17025 Site Checklist

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American Association for Laboratory Accreditation

C103 – General Checklist: Accreditation of Field Testing and

Field Calibration Laboratories

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The following pages present the requirements from R104 – General Requirements: Accreditation of Field Testing and Field Calibration Laboratories in a checklist format. The policies, procedures and activities of laboratories performing field tests or calibrations must meet these

requirements. Management system documentation and supporting records must be available for the assessor’s review.

(efore the assessment# the laborator) is asked to com"lete all of the document reference identifiers associated *ith the each of the

re+uirements *ithin a thick# black border,

This helps both the laboratory and the assessor(s) prepare for the assessment and may save a significant amount of assessment time and cost. Theappropriate document reference! should include quality manual, laboratory manual, "#$, etc. references. The noted references should specify

procedure number, page number and section number, if possible, where each checklist item is addressed.

A2LA Assessor Instructions: Review the laboratory’s documented management system to verify compliance with the applicable Field Testing!alibration criteria documentation re"uirements# Assess to verify that the documented management system is indeed implemented as

described# $lace a tic% mar% in the yes &'() no &*( or not applicable &*A( space for each re"uirement# $lease note that for all *A indications) you must document the reason why this re"uirement is *A in the comments section# Record comments related to any re"uirement in the space

provided# Assess the laboratory’s technical competence to perform specific tests or specific types of tests# Record comments related totestscalibrations on the testcalibration method review matri+# ,erify that all field testingcalibration personnel and methods have been identified

and submitted to A2LA# All deficiencies must be identified and e+plained in the assessor deficiency report#

© %&' by %* ll rights reserved. +o part of this document may be reproduced in any form or by any means without the prior written permission of %*.

*-hecklists-'&/ 0 1eneral hecklist ccreditation of 2ield Testing and 2ield alibration *aboratories


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To the best of my knowledge, actual laboratory practice has been assessed for compliance with the relevant clauses of R104 – General Requirements:

Accreditation of Field Testing and Field Calibration Laboratories. 3 hereby attest that all 45es’ marked compliance clauses, whether initialed or not, meet the

aforementioned requirements. ny areas of noncompliance have been fully described in the ssessor 6eficiency 7eport.

CA( -ame:

Address:

Contact:

&hone: .mail:

/aster Code: Assessment D:

Certificates2: Conformit) tandard:

Assessment Dates: Assessment T)"e:

Assessors2: Assessor ignatures2:

Ac4:



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3, Definitions3,1 &ermanent Laborator): calibration or testing laboratory erected on a fi8ed location. This is the laboratory location (address) denoted on the scope of

accreditation.

3,$ Authori5ed Field e"resentati!e: The contracted organi9ation performing field service work under the auspices of the accredited laboratory’s scope of

accreditation

3,3 6e) Functions2: These are primary functions conducted by the accredited laboratory (i.e. policy formulation, process and:or procedure development,

contract review, reporting of final results, planning conformity assessments, review, approval and decision on the results of conformity assessments).

3,% Field: ny location where testing or calibration takes place as defined in /. below.

3,7 Field Testing8Calibration: Testing:alibration performed by staff of a laboratory or organi9ation outside of the premises or grounds on which the permanent

laboratory or the organi9ation’s permanent base or headquarters is located. 2ield testing:calibration may include sampling where it forms part of the

documented calibration or test procedure. ccreditation for sampling alone is offered and R2-. / 0pecific Re"uirements: T*I Field 0ampling and

1easurement rgani3ation Accreditation should be consulted for further details.

2ield Tests or alibrations are normally performed under two categories

• 2ield tests or calibrations performed by staff sent out in the field by an accredited, permanent laboratory. This includes in;situ testing'.

• 2ield tests or calibrations performed in the field by organi9ations that do not have a permanent laboratory.

3,9 Field Laborator): testing or calibration laboratory facility set up in a dedicated area location or at a customer’s premises, outside of the organi9ation’s

permanent base or headquarters for the duration of the testing or calibration activities but not for periods e8pected to e8ceed three years (e.g. a onstruction

Materials laboratory set up at an airport construction site, a calibration laboratory under contract set up in support of a customers manufacturing process).

ll field laboratories must be identified on the application paperwork, be assessed as part of the permanent laboratory assessment, and be identified on the

laboratory’s scope of accreditation.

3,9 /obile Laborator): 2ully equipped, self;contained, transportable testing or calibration laboratory capable of performing tests or calibrations under

controlled environmental conditions. mobile laboratory may be a main or branch laboratory and is sub


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3, Definitions cont2

3, ;mbrella Accreditation: form of field service accreditation whereby an accredited laboratory contracts with another party, usually their authori9ed dealers

or representatives, to provide accredited testing or calibration service on their behalf and who serves as a 4e facto field service employee of the accredited

laboratory.

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%,$ M anagement s)stem

.% ".' The quality manual or related quality

documentation of the permanent laboratory or organi9ation

shall contain a section covering the arrangements for the

field testing:calibration, field laboratory and:or mobile

laboratory operations. This shall include

.% ".'.' an up;to;date record of field laboratory and:ormobile laboratory locations and the purpose for which they

were used=



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.% ".'.% details of how the management system is applied

to and incorporates field testing:calibration (e.g., an

organi9ational chart for the permanent laboratory showing

lines of responsibility and authority for field

testing:calibration, etc.) as well as arrangements for the

supervision of field testing or calibrations where the field is

not controlled by the client but rather by a third party.

.% ".'./ identification of approved signatories, criteria for

signatory approval and limits of signatory authority. This

criteria should include an assessment of the following

attributes

• qualifications and e8perience=

• position in the overall staff structure=

• familiarity with the calibration or test procedures

and awareness of any limitations of these

procedures=

• knowledge of the procedures for recording,reporting and checking results=

• awareness of the needs for periodic recalibration of

equipment= and

• awareness of the requirements and conditions for

%* accreditation, particularly those related to

calibration or test reports.



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.% ".% The relevant parts of the quality manual shall be

available to the personnel performing field

testing:calibration.

%,13 Control of records

.'/ ".' $rocedures shall e8ist for recording andreporting all results obtained in the field and shall be

coordinated with the system operating in the permanent

laboratory (where appropriate). 7ecords of original

observations, calculations, data transfers and checks shall be

identifiable by person and date. 7ecords shall be made in a

permanent manner and maintained so that they are not

obliterated by rain, humidity, spills, leaks or other

environmental factors that may affect the immediate or

future readability of the records.

.'/ ".% $rocedures shall e8ist for ensuring the security

and confidentiality of test:calibration data obtained and heldin the field.

%,1% nternal audits

.' ".' 3nternal audits shall be conducted of the

management system implemented for field

testing:calibration, field laboratory, and:or mobile laboratory



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using similar procedures as those applied to a permanent

laboratory.

.' ".% The designated internal auditor shall audit field

testing:calibration activities and shall visit field and mobile

laboratories (when applicable) as part of the internal audit

process. The audit process shall be to the same degree ofrigor as auditing testing:calibration activities at a permanent

facility and shall contain specific elements to assess whether

field tests and:or calibrations continue to comply with the

requirements of the management system.

+#T> for field testing:calibration, a mock! service

demonstration to determine compliance is acceptable in lieu

of an actual field visit. 2ield laboratories and mobile

laboratories may be evaluated by various mean, including

remote demonstrations.

%,17 /anagement re!ie*s

.'? ".' Management review shall take account of field

testing:calibration, field laboratory, and mobile laboratory

activities, as applicable.

7 Technical re+uirements

7,$ &ersonnel



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?.% ".' The permanent laboratory or organi9ation shall

have procedures for ensuring that field testing:calibration,

field laboratory and:or mobile laboratory staff are properly

trained and competent. >vidence of the competence of staff

performing the specific field tests or calibrations shall be

available. (This evidence should include training records,

appropriate analysis of blind proficiency samples (whereavailable) and other demonstrations of method proficiency.)

?.% ".% 2ield testing:calibration, field laboratory and:or

mobile laboratory personnel not employed or sub;contracted

by the permanent laboratory or organi9ation shall not assist

in the performance of accredited tests or calibrations unless

adequately supervised by trained staff employed or sub;

contracted by the permanent laboratory or organi9ation.

2ield testing:calibration, field laboratory and:or mobile

laboratory personnel not employed or sub;contracted by the

permanent laboratory or organi9ation shall not perform

accredited tests or calibrations, unassisted, under any

circumstances.



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7,3 Accommodation and en!ironmental conditions

?./ ".' @here the environment may affect the

instrumentation, the test specimen or the required accuracy

and precision of measurement, the data shall be qualified

per the requirements of these criteria.

?./ ".% @here tests:calibrations are undertaken in a

hostile or unstable environment or in an environment that

may affect the test or calibration results, there shall be

procedures for monitoring these conditions and the effect of

the environment on the performance of the test or

calibration. This monitoring shall be documented.

?./ "./ There shall be provisions for restricting access to

the field laboratory when unrestricted access could

invalidate the test or calibration results.

7,% Test and calibration methods and method !alidation

?. ".' Ap;to;date test:calibration procedures (whether

standard methods or internal

procedures:amplifications:modifications) shall be available

to all staff performing field tests or calibrations.

?. ".% $rocedures shall e8ist for the supply and

updating of test:calibration procedures required by staff



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performing field work.

?. "./ @here appropriate, the uncertainty of

measurement must be estimated using appropriate methods

of analysis, taking into account the prevailing environmental

conditions. @here it is not appropriate to determinemeasurement uncertainty, the laboratory shall demonstrate

that method performance is within the defined control limits

of the reference test method.

7,7 .+ui"ment

?.? ".' There shall be procedures for operating,

maintaining, storing and calibrating equipment used in field

testing:calibration, field laboratory and:or mobile laboratory

testing or calibration. >quipment maintenance and

calibration records shall include the location, date and

operator for all maintenance and calibration as well as

details of storage between use.



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?.? ".% ppropriate checks shall be made to confirm the

calibration status and fitness for use of equipment before

field testing:calibration, field laboratory and:or mobile

laboratory testing or calibration begins.

@here such checks cannot be made (for equipment whose

performance is not sensitive to movement), calibrationstatus and fitness for use shall be checked in the permanent

laboratory or at the organi9ation’s permanent base before

and after field testing or calibration.

>quipment whose performance is sensitive to movement

shall be verified:calibrated in the field before use.

3f equipment is found to be unfit for use and:or out of

calibration, it shall not be used and shall be immediately

withdrawn from service.

The laboratory shall e8amine the effects of such equipment

on previous tests or calibrations.



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?.? "./ 3f equipment other than that owned by the

permanent laboratory or organi9ation is used, the provider

of such equipment shall be considered as a supplier of

outside services:supplies, sub 'C&%?%&&?.

The laboratory shall document and archive calibrationcertificates (where appropriate) and other relevant details of

the borrowed! or rented equipment.

Dorrowed or rented equipment must be inspected for

damage or malfunction before each use. 3t is the field

laboratory’s responsibility to ensure that borrowed or rented

equipment receives the same checks:calibrations and other

controls as laboratory;owned equipment, prior to and during

use.

?.?.". laboratory that performs calibrations on a

customerEs site shall make a full list of all the equipment thatis transported. 2or each parameter, the laboratory shall

define the alibration and Measurement apability (M)

that it can achieve with that transported equipment.



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7,9 /easurement traceabilit)

?.B ".' @hen it is necessary to utili9e reference

standards, adequate measures shall be taken to ensure that

the necessary calibration status is maintained during

transportation and while in the field. The response of such

reference standards to environmental changes or other

relevant parameters shall be known and documented.

?.B ".% 7eference standards shall be maintained in a

suitable environment at all times, such that handling,

transport and storage do not invalidate their calibration

status.

7,' andling of test and calibration items

?.F ".' ppropriate precautions shall be taken during

storage, handling, transportation and preparation to prevent

damage to items field tested or calibrated.

7,10 e"orting the results

?.'& ".' 7esults obtained from field testing:calibration,

field laboratory and:or mobile laboratory tests:calibrations

shall be identified as such on issued ertificates: 7eports,

whether they form part or all of the information presented.



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?.'& ".% 3n addition to the information specified in

3"#:3> 'C&%?, "ection ?.'&, ertificates:7eports shall

contain any details relevant to the calibration:test such as

location of calibration:test item.

9,0 ;mbrella Accreditation 4"tional2

-4T. T4 A.4: BBBBBCheck here if the organi5ation does -4T "erform umbrella accreditation, The remainder of section 9,0 *ill then be

considered -A,

9,1 The authori9ed field representative(s) of the accredited

laboratory shall

a. +ot perform any key functions=

b. De trained on the accredited laboratory’s qualitymanagement system, 3"#:3> 'C&%? and all %*

$olicies:7equirements by the accredited laboratory

with records retained of the training=

c. De included on the accredited laboratory’sorgani9ational chart=

d. De included in the accredited laboratory’s internalaudit process with records retained of the audit of

the authori9ed field representatives=



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e. De included in the accredited laboratory’smanagement review with records retained of any

action items pertaining to authori9ed field

representatives=

f. De available during %* assessments for observation and:or interview (sampling si9e

determined by the %* assessor in accordance

with %* internal policy)=

g. De included in the accredited laboratory’s four;year proficiency testing plan and participate in relevant

and available proficiency testing. 3f there are four

or more authori9ed field representatives then at

least %?G of them must participate each year with

participation equally distributed in a four;year

timeframe=

h. +ot use the %* ccredited! symbol in anymanner nor make statements implying %*

accredited status for the authori9ed field

representative. The accredited laboratory is

responsible for ensuring that their authori9ed field

representatives make no such claims or statements.



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9,$ uthori9ed field representatives may

a. 3nclude on their website and in promotional

materials a statement that they are an authori9ed

field representative for the accredited laboratory=

b. *ink to the accredited laboratory’s website, but

only the accredited laboratory itself may use the

%* ccredited! symbol and make any

statements about the %* accredited status of the

work they perform through their authori9ed field

representatives#

9,3 Ander no circumstances may it be stated or implied that

the accredited laboratory’s accreditation e8tends to cover

any other company.

9,% uthori9ed field representatives are considered to be 4e

facto employees of the accredited laboratory= therefore, it isthe accredited laboratory’s responsibility to generate and

maintain records, and to provide training and ensure

compliance by the authori9ed field representatives with

3"#:3> 'C&%? and %* policies and requirements.

9,7 ll final reports must be issued by the accredited

laboratory.



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9,9 ny failure by a field representative providing services

on behalf of the accredited laboratory to adhere to these

requirements is the responsibility of the accredited

organi9ation that utili9es this field representative in the

course of its work.



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Document e!ision istor)

6ate 6escription

'%:'H:%&'' dded D 3nformation Dlock

&H:&B:%&'% 7evised to align with R-56 / 7eneral Re"uirements: Accreditation of Field Testing and Field !alibration

Laboratories (&H:&B:'%)

:'&:%&' dded section B.& for umbrella accreditation


17025 Site Checklist

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