>
c? Notification to client3 if needed
d? .efined responsibilit2 for resumption of 4or>
-.).& In case of possibilit2 of recurrence 3 initiation of
suitable correcti+e action
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-.#% C,,"CTI6" ACTIN
-.#%.# 1rocedure for implementing Correcti+e Action
-.#%.& Cause Anal2sis - In+estigation of root cause
-.#%.* Selection and implementation of Correcti+e
Action

Selection and implementation of most suitable

Correcti+e Action

.ocument and implement an2 changes as result

of Correcti+e Action
-.#%.- /onitoring of Correcti+e Action
-.#%.' Additional Audits3 4here needed
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-.## 1,"6"NTI6" ACTIN
-.##.# Identification and implementation of
1re+enti+e Actions
-.##.& 1rocedure for 1re+enti+e Action shall
include initiation and control
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-.#& CNT,L 7 ,"C,.S
-.#&.# G"N",AL
-.#&..#.# 1rocedure for 8ualit2 and Technical
,ecords Fidentification3 collection3 indeCing3
access filing3 storage3 maintenance and
disposal ?
-.#&.#.& ,ecords shall be legible
-.#&.#.* Securit2 of records
-.#&.#.- 1rocedure for protection and bac>-up
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-.#&.& T"CDNICAL ,"1,TS
-.#&.&.# ,ecords of original obser+ations3 deri+ed
data and personnel responsible for chec>ing
-.#&.&.& bser+ations3 data and conclusions shall be
made 4hen the2 are made
-.#&.&.* Ehen mista>es occur the changes are entered
after crossing the original obser+ationG not b2
erasing
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-.#* INT",NAL A<.ITS
-.#*.# Internal Audits as per predetermined
schedule and procedure
H All elements of 8ualit2 S2stem shall be co+ered
8ualit2 /anager to ensure conducting audits
H Audits b2 qualified and trained personnel3 if
possible independent of the area being audited
C2cle time for audits is usuall2 # 2ear
-.#*.& Timel2 correcti+e action and notification to
client3 if needed
-.#*.* ,ecords of Internal Audits
-.#*.- 7ollo4 up audit to +erif2 effecti+eness of
correcti+e actions
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-.#- /ANAG"/"NT ,"6I"ES
-.#-.# 1redetermined procedure and schedule for
/anagement re+ie4. The re+ie4 shall co+er

Suitabilit2 of policies and procedures

,eports from /anagement and super+isors

utcome of Internal Audits

Correcti+e and 1re+enti+e actions

Assessment b2 eCternal agencies

Inter-laborator2 comparisons! proficienc2 testing

Changes in +olume and t2pe of 4or>

Client feedbac> ! complaints

-.#-.& ,ecords of /anagement ,e+ie4 and follo4
up for actions
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'. T"CDNICAL ,"8<I,"/"NTS
'.# General
'.& 1ersonnel
'.* Accommodation and en+ironmental conditions
'.- Test and calibration methods and method
+alidation
'.' "quipment
'.0 /easurement traceabilit2
'.$ Sampling
'.; Dandling of test and calibration items
'.) Assuring qualit2 of test and calibration results
'.#% ,eporting the results
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'.# G"N",AL
'.#.# 7actors affecting calibration ! Test results
'.#.& All these shall be ta>en into account 4hile
de+eloping procedures3 selection of equipment
and training of personnel
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'.& 1",SNN"L
'.&.# 1ersonnel performing specific tas>s shall be
qualified on the basis of education3 training3
eCperience and s>ills
'.&.& 1olic2 and procedure for identif2ing training
needs and pro+iding training
'.&.* "nsure that contracted personnel 4or> in
accordance 4ith laborator2@s 8ualit2 S2stem
'.&.- /aintenance of Bob description of technical3
managerial and >e2 personnel
'.&.' Authori:ation for sampling3 testing!
Calibration.
Issue of certificates3 interpretations! opinions3
operation of particular equipment
/aintenance of ,ecords of qualifications3 training
and s>ills of personnel
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'.* ACC//.ATIN AN.
"N6I,N/"NTAL CN.ITINS
'.*.# Technical requirements of accommodation and
en+ironmental conditions affecting testing!
calibration shall be documented and controlled
'.*.& /onitor3 control and record en+ironmental
conditions
'.*.* "ffecti+e separation bet4een neighboring
areas
'.*.- Controlled access to testing! calibration areas
'.*.' Good house>eeping

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'.- T"ST AN. CALIB,ATIN /"TD.S
AN. /"TD. 6ALI.ATIN
'.-.# G"N",AL

<se of appropriate methods for tests !

calibration

These include sampling3 transport3 storage3

estimation of uncertaint2 etc.

A+ailabilit2 of up to date instructions3

standards3 manuals and data at 4or> places
'.-.& S"L"CTIN 7 /"TD.S

<se of published methods! procedures

<se of +alidated laborator2 de+eloped methods

Information to client 4hen client suggested

method is inappropriate

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'.-.* LAB,AT,A ."6"L1". /"TD.S

1lan for de+elopment of test! calibration

methods

Assignment of acti+it2 to qualified personnel

<pdating of plan as the de+elopment proceeds

5
'.-.- NN-STAN.A,. /"TD.S

<se of non-standard method is subBect to

agreement b2 client

6alidation of such methods before use

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'.-.' 6ALI.ATIN 7 /"TD.S
'.-.'.# 6alidation is the confirmation b2
eCamination and pro+ision of obBecti+e
e+idence for suitabilit2
'.-.'.& 6alidation of non-standard3 laborator2
de+eloped methods. /aintenance of
records of +alidation
'.-.'.* ,ange and accurac2 obtainable from
+alidation methods to suit client@s needs

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'.-.0 "STI/ATIN 7 <NC",TAINTA 7
/"AS<,"/"NT
'.-.0.# 1rocedure for estimation of uncertaint2 of
measurement in all calibrations
'.-.0.& 1rocedure for estimation of uncertaint2 of
measurement in testing3 to the eCtent possible
using statistical methods
'.-.0.* Consideration to all components in uncertaint2
estimation
'.-.$ CNT,L 7 .ATA
'.-.$.# Chec>s on calculations and data transfers
'.-.$.& Suitable controls 4hen data is acquired and
processed through computers or automated
equipment

'.' "8<I1/"NT
'.'.# A+ailabilit2 of necessar2 equipment
'.'.& "quipment and soft4are shall be suitable
for achie+ing the required accurac2.
"stablishment of calibration programme
'.'.* peration b2 authori:ed personnel using
up to date instructions
'.'.- <nique identification of each item of
equipment
'.'.' /aintenance of records of equipment
'.'.0 1rocedures for safe handling3 transport3
storage3 use and planned maintenance
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'.'.$ ,emo+al from ser+ice subBected to
o+erloading! mishandling. <se of such
equipment onl2 after chec>ing or calibration
after repair
'.'.; Indication of calibration status on the equipment
'.'.) Ehen an equipment goes outside the control
of the laborator23 chec>ing calibration
+alidit2 before reuse
'.'.#% Intermediate chec>s as per defined procedure
'.'.## 1rocedure to ensure application of correction
factors 4here needed
'.'.#& Safeguarding equipment against unintentional
adBustments

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'.0 /"AS<,"/"NT T,AC"ABILITA
'.0.# G"N",AL

Calibration of equipment before use

A programme for calibration

'.0.& S1"CI7IC ,"8<I,"/"NTS
'.0.&.# Calibration
'.0.&.#.# Calibrations traceable to International
S2stem of <nits FSI <nits?
'.0.&.#.& Ehere there is no possibilit2 of use of SI
units3 establishment of measurement
traceabilit2 through

<se of certified materials and specified methods

Inter-laborator2 comparisons

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'.0.* ,"7","NC" STAN.A,.S AN. /AT",IALS
'.0.*.# ,eference Standards

1rogramme for calibration of reference

Standards

<se onl2 for calibrations

Calibration before after adBustments3 if an2

'.0.*.& ,eference /aterials

,eference /aterials traceable to SI units3

4here+er possible
'.0.*.* Intermediate Chec>s

Intermediate chec>s as per defined procedures

and schedules
'.0.*.- Transport and Storage

1rocedures for safe handling of reference

materials3 reference standards

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'.$ SA/1LING
'.$.# Sampling 1lan ! procedure for sampling 4here
needed. This shall be based on appropriate
statistical techniques3 4here possible
'.$.& Ehere client 4ants de+iation to the procedure
necessar2 details shall be included in all
documents related to testing! calibration
'.$.* 1rocedures for recording rele+ant data on
sampling carried out

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'.; DAN.LING 7 T"ST AN. CALIB,ATIN

IT"/S
5.8.1 1rocedure for transportation3 receipt3 handling3
protection3 storage3 retention and disposal of
items recei+ed for testing! calibration
'.;.& A s2stem! procedure for identification of test!
calibration items
'.;.* ,ecording abnormalities of items3 if an2 and
consultation 4ith the client for necessar2
further instructions! action
'.;.- 1rocedure for a+oiding deterioration during
handling3 storage and preparation

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'.) ASS<,ING TD" 8<ALITA 7 T"ST AN.
CALIB,ATIN ,"S<LTS

<se of qualit2 control procedures for monitoring

the +alidit2 of test! calibrations

/onitoring ma2 include3 but not limited to

<se of certified materials

1articipation in inter-laborator2 comparisons!

proficienc2 testing

,eplicate testing

,e-testing ! re-calibration of retained items

Correlation of results for different characteristics

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'.#% ,"1,TING TD" ,"S<LTS
'.#%.# G"N",AL

,eporting the results clearl2 and obBecti+el2 in a

Test ! Calibration ,eport form

In case of internal client or special agreement

4ith client the results ma2 be reported in a
simplified 4a2G ho4e+er complete information
Flisted in '.#%.& 9 '.#%.-? shall be maintained b2
the laborator2

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'.#%.& T"ST AN. CALIB,ATIN C",TI7ICAT"S

Test ,eport! Calibration Certificate shall contain

Title FTest ,eport! Calibration Certificate?

Name I address of the laborator2

<nique identification Fli>e serial number?

Name I address of the client

Identification of Test /ethod

Condition I identification of Test! Calibration item

.ate of receipt I date of test! calibration

,eference to sampling plan3 if an2

Test! calibration results

Name I designation of persons authori:ing report

A statement to the effect that the results relate to

onl2 the items tested! calibrated

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'.#%.* T"ST ,"1,TS
'.#%.*.# In addition to the abo+e F'.#%.&? Test ,eports
shall contain
d? .e+iations from Test 1rocedures I en+ironmental
conditions3 if applicable
e? Statement of compliance ! non-compliance3 if
rele+ant
f? Statement of estimated uncertaint2
g? pinions! interpretations3 if applicable
h? Additional information required b2 client
'.#%.*.& Ehere sampling is applicable details of date3
method3 en+ironmental conditions etc. shall
be included

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'.#%.- CALIB,ATIN C",TI7ICAT"
'.#%.-.# In addition to the details gi+en in '.#%.&
Calibration Certificates shall include
a? "n+ironmental conditions3 if applicable
b? <ncertaint2 of measurement
c? "+idence measurement traceabilit2
'.#%.-.& Statement of compliance shall include
4hich parameters of specification are met !
not met
'.#%.-.* An2 adBustments! repairs carried out shall
be reported
'.#%.-.- No recommendation on calibration inter+al

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'.#%.' 1ININS AN. INT",1,"TATINS

.ocument the basis of gi+ing opinions!

interpretations

Clear mar>ing of the same in the reports

'.#%.0 T"STING! CALIB,ATIN ,"S<LTS 7,/
S<BCNT,ACT,S

Clear identification of results from subcontractor

'.#%.$ "L"CT,NIC T,ANS/ISSIN 7 ,"S<LTS

Necessar2 controls to protect confidentialit2

4hile transmitting results b2 electronic media
li>e faC3 telephone etc

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'.#%.; 7,/AT 7 ,"1,TS! C",TI7ICAT"S

Suitable format for test! calibration report!

certificate to a+oid misunderstanding
'.#%.) A/"N./"NTS T T"ST ,"1,TS AN.
CALIB,ATIN C",TI7ICAT"S

/aterial amendments to test! calibration reports

through a further report3 gi+ing reference to
earlier report

Amendments shall meet this international

standard